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

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A total of 81 subjects are discontinued from the study population (1800) due to death:17, withdrawal of consent:5, withdrawn by physician:2, loss to follow-up:53 and unknown reasons:4.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Subjects withdrawn consent	5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

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

1.  Primary:

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

2.  Secondary:

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

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 ]

4.  Secondary:

Acute Scaffold Thrombosis   [ Time Frame: <1 day ]

5.  Secondary:

Subacute ScaffoldThrombosis   [ Time Frame: 1 to 30 days ]

6.  Secondary:

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

7.  Secondary:

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

8.  Secondary:

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

9.  Secondary:

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

10.  Secondary:

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

11.  Secondary:

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

12.  Secondary:

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

13.  Secondary:

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

14.  Secondary:

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

15.  Secondary:

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

16.  Secondary:

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

17.  Secondary:

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

18.  Secondary:

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

19.  Secondary:

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

20.  Secondary:

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

21.  Secondary:

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

22.  Secondary:

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

23.  Secondary:

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

24.  Secondary:

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

25.  Secondary:

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

26.  Secondary:

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

27.  Secondary:

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

28.  Secondary:

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

29.  Secondary:

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

30.  Secondary:

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

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) ]

32.  Secondary:

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

33.  Secondary:

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

34.  Secondary:

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

35.  Secondary:

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

36.  Secondary:

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

37.  Secondary:

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

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 ]

39.  Secondary:

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

40.  Secondary:

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

41.  Secondary:

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

42.  Secondary:

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

43.  Secondary:

All Revascularization   [ Time Frame: 0 to 37 days ]

44.  Secondary:

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

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 ]

46.  Secondary:

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

47.  Secondary:

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

48.  Secondary:

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

49.  Secondary:

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

50.  Secondary:

All Revascularization   [ Time Frame: 0 to 180 days ]

51.  Secondary:

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

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 ]

53.  Secondary:

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

54.  Secondary:

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

55.  Secondary:

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

56.  Secondary:

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

57.  Secondary:

All Revascularization   [ Time Frame: 0 to 407 days ]

Time Frame	1 year
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	0%

Reporting Groups

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

Other Adverse Events

	Absorb Bioresorbable Vascular Scaffold
Total, Other (not including serious) Adverse Events
# participants affected / at risk	395/1800 (21.94%)
Cardiac disorders
Accelerated idioventricular rhythm † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Acute coronary syndrome † 1
# participants affected / at risk	8/1800 (0.44%)
# events	10
Acute myocardial infarction † 1
# participants affected / at risk	22/1800 (1.22%)
# events	22
Angina pectoris † 1
# participants affected / at risk	69/1800 (3.83%)
# events	76
Angina unstable † 1
# participants affected / at risk	17/1800 (0.94%)
# events	17
Aortic valve disease mixed † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Arrhythmia † 1
# participants affected / at risk	2/1800 (0.11%)
# events	2
Arteriosclerosis coronary artery † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Arteriospasm coronary † 1
# participants affected / at risk	2/1800 (0.11%)
# events	2
Atrial fibrillation † 1
# participants affected / at risk	16/1800 (0.89%)
# events	16
Atrial flutter † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Bradycardia † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Cardiac arrest † 1
# participants affected / at risk	2/1800 (0.11%)
# events	2
Cardiac failure † 1
# participants affected / at risk	7/1800 (0.39%)
# events	7
Cardiac failure acute † 1
# participants affected / at risk	1/1800 (0.06%)
# events	2
Cardiac failure congestive † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Cardiogenic shock † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Coronary artery disease † 1
# participants affected / at risk	19/1800 (1.06%)
# events	21
Coronary artery dissection † 1
# participants affected / at risk	10/1800 (0.56%)
# events	10
Coronary artery occlusion † 1
# participants affected / at risk	5/1800 (0.28%)
# events	5
Coronary artery perforation † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Coronary artery stenosis † 1
# participants affected / at risk	33/1800 (1.83%)
# events	35
Coronary artery thrombosis † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Dressler's syndrome † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Extrasystoles † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Ischaemic cardiomyopathy † 1
# participants affected / at risk	3/1800 (0.17%)
# events	3
Mitral valve incompetence † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Myocardial infarction † 1
# participants affected / at risk	4/1800 (0.22%)
# events	5
Myocardial ischaemia † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Myocarditis † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Palpitations † 1
# participants affected / at risk	10/1800 (0.56%)
# events	10
Pericardial effusion † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Pericardial haemorrhage † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Sick sinus syndrome † 1
# participants affected / at risk	2/1800 (0.11%)
# events	2
Supraventricular extrasystoles † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Supraventricular tachycardia † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Tachycardia † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Ventricular dysfunction † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Ventricular extrasystoles † 1
# participants affected / at risk	2/1800 (0.11%)
# events	2
Ventricular fibrillation † 1
# participants affected / at risk	3/1800 (0.17%)
# events	3
Ventricular tachycardia † 1
# participants affected / at risk	6/1800 (0.33%)
# events	6
Ear and labyrinth disorders
Vertigo † 1
# participants affected / at risk	3/1800 (0.17%)
# events	3
Gastrointestinal disorders
Abdominal pain upper † 1
# participants affected / at risk	2/1800 (0.11%)
# events	2
Diarrhoea † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Nausea † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
General disorders
Chest discomfort † 1
# participants affected / at risk	3/1800 (0.17%)
# events	3
Chest pain † 1
# participants affected / at risk	16/1800 (0.89%)
# events	17
Death † 1
# participants affected / at risk	2/1800 (0.11%)
# events	2
Device failure † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Device malfunction † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Fatigue † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Feeling abnormal † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Malaise † 1
# participants affected / at risk	3/1800 (0.17%)
# events	3
Multi-organ failure † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Non-cardiac chest pain † 1
# participants affected / at risk	34/1800 (1.89%)
# events	40
Oedema peripheral † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Sudden cardiac death † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Thrombosis in device † 1
# participants affected / at risk	9/1800 (0.50%)
# events	11
Hepatobiliary disorders
Jaundice † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Immune system disorders
Drug hypersensitivity † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Primary amyloidosis † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Infections and infestations
Diverticulitis † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Febrile infection † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Meningitis † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Pneumonia † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Postoperative abscess † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Prostatic abscess † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Sepsis † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Septic shock † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Injury, poisoning and procedural complications
Cardiac function disturbance postoperative † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Cardiac procedure complication † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Coronary artery restenosis † 1
# participants affected / at risk	3/1800 (0.17%)
# events	3
Post procedural haematoma † 1
# participants affected / at risk	2/1800 (0.11%)
# events	2
Post procedural haemorrhage † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Renal haematoma † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Vascular pseudoaneurysm † 1
# participants affected / at risk	3/1800 (0.17%)
# events	3
Investigations
Blood creatine phosphokinase increased † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Blood creatinine increased † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Blood pressure increased † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Cardiac enzymes increased † 1
# participants affected / at risk	69/1800 (3.83%)
# events	69
Cardiac stress test abnormal † 1
# participants affected / at risk	2/1800 (0.11%)
# events	2
Electrocardiogram change † 1
# participants affected / at risk	3/1800 (0.17%)
# events	3
Exercise electrocardiogram abnormal † 1
# participants affected / at risk	3/1800 (0.17%)
# events	3
Stress echocardiogram abnormal † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Troponin I increased † 1
# participants affected / at risk	8/1800 (0.44%)
# events	8
Troponin T increased † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Troponin increased † 1
# participants affected / at risk	14/1800 (0.78%)
# events	14
Metabolism and nutrition disorders
Metabolic acidosis † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Musculoskeletal and connective tissue disorders
Muscle necrosis † 1
# participants affected / at risk	2/1800 (0.11%)
# events	2
Musculoskeletal pain † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Nervous system disorders
Cerebellar embolism † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Cerebral haemorrhage † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Cerebrovascular accident † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Dizziness † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Headache † 1
# participants affected / at risk	2/1800 (0.11%)
# events	2
Subarachnoid haemorrhage † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Syncope † 1
# participants affected / at risk	7/1800 (0.39%)
# events	7
Transient ischaemic attack † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Psychiatric disorders
Depression † 1
# participants affected / at risk	1/1800 (0.06%)
# events	2
Panic attack † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Personality disorder † 1
# participants affected / at risk	2/1800 (0.11%)
# events	2
Renal and urinary disorders
Renal colic † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Renal failure acute † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Respiratory, thoracic and mediastinal disorders
Apnoea † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Asthma † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Dyspnoea † 1
# participants affected / at risk	18/1800 (1.00%)
# events	19
Dyspnoea exertional † 1
# participants affected / at risk	7/1800 (0.39%)
# events	7
Epistaxis † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Pneumothorax † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Pulmonary embolism † 1
# participants affected / at risk	2/1800 (0.11%)
# events	2
Pulmonary oedema † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Skin and subcutaneous tissue disorders
Drug eruption † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Rash † 1
# participants affected / at risk	2/1800 (0.11%)
# events	2
Surgical and medical procedures
Hospitalisation † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Vascular disorders
Aneurysm † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Aortic stenosis † 1
# participants affected / at risk	3/1800 (0.17%)
# events	3
Arterial stenosis † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Arteriosclerosis † 1
# participants affected / at risk	5/1800 (0.28%)
# events	5
Haematoma † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Hypertension † 1
# participants affected / at risk	4/1800 (0.22%)
# events	4
Hypertensive crisis † 1
# participants affected / at risk	6/1800 (0.33%)
# events	6
Ischaemia † 1
# participants affected / at risk	2/1800 (0.11%)
# events	2
Peripheral arterial occlusive disease † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Peripheral ischaemia † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1
Peripheral vascular disorder † 1
# participants affected / at risk	1/1800 (0.06%)
# events	1

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
No text entered.