Trial Outcomes & Findings for XIENCE 28 USA Study (NCT NCT03815175)

Last Updated: 2022-05-03

Results Overview

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 Definition (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: * Peripheral MI * Spontaneous MI (\> 48h following PCI, \> 72h following CABG): CK-MB \> URL or Troponin \> URL with baseline value \< URL

Recruitment status

COMPLETED

Study phase

Target enrollment

1605 participants

Primary outcome timeframe

From 1 to 6 months

Results posted on

2022-05-03

Participant Flow

A total of 1605 subjects were enrolled in XIENCE 28 study. The XIENCE 28 USA study was conducted at 58 sites in the US and Canada between February 25, 2019 and February 7, 2020. While XIENCE 28 Global study was conducted at 52 sites in Europe and Asia between February 9, 2018 and April 22, 2019.

The data collected from the XIENCE 28 USA Study was pooled with the data from the XIENCE 28 Global Study (NCT # NCT03355742) to compare with the historical control of non-complex HBR subjects treated with standard DAPT duration of up to 12 months from the XIENCE V USA Study.

Participant milestones

Participant milestones
Measure	XIENCE XIENCE + 1 month dual antiplatelet therapy (DAPT) XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Overall Study STARTED	1605
Overall Study COMPLETED	1439
Overall Study NOT COMPLETED	166

Reasons for withdrawal

Reasons for withdrawal
Measure	XIENCE XIENCE + 1 month dual antiplatelet therapy (DAPT) XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Overall Study Subject Lost to Follow-up	6
Overall Study Subject Withdrew Consent	48
Overall Study Subject Withdrawn by Physician/Site	10
Overall Study Death	86
Overall Study Improper/Duplicate SubjectEnrollment	1
Overall Study Subject Discontinued by Sponsor	2
Overall Study Other Status Change Reason	1
Overall Study Missed Visit	12

Baseline Characteristics

XIENCE 28 USA Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	XIENCE n=1605 Participants XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Age, Continuous	76.15 years STANDARD_DEVIATION 8.29 • n=93 Participants
Sex: Female, Male Female	538 Participants n=93 Participants
Sex: Female, Male Male	1067 Participants n=93 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 Participants n=93 Participants
Race/Ethnicity, Customized Asian	137 Participants n=93 Participants
Race/Ethnicity, Customized Black or African American	42 Participants n=93 Participants
Race/Ethnicity, Customized Hispanic or Latino	168 Participants n=93 Participants
Race/Ethnicity, Customized Native Hawaiian or Pacific Islander	0 Participants n=93 Participants
Race/Ethnicity, Customized White	939 Participants n=93 Participants
Race/Ethnicity, Customized Did Not Wish to Disclose	40 Participants n=93 Participants
Race/Ethnicity, Customized Not Available	445 Participants n=93 Participants
Region of Enrollment Germany	327 Participants n=93 Participants
Region of Enrollment Italy	231 Participants n=93 Participants
Region of Enrollment Canada	70 Participants n=93 Participants
Region of Enrollment United States	572 Participants n=93 Participants
Region of Enrollment Hong Kong	48 Participants n=93 Participants
Region of Enrollment Belgium	64 Participants n=93 Participants
Region of Enrollment Spain	89 Participants n=93 Participants
Region of Enrollment Netherlands	49 Participants n=93 Participants
Region of Enrollment Switzerland	37 Participants n=93 Participants
Region of Enrollment Taiwan	48 Participants n=93 Participants
Region of Enrollment Singapore	22 Participants n=93 Participants
Region of Enrollment United Kingdom	30 Participants n=93 Participants
Region of Enrollment China	7 Participants n=93 Participants
Region of Enrollment Portugal	8 Participants n=93 Participants
Region of Enrollment Austria	3 Participants n=93 Participants
Prior Percutaneous Coronary Intervention (PCI)	451 Participants n=93 Participants

PRIMARY outcome

Timeframe: From 1 to 6 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Outcome measures

Outcome measures
Measure	XIENCE n=1380 Participants XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (MI) (Modified Academic Research Consortium [ARC]), by Propensity Score Quintile Q5	3.9 percentage of participants
Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (MI) (Modified Academic Research Consortium [ARC]), by Propensity Score Quintile Adjusted Overall Rate	3.5 percentage of participants
Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (MI) (Modified Academic Research Consortium [ARC]), by Propensity Score Quintile Q1	4.3 percentage of participants
Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (MI) (Modified Academic Research Consortium [ARC]), by Propensity Score Quintile Q2	4.1 percentage of participants
Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (MI) (Modified Academic Research Consortium [ARC]), by Propensity Score Quintile Q3	2.6 percentage of participants
Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (MI) (Modified Academic Research Consortium [ARC]), by Propensity Score Quintile Q4	2.7 percentage of participants

PRIMARY outcome

Timeframe: From 6 to 12 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Outcome measures

Outcome measures
Measure	XIENCE n=1356 Participants XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (Modified ARC), by Propensity Score Quintile Adjusted Overall Rate	3.2 percentage of participants
Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (Modified ARC), by Propensity Score Quintile Q1	0.0 percentage of participants
Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (Modified ARC), by Propensity Score Quintile Q2	2.7 percentage of participants
Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (Modified ARC), by Propensity Score Quintile Q3	3.4 percentage of participants
Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (Modified ARC), by Propensity Score Quintile Q4	5.5 percentage of participants
Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (Modified ARC), by Propensity Score Quintile Q5	4.4 percentage of participants

PRIMARY outcome

Timeframe: From 1 to 12 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Outcome measures

Outcome measures
Measure	XIENCE n=1381 Participants XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (Modified ARC), by Propensity Score Quintile Adjusted Overall Rate	6.7 percentage of participants
Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (Modified ARC), by Propensity Score Quintile Q1	4.3 percentage of participants
Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (Modified ARC), by Propensity Score Quintile Q2	6.7 percentage of participants
Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (Modified ARC), by Propensity Score Quintile Q3	6.0 percentage of participants
Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (Modified ARC), by Propensity Score Quintile Q4	7.9 percentage of participants
Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (Modified ARC), by Propensity Score Quintile Q5	8.4 percentage of participants

SECONDARY outcome

Timeframe: From 1 to 6 months

Population: The number of participants analyzed for each time frame and outcome measure will vary based on: 1. Number of subjects who actually completed follow-up for the given time point analyzed 2. The denominator rule used to calculate event rates: subjects that were lost to follow-up, or withdrew consent, or died before the time point of interest, without having the endpoint of interest are excluded from the denominator.

Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions: * Type 2: Any overt, actionable sign of hemorrhage * Type 3a: Overt bleeding plus Hb drop of 3 to \< 5g/dL;Any transfusion with overt bleeding * Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL;Cardiac tamponade;Bleeding requiring surgical intervention for control;Bleeding requiring IV vasoactive agents * Type 3c: Intracranial hemorrhage; Subcategories confirmed by autopsy/imaging/lumbar puncture;Intraocular bleed compromising vision * Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48h;Reoperation after closure of sternotomy for the purpose of controlling bleeding;Transfusion of ≥ 5 U whole blood/packed red blood cells within a 48h period;Chest tube output ≥ 2L within 24-h period * Type 5: Fatal bleeding * Type 5a: Probable fatal bleeding;no autopsy/imaging confirmation but clinically suspicious * Type 5b: Definite fatal bleeding;overt bleeding/autopsy/imaging confirmation

Outcome measures

Outcome measures
Measure	XIENCE n=1362 Participants XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Percentage of Participants With Major Bleeding Rate (Bleeding Academic Research Consortium [BARC] Type 2-5), by Propensity Score Quintiles Adjusted Overall Rate	4.9 percentage of participants
Percentage of Participants With Major Bleeding Rate (Bleeding Academic Research Consortium [BARC] Type 2-5), by Propensity Score Quintiles Q1	4.3 percentage of participants
Percentage of Participants With Major Bleeding Rate (Bleeding Academic Research Consortium [BARC] Type 2-5), by Propensity Score Quintiles Q2	5.5 percentage of participants
Percentage of Participants With Major Bleeding Rate (Bleeding Academic Research Consortium [BARC] Type 2-5), by Propensity Score Quintiles Q3	2.3 percentage of participants
Percentage of Participants With Major Bleeding Rate (Bleeding Academic Research Consortium [BARC] Type 2-5), by Propensity Score Quintiles Q4	5.2 percentage of participants
Percentage of Participants With Major Bleeding Rate (Bleeding Academic Research Consortium [BARC] Type 2-5), by Propensity Score Quintiles Q5	7.0 percentage of participants

SECONDARY outcome

Timeframe: From 6 to 12 months

Outcome measures

Outcome measures
Measure	XIENCE n=1325 Participants XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Percentage of Participants With Major Bleeding Rate (BARC Type 2-5), by Propensity Score Quintiles Adjusted Overall Rate	2.5 percentage of participants
Percentage of Participants With Major Bleeding Rate (BARC Type 2-5), by Propensity Score Quintiles Q1	2.2 percentage of participants
Percentage of Participants With Major Bleeding Rate (BARC Type 2-5), by Propensity Score Quintiles Q2	1.4 percentage of participants
Percentage of Participants With Major Bleeding Rate (BARC Type 2-5), by Propensity Score Quintiles Q3	3.1 percentage of participants
Percentage of Participants With Major Bleeding Rate (BARC Type 2-5), by Propensity Score Quintiles Q4	2.0 percentage of participants
Percentage of Participants With Major Bleeding Rate (BARC Type 2-5), by Propensity Score Quintiles Q5	3.7 percentage of participants

SECONDARY outcome

Timeframe: From 1 to 12 months

Outcome measures

Outcome measures
Measure	XIENCE n=1333 Participants XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Percentage of Participants With Major Bleeding Rate (BARC Type 2-5), by Propensity Score Quintiles Q5	10.1 percentage of participants
Percentage of Participants With Major Bleeding Rate (BARC Type 2-5), by Propensity Score Quintiles Adjusted Overall Rate	7.1 percentage of participants
Percentage of Participants With Major Bleeding Rate (BARC Type 2-5), by Propensity Score Quintiles Q1	6.5 percentage of participants
Percentage of Participants With Major Bleeding Rate (BARC Type 2-5), by Propensity Score Quintiles Q2	6.8 percentage of participants
Percentage of Participants With Major Bleeding Rate (BARC Type 2-5), by Propensity Score Quintiles Q3	5.4 percentage of participants
Percentage of Participants With Major Bleeding Rate (BARC Type 2-5), by Propensity Score Quintiles Q4	6.8 percentage of participants

SECONDARY outcome

Timeframe: From 1 to 6 months

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

Outcome measures

Outcome measures
Measure	XIENCE n=1361 Participants XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)	4 Participants

SECONDARY outcome

Timeframe: From 6 to 12 months

Outcome measures

Outcome measures
Measure	XIENCE n=1328 Participants XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)	0 Participants

SECONDARY outcome

Timeframe: From 1 to 12 months

Outcome measures

Outcome measures
Measure	XIENCE n=1333 Participants XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)	4 Participants

SECONDARY outcome

Timeframe: From 1 to 6 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

All Death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even inpatients 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.

Outcome measures

Outcome measures
Measure	XIENCE n=1380 Participants XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Number of All Death (Cardiac Death, Vascular Death, Non-cardiovascular Death)	23 Participants

SECONDARY outcome

Timeframe: From 6 to 12 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Outcome measures

Outcome measures
Measure	XIENCE n=1356 Participants XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Number of All Death (Cardiac Death, Vascular Death, Non-cardiovascular Death)	40 Participants

SECONDARY outcome

Timeframe: From 1 to 12 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Outcome measures

Outcome measures
Measure	XIENCE n=1381 Participants XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Number of All Death (Cardiac Death, Vascular Death, Non-cardiovascular Death)	64 Participants

SECONDARY outcome

Timeframe: From 1 to 6 months

All Myocardial Infarction (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 TV-MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.

Outcome measures

Outcome measures
Measure	XIENCE n=1380 Participants XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)	24 Participants

SECONDARY outcome

Timeframe: From 6 to 12 months

Outcome measures

Outcome measures
Measure	XIENCE n=1356 Participants XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Number of Participants With All MI and MI Attributed to Target Vessel (TV-MI, Modified ARC)	18 Participants

SECONDARY outcome

Timeframe: From 1 to 12 months

Outcome measures

Outcome measures
Measure	XIENCE n=1381 Participants XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Number of Participants With All MI and MI Attributed to Target Vessel (TV-MI, Modified ARC)	41 Participants

SECONDARY outcome

Timeframe: From 1 to 6 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

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 URLwith 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

Outcome measures

Outcome measures
Measure	XIENCE n=1380 Participants XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Number of Participants With Composite of Cardiac Death or MI (Modified ARC)	35 Participants

SECONDARY outcome

Timeframe: From 6 to 12 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Outcome measures

Outcome measures
Measure	XIENCE n=1356 Participants XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Number of Participants With Composite of Cardiac Death or MI (Modified ARC)	33 Participants

SECONDARY outcome

Timeframe: From 1 to 12 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Outcome measures

Outcome measures
Measure	XIENCE n=1381 Participants XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Number of Participants With Composite of Cardiac Death or MI (Modified ARC)	68 Participants

SECONDARY outcome

Timeframe: From 1 to 6 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

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

Outcome measures

Outcome measures
Measure	XIENCE n=1380 Participants XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Number of Participants With Composite of All Death or All MI (Modified ARC)	46 Participants

SECONDARY outcome

Timeframe: From 6 to 12 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

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

Outcome measures

Outcome measures
Measure	XIENCE n=1356 Participants XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Number of Participants With Composite of All Death or All MI (Modified ARC)	57 Participants

SECONDARY outcome

Timeframe: From 1 to 12 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

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

Outcome measures

Outcome measures
Measure	XIENCE n=1381 Participants XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Number of Participants With Composite of All Death or All MI (Modified ARC)	103 Participants

SECONDARY outcome

Timeframe: From 1 to 6 months

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)

Outcome measures

Outcome measures
Measure	XIENCE n=1357 Participants XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Number of Participants With All Stroke (Ischemic Stroke and Hemorrhagic Stroke)	4 Participants

SECONDARY outcome

Timeframe: From 6 to 12 months

Outcome measures

Outcome measures
Measure	XIENCE n=1320 Participants XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Number of Participants With All Stroke (Ischemic Stroke and Hemorrhagic Stroke)	7 Participants

SECONDARY outcome

Timeframe: From 1 to 12 months

Outcome measures

Outcome measures
Measure	XIENCE n=1321 Participants XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Number of Participants With All Stroke (Ischemic Stroke and Hemorrhagic Stroke)	11 Participants

SECONDARY outcome

Timeframe: From 1 to 6 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion 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 clinically indicated by the investigator prior to repeat angiography. Clinically Indicated \[CI\] Revascularization: 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 * A TLR/TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.

Outcome measures

Outcome measures
Measure	XIENCE n=1380 Participants XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)	10 Participants

SECONDARY outcome

Timeframe: From 6 to 12 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Outcome measures

Outcome measures
Measure	XIENCE n=1356 Participants XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Number of Participants With CI-TLR	8 Participants

SECONDARY outcome

Timeframe: From 1 to 12 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Outcome measures

Outcome measures
Measure	XIENCE n=1381 Participants XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Number of Participants With CI-TLR	18 Participants

SECONDARY outcome

Timeframe: From 1 to 6 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

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.

Outcome measures

Outcome measures
Measure	XIENCE n=1380 Participants XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR)	14 Participants

SECONDARY outcome

Timeframe: From 6 to 12 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Outcome measures

Outcome measures
Measure	XIENCE n=1356 Participants XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Number of Participants With CI-TVR	15 Participants

SECONDARY outcome

Timeframe: From 1 to 12 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Outcome measures

Outcome measures
Measure	XIENCE n=1381 Participants XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Number of Participants With CI-TVR	29 Participants

SECONDARY outcome

Timeframe: From 1 to 6 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.

Outcome measures

Outcome measures
Measure	XIENCE n=1380 Participants XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)	35 Participants

SECONDARY outcome

Timeframe: From 6 to 12 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.

Outcome measures

Outcome measures
Measure	XIENCE n=1356 Participants XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)	34 Participants

SECONDARY outcome

Timeframe: From 1 to 12 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.

Outcome measures

Outcome measures
Measure	XIENCE n=1381 Participants XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)	69 Participants

SECONDARY outcome

Timeframe: From 1 to 6 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.

Outcome measures

Outcome measures
Measure	XIENCE n=1380 Participants XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Number of Participants With Target Vessel Failure (TVF, Composite of Cardiac Death, TV-MI and CI-TVR)	38 Participants

SECONDARY outcome

Timeframe: From 6 to 12 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.

Outcome measures

Outcome measures
Measure	XIENCE n=1356 Participants XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Number of Participants With Target Vessel Failure (TVF, Composite of Cardiac Death, TV-MI and CI-TVR)	39 Participants

SECONDARY outcome

Timeframe: From 1 to 12 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.

Outcome measures

Outcome measures
Measure	XIENCE n=1381 Participants XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Number of Participants With Target Vessel Failure (TVF, Composite of Cardiac Death, TV-MI and CI-TVR)	77 Participants

SECONDARY outcome

Timeframe: From 1 to 6 months

Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions are as follows: * Type 3a: Overt bleeding plus Hemoglobin(Hb) drop of 3 to \< 5 g/dL; Any transfusion with overt bleeding * Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL; Cardiac tamponade; Bleeding requiring surgical intervention for control; Bleeding requiring IV vasoactive agents * Type 3c: Intracranial hemorrhage;Subcategories confirmed by autopsy or imaging or lumbar puncture; Intraocular bleed compromising vision * Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48 h; Reoperation after closure of sternotomy for the purpose of controlling bleeding; Transfusion of ≥ 5 U whole blood or packed red blood cells within a 48-h period; Chest tube output ≥ 2L within a 24-h period * Type 5: Fatal bleeding * Type 5a: Probable fatal bleeding; no autopsy/imaging confirmation but clinically suspicious * Type 5b: Definite fatal bleeding;overt bleeding/autopsy or imaging confirmation

Outcome measures

Outcome measures
Measure	XIENCE n=1362 Participants XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Number of Participants With Major Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 3-5	33 Participants

SECONDARY outcome

Timeframe: From 6 to 12 months

Outcome measures

Outcome measures
Measure	XIENCE n=1325 Participants XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Number of Participants With Major Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 3-5	18 Participants

SECONDARY outcome

Timeframe: From 1 to 12 months

Outcome measures

Outcome measures
Measure	XIENCE n=1333 Participants XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Number of Participants With Major Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 3-5	49 Participants

Adverse Events

XIENCE

Serious events: 615 serious events

Other events: 296 other events

Deaths: 86 deaths

Serious adverse events

Serious adverse events
Measure	XIENCE n=1605 participants at risk XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Injury, poisoning and procedural complications Wound Dehiscence	0.06% 1/1605 • 1 year
Investigations Arteriogram Coronary	0.06% 1/1605 • 1 year
Investigations Blood Glucose Increased	0.06% 1/1605 • 1 year
Investigations Blood Pressure Abnormal	0.06% 1/1605 • 1 year
Investigations Blood Pressure Increased	0.06% 1/1605 • 1 year
Investigations Blood Urine Present	0.06% 1/1605 • 1 year
Investigations Cardiac Stress Test Abnormal	0.06% 1/1605 • 1 year
Investigations Ejection Fraction Decreased	0.06% 1/1605 • 1 year
Investigations Electrocardiogram Abnormal	0.06% 1/1605 • 1 year
Investigations Heart Rate Decreased	0.06% 1/1605 • 1 year
Investigations Hepatic Enzyme Increased	0.06% 1/1605 • 1 year
Investigations Troponin Increased	0.06% 1/1605 • 1 year
Metabolism and nutrition disorders Dehydration	0.06% 1/1605 • 1 year
Metabolism and nutrition disorders Diabetes Mellitus	0.19% 3/1605 • 1 year
Metabolism and nutrition disorders Diabetes Mellitus Inadequate Control	0.12% 2/1605 • 1 year
Metabolism and nutrition disorders Diabetic Ketoacidosis	0.12% 2/1605 • 1 year
Metabolism and nutrition disorders Fluid Overload	0.44% 7/1605 • 1 year
Metabolism and nutrition disorders Gout	0.06% 1/1605 • 1 year
Metabolism and nutrition disorders Hyperglycaemia	0.12% 2/1605 • 1 year
Metabolism and nutrition disorders Hyperkalaemia	0.19% 3/1605 • 1 year
Metabolism and nutrition disorders Hypoglycaemia	0.25% 4/1605 • 1 year
Metabolism and nutrition disorders Hyponatraemia	0.19% 3/1605 • 1 year
Metabolism and nutrition disorders Type 2 Diabetes Mellitus	0.12% 2/1605 • 1 year
Musculoskeletal and connective tissue disorders Arthritis	0.12% 2/1605 • 1 year
Musculoskeletal and connective tissue disorders Back Pain	0.19% 3/1605 • 1 year
Musculoskeletal and connective tissue disorders Fistula	0.06% 1/1605 • 1 year
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	0.06% 1/1605 • 1 year
Musculoskeletal and connective tissue disorders Joint Effusion	0.06% 1/1605 • 1 year
Musculoskeletal and connective tissue disorders Lumbar Spinal Stenosis	0.06% 1/1605 • 1 year
Musculoskeletal and connective tissue disorders Muscular Weakness	0.06% 1/1605 • 1 year
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	0.06% 1/1605 • 1 year
Musculoskeletal and connective tissue disorders Musculoskeletal Disorder	0.06% 1/1605 • 1 year
Musculoskeletal and connective tissue disorders Osteoarthritis	0.69% 11/1605 • 1 year
Musculoskeletal and connective tissue disorders Osteochondrosis	0.06% 1/1605 • 1 year
Musculoskeletal and connective tissue disorders Pain In Extremity	0.06% 1/1605 • 1 year
Musculoskeletal and connective tissue disorders Polyarthritis	0.06% 1/1605 • 1 year
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.06% 1/1605 • 1 year
Musculoskeletal and connective tissue disorders Spondylitis	0.06% 1/1605 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute Lymphocytic Leukaemia Recurrent	0.06% 1/1605 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Biliary Neoplasm	0.12% 2/1605 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Cancer	0.19% 3/1605 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Transitional Cell Carcinoma	0.06% 1/1605 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer	0.06% 1/1605 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Neoplasm	0.06% 1/1605 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial Cancer	0.12% 2/1605 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric Cancer	0.06% 1/1605 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal Tract Adenoma	0.06% 1/1605 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic Neoplasm Malignant	0.06% 1/1605 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.06% 1/1605 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Cancer Metastatic	0.06% 1/1605 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Neoplasm	0.19% 3/1605 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Neoplasm Malignant	0.19% 3/1605 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Central Nervous	0.06% 1/1605 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Multiple Myeloma	0.12% 2/1605 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic Syndrome	0.06% 1/1605 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelofibrosis	0.06% 1/1605 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm Malignant	0.06% 1/1605 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine Carcinoma	0.06% 1/1605 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Small Cell Lung Cancer	0.06% 1/1605 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal Adenocarcinoma	0.06% 1/1605 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Carcinoma	0.06% 1/1605 • 1 year
Blood and lymphatic system disorders Anaemia	1.1% 18/1605 • 1 year
Blood and lymphatic system disorders Bicytopenia	0.06% 1/1605 • 1 year
Blood and lymphatic system disorders Hypochromic Anaemia	0.06% 1/1605 • 1 year
Blood and lymphatic system disorders Iron Deficiency Anaemia	0.25% 4/1605 • 1 year
Blood and lymphatic system disorders Nephrogenic Anaemia	0.06% 1/1605 • 1 year
Blood and lymphatic system disorders Normochromic Normocytic Anaemia	0.06% 1/1605 • 1 year
Cardiac disorders Angina Pectoris	5.7% 91/1605 • 1 year
Cardiac disorders Angina Unstable	0.06% 1/1605 • 1 year
Cardiac disorders Aortic Valve Incompetence	0.19% 3/1605 • 1 year
Cardiac disorders Aortic Valve Stenosis	0.19% 3/1605 • 1 year
Cardiac disorders Arrhythmia	0.12% 2/1605 • 1 year
Cardiac disorders Atrial Fibrillation	3.1% 49/1605 • 1 year
Cardiac disorders Atrial Flutter	0.31% 5/1605 • 1 year
Cardiac disorders Atrial Tachycardia	0.06% 1/1605 • 1 year
Cardiac disorders Atrioventricular Block	0.12% 2/1605 • 1 year
Cardiac disorders Atrioventricular Block Complete	0.31% 5/1605 • 1 year
Cardiac disorders Atrioventricular Block Second Degree	0.06% 1/1605 • 1 year
Cardiac disorders Bifascicular Block	0.06% 1/1605 • 1 year
Cardiac disorders Bradycardia	0.37% 6/1605 • 1 year
Cardiac disorders Cardiac Arrest	0.19% 3/1605 • 1 year
Cardiac disorders Cardiac Failure	2.0% 32/1605 • 1 year
Cardiac disorders Cardiac Failure Acute	0.50% 8/1605 • 1 year
Cardiac disorders Cardiac Failure Chronic	0.25% 4/1605 • 1 year
Cardiac disorders Cardiac Failure Congestive	2.1% 34/1605 • 1 year
Cardiac disorders Cardiac Tamponade	0.06% 1/1605 • 1 year
Cardiac disorders Cardiogenic Shock	0.19% 3/1605 • 1 year
Cardiac disorders Cardiomegaly	0.06% 1/1605 • 1 year
Cardiac disorders Cardiomyopathy	0.12% 2/1605 • 1 year
Cardiac disorders Congestive Cardiomyopathy	0.06% 1/1605 • 1 year
Cardiac disorders Coronary Artery Disease	0.56% 9/1605 • 1 year
Cardiac disorders Coronary Artery Stenosis	0.12% 2/1605 • 1 year
Cardiac disorders Diastolic Dysfunction	0.06% 1/1605 • 1 year
Cardiac disorders Dressler's Syndrome	0.06% 1/1605 • 1 year
Cardiac disorders Ischaemic Cardiomyopathy	0.06% 1/1605 • 1 year
Cardiac disorders Mitral Valve Incompetence	0.37% 6/1605 • 1 year
Cardiac disorders Myocardial Infarction	1.9% 30/1605 • 1 year
Cardiac disorders Myocardial Ischaemia	0.12% 2/1605 • 1 year
Cardiac disorders Myopericarditis	0.06% 1/1605 • 1 year
Cardiac disorders Palpitations	0.06% 1/1605 • 1 year
Cardiac disorders Pericardial Effusion	0.06% 1/1605 • 1 year
Cardiac disorders Pericarditis	0.06% 1/1605 • 1 year
Cardiac disorders Pleuropericarditis	0.06% 1/1605 • 1 year
Cardiac disorders Pulseless Electrical Activity	0.06% 1/1605 • 1 year
Cardiac disorders Right Ventricular Failure	0.12% 2/1605 • 1 year
Cardiac disorders Sick Sinus Syndrome	0.25% 4/1605 • 1 year
Cardiac disorders Sinoatrial Block	0.06% 1/1605 • 1 year
Cardiac disorders Sinus Bradycardia	0.12% 2/1605 • 1 year
Cardiac disorders Supraventricular Tachycardia	0.19% 3/1605 • 1 year
Cardiac disorders Tachyarrhythmia	0.25% 4/1605 • 1 year
Cardiac disorders Tachycardia	0.06% 1/1605 • 1 year
Cardiac disorders Tricuspid Valve Incompetence	0.12% 2/1605 • 1 year
Cardiac disorders Ventricular Extrasystoles	0.25% 4/1605 • 1 year
Cardiac disorders Ventricular Fibrillation	0.06% 1/1605 • 1 year
Cardiac disorders Ventricular Tachycardia	0.37% 6/1605 • 1 year
Ear and labyrinth disorders Vertigo	0.19% 3/1605 • 1 year
Ear and labyrinth disorders Vertigo Positional	0.12% 2/1605 • 1 year
Endocrine disorders Hyperparathyroidism	0.06% 1/1605 • 1 year
Endocrine disorders Hypothyroidism	0.06% 1/1605 • 1 year
Eye disorders Cataract	0.06% 1/1605 • 1 year
Eye disorders Retinal Artery Occlusion	0.06% 1/1605 • 1 year
Gastrointestinal disorders Abdominal Pain	0.37% 6/1605 • 1 year
Gastrointestinal disorders Abdominal Pain Upper	0.19% 3/1605 • 1 year
Gastrointestinal disorders Colitis Ulcerative	0.06% 1/1605 • 1 year
Gastrointestinal disorders Colonic Polyp	0.25% 4/1605 • 1 year
Gastrointestinal disorders Constipation	0.06% 1/1605 • 1 year
Gastrointestinal disorders Diarrhoea	0.25% 4/1605 • 1 year
Gastrointestinal disorders Duodenal Ulcer	0.06% 1/1605 • 1 year
Gastrointestinal disorders Dysphagia	0.06% 1/1605 • 1 year
Gastrointestinal disorders Enteritis	0.19% 3/1605 • 1 year
Gastrointestinal disorders Faeces Discoloured	0.06% 1/1605 • 1 year
Gastrointestinal disorders Gastric Ulcer	0.06% 1/1605 • 1 year
Gastrointestinal disorders Gastritis	0.06% 1/1605 • 1 year
Gastrointestinal disorders Gastritis Erosive	0.12% 2/1605 • 1 year
Gastrointestinal disorders Gastrointestinal Haemorrhage	0.06% 1/1605 • 1 year
Gastrointestinal disorders Haematemesis	0.06% 1/1605 • 1 year
Gastrointestinal disorders Inguinal Hernia	0.12% 2/1605 • 1 year
Gastrointestinal disorders Intestinal Ischaemia	0.06% 1/1605 • 1 year
Gastrointestinal disorders Nausea	0.06% 1/1605 • 1 year
Gastrointestinal disorders Odynophagia	0.06% 1/1605 • 1 year
Gastrointestinal disorders Oesophageal Stenosis	0.06% 1/1605 • 1 year
Gastrointestinal disorders Pancreatitis	0.06% 1/1605 • 1 year
Gastrointestinal disorders Pancreatitis Acute	0.06% 1/1605 • 1 year
Gastrointestinal disorders Pancreatitis Necrotising	0.06% 1/1605 • 1 year
Gastrointestinal disorders Rectal Ulcer	0.06% 1/1605 • 1 year
Gastrointestinal disorders Small Intestinal Obstruction	0.12% 2/1605 • 1 year
Gastrointestinal disorders Varices Oesophageal	0.06% 1/1605 • 1 year
Gastrointestinal disorders Vomiting	0.06% 1/1605 • 1 year
General disorders Asthenia	0.12% 2/1605 • 1 year
General disorders Catheter Site Haemorrhage	0.06% 1/1605 • 1 year
General disorders Chest Discomfort	0.12% 2/1605 • 1 year
General disorders Chest Pain	0.56% 9/1605 • 1 year
General disorders Death	1.4% 23/1605 • 1 year
General disorders Dysplasia	0.06% 1/1605 • 1 year
General disorders Fatigue	0.06% 1/1605 • 1 year
General disorders General Physical Health Deterioration	0.06% 1/1605 • 1 year
General disorders Hernia Obstructive	0.06% 1/1605 • 1 year
General disorders Impaired Healing	0.06% 1/1605 • 1 year
General disorders Multi-Organ Failure	0.12% 2/1605 • 1 year
General disorders Non-Cardiac Chest Pain	0.19% 3/1605 • 1 year
General disorders Oedema Peripheral	0.06% 1/1605 • 1 year
General disorders Pain	0.12% 2/1605 • 1 year
General disorders Pyrexia	0.19% 3/1605 • 1 year
Hepatobiliary disorders Cholangitis	0.25% 4/1605 • 1 year
Hepatobiliary disorders Cholecystitis	0.12% 2/1605 • 1 year
Hepatobiliary disorders Cholecystitis Acute	0.12% 2/1605 • 1 year
Hepatobiliary disorders Cholelithiasis	0.12% 2/1605 • 1 year
Hepatobiliary disorders Hepatic Cirrhosis	0.12% 2/1605 • 1 year
Hepatobiliary disorders Jaundice Cholestatic	0.06% 1/1605 • 1 year
Infections and infestations Abdominal Infection	0.06% 1/1605 • 1 year
Infections and infestations Abscess Limb	0.12% 2/1605 • 1 year
Infections and infestations Arthritis Infective	0.06% 1/1605 • 1 year
Infections and infestations Bronchitis	0.25% 4/1605 • 1 year
Infections and infestations Bronchopneumonia	0.06% 1/1605 • 1 year
Infections and infestations Cellulitis	0.37% 6/1605 • 1 year
Infections and infestations Cholecystitis Infective	0.06% 1/1605 • 1 year
Infections and infestations Corona Virus Infection	0.06% 1/1605 • 1 year
Infections and infestations Diverticulitis	0.19% 3/1605 • 1 year
Infections and infestations Endocarditis	0.06% 1/1605 • 1 year
Infections and infestations Erysipelas	0.12% 2/1605 • 1 year
Infections and infestations Gallbladder Abscess	0.06% 1/1605 • 1 year
Infections and infestations Gangrene	0.19% 3/1605 • 1 year
Infections and infestations Gastroenteritis	0.31% 5/1605 • 1 year
Infections and infestations Haematoma Infection	0.06% 1/1605 • 1 year
Infections and infestations Herpes Zoster	0.06% 1/1605 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Neoplasm	0.06% 1/1605 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pleural Mesothelioma	0.06% 1/1605 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.19% 3/1605 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer Metastatic	0.12% 2/1605 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Cancer	0.06% 1/1605 • 1 year
Infections and infestations Infection	0.25% 4/1605 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cancer	0.06% 1/1605 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small Cell Lung Cancer Metastatic	0.06% 1/1605 • 1 year
Infections and infestations Infectious Pleural Effusion	0.06% 1/1605 • 1 year
Infections and infestations Influenza	0.19% 3/1605 • 1 year
Infections and infestations Lobar Pneumonia	0.12% 2/1605 • 1 year
Infections and infestations Localised Infection	0.06% 1/1605 • 1 year
Infections and infestations Lower Respiratory Tract Infection	0.06% 1/1605 • 1 year
Infections and infestations Lung Abscess	0.06% 1/1605 • 1 year
Infections and infestations Muscle Abscess	0.06% 1/1605 • 1 year
Infections and infestations Osteomyelitis	0.06% 1/1605 • 1 year
Infections and infestations Otitis Externa	0.06% 1/1605 • 1 year
Infections and infestations Peritonitis	0.06% 1/1605 • 1 year
Infections and infestations Pharyngitis Streptococcal	0.06% 1/1605 • 1 year
Infections and infestations Pneumonia	2.2% 36/1605 • 1 year
Infections and infestations Postoperative Wound Infection	0.06% 1/1605 • 1 year
Infections and infestations Pyelonephritis Acute	0.06% 1/1605 • 1 year
Infections and infestations Respiratory Tract Infection	0.37% 6/1605 • 1 year
Infections and infestations Sepsis	0.87% 14/1605 • 1 year
Infections and infestations Sepsis Syndrome	0.12% 2/1605 • 1 year
Infections and infestations Septic Shock	0.44% 7/1605 • 1 year
Infections and infestations Severe Acute Respiratory Syndrome	0.06% 1/1605 • 1 year
Infections and infestations Sinusitis	0.06% 1/1605 • 1 year
Infections and infestations Soft Tissue Infection	0.06% 1/1605 • 1 year
Infections and infestations Upper Respiratory Tract Infection	0.12% 2/1605 • 1 year
Infections and infestations Urinary Tract Infection	1.1% 17/1605 • 1 year
Infections and infestations Urosepsis	0.19% 3/1605 • 1 year
Infections and infestations Vulval Abscess	0.06% 1/1605 • 1 year
Infections and infestations Wound Infection	0.19% 3/1605 • 1 year
Injury, poisoning and procedural complications Clavicle Fracture	0.06% 1/1605 • 1 year
Injury, poisoning and procedural complications Compression Fracture	0.06% 1/1605 • 1 year
Injury, poisoning and procedural complications Cranial Nerve Injury	0.06% 1/1605 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma	0.12% 2/1605 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma Of Skin	0.06% 1/1605 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional Cell Carcinoma	0.06% 1/1605 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Urethral Cancer	0.06% 1/1605 • 1 year
Nervous system disorders Aphasia	0.06% 1/1605 • 1 year
Nervous system disorders Carotid Artery Disease	0.06% 1/1605 • 1 year
Nervous system disorders Carotid Artery Stenosis	0.12% 2/1605 • 1 year
Nervous system disorders Cauda Equina Syndrome	0.06% 1/1605 • 1 year
Nervous system disorders Cerebrovascular Accident	0.93% 15/1605 • 1 year
Nervous system disorders Cognitive Disorder	0.12% 2/1605 • 1 year
Nervous system disorders Complex Regional Pain Syndrome	0.06% 1/1605 • 1 year
Nervous system disorders Dementia	0.12% 2/1605 • 1 year
Nervous system disorders Dizziness	0.12% 2/1605 • 1 year
Nervous system disorders Dizziness Postural	0.06% 1/1605 • 1 year
Nervous system disorders Epilepsy	0.06% 1/1605 • 1 year
Nervous system disorders Headache	0.12% 2/1605 • 1 year
Nervous system disorders Hemiparesis	0.06% 1/1605 • 1 year
Nervous system disorders Hepatic Encephalopathy	0.06% 1/1605 • 1 year
Nervous system disorders Hypoaesthesia	0.06% 1/1605 • 1 year
Nervous system disorders Loss Of Consciousness	0.06% 1/1605 • 1 year
Nervous system disorders Lumbar Radiculopathy	0.06% 1/1605 • 1 year
Nervous system disorders Metabolic Encephalopathy	0.12% 2/1605 • 1 year
Nervous system disorders Neurodegenerative Disorder	0.06% 1/1605 • 1 year
Nervous system disorders Subarachnoid Haemorrhage	0.06% 1/1605 • 1 year
Nervous system disorders Syncope	0.93% 15/1605 • 1 year
Nervous system disorders Transient Ischaemic Attack	0.31% 5/1605 • 1 year
Nervous system disorders Viith Nerve Paralysis	0.06% 1/1605 • 1 year
Psychiatric disorders Confusional State	0.06% 1/1605 • 1 year
Psychiatric disorders Delirium	0.06% 1/1605 • 1 year
Psychiatric disorders Mental Disorder	0.06% 1/1605 • 1 year
Renal and urinary disorders Diabetic Nephropathy	0.06% 1/1605 • 1 year
Renal and urinary disorders Haematuria	0.06% 1/1605 • 1 year
Renal and urinary disorders Nephrolithiasis	0.19% 3/1605 • 1 year
Renal and urinary disorders Prerenal Failure	0.06% 1/1605 • 1 year
Renal and urinary disorders Renal Failure	0.44% 7/1605 • 1 year
Renal and urinary disorders Renal Failure Acute	1.2% 20/1605 • 1 year
Renal and urinary disorders Renal Failure Chronic	0.37% 6/1605 • 1 year
Renal and urinary disorders Urinary Retention	0.12% 2/1605 • 1 year
Reproductive system and breast disorders Benign Prostatic Hyperplasia	0.19% 3/1605 • 1 year
Reproductive system and breast disorders Prostatomegaly	0.06% 1/1605 • 1 year
Reproductive system and breast disorders Scrotal Mass	0.06% 1/1605 • 1 year
Respiratory, thoracic and mediastinal disorders Acute Pulmonary Oedema	0.19% 3/1605 • 1 year
Respiratory, thoracic and mediastinal disorders Acute Respiratory Distress Syndrome	0.06% 1/1605 • 1 year
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.75% 12/1605 • 1 year
Respiratory, thoracic and mediastinal disorders Asthma	0.19% 3/1605 • 1 year
Respiratory, thoracic and mediastinal disorders Bronchial Hyperreactivity	0.06% 1/1605 • 1 year
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	1.00% 16/1605 • 1 year
Respiratory, thoracic and mediastinal disorders Cough	0.12% 2/1605 • 1 year
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.5% 24/1605 • 1 year
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.06% 1/1605 • 1 year
Respiratory, thoracic and mediastinal disorders Idiopathic Pulmonary Fibrosis	0.06% 1/1605 • 1 year
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.50% 8/1605 • 1 year
Respiratory, thoracic and mediastinal disorders Pneumonia Aspiration	0.19% 3/1605 • 1 year
Injury, poisoning and procedural complications Fall	0.50% 8/1605 • 1 year
Injury, poisoning and procedural complications Femoral Neck Fracture	0.06% 1/1605 • 1 year
Injury, poisoning and procedural complications Femur Fracture	0.37% 6/1605 • 1 year
Injury, poisoning and procedural complications Foot Fracture	0.06% 1/1605 • 1 year
Injury, poisoning and procedural complications Forearm Fracture	0.06% 1/1605 • 1 year
Injury, poisoning and procedural complications Hip Fracture	0.12% 2/1605 • 1 year
Injury, poisoning and procedural complications Lumbar Vertebral Fracture	0.06% 1/1605 • 1 year
Injury, poisoning and procedural complications Patella Fracture	0.19% 3/1605 • 1 year
Injury, poisoning and procedural complications Pelvic Fracture	0.12% 2/1605 • 1 year
Injury, poisoning and procedural complications Perirenal Haematoma	0.06% 1/1605 • 1 year
Injury, poisoning and procedural complications Pubis Fracture	0.06% 1/1605 • 1 year
Injury, poisoning and procedural complications Rib Fracture	0.06% 1/1605 • 1 year
Injury, poisoning and procedural complications Subdural Haematoma	0.12% 2/1605 • 1 year
Injury, poisoning and procedural complications Tibia Fracture	0.06% 1/1605 • 1 year
Injury, poisoning and procedural complications Toxicity To Various Agents	0.06% 1/1605 • 1 year
Injury, poisoning and procedural complications Vascular Graft Complication	0.06% 1/1605 • 1 year
Injury, poisoning and procedural complications Vascular Pseudoaneurysm	0.31% 5/1605 • 1 year
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.06% 1/1605 • 1 year
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.19% 3/1605 • 1 year
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.25% 4/1605 • 1 year
Respiratory, thoracic and mediastinal disorders Pulmonary Fibrosis	0.06% 1/1605 • 1 year
Respiratory, thoracic and mediastinal disorders Pulmonary Hypertension	0.06% 1/1605 • 1 year
Respiratory, thoracic and mediastinal disorders Pulmonary Mass	0.06% 1/1605 • 1 year
Respiratory, thoracic and mediastinal disorders Pulmonary Oedema	0.25% 4/1605 • 1 year
Respiratory, thoracic and mediastinal disorders Respiratory Arrest	0.06% 1/1605 • 1 year
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.31% 5/1605 • 1 year
Skin and subcutaneous tissue disorders Angioedema	0.06% 1/1605 • 1 year
Skin and subcutaneous tissue disorders Diabetic Foot	0.25% 4/1605 • 1 year
Skin and subcutaneous tissue disorders Skin Ulcer	0.12% 2/1605 • 1 year
Skin and subcutaneous tissue disorders Subcutaneous Emphysema	0.06% 1/1605 • 1 year
Skin and subcutaneous tissue disorders Telangiectasia	0.06% 1/1605 • 1 year
Surgical and medical procedures Arteriovenous Fistula Operation	0.06% 1/1605 • 1 year
Surgical and medical procedures Cardiac Pacemaker Insertion	0.06% 1/1605 • 1 year
Surgical and medical procedures Cataract Operation	0.06% 1/1605 • 1 year
Surgical and medical procedures Colon Polypectomy	0.06% 1/1605 • 1 year
Surgical and medical procedures Hip Arthroplasty	0.06% 1/1605 • 1 year
Surgical and medical procedures Hospitalisation	0.06% 1/1605 • 1 year
Surgical and medical procedures Limb Immobilisation	0.06% 1/1605 • 1 year
Surgical and medical procedures Mitral Valve Repair	0.06% 1/1605 • 1 year
Surgical and medical procedures Osteomyelitis Drainage	0.06% 1/1605 • 1 year
Vascular disorders Aortic Stenosis	0.62% 10/1605 • 1 year
Vascular disorders Arteriovenous Fistula	0.12% 2/1605 • 1 year
Vascular disorders Deep Vein Thrombosis	0.19% 3/1605 • 1 year
Vascular disorders Femoral Arterial Stenosis	0.06% 1/1605 • 1 year
Vascular disorders Haematoma	0.06% 1/1605 • 1 year
Vascular disorders Haemorrhage	5.2% 84/1605 • 1 year
Vascular disorders Hypertension	0.12% 2/1605 • 1 year
Vascular disorders Hypertensive Crisis	0.50% 8/1605 • 1 year
Vascular disorders Hypertensive Emergency	0.12% 2/1605 • 1 year
Vascular disorders Hypotension	0.31% 5/1605 • 1 year
Vascular disorders Intermittent Claudication	0.06% 1/1605 • 1 year
Vascular disorders Orthostatic Hypotension	0.12% 2/1605 • 1 year
Vascular disorders Peripheral Arterial Occlusive Disease	0.19% 3/1605 • 1 year
Vascular disorders Peripheral Ischaemia	0.25% 4/1605 • 1 year
Vascular disorders Peripheral Vascular Disorder	0.06% 1/1605 • 1 year
Vascular disorders Thrombosis	0.06% 1/1605 • 1 year
Vascular disorders Vascular Stenosis	0.06% 1/1605 • 1 year

Other adverse events

Other adverse events
Measure	XIENCE n=1605 participants at risk XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Cardiac disorders Angina Pectoris	7.7% 123/1605 • 1 year
Vascular disorders Haemorrhage	10.8% 173/1605 • 1 year

Additional Information

Lijuan Jenn Wang

Abbott

Phone: 01-408-8453133

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60