XIENCE 28 Global Study

• ClinicalTrials.gov Identifier: NCT03355742
• Recruitment Status: Completed
• First Posted: November 28, 2017
• Results First Posted: February 8, 2021
• Last Update Posted: March 4, 2021
• Sponsor: Abbott Medical Devices
• Information provided by (Responsible Party): Abbott Medical Devices

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Bleeding Disorder; Stroke, Ischemic; Stroke Hemorrhagic; Hematological Disease; Thrombocytopenia; Coagulation Disorder; Anemia; Renal Insufficiency; Coronary Artery Disease
• Interventions: Device: XIENCE; Drug: DAPT
• Enrollment: 963

Participant Flow

Recruitment Details	A total of 963 subjects were enrolled across 52 sites globally, between 09 February, 2018 and 30 April, 2020. The last subject last visit was on 30 April, 2020 and the final data was extracted from the database on 01 July, 2020.
Pre-assignment Details

Arm/Group Title	XIENCE
Arm/Group Description	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Period Title: Overall Study
Started	963
Completed	864
Not Completed	99
Reason Not Completed
Lost to Follow-up	4
Withdrawal by Subject	29
Physician Decision	6
Death	55
Administrative Closure of the Study, Other Status Change Reason, Missed Visit, Protocol Violation	5

Baseline Characteristics

Arm/Group Title		XIENCE
Arm/Group Description		XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Overall Number of Baseline Participants		963
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	963 participants
		76.84 (7.73)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	963 participants
	Female	320 33.2%
	Male	643 66.8%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	963 participants
	Hispanic or Latino	145 15.1%
	Not Hispanic or Latino	360 37.4%
	Unknown or Not Reported	458 47.6%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	963 participants
	American Indian or Alaska Native	0 0.0%
	Asian	124 12.9%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	0 0.0%
	White	381 39.6%
	More than one race	0 0.0%
	Unknown or Not Reported	458 47.6%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
Singapore	Number Analyzed	963 participants
		22
Hong Kong	Number Analyzed	963 participants
		48
United Kingdom	Number Analyzed	963 participants
		30
Portugal	Number Analyzed	963 participants
		8
Switzerland	Number Analyzed	963 participants
		37
Spain	Number Analyzed	963 participants
		89
Austria	Number Analyzed	963 participants
		3
Netherlands	Number Analyzed	963 participants
		49
Belgium	Number Analyzed	963 participants
		64
China	Number Analyzed	963 participants
		7
Taiwan	Number Analyzed	963 participants
		48
Italy	Number Analyzed	963 participants
		231
Germany	Number Analyzed	963 participants
		327
Prior Percutaneous Coronary Intervention (PCI); Measure Type: Number; Unit of measure: Participants
	Number Analyzed	963 participants
		276
History of Major Bleeding [1]; Measure Type: Number; Unit of measure: Participants
	Number Analyzed	961 participants
		26
		[1] Measure Analysis Population Description: The number of participants analyzed includes subjects who were available at that time of analysis

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Composite of Net Adverse Clinical Endpoint (NACE), by Propensity Score Quintiles
Description	Net Adverse Clinical Endpoint (NACE): A composite rate of all-cause death, all myocardial infarction (modified Academic Research Consortium [ARC]), stent thrombosis (ARC definite or probable), stroke or major bleeding (Bleeding defined by the Bleeding Academic Research Consortium [BARC] type 2-5)
Time Frame	From 1 to 6 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title		XIENCE
Arm/Group Description:		XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Overall Number of Participants Analyzed		828
Measure Type: Count of Participants; Unit of Measure: Participants
Q1	Number Analyzed	15 participants
		2 13.3%
Q2	Number Analyzed	55 participants
		5 9.1%
Q3	Number Analyzed	124 participants
		10 8.1%
Q4	Number Analyzed	245 participants
		15 6.1%
Q5	Number Analyzed	389 participants
		40 10.3%

2. Secondary Outcome

Title	Number of Participants With Composite of Net Adverse Clinical Endpoint (NACE)
Description	Net Adverse Clinical Endpoint (NACE): A composite rate of all-cause death, all myocardial infarction (modified Academic Research Consortium [ARC]), stent thrombosis (ARC definite or probable), stroke or major bleeding (Bleeding defined by the Bleeding Academic Research Consortium [BARC] type 2-5)
Time Frame	From 6 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description:	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Overall Number of Participants Analyzed	811
Measure Type: Count of Participants; Unit of Measure: Participants
	55 6.8%

3. Secondary Outcome

Title	Number of Participants With Composite of Net Adverse Clinical Endpoint (NACE)
Description	Net Adverse Clinical Endpoint (NACE): A composite rate of all-cause death, all myocardial infarction (modified Academic Research Consortium [ARC]), stent thrombosis (ARC definite or probable), stroke or major bleeding (Bleeding defined by the Bleeding Academic Research Consortium [BARC] type 2-5)
Time Frame	From 1 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description:	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Overall Number of Participants Analyzed	825
Measure Type: Count of Participants; Unit of Measure: Participants
	121 14.7%

4. Secondary Outcome

Title	Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)
Description	Definite stent thrombosis: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis: Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases: Any unexplained death within the first 30 days; Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause
Time Frame	From 1 to 6 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up, or withdrew consent, or died before time point analyzed, without any Stent Thrombosis event, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description:	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Overall Number of Participants Analyzed	816
Measure Type: Count of Participants; Unit of Measure: Participants
	4 0.5%

5. Secondary Outcome

Title	Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)
Description	Definite stent thrombosis: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis: Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases: Any unexplained death within the first 30 days; Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause
Time Frame	From 6 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up, or withdrew consent, or died before time point analyzed, without any Stent Thrombosis event, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description:	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Overall Number of Participants Analyzed	791
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%

6. Secondary Outcome

Title	Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)
Description	Definite stent thrombosis: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis: Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases: Any unexplained death within the first 30 days; Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause
Time Frame	From 1 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up, or withdrew consent, or died before time point analyzed, without any Stent Thrombosis event, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description:	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Overall Number of Participants Analyzed	793
Measure Type: Count of Participants; Unit of Measure: Participants
	4 0.5%

7. Secondary Outcome

Title	Number of Participants With All Death, Cardiac Death, Vascular Death, Non-cardiovascular Death
Description	All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame	From 1 to 6 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description:	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Overall Number of Participants Analyzed	828
Measure Type: Count of Participants; Unit of Measure: Participants
	13 1.6%

8. Secondary Outcome

Title	Number of Participants With All Death, Cardiac Death, Vascular Death, Non-cardiovascular Death
Description	All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame	From 6 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description:	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Overall Number of Participants Analyzed	811
Measure Type: Count of Participants; Unit of Measure: Participants
	30 3.7%

9. Secondary Outcome

Title	Number of Participants With All Death, Cardiac Death, Vascular Death, Non-cardiovascular Death
Description	All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame	From 1 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description:	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Overall Number of Participants Analyzed	825
Measure Type: Count of Participants; Unit of Measure: Participants
	43 5.2%

10. Secondary Outcome

Title	Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)
Description	Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia;; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI: Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL; Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Time Frame	From 1 to 6 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description:	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Overall Number of Participants Analyzed	828
Measure Type: Count of Participants; Unit of Measure: Participants
	16 1.9%

11. Secondary Outcome

Title	Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)
Description	Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia;; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI: Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL; Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Time Frame	From 6 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description:	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Overall Number of Participants Analyzed	811
Measure Type: Count of Participants; Unit of Measure: Participants
	11 1.4%

12. Secondary Outcome

Title	Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)
Description	Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia;; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI: Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL; Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Time Frame	From 1 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description:	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Overall Number of Participants Analyzed	825
Measure Type: Count of Participants; Unit of Measure: Participants
	27 3.3%

13. Secondary Outcome

Title	Number of Participants With Composite of Cardiac Death or MI (Modified ARC)
Description	Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia;; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI: Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL; Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Time Frame	From 1 to 6 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description:	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Overall Number of Participants Analyzed	828
Measure Type: Count of Participants; Unit of Measure: Participants
	22 2.7%

14. Secondary Outcome

Title	Number of Participants With Composite of Cardiac Death or MI (Modified ARC)
Description	Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia;; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI: Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL; Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Time Frame	From 6 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description:	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Overall Number of Participants Analyzed	811
Measure Type: Count of Participants; Unit of Measure: Participants
	23 2.8%

15. Secondary Outcome

Title	Number of Participants With Composite of Cardiac Death or MI (Modified ARC)
Description	Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia;; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI: Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL; Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Time Frame	From 1 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description:	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Overall Number of Participants Analyzed	825
Measure Type: Count of Participants; Unit of Measure: Participants
	45 5.5%

16. Secondary Outcome

Title	Number of Participants With Composite of All Death or All MI (Modified ARC)
Description	All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia;; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI; Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Time Frame	From 1 to 6 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description:	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Overall Number of Participants Analyzed	828
Measure Type: Count of Participants; Unit of Measure: Participants
	29 3.5%

17. Secondary Outcome

Title	Number of Participants With Composite of All Death or All MI (Modified ARC)
Description	All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia;; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI; Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Time Frame	From 6 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description:	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Overall Number of Participants Analyzed	811
Measure Type: Count of Participants; Unit of Measure: Participants
	41 5.1%

18. Secondary Outcome

Title	Number of Participants With Composite of All Death or All MI (Modified ARC)
Description	All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia;; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI; Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Time Frame	From 1 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description:	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Overall Number of Participants Analyzed	825
Measure Type: Count of Participants; Unit of Measure: Participants
	70 8.5%

19. Secondary Outcome

Title	Number of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke
Description	An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction.; Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue.; Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage.; Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic.; Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)
Time Frame	From 1 to 6 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description:	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Overall Number of Participants Analyzed	815
Measure Type: Count of Participants; Unit of Measure: Participants
	3 0.4%

20. Secondary Outcome

Title	Number of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke
Description	An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction.; Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue.; Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage.; Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic.; Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)
Time Frame	From 6 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description:	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Overall Number of Participants Analyzed	784
Measure Type: Count of Participants; Unit of Measure: Participants
	3 0.4%

21. Secondary Outcome

Title	Number of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke
Description	An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction.; Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue.; Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage.; Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic.; Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)
Time Frame	From 1 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description:	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Overall Number of Participants Analyzed	785
Measure Type: Count of Participants; Unit of Measure: Participants
	6 0.8%

22. Secondary Outcome

Title	Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)
Description	TLR is defined as any repeat percutaneous intervention of the target lesion (the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent) or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not CI by the investigator prior to repeat angiography. A revascularization is considered CI if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if any one below occurs: A positive history of recurrent angina pectoris, presumably related to the target vessel;; Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;; Abnormal results of any invasive functional diagnostic test (e.g: Doppler flow velocity reserve, fractional flow reserve);; A TLR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
Time Frame	From 1 to 6 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description:	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Overall Number of Participants Analyzed	828
Measure Type: Count of Participants; Unit of Measure: Participants
	7 0.8%

23. Secondary Outcome

Title	Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)
Description	TLR is defined as any repeat percutaneous intervention of the target lesion (the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent) or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not CI by the investigator prior to repeat angiography. A revascularization is considered CI if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if any one below occurs: A positive history of recurrent angina pectoris, presumably related to the target vessel;; Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;; Abnormal results of any invasive functional diagnostic test (e.g: Doppler flow velocity reserve, fractional flow reserve);; A TLR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
Time Frame	From 6 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description:	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Overall Number of Participants Analyzed	811
Measure Type: Count of Participants; Unit of Measure: Participants
	3 0.4%

24. Secondary Outcome

Title	Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)
Description	TLR is defined as any repeat percutaneous intervention of the target lesion (the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent) or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not CI by the investigator prior to repeat angiography. A revascularization is considered CI if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if any one below occurs: A positive history of recurrent angina pectoris, presumably related to the target vessel;; Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;; Abnormal results of any invasive functional diagnostic test (e.g: Doppler flow velocity reserve, fractional flow reserve);; A TLR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
Time Frame	From 1 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description:	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Overall Number of Participants Analyzed	825
Measure Type: Count of Participants; Unit of Measure: Participants
	10 1.2%

25. Secondary Outcome

Title	Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR)
Description	TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs: A positive history of recurrent angina pectoris, presumably related to the target vessel;; Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;; Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve);; A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
Time Frame	From 1 to 6 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description:	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Overall Number of Participants Analyzed	828
Measure Type: Count of Participants; Unit of Measure: Participants
	5 0.6%

26. Secondary Outcome

Title	Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR)
Description	TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs: A positive history of recurrent angina pectoris, presumably related to the target vessel;; Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;; Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve);; A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
Time Frame	From 6 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description:	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Overall Number of Participants Analyzed	811
Measure Type: Count of Participants; Unit of Measure: Participants
	4 0.5%

27. Secondary Outcome

Title	Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR)
Description	TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs: A positive history of recurrent angina pectoris, presumably related to the target vessel;; Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;; Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve);; A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
Time Frame	From 1 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description:	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Overall Number of Participants Analyzed	825
Measure Type: Count of Participants; Unit of Measure: Participants
	9 1.1%

28. Secondary Outcome

Title	Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)
Description	TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.
Time Frame	From 1 to 6 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description:	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Overall Number of Participants Analyzed	828
Measure Type: Count of Participants; Unit of Measure: Participants
	21 2.5%

29. Secondary Outcome

Title	Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)
Description	TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.
Time Frame	From 6 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description:	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Overall Number of Participants Analyzed	811
Measure Type: Count of Participants; Unit of Measure: Participants
	21 2.6%

30. Secondary Outcome

Title	Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)
Description	TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.
Time Frame	From 1 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description:	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Overall Number of Participants Analyzed	825
Measure Type: Count of Participants; Unit of Measure: Participants
	42 5.1%

31. Secondary Outcome

Title	Number of Participants With Target Vessel Failure (TVF, a Composite of Cardiac Death, TV-MI and CI-TVR)
Description	TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.
Time Frame	From 1 to 6 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description:	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Overall Number of Participants Analyzed	828
Measure Type: Count of Participants; Unit of Measure: Participants
	22 2.7%

32. Secondary Outcome

Title	Number of Participants With Target Vessel Failure (TVF, a Composite of Cardiac Death, TV-MI and CI-TVR)
Description	TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.
Time Frame	From 6 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description:	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Overall Number of Participants Analyzed	811
Measure Type: Count of Participants; Unit of Measure: Participants
	22 2.7%

33. Secondary Outcome

Title	Number of Participants With Target Vessel Failure (TVF, a Composite of Cardiac Death, TV-MI and CI-TVR)
Description	TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.
Time Frame	From 1 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description:	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Overall Number of Participants Analyzed	825
Measure Type: Count of Participants; Unit of Measure: Participants
	44 5.3%

34. Secondary Outcome

Title	Number of Participants With Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 2-5 and Type 3-5
Description	Bleeding per Bleeding Academic Research Consortium (BARC)definitions are as follows: Type 0 Type 1 Type 2 Type 3 Type 4 Type 5 Where, Type 0 indicates no bleeding and type 5 indicates fatal bleeding.
Time Frame	From 1 to 6 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description:	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Overall Number of Participants Analyzed	817
Measure Type: Count of Participants; Unit of Measure: Participants
BARC Type 2-5	44 5.4%
BARC Type 3-5	20 2.4%

35. Secondary Outcome

Title	Number of Participants With Bleeding Defined by the BARC, Type 2-5 and Type 3-5
Description	Bleeding per Bleeding Academic Research Consortium (BARC)definitions are as follows: Type 0 Type 1 Type 2 Type 3 Type 4 Type 5 Where, Type 0 indicates no bleeding and type 5 indicates fatal bleeding.
Time Frame	From 6 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description:	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Overall Number of Participants Analyzed	789
Measure Type: Count of Participants; Unit of Measure: Participants
BARC Type 2-5	19 2.4%
BARC Type 3-5	7 0.9%

36. Secondary Outcome

Title	Number of Participants With Bleeding Defined by BARC, Type 2-5 and Type 3-5
Description	Bleeding per Bleeding Academic Research Consortium (BARC)definitions are as follows: Type 0 Type 1 Type 2 Type 3 Type 4 Type 5 Where, Type 0 indicates no bleeding and type 5 indicates fatal bleeding.
Time Frame	From 1 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description:	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Overall Number of Participants Analyzed	792
Measure Type: Count of Participants; Unit of Measure: Participants
BARC Type 2-5	61 7.7%
BARC Type 3-5	27 3.4%

Adverse Events

Time Frame	1 Year
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	XIENCE
Arm/Group Description	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
All-Cause Mortality
	XIENCE
	Affected / at Risk (%)
Total	55/963 (5.71%)
Serious Adverse Events
	XIENCE
	Affected / at Risk (%)
Total	374/963 (38.84%)
Blood and lymphatic system disorders
Anaemia † 1	11/963 (1.14%)
Bicytopenia † 1	1/963 (0.10%)
Hypochromic Anaemia † 1	1/963 (0.10%)
Nephrogenic Anaemia † 1	1/963 (0.10%)
Normochromic Normocytic Anaemia † 1	1/963 (0.10%)
Cardiac disorders
Angina Pectoris † 1	55/963 (5.71%)
Angina Unstable † 1	1/963 (0.10%)
Aortic Valve Incompetence † 1	2/963 (0.21%)
Aortic Valve Stenosis † 1	3/963 (0.31%)
Arrhythmia † 1	2/963 (0.21%)
Atrial Fibrillation † 1	27/963 (2.80%)
Atrial Flutter † 1	3/963 (0.31%)
Atrial Tachycardia † 1	1/963 (0.10%)
Atrioventricular Block † 1	2/963 (0.21%)
Atrioventricular Block Complete † 1	3/963 (0.31%)
Atrioventricular Block Second Degree † 1	1/963 (0.10%)
Bifascicular Block † 1	1/963 (0.10%)
Bradycardia † 1	3/963 (0.31%)
Cardiac Failure † 1	30/963 (3.12%)
Cardiac Failure Acute † 1	6/963 (0.62%)
Cardiac Failure Congestive † 1	4/963 (0.42%)
Cardiac Tamponade † 1	1/963 (0.10%)
Cardiomyopathy † 1	1/963 (0.10%)
Congestive Cardiomyopathy † 1	1/963 (0.10%)
Coronary Artery Disease † 1	7/963 (0.73%)
Dressler's Syndrome † 1	1/963 (0.10%)
Mitral Valve Incompetence † 1	5/963 (0.52%)
Myocardial Infarction † 1	18/963 (1.87%)
Myocardial Ischaemia † 1	1/963 (0.10%)
Myopericarditis † 1	1/963 (0.10%)
Palpitations † 1	1/963 (0.10%)
Pericarditis † 1	1/963 (0.10%)
Pleuropericarditis † 1	1/963 (0.10%)
Right Ventricular Failure † 1	1/963 (0.10%)
Sick Sinus Syndrome † 1	3/963 (0.31%)
Sinoatrial Block † 1	1/963 (0.10%)
Sinus Bradycardia † 1	2/963 (0.21%)
Supraventricular Tachycardia † 1	2/963 (0.21%)
Tachyarrhythmia † 1	4/963 (0.42%)
Tricuspid Valve Incompetence † 1	2/963 (0.21%)
Ventricular Extrasystoles † 1	3/963 (0.31%)
Ventricular Fibrillation † 1	1/963 (0.10%)
Ventricular Tachycardia † 1	5/963 (0.52%)
Ear and labyrinth disorders
Vertigo † 1	3/963 (0.31%)
Vertigo Positional † 1	2/963 (0.21%)
Endocrine disorders
Hypothyroidism † 1	1/963 (0.10%)
Eye disorders
Retinal Artery Occlusion † 1	1/963 (0.10%)
Gastrointestinal disorders
Abdominal Pain † 1	4/963 (0.42%)
Abdominal Pain Upper † 1	1/963 (0.10%)
Colonic Polyp † 1	2/963 (0.21%)
Constipation † 1	1/963 (0.10%)
Diarrhoea † 1	1/963 (0.10%)
Duodenal Ulcer † 1	1/963 (0.10%)
Enteritis † 1	2/963 (0.21%)
Faeces Discoloured † 1	1/963 (0.10%)
Gastric Ulcer † 1	1/963 (0.10%)
Gastritis † 1	1/963 (0.10%)
Gastritis Erosive † 1	2/963 (0.21%)
Gastrointestinal Haemorrhage † 1	1/963 (0.10%)
Inguinal Hernia † 1	2/963 (0.21%)
Intestinal Ischaemia † 1	1/963 (0.10%)
Nausea † 1	1/963 (0.10%)
Peritoneal Haemorrhage † 1	1/963 (0.10%)
Small Intestinal Obstruction † 1	1/963 (0.10%)
Vomiting † 1	1/963 (0.10%)
General disorders
Chest Pain † 1	5/963 (0.52%)
Death † 1	15/963 (1.56%)
General Physical Health Deterioration † 1	1/963 (0.10%)
Hernia Obstructive † 1	1/963 (0.10%)
Impaired Healing † 1	1/963 (0.10%)
Multi-Organ Failure † 1	2/963 (0.21%)
Pain † 1	2/963 (0.21%)
Pyrexia † 1	3/963 (0.31%)
Hepatobiliary disorders
Cholangitis † 1	4/963 (0.42%)
Cholecystitis † 1	2/963 (0.21%)
Hepatic Cirrhosis † 1	1/963 (0.10%)
Jaundice Cholestatic † 1	1/963 (0.10%)
Infections and infestations
Abscess Limb † 1	2/963 (0.21%)
Arthritis Infective † 1	1/963 (0.10%)
Bronchitis † 1	4/963 (0.42%)
Bronchopneumonia † 1	1/963 (0.10%)
Cellulitis † 1	3/963 (0.31%)
Cholecystitis Infective † 1	1/963 (0.10%)
Diverticulitis † 1	1/963 (0.10%)
Endocarditis † 1	1/963 (0.10%)
Erysipelas † 1	2/963 (0.21%)
Gangrene † 1	1/963 (0.10%)
Gastroenteritis † 1	5/963 (0.52%)
Haematoma Infection † 1	1/963 (0.10%)
Herpes Zoster † 1	1/963 (0.10%)
Infection † 1	4/963 (0.42%)
Infectious Pleural Effusion † 1	1/963 (0.10%)
Influenza † 1	1/963 (0.10%)
Lobar Pneumonia † 1	1/963 (0.10%)
Localised Infection † 1	1/963 (0.10%)
Lower Respiratory Tract Infection † 1	1/963 (0.10%)
Lung Abscess † 1	1/963 (0.10%)
Muscle Abscess † 1	1/963 (0.10%)
Osteomyelitis † 1	1/963 (0.10%)
Otitis Externa † 1	1/963 (0.10%)
Peritonitis † 1	1/963 (0.10%)
Pneumonia † 1	22/963 (2.28%)
Pyelonephritis Acute † 1	1/963 (0.10%)
Respiratory Tract Infection † 1	6/963 (0.62%)
Sepsis † 1	6/963 (0.62%)
Septic Shock † 1	4/963 (0.42%)
Sinusitis † 1	1/963 (0.10%)
Soft Tissue Infection † 1	1/963 (0.10%)
Upper Respiratory Tract Infection † 1	2/963 (0.21%)
Urinary Tract Infection † 1	10/963 (1.04%)
Vulval Abscess † 1	1/963 (0.10%)
Wound Infection † 1	2/963 (0.21%)
Injury, poisoning and procedural complications
Clavicle Fracture † 1	1/963 (0.10%)
Compression Fracture † 1	1/963 (0.10%)
Cranial Nerve Injury † 1	1/963 (0.10%)
Fall † 1	5/963 (0.52%)
Femoral Neck Fracture † 1	1/963 (0.10%)
Femur Fracture † 1	5/963 (0.52%)
Hip Fracture † 1	1/963 (0.10%)
Lumbar Vertebral Fracture † 1	1/963 (0.10%)
Patella Fracture † 1	2/963 (0.21%)
Pelvic Fracture † 1	2/963 (0.21%)
Pubis Fracture † 1	1/963 (0.10%)
Rib Fracture † 1	1/963 (0.10%)
Subdural Haematoma † 1	1/963 (0.10%)
Vascular Pseudoaneurysm † 1	1/963 (0.10%)
Investigations
Arteriogram Coronary † 1	1/963 (0.10%)
Blood Pressure Abnormal † 1	1/963 (0.10%)
Ejection Fraction Decreased † 1	1/963 (0.10%)
Electrocardiogram Abnormal † 1	1/963 (0.10%)
Metabolism and nutrition disorders
Dehydration † 1	1/963 (0.10%)
Diabetes Mellitus † 1	3/963 (0.31%)
Diabetic Ketoacidosis † 1	1/963 (0.10%)
Fluid Overload † 1	4/963 (0.42%)
Hyperglycaemia † 1	1/963 (0.10%)
Hyperkalaemia † 1	2/963 (0.21%)
Hypoglycaemia † 1	1/963 (0.10%)
Type 2 Diabetes Mellitus † 1	1/963 (0.10%)
Musculoskeletal and connective tissue disorders
Arthritis † 1	1/963 (0.10%)
Back Pain † 1	2/963 (0.21%)
Fistula † 1	1/963 (0.10%)
Intervertebral Disc Protrusion † 1	1/963 (0.10%)
Joint Effusion † 1	1/963 (0.10%)
Lumbar Spinal Stenosis † 1	1/963 (0.10%)
Muscular Weakness † 1	1/963 (0.10%)
Musculoskeletal Disorder † 1	1/963 (0.10%)
Osteoarthritis † 1	10/963 (1.04%)
Osteochondrosis † 1	1/963 (0.10%)
Polyarthritis † 1	1/963 (0.10%)
Spondylitis † 1	1/963 (0.10%)
Systemic Lupus Erythematosus † 1	1/963 (0.10%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Lymphocytic Leukaemia Re † 1	1/963 (0.10%)
Biliary Neoplasm † 1	2/963 (0.21%)
Bladder Cancer † 1	2/963 (0.21%)
Bladder Transitional Cell Carc † 1	1/963 (0.10%)
Colon Cancer † 1	1/963 (0.10%)
Endometrial Cancer † 1	1/963 (0.10%)
Gastric Cancer † 1	1/963 (0.10%)
Gastrointestinal Tract Adenoma † 1	1/963 (0.10%)
Hepatic Neoplasm Malignant † 1	1/963 (0.10%)
Lipoma † 1	1/963 (0.10%)
Lung Cancer Metastatic † 1	1/963 (0.10%)
Lung Neoplasm † 1	2/963 (0.21%)
Lung Neoplasm Malignant † 1	2/963 (0.21%)
Multiple Myeloma † 1	1/963 (0.10%)
Myelodysplastic Syndrome † 1	1/963 (0.10%)
Myelofibrosis † 1	1/963 (0.10%)
Neoplasm Malignant † 1	1/963 (0.10%)
Oesophageal Adenocarcinoma † 1	1/963 (0.10%)
Pancreatic Carcinoma † 1	1/963 (0.10%)
Pancreatic Neoplasm † 1	1/963 (0.10%)
Pleural Mesothelioma † 1	1/963 (0.10%)
Prostate Cancer † 1	2/963 (0.21%)
Prostate Cancer Metastatic † 1	1/963 (0.10%)
Renal Cancer † 1	1/963 (0.10%)
Squamous Cell Carcinoma † 1	2/963 (0.21%)
Transitional Cell Carcinoma † 1	1/963 (0.10%)
Urethral Cancer † 1	1/963 (0.10%)
Nervous system disorders
Carotid Artery Stenosis † 1	1/963 (0.10%)
Cauda Equina Syndrome † 1	1/963 (0.10%)
Cerebrovascular Accident † 1	7/963 (0.73%)
Cognitive Disorder † 1	1/963 (0.10%)
Complex Regional Pain Syndrome † 1	1/963 (0.10%)
Dementia † 1	2/963 (0.21%)
Dizziness Postural † 1	1/963 (0.10%)
Epilepsy † 1	1/963 (0.10%)
Headache † 1	2/963 (0.21%)
Hepatic Encephalopathy † 1	1/963 (0.10%)
Loss Of Consciousness † 1	1/963 (0.10%)
Neurodegenerative Disorder † 1	1/963 (0.10%)
Syncope † 1	5/963 (0.52%)
Transient Ischaemic Attack † 1	2/963 (0.21%)
Viith Nerve Paralysis † 1	1/963 (0.10%)
Psychiatric disorders
Confusional State † 1	1/963 (0.10%)
Delirium † 1	1/963 (0.10%)
Mental Disorder † 1	1/963 (0.10%)
Renal and urinary disorders
Diabetic Nephropathy † 1	1/963 (0.10%)
Nephrolithiasis † 1	1/963 (0.10%)
Prerenal Failure † 1	1/963 (0.10%)
Renal Failure † 1	6/963 (0.62%)
Renal Failure Acute † 1	13/963 (1.35%)
Renal Failure Chronic † 1	3/963 (0.31%)
Urinary Retention † 1	2/963 (0.21%)
Reproductive system and breast disorders
Benign Prostatic Hyperplasia † 1	2/963 (0.21%)
Prostatomegaly † 1	1/963 (0.10%)
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema † 1	2/963 (0.21%)
Acute Respiratory Failure † 1	1/963 (0.10%)
Asthma † 1	1/963 (0.10%)
Bronchial Hyperreactivity † 1	1/963 (0.10%)
Chronic Obstructive Pulmonary Disease † 1	9/963 (0.93%)
Cough † 1	1/963 (0.10%)
Dyspnoea † 1	10/963 (1.04%)
Haemoptysis † 1	1/963 (0.10%)
Idiopathic Pulmonary Fibrosis † 1	1/963 (0.10%)
Pleural Effusion † 1	4/963 (0.42%)
Pneumonia Aspiration † 1	3/963 (0.31%)
Pneumothorax † 1	2/963 (0.21%)
Pulmonary Embolism † 1	2/963 (0.21%)
Pulmonary Fibrosis † 1	1/963 (0.10%)
Pulmonary Oedema † 1	1/963 (0.10%)
Respiratory Failure † 1	1/963 (0.10%)
Skin and subcutaneous tissue disorders
Diabetic Foot † 1	2/963 (0.21%)
Skin Ulcer † 1	2/963 (0.21%)
Subcutaneous Emphysema † 1	1/963 (0.10%)
Telangiectasia † 1	1/963 (0.10%)
Surgical and medical procedures
Arteriovenous Fistula Operation † 1	1/963 (0.10%)
Cardiac Pacemaker Insertion † 1	1/963 (0.10%)
Cataract Operation † 1	1/963 (0.10%)
Colon Polypectomy † 1	1/963 (0.10%)
Hip Arthroplasty † 1	1/963 (0.10%)
Hospitalisation † 1	1/963 (0.10%)
Limb Immobilisation † 1	1/963 (0.10%)
Vascular disorders
Aortic Stenosis † 1	6/963 (0.62%)
Arteriovenous Fistula † 1	2/963 (0.21%)
Deep Vein Thrombosis † 1	1/963 (0.10%)
Femoral Arterial Stenosis † 1	1/963 (0.10%)
Haemorrhage † 1	54/963 (5.61%)
Hypertension † 1	2/963 (0.21%)
Hypertensive Crisis † 1	6/963 (0.62%)
Hypotension † 1	1/963 (0.10%)
Orthostatic Hypotension † 1	1/963 (0.10%)
Peripheral Arterial Occlusive Disease † 1	2/963 (0.21%)
Peripheral Ischaemia † 1	2/963 (0.21%)
Thrombosis † 1	1/963 (0.10%)
Vascular Stenosis † 1	1/963 (0.10%)
1 Term from vocabulary, MedDRA 11.0; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	XIENCE
	Affected / at Risk (%)
Total	357/963 (37.07%)
Blood and lymphatic system disorders
Anaemia † 1	6/963 (0.62%)
Hypochromic Anaemia † 1	1/963 (0.10%)
Iron Deficiency Anaemia † 1	2/963 (0.21%)
Microcytic Anaemia † 1	1/963 (0.10%)
Normochromic Normocytic Anaemia † 1	1/963 (0.10%)
Splenomegaly † 1	1/963 (0.10%)
Spontaneous Haematoma † 1	1/963 (0.10%)
Thrombocytopenia † 1	1/963 (0.10%)
Cardiac disorders
Acute Coronary Syndrome † 1	1/963 (0.10%)
Angina Pectoris † 1	54/963 (5.61%)
Atrial Fibrillation † 1	15/963 (1.56%)
Atrial Flutter † 1	1/963 (0.10%)
Atrial Thrombosis † 1	1/963 (0.10%)
Atrioventricular Block Complete † 1	1/963 (0.10%)
Atrioventricular Block First Degree † 1	3/963 (0.31%)
Atrioventricular Block Second Degree † 1	1/963 (0.10%)
Bradyarrhythmia † 1	1/963 (0.10%)
Bradycardia † 1	4/963 (0.42%)
Bundle Branch Block Left † 1	2/963 (0.21%)
Bundle Branch Block Right † 1	1/963 (0.10%)
Cardiac Arrest † 1	1/963 (0.10%)
Cardiac Failure † 1	7/963 (0.73%)
Cardiac Failure Congestive † 1	1/963 (0.10%)
Coronary Artery Dissection † 1	1/963 (0.10%)
Myocardial Infarction † 1	2/963 (0.21%)
Palpitations † 1	8/963 (0.83%)
Pericardial Effusion † 1	1/963 (0.10%)
Pericarditis † 1	1/963 (0.10%)
Tachyarrhythmia † 1	1/963 (0.10%)
Tachycardia † 1	2/963 (0.21%)
Ventricular Tachycardia † 1	1/963 (0.10%)
Congenital, familial and genetic disorders
Phimosis † 1	1/963 (0.10%)
Ear and labyrinth disorders
Otorrhoea † 1	1/963 (0.10%)
Vertigo † 1	8/963 (0.83%)
Eye disorders
Cataract † 1	1/963 (0.10%)
Conjunctivitis † 1	1/963 (0.10%)
Visual Impairment † 1	1/963 (0.10%)
Gastrointestinal disorders
Abdominal Discomfort † 1	1/963 (0.10%)
Abdominal Pain † 1	3/963 (0.31%)
Abdominal Pain Upper † 1	4/963 (0.42%)
Aphthous Stomatitis † 1	1/963 (0.10%)
Constipation † 1	1/963 (0.10%)
Diarrhoea † 1	6/963 (0.62%)
Diverticulum † 1	2/963 (0.21%)
Dry Mouth † 1	1/963 (0.10%)
Dyspepsia † 1	2/963 (0.21%)
Epigastric Discomfort † 1	1/963 (0.10%)
Gastric Disorder † 1	1/963 (0.10%)
Gastric Ulcer † 1	1/963 (0.10%)
Gastritis † 1	8/963 (0.83%)
Gastritis Erosive † 1	1/963 (0.10%)
Gingival Bleeding † 1	1/963 (0.10%)
Haematochezia † 1	1/963 (0.10%)
Hiatus Hernia † 1	1/963 (0.10%)
Inguinal Hernia † 1	1/963 (0.10%)
Nausea † 1	1/963 (0.10%)
Peptic Ulcer † 1	1/963 (0.10%)
Tooth Loss † 1	1/963 (0.10%)
Toothache † 1	2/963 (0.21%)
Upper Gastrointestinal Haemorrhage † 1	1/963 (0.10%)
Vomiting † 1	4/963 (0.42%)
General disorders
Chest Discomfort † 1	4/963 (0.42%)
Chest Pain † 1	5/963 (0.52%)
Fatigue † 1	3/963 (0.31%)
Impaired Healing † 1	1/963 (0.10%)
Nodule † 1	1/963 (0.10%)
Non-Cardiac Chest Pain † 1	4/963 (0.42%)
Oedema † 1	3/963 (0.31%)
Oedema Peripheral † 1	9/963 (0.93%)
Pacemaker Generated Arrhythmia † 1	1/963 (0.10%)
Pain † 1	2/963 (0.21%)
Pyrexia † 1	2/963 (0.21%)
Spinal Pain † 1	1/963 (0.10%)
Ulcer † 1	2/963 (0.21%)
Hepatobiliary disorders
Biliary Colic † 1	1/963 (0.10%)
Hepatic Cirrhosis † 1	1/963 (0.10%)
Hepatic Steatosis † 1	3/963 (0.31%)
Liver Disorder † 1	1/963 (0.10%)
Infections and infestations
Asymptomatic Bacteriuria † 1	1/963 (0.10%)
Bronchitis † 1	2/963 (0.21%)
Bronchopneumonia † 1	1/963 (0.10%)
Cellulitis † 1	1/963 (0.10%)
Cystitis † 1	2/963 (0.21%)
Enterobiasis † 1	1/963 (0.10%)
Erysipelas † 1	1/963 (0.10%)
Gastroenteritis † 1	1/963 (0.10%)
Gastroenteritis Viral † 1	1/963 (0.10%)
Herpes Zoster † 1	1/963 (0.10%)
Influenza † 1	2/963 (0.21%)
Lower Respiratory Tract Infection † 1	1/963 (0.10%)
Lung Infection † 1	1/963 (0.10%)
Nasopharyngitis † 1	5/963 (0.52%)
Osteomyelitis † 1	1/963 (0.10%)
Paronychia † 1	1/963 (0.10%)
Pneumonia † 1	7/963 (0.73%)
Respiratory Tract Infection † 1	1/963 (0.10%)
Sinusitis † 1	1/963 (0.10%)
Tinea Cruris † 1	1/963 (0.10%)
Upper Respiratory Tract Infection † 1	2/963 (0.21%)
Urethritis † 1	2/963 (0.21%)
Urinary Tract Infection † 1	15/963 (1.56%)
Vaginal Infection † 1	1/963 (0.10%)
Viral Infection † 1	1/963 (0.10%)
Injury, poisoning and procedural complications
Cardiac Procedure Complication † 1	2/963 (0.21%)
Contusion † 1	3/963 (0.31%)
Fall † 1	6/963 (0.62%)
Joint Injury † 1	1/963 (0.10%)
Lumbar Vertebral Fracture † 1	1/963 (0.10%)
Rib Fracture † 1	1/963 (0.10%)
Spinal Compression Fracture † 1	1/963 (0.10%)
Vascular Pseudoaneurysm † 1	4/963 (0.42%)
Wound † 1	1/963 (0.10%)
Wound Complication † 1	1/963 (0.10%)
Investigations
Blood Calcium Increased † 1	1/963 (0.10%)
Blood Creatinine Increased † 1	2/963 (0.21%)
Blood Glucose Abnormal † 1	1/963 (0.10%)
Blood Thyroid Stimulating Hormone Increased † 1	1/963 (0.10%)
Cardiac Enzymes Increased † 1	1/963 (0.10%)
Ejection Fraction Decreased † 1	2/963 (0.21%)
Glycosylated Haemoglobin Increased † 1	1/963 (0.10%)
Haemoglobin Decreased † 1	1/963 (0.10%)
Prostatic Specific Antigen Increased † 1	1/963 (0.10%)
Troponin I Increased † 1	1/963 (0.10%)
Metabolism and nutrition disorders
Decreased Appetite † 1	1/963 (0.10%)
Dehydration † 1	1/963 (0.10%)
Diabetes Mellitus † 1	4/963 (0.42%)
Diabetes Mellitus Inadequate Control † 1	1/963 (0.10%)
Gout † 1	1/963 (0.10%)
Hypercholesterolaemia † 1	1/963 (0.10%)
Hyperkalaemia † 1	2/963 (0.21%)
Hyperlipidaemia † 1	1/963 (0.10%)
Hypoglycaemia † 1	1/963 (0.10%)
Hypokalaemia † 1	4/963 (0.42%)
Hyponatraemia † 1	3/963 (0.31%)
Hypoproteinaemia † 1	1/963 (0.10%)
Musculoskeletal and connective tissue disorders
Arthralgia † 1	3/963 (0.31%)
Arthritis † 1	1/963 (0.10%)
Back Pain † 1	3/963 (0.31%)
Bursitis † 1	1/963 (0.10%)
Exostosis † 1	1/963 (0.10%)
Foot Deformity † 1	1/963 (0.10%)
Intervertebral Disc Protrusion † 1	1/963 (0.10%)
Joint Swelling † 1	3/963 (0.31%)
Muscle Fatigue † 1	1/963 (0.10%)
Muscle Spasms † 1	1/963 (0.10%)
Musculoskeletal Chest Pain † 1	1/963 (0.10%)
Musculoskeletal Pain † 1	2/963 (0.21%)
Myalgia † 1	5/963 (0.52%)
Neck Pain † 1	2/963 (0.21%)
Osteoarthritis † 1	2/963 (0.21%)
Pain In Extremity † 1	6/963 (0.62%)
Spondylolisthesis † 1	1/963 (0.10%)
Systemic Sclerosis † 1	1/963 (0.10%)
Tendonitis † 1	1/963 (0.10%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Neoplasm † 1	1/963 (0.10%)
Lung Neoplasm Malignant † 1	1/963 (0.10%)
Neoplasm Malignant † 1	1/963 (0.10%)
Oesophageal Papilloma † 1	1/963 (0.10%)
Prostate Cancer † 1	1/963 (0.10%)
Nervous system disorders
Amnesia † 1	1/963 (0.10%)
Balance Disorder † 1	1/963 (0.10%)
Cerebrovascular Accident † 1	3/963 (0.31%)
Cervicogenic Headache † 1	1/963 (0.10%)
Dizziness † 1	9/963 (0.93%)
Dizziness Postural † 1	1/963 (0.10%)
Headache † 1	4/963 (0.42%)
Paraesthesia † 1	1/963 (0.10%)
Petit Mal Epilepsy † 1	1/963 (0.10%)
Polyneuropathy † 1	2/963 (0.21%)
Presyncope † 1	2/963 (0.21%)
Restless Legs Syndrome † 1	1/963 (0.10%)
Sciatica † 1	1/963 (0.10%)
Syncope † 1	4/963 (0.42%)
Transient Ischaemic Attack † 1	2/963 (0.21%)
Tunnel Vision † 1	1/963 (0.10%)
Psychiatric disorders
Delirium † 1	1/963 (0.10%)
Depression † 1	2/963 (0.21%)
Listless † 1	1/963 (0.10%)
Sleep Disorder † 1	1/963 (0.10%)
Renal and urinary disorders
Cystitis Haemorrhagic † 1	1/963 (0.10%)
Dysuria † 1	1/963 (0.10%)
Haematuria † 1	3/963 (0.31%)
Nephrolithiasis † 1	1/963 (0.10%)
Renal Failure † 1	2/963 (0.21%)
Renal Failure Acute † 1	6/963 (0.62%)
Renal Failure Chronic † 1	3/963 (0.31%)
Renal Impairment † 1	1/963 (0.10%)
Urinary Retention † 1	2/963 (0.21%)
Reproductive system and breast disorders
Benign Prostatic Hyperplasia † 1	1/963 (0.10%)
Vaginismus † 1	1/963 (0.10%)
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease † 1	3/963 (0.31%)
Cough † 1	6/963 (0.62%)
Dyspnoea † 1	29/963 (3.01%)
Dyspnoea Exertional † 1	2/963 (0.21%)
Epistaxis † 1	2/963 (0.21%)
Haemoptysis † 1	1/963 (0.10%)
Oropharyngeal Pain † 1	1/963 (0.10%)
Productive Cough † 1	1/963 (0.10%)
Pulmonary Oedema † 1	2/963 (0.21%)
Rhinitis Allergic † 1	2/963 (0.21%)
Skin and subcutaneous tissue disorders
Alopecia † 1	1/963 (0.10%)
Decubitus Ulcer † 1	1/963 (0.10%)
Dermatitis † 1	2/963 (0.21%)
Hyperhidrosis † 1	3/963 (0.31%)
Pruritus † 1	5/963 (0.52%)
Rash † 1	5/963 (0.52%)
Rash Generalised † 1	1/963 (0.10%)
Skin Ulcer † 1	1/963 (0.10%)
Urticaria † 1	2/963 (0.21%)
Surgical and medical procedures
Cardiac Ablation † 1	1/963 (0.10%)
Vascular disorders
Aortic Aneurysm † 1	2/963 (0.21%)
Arteriosclerosis † 1	1/963 (0.10%)
Femoral Arterial Stenosis † 1	1/963 (0.10%)
Haematoma † 1	8/963 (0.83%)
Haemorrhage † 1	100/963 (10.38%)
Hypertension † 1	17/963 (1.77%)
Hypertensive Crisis † 1	4/963 (0.42%)
Hypotension † 1	5/963 (0.52%)
Intermittent Claudication † 1	1/963 (0.10%)
Orthostatic Hypotension † 1	1/963 (0.10%)
Peripheral Arterial Occlusive Disease † 1	2/963 (0.21%)
Vascular Dissection † 1	1/963 (0.10%)
Vascular Stenosis † 1	1/963 (0.10%)
1 Term from vocabulary, MedDRA 11.0; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

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.

Results Point of Contact

• Name/Title: Siok Hwee Tan, PhD, Principal Clinical Research Scientist
• Organization: Clinical Affairs, Abbott Vascular
• Phone: +1 408-845-3581
• EMail: siokhwee.tan@abbott.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Valgimigli M, Cao D, Angiolillo DJ, Bangalore S, Bhatt DL, Ge J, Hermiller J, Makkar RR, Neumann FJ, Saito S, Picon H, Toelg R, Maksoud A, Chehab BM, Choi JW, Campo G, De la Torre Hernandez JM, Kunadian V, Sardella G, Thiele H, Varenne O, Vranckx P, Windecker S, Zhou Y, Krucoff MW, Ruster K, Zheng Y, Mehran R; XIENCE 90 and XIENCE 28 Investigators. Duration of Dual Antiplatelet Therapy for Patients at High Bleeding Risk Undergoing PCI. J Am Coll Cardiol. 2021 Nov 23;78(21):2060-2072. doi: 10.1016/j.jacc.2021.08.074.

Valgimigli M, Cao D, Makkar RR, Bangalore S, Bhatt DL, Angiolillo DJ, Saito S, Ge J, Neumann FJ, Hermiller J, Picon H, Toelg R, Maksoud A, Chehab BM, Wang LJ, Wang J, Mehran R. Design and rationale of the XIENCE short DAPT clinical program: An assessment of the safety of 3-month and 1-month DAPT in patients at high bleeding risk undergoing PCI with an everolimus-eluting stent. Am Heart J. 2021 Jan;231:147-156. doi: 10.1016/j.ahj.2020.09.019. Epub 2020 Oct 6.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT03355742
• Other Study ID Numbers: ABT-CIP-10235
• First Submitted: November 22, 2017
• First Posted: November 28, 2017
• Results First Submitted: October 28, 2020
• Results First Posted: February 8, 2021
• Last Update Posted: March 4, 2021