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ABSORB FIRST is a Registry Designed to Evaluate the Safety and Performance of Absorb Bioresorbable Vascular Scaffold (Absorb BVS) Used in Real-world Patients.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT01759290
First received: December 14, 2012
Last updated: August 26, 2016
Last verified: August 2016
History of Changes
Results First Received: August 26, 2016  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Chronic Total Occlusion of Coronary Artery
Coronary Occlusion
Coronary Artery Disease
Coronary Artery Restenosis
Coronary Artery Stenosis
Coronary Disease
Coronary Restenosis
Intervention: Device: Absorb Bioresorbable Vascular Scaffold

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 1800 subjects were enrolled at 87 outside US (OUS) study sites across 21 counties worldwide. The first patient registered on January 21, 2013. The patient registration was complete on Aug 30, 2014, and the last patient completed the 1-year clinical follow-up on Sep 09, 2015. The database has been closed on Oct 30, 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 81 subjects are discontinued from the study population (1800) due to death:17, withdrawal of consent:5, withdrawn by physician:2, loss to follow-up:53 and unknown reasons:4. A total of 28 subjects with MI/revascularization events or reached 1-year follow-up window were included in the clinical outcome analysis.

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Participant Flow:   Overall Study
    Absorb Bioresorbable Vascular Scaffold
STARTED   1800 
COMPLETED   1719 
NOT COMPLETED   81 
Subjects withdrawn consent                5 
Physician Decision                2 
Death                17 
Lost to Follow-up                53 
Unknown reason                4 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Baseline Measures
   Absorb Bioresorbable Vascular Scaffold 
Overall Participants Analyzed 
[Units: Participants]
 		 1800 
Age 
[Units: Years]
Mean (Standard Deviation) 		 58.8  (11) 
Gender 
[Units: Participants]
 		 
Female   362 
Male   1438 
Region of Enrollment 
[Units: Participants]
 		 
Germany   378 
Spain   308 
Netherlands   144 
Belgium   119 
Singapore   93 
Malaysia   88 
Thailand   75 
Colombia   74 
United Arab Emirates   65 
Indonesia   64 
France   59 
Switzerland   59 
Austria   51 
New Zealand   42 
Saudi Arabia   39 
Jordan   37 
Bahrain   33 
Vietnam   33 
Poland   22 
Italy   12 
Philippines   5 


  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))   [ Time Frame: 0 to 407 days ]

Measure Type Primary
Measure Title Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))
Measure Description Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Time Frame 0 to 407 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1764 
Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 2.8 
 (2.11 to 3.72) 

No statistical analysis provided for Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))



2.  Secondary:   Acute Success: Clinical Device Success (Lesion Level Analysis)   [ Time Frame: < or = 1 day ]

Measure Type Secondary
Measure Title Acute Success: Clinical Device Success (Lesion Level Analysis)
Measure Description Device success was defined as the achievement of a final in-scaffold residual diameter stenosis of <50% assessed by online quantitative angiography or visual estimation, using Absorb BVS and without a device deficiency. A device was considered to have failed if it did not meet the requirements of the definition for clinical device success.
Time Frame < or = 1 day  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1800 
Units Analyzed (Target Lesions) 
[Units: Target Lesions]
 		 2183 
Acute Success: Clinical Device Success (Lesion Level Analysis) 
[Units: Percentage of lesions]
Number (95% Confidence Interval) 		 98.0 
 (97.30 to 98.53) 

No statistical analysis provided for Acute Success: Clinical Device Success (Lesion Level Analysis)



3.  Secondary:   Acute Success: Clinical Procedure Success (Per Subject Analysis)   [ Time Frame: During the hospital stay with a maximum of 3 days post index procedure ]

Measure Type Secondary
Measure Title Acute Success: Clinical Procedure Success (Per Subject Analysis)
Measure Description Procedure success was defined as the achievement of a final in-scaffold diameter stenosis of <50% by online quantitative coronary angiography (QCA) or visual estimation using Absorb BVS, with or without any adjunctive devices, and without the occurrence of cardiac death, target vessel MI (Q-wave and non-Q-wave MI), or repeat revascularization of the target lesion within 3 days of the index procedure.
Time Frame During the hospital stay with a maximum of 3 days post index procedure  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1800 
Acute Success: Clinical Procedure Success (Per Subject Analysis) 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 97.0 
 (96.10 to 97.74) 

No statistical analysis provided for Acute Success: Clinical Procedure Success (Per Subject Analysis)



4.  Secondary:   Acute Scaffold Thrombosis   [ Time Frame: <1 day ]

Measure Type Secondary
Measure Title Acute Scaffold Thrombosis
Measure Description No text entered.
Time Frame <1 day  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Scaffold Thrombosis event.

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1770 
Acute Scaffold Thrombosis 
[Units: Percentage of participants]
 		 
Definite   0 
Probable   1 
Definite/Probable   1 

No statistical analysis provided for Acute Scaffold Thrombosis



5.  Secondary:   Subacute ScaffoldThrombosis   [ Time Frame: 1 to 30 days ]

Measure Type Secondary
Measure Title Subacute ScaffoldThrombosis
Measure Description No text entered.
Time Frame 1 to 30 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Scaffold Thrombosis event.

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1770 
Subacute ScaffoldThrombosis 
[Units: Percentage of participants]
 		 
Definite   9 
Probable   2 
Definite/Probable   11 

No statistical analysis provided for Subacute ScaffoldThrombosis



6.  Secondary:   Late Scaffold Thrombosis   [ Time Frame: 31 to 365 Days ]

Measure Type Secondary
Measure Title Late Scaffold Thrombosis
Measure Description No text entered.
Time Frame 31 to 365 Days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Scaffold Thrombosis event.

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1756 
Late Scaffold Thrombosis 
[Units: Percentage of participants]
 		 
Definite   5 
Probable   2 
Definite/Probable   7 

No statistical analysis provided for Late Scaffold Thrombosis



7.  Secondary:   All Death, All MI, All Revascularization (DMR)   [ Time Frame: 0 to 7 days (In-hospital) ]

Measure Type Secondary
Measure Title All Death, All MI, All Revascularization (DMR)
Measure Description No text entered.
Time Frame 0 to 7 days (In-hospital)  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1771 
All Death, All MI, All Revascularization (DMR) 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 1.9 
 (1.33 to 2.67) 

No statistical analysis provided for All Death, All MI, All Revascularization (DMR)



8.  Secondary:   Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)   [ Time Frame: 0 to 7 days (In-hospital) ]

Measure Type Secondary
Measure Title Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)
Measure Description Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Time Frame 0 to 7 days (In-hospital)  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1771 
Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF) 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 1.0 
 (0.56 to 1.53) 

No statistical analysis provided for Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)



9.  Secondary:   Major Adverse Cardiac Event (MACE)   [ Time Frame: 0 to 7 days (In-hospital) ]

Measure Type Secondary
Measure Title Major Adverse Cardiac Event (MACE)
Measure Description MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Time Frame 0 to 7 days (In-hospital)  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1771 
Major Adverse Cardiac Event (MACE) 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 0.9 
 (0.52 to 1.46) 

No statistical analysis provided for Major Adverse Cardiac Event (MACE)



10.  Secondary:   Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))   [ Time Frame: 0 to 7 days (In-hospital) ]

Measure Type Secondary
Measure Title Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))
Measure Description Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Time Frame 0 to 7 days (In-hospital)  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1771 
Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 0.8 
 (0.43 to 1.32) 

No statistical analysis provided for Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))



11.  Secondary:   Cardiac Death/All MI   [ Time Frame: 0 to 7 days (In-hospital) ]

Measure Type Secondary
Measure Title Cardiac Death/All MI
Measure Description No text entered.
Time Frame 0 to 7 days (In-hospital)  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1771 
Cardiac Death/All MI 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 0.8 
 (0.43 to 1.32) 

No statistical analysis provided for Cardiac Death/All MI



12.  Secondary:   All Death/All MI   [ Time Frame: 0 to 7 days (In-hospital) ]

Measure Type Secondary
Measure Title All Death/All MI
Measure Description No text entered.
Time Frame 0 to 7 days (In-hospital)  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1771 
All Death/All MI 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 0.8 
 (0.43 to 1.32) 

No statistical analysis provided for All Death/All MI



13.  Secondary:   All Death, All MI, All Revascularization (DMR)   [ Time Frame: 0 to 37 days ]

Measure Type Secondary
Measure Title All Death, All MI, All Revascularization (DMR)
Measure Description No text entered.
Time Frame 0 to 37 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1771 
All Death, All MI, All Revascularization (DMR) 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 3.0 
 (2.30 to 3.96) 

No statistical analysis provided for All Death, All MI, All Revascularization (DMR)



14.  Secondary:   Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)   [ Time Frame: 0 to 37 days ]

Measure Type Secondary
Measure Title Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)
Measure Description Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Time Frame 0 to 37 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1771 
Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF) 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 1.4 
 (0.87 to 2.01) 

No statistical analysis provided for Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)



15.  Secondary:   Major Adverse Cardiac Event (MACE)   [ Time Frame: 0 - 37 Days ]

Measure Type Secondary
Measure Title Major Adverse Cardiac Event (MACE)
Measure Description MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Time Frame 0 - 37 Days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1771 
Major Adverse Cardiac Event (MACE) 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 1.2 
 (0.78 to 1.87) 

No statistical analysis provided for Major Adverse Cardiac Event (MACE)



16.  Secondary:   Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))   [ Time Frame: 0 to 37 Days ]

Measure Type Secondary
Measure Title Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))
Measure Description Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Time Frame 0 to 37 Days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1771 
Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 1.1 
 (0.65 to 1.67) 

No statistical analysis provided for Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))



17.  Secondary:   Cardiac Death/All MI   [ Time Frame: 0 to 37 days ]

Measure Type Secondary
Measure Title Cardiac Death/All MI
Measure Description No text entered.
Time Frame 0 to 37 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1771 
Cardiac Death/All MI 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 1.1 
 (0.69 to 1.74) 

No statistical analysis provided for Cardiac Death/All MI



18.  Secondary:   All Death/All MI   [ Time Frame: 0 to 37 days ]

Measure Type Secondary
Measure Title All Death/All MI
Measure Description No text entered.
Time Frame 0 to 37 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1771 
All Death/All MI 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 1.1 
 (0.69 to 1.74) 

No statistical analysis provided for All Death/All MI



19.  Secondary:   All Death, All MI, All Revascularization (DMR)   [ Time Frame: 0 to 180 days ]

Measure Type Secondary
Measure Title All Death, All MI, All Revascularization (DMR)
Measure Description No text entered.
Time Frame 0 to 180 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1768 
All Death, All MI, All Revascularization (DMR) 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 6.5 
 (5.40 to 7.76) 

No statistical analysis provided for All Death, All MI, All Revascularization (DMR)



20.  Secondary:   Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)   [ Time Frame: 0 to 180 days ]

Measure Type Secondary
Measure Title Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)
Measure Description Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Time Frame 0 to 180 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1768 
Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF) 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 2.8 
 (2.06 to 3.65) 

No statistical analysis provided for Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)



21.  Secondary:   Major Adverse Cardiac Event (MACE)   [ Time Frame: 0 to 180 Days ]

Measure Type Secondary
Measure Title Major Adverse Cardiac Event (MACE)
Measure Description MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Time Frame 0 to 180 Days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1768 
Major Adverse Cardiac Event (MACE) 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 2.4 
 (1.77 to 3.26) 

No statistical analysis provided for Major Adverse Cardiac Event (MACE)



22.  Secondary:   Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))   [ Time Frame: 0 to 180 Days ]

Measure Type Secondary
Measure Title Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))
Measure Description Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Time Frame 0 to 180 Days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1768 
Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 2.1 
 (1.53 to 2.94) 

No statistical analysis provided for Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))



23.  Secondary:   Cardiac Death/All MI   [ Time Frame: 0 to 180 days ]

Measure Type Secondary
Measure Title Cardiac Death/All MI
Measure Description No text entered.
Time Frame 0 to 180 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1768 
Cardiac Death/All MI 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 1.9 
 (1.29 to 2.61) 

No statistical analysis provided for Cardiac Death/All MI



24.  Secondary:   All Death/All MI   [ Time Frame: 0 to 180 days ]

Measure Type Secondary
Measure Title All Death/All MI
Measure Description No text entered.
Time Frame 0 to 180 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1768 
All Death/All MI 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 2.0 
 (1.43 to 2.81) 

No statistical analysis provided for All Death/All MI



25.  Secondary:   All Death, All MI, All Revascularization (DMR)   [ Time Frame: 0 to 407 days ]

Measure Type Secondary
Measure Title All Death, All MI, All Revascularization (DMR)
Measure Description No text entered.
Time Frame 0 to 407 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1764 
All Death, All MI, All Revascularization (DMR) 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 8.4 
 (7.14 to 9.78) 

No statistical analysis provided for All Death, All MI, All Revascularization (DMR)



26.  Secondary:   Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)   [ Time Frame: 0 to 407 days ]

Measure Type Secondary
Measure Title Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)
Measure Description Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Time Frame 0 to 407 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1764 
Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF) 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 3.7 
 (2.86 to 4.67) 

No statistical analysis provided for Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)



27.  Secondary:   Major Adverse Cardiac Event (MACE)   [ Time Frame: 0 to 407 Days ]

Measure Type Secondary
Measure Title Major Adverse Cardiac Event (MACE)
Measure Description MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Time Frame 0 to 407 Days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1764 
Major Adverse Cardiac Event (MACE) 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 3.1 
 (2.36 to 4.04) 

No statistical analysis provided for Major Adverse Cardiac Event (MACE)



28.  Secondary:   Cardiac Death/All MI   [ Time Frame: 0 to 407 days ]

Measure Type Secondary
Measure Title Cardiac Death/All MI
Measure Description No text entered.
Time Frame 0 to 407 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1764 
Cardiac Death/All MI 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 2.1 
 (1.48 to 2.88) 

No statistical analysis provided for Cardiac Death/All MI



29.  Secondary:   All Death/All MI   [ Time Frame: 0 to 407 days ]

Measure Type Secondary
Measure Title All Death/All MI
Measure Description No text entered.
Time Frame 0 to 407 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1764 
All Death/All MI 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 2.3 
 (1.67 to 3.14) 

No statistical analysis provided for All Death/All MI



30.  Secondary:   Death (Cardiovascular, Non-Cardiovascular)   [ Time Frame: 0 to 7 days (In-hospital) ]

Measure Type Secondary
Measure Title Death (Cardiovascular, Non-Cardiovascular)
Measure Description This is one of the Safety Component (non-hierarchical) endpoints.
Time Frame 0 to 7 days (In-hospital)  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1771 
Death (Cardiovascular, Non-Cardiovascular) 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 0.1 
 (0.01 to 0.41) 

No statistical analysis provided for Death (Cardiovascular, Non-Cardiovascular)



31.  Secondary:   All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).   [ Time Frame: 0 to 7 days (In-hospital) ]

Measure Type Secondary
Measure Title All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).
Measure Description This is one of the Safety Component (non-hierarchical) endpoints.
Time Frame 0 to 7 days (In-hospital)  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1771 
All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV). 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 0.7 
 (0.35 to 1.18) 

No statistical analysis provided for All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).



32.  Secondary:   Target Lesion Revascularization (TLR): All TLR   [ Time Frame: 0 to 7 days (In-hospital) ]

Measure Type Secondary
Measure Title Target Lesion Revascularization (TLR): All TLR
Measure Description This is one of the Efficacy Component (non-hierarchical) endpoints.
Time Frame 0 to 7 days (In-hospital)  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1771 
Target Lesion Revascularization (TLR): All TLR 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 0.4 
 (0.16 to 0.81) 

No statistical analysis provided for Target Lesion Revascularization (TLR): All TLR



33.  Secondary:   Target Lesion Revascularization : Ischemia-Driven (ID-TLR)   [ Time Frame: 0 to 7 days (In-hospital) ]

Measure Type Secondary
Measure Title Target Lesion Revascularization : Ischemia-Driven (ID-TLR)
Measure Description This is one of the Efficacy Component (non-hierarchical) endpoints.
Time Frame 0 to 7 days (In-hospital)  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1771 
Target Lesion Revascularization : Ischemia-Driven (ID-TLR) 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 0.4 
 (0.16 to 0.81) 

No statistical analysis provided for Target Lesion Revascularization : Ischemia-Driven (ID-TLR)



34.  Secondary:   Target Vessel Revascularization (TVR): All TVR   [ Time Frame: 0 to 7 days (In-hospital) ]

Measure Type Secondary
Measure Title Target Vessel Revascularization (TVR): All TVR
Measure Description This is one of the Efficacy Component (non-hierarchical) endpoints.
Time Frame 0 to 7 days (In-hospital)  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1771 
Target Vessel Revascularization (TVR): All TVR 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 0.5 
 (0.20 to 0.89) 

No statistical analysis provided for Target Vessel Revascularization (TVR): All TVR



35.  Secondary:   Target Vessel Revascularization : Ischemic-driven (ID-TVR)   [ Time Frame: 0 to 7 days (In-hospital) ]

Measure Type Secondary
Measure Title Target Vessel Revascularization : Ischemic-driven (ID-TVR)
Measure Description This is one of the Efficacy Component (non-hierarchical) endpoints.
Time Frame 0 to 7 days (In-hospital)  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1771 
Target Vessel Revascularization : Ischemic-driven (ID-TVR) 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 0.5 
 (0.20 to 0.89) 

No statistical analysis provided for Target Vessel Revascularization : Ischemic-driven (ID-TVR)



36.  Secondary:   All Revascularization   [ Time Frame: 0 to 7 days (In-hospital) ]

Measure Type Secondary
Measure Title All Revascularization
Measure Description This is one of the Efficacy Component (non-hierarchical) endpoints.
Time Frame 0 to 7 days (In-hospital)  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1771 
All Revascularization 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 1.4 
 (0.92 to 2.08) 

No statistical analysis provided for All Revascularization



37.  Secondary:   Death (Cardiovascular, Non-Cardiovascular)   [ Time Frame: 0 to 37 days ]

Measure Type Secondary
Measure Title Death (Cardiovascular, Non-Cardiovascular)
Measure Description This is one of the Safety Component (non-hierarchical) endpoints.
Time Frame 0 to 37 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1771 
Death (Cardiovascular, Non-Cardiovascular) 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 0.1 
 (0.01 to 0.41) 

No statistical analysis provided for Death (Cardiovascular, Non-Cardiovascular)



38.  Secondary:   All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).   [ Time Frame: 0 to 37 days ]

Measure Type Secondary
Measure Title All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).
Measure Description This is one of the Safety Component (non-hierarchical) endpoints.
Time Frame 0 to 37 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1771 
All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV). 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 1.0 
 (0.60 to 1.60) 

No statistical analysis provided for All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).



39.  Secondary:   Target Lesion Revascularization (TLR): All TLR   [ Time Frame: 0 to 37 days ]

Measure Type Secondary
Measure Title Target Lesion Revascularization (TLR): All TLR
Measure Description This is one of the Efficacy Component (non-hierarchical) endpoints.
Time Frame 0 to 37 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1771 
Target Lesion Revascularization (TLR): All TLR 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 0.6 
 (0.31 to 1.11) 

No statistical analysis provided for Target Lesion Revascularization (TLR): All TLR



40.  Secondary:   Target Lesion Revascularization : Ischemia-Driven (ID-TLR)   [ Time Frame: 0 to 37 days ]

Measure Type Secondary
Measure Title Target Lesion Revascularization : Ischemia-Driven (ID-TLR)
Measure Description This is one of the Efficacy Component (non-hierarchical) endpoints.
Time Frame 0 to 37 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1771 
Target Lesion Revascularization : Ischemia-Driven (ID-TLR) 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 0.6 
 (0.31 to 1.11) 

No statistical analysis provided for Target Lesion Revascularization : Ischemia-Driven (ID-TLR)



41.  Secondary:   Target Vessel Revascularization (TVR): All TVR   [ Time Frame: 0 to 37 days ]

Measure Type Secondary
Measure Title Target Vessel Revascularization (TVR): All TVR
Measure Description This is one of the Efficacy Component (non-hierarchical) endpoints.
Time Frame 0 to 37 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1771 
Target Vessel Revascularization (TVR): All TVR 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 0.8 
 (0.47 to 1.39) 

No statistical analysis provided for Target Vessel Revascularization (TVR): All TVR



42.  Secondary:   Target Vessel Revascularization : Ischemic-driven (ID-TVR)   [ Time Frame: 0 to 37 days ]

Measure Type Secondary
Measure Title Target Vessel Revascularization : Ischemic-driven (ID-TVR)
Measure Description This is one of the Efficacy Component (non-hierarchical) endpoints.
Time Frame 0 to 37 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1771 
Target Vessel Revascularization : Ischemic-driven (ID-TVR) 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 0.8 
 (0.43 to 1.32) 

No statistical analysis provided for Target Vessel Revascularization : Ischemic-driven (ID-TVR)



43.  Secondary:   All Revascularization   [ Time Frame: 0 to 37 days ]

Measure Type Secondary
Measure Title All Revascularization
Measure Description This is one of the Efficacy Component (non-hierarchical) endpoints.
Time Frame 0 to 37 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1771 
All Revascularization 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 2.5 
 (1.86 to 3.39) 

No statistical analysis provided for All Revascularization



44.  Secondary:   Death (Cardiovascular, Non-Cardiovascular)   [ Time Frame: 0 to 180 days ]

Measure Type Secondary
Measure Title Death (Cardiovascular, Non-Cardiovascular)
Measure Description This is one of the Safety Component (non-hierarchical) endpoints.
Time Frame 0 to 180 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1768 
Death (Cardiovascular, Non-Cardiovascular) 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 0.7 
 (0.39 to 1.25) 

No statistical analysis provided for Death (Cardiovascular, Non-Cardiovascular)



45.  Secondary:   All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).   [ Time Frame: 0 to 180 days ]

Measure Type Secondary
Measure Title All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).
Measure Description This is one of the Safety Component (non-hierarchical) endpoints.
Time Frame 0 to 180 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1768 
All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV). 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 1.3 
 (0.83 to 1.95) 

No statistical analysis provided for All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).



46.  Secondary:   Target Lesion Revascularization (TLR): All TLR   [ Time Frame: 0 to 180 days ]

Measure Type Secondary
Measure Title Target Lesion Revascularization (TLR): All TLR
Measure Description This is one of the Efficacy Component (non-hierarchical) endpoints.
Time Frame 0 to 180 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1768 
Target Lesion Revascularization (TLR): All TLR 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 1.3 
 (0.83 to 1.95) 

No statistical analysis provided for Target Lesion Revascularization (TLR): All TLR



47.  Secondary:   Target Lesion Revascularization : Ischemia-Driven (ID-TLR)   [ Time Frame: 0 to 180 days ]

Measure Type Secondary
Measure Title Target Lesion Revascularization : Ischemia-Driven (ID-TLR)
Measure Description This is one of the Efficacy Component (non-hierarchical) endpoints.
Time Frame 0 to 180 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1768 
Target Lesion Revascularization : Ischemia-Driven (ID-TLR) 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 1.3 
 (0.83 to 1.95) 

No statistical analysis provided for Target Lesion Revascularization : Ischemia-Driven (ID-TLR)



48.  Secondary:   Target Vessel Revascularization (TVR): All TVR   [ Time Frame: 0 to 180 days ]

Measure Type Secondary
Measure Title Target Vessel Revascularization (TVR): All TVR
Measure Description This is one of the Efficacy Component (non-hierarchical) endpoints.
Time Frame 0 to 180 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1768 
Target Vessel Revascularization (TVR): All TVR 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 1.9 
 (1.34 to 2.68) 

No statistical analysis provided for Target Vessel Revascularization (TVR): All TVR



49.  Secondary:   Target Vessel Revascularization : Ischemic-driven (ID-TVR)   [ Time Frame: 0 to 180 days ]

Measure Type Secondary
Measure Title Target Vessel Revascularization : Ischemic-driven (ID-TVR)
Measure Description This is one of the Efficacy Component (non-hierarchical) endpoints.
Time Frame 0 to 180 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1768 
Target Vessel Revascularization : Ischemic-driven (ID-TVR) 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 1.8 
 (1.19 to 2.48) 

No statistical analysis provided for Target Vessel Revascularization : Ischemic-driven (ID-TVR)



50.  Secondary:   All Revascularization   [ Time Frame: 0 to 180 days ]

Measure Type Secondary
Measure Title All Revascularization
Measure Description This is one of the Efficacy Component (non-hierarchical) endpoints.
Time Frame 0 to 180 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1768 
All Revascularization 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 5.5 
 (4.47 to 6.65) 

No statistical analysis provided for All Revascularization



51.  Secondary:   Death (Cardiovascular, Non-Cardiovascular)   [ Time Frame: 0 to 407 days ]

Measure Type Secondary
Measure Title Death (Cardiovascular, Non-Cardiovascular)
Measure Description This is one of the Safety Component (non-hierarchical) endpoints.
Time Frame 0 to 407 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1764 
Death (Cardiovascular, Non-Cardiovascular) 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 1.0 
 (0.56 to 1.54) 

No statistical analysis provided for Death (Cardiovascular, Non-Cardiovascular)



52.  Secondary:   All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).   [ Time Frame: 0 to 407 days ]

Measure Type Secondary
Measure Title All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).
Measure Description This is one of the Safety Component (non-hierarchical) endpoints.
Time Frame 0 to 407 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1764 
All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV). 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 1.4 
 (0.92 to 2.09) 

No statistical analysis provided for All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).



53.  Secondary:   Target Lesion Revascularization (TLR): All TLR   [ Time Frame: 0 to 407 days ]

Measure Type Secondary
Measure Title Target Lesion Revascularization (TLR): All TLR
Measure Description This is one of the Efficacy Component (non-hierarchical) endpoints.
Time Frame 0 to 407 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1764 
Target Lesion Revascularization (TLR): All TLR 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 2.0 
 (1.43 to 2.81) 

No statistical analysis provided for Target Lesion Revascularization (TLR): All TLR



54.  Secondary:   Target Lesion Revascularization : Ischemia-Driven (ID-TLR)   [ Time Frame: 0 to 407 days ]

Measure Type Secondary
Measure Title Target Lesion Revascularization : Ischemia-Driven (ID-TLR)
Measure Description This is one of the Efficacy Component (non-hierarchical) endpoints.
Time Frame 0 to 407 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1764 
Target Lesion Revascularization : Ischemia-Driven (ID-TLR) 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 1.9 
 (1.29 to 2.62) 

No statistical analysis provided for Target Lesion Revascularization : Ischemia-Driven (ID-TLR)



55.  Secondary:   Target Vessel Revascularization (TVR): All TVR   [ Time Frame: 0 to 407 days ]

Measure Type Secondary
Measure Title Target Vessel Revascularization (TVR): All TVR
Measure Description This is one of the Efficacy Component (non-hierarchical) endpoints.
Time Frame 0 to 407 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1764 
Target Vessel Revascularization (TVR): All TVR 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 2.9 
 (2.21 to 3.85) 

No statistical analysis provided for Target Vessel Revascularization (TVR): All TVR



56.  Secondary:   Target Vessel Revascularization : Ischemic-driven (ID-TVR)   [ Time Frame: 0 to 407 days ]

Measure Type Secondary
Measure Title Target Vessel Revascularization : Ischemic-driven (ID-TVR)
Measure Description This is one of the Efficacy Component (non-hierarchical) endpoints.
Time Frame 0 to 407 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1764 
Target Vessel Revascularization : Ischemic-driven (ID-TVR) 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 2.6 
 (1.87 to 3.40) 

No statistical analysis provided for Target Vessel Revascularization : Ischemic-driven (ID-TVR)



57.  Secondary:   All Revascularization   [ Time Frame: 0 to 407 days ]

Measure Type Secondary
Measure Title All Revascularization
Measure Description This is one of the Efficacy Component (non-hierarchical) endpoints.
Time Frame 0 to 407 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).

Reporting Groups
  Description
Absorb Bioresorbable Vascular Scaffold Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Measured Values
   Absorb Bioresorbable Vascular Scaffold 
Participants Analyzed 
[Units: Participants]
 		 1764 
All Revascularization 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 7.3 
 (6.09 to 8.57) 

No statistical analysis provided for All Revascularization




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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Kunal Sampat
Organization: Abbott Vascular
phone: 408-845-0746
e-mail: kunal.sampat@av.abbott.com



Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01759290     History of Changes
Other Study ID Numbers: 12-302
Study First Received: December 14, 2012
Results First Received: August 26, 2016
Last Updated: August 26, 2016