Trial Outcomes & Findings for XIENCE 28 Global Study (NCT NCT03355742)
NCT ID: NCT03355742
Last Updated: 2021-03-04
Results Overview
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)
COMPLETED
NA
963 participants
From 1 to 6 months
2021-03-04
Participant Flow
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.
Participant milestones
| Measure |
XIENCE
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 Study
STARTED
|
963
|
|
Overall Study
COMPLETED
|
864
|
|
Overall Study
NOT COMPLETED
|
99
|
Reasons for withdrawal
| Measure |
XIENCE
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 Study
Lost to Follow-up
|
4
|
|
Overall Study
Withdrawal by Subject
|
29
|
|
Overall Study
Physician Decision
|
6
|
|
Overall Study
Death
|
55
|
|
Overall Study
Administrative Closure of the Study, Other Status Change Reason, Missed Visit, Protocol Violation
|
5
|
Baseline Characteristics
The number of participants analyzed includes subjects who were available at that time of analysis
Baseline characteristics by cohort
| Measure |
XIENCE
n=963 Participants
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.
|
|---|---|
|
Age, Continuous
|
76.84 years
STANDARD_DEVIATION 7.73 • n=963 Participants
|
|
Sex: Female, Male
Female
|
320 Participants
n=963 Participants
|
|
Sex: Female, Male
Male
|
643 Participants
n=963 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
145 Participants
n=963 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
360 Participants
n=963 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
458 Participants
n=963 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=963 Participants
|
|
Race (NIH/OMB)
Asian
|
124 Participants
n=963 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=963 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=963 Participants
|
|
Race (NIH/OMB)
White
|
381 Participants
n=963 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=963 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
458 Participants
n=963 Participants
|
|
Region of Enrollment
Singapore
|
22 participants
n=963 Participants
|
|
Region of Enrollment
Hong Kong
|
48 participants
n=963 Participants
|
|
Region of Enrollment
United Kingdom
|
30 participants
n=963 Participants
|
|
Region of Enrollment
Portugal
|
8 participants
n=963 Participants
|
|
Region of Enrollment
Switzerland
|
37 participants
n=963 Participants
|
|
Region of Enrollment
Spain
|
89 participants
n=963 Participants
|
|
Region of Enrollment
Austria
|
3 participants
n=963 Participants
|
|
Region of Enrollment
Netherlands
|
49 participants
n=963 Participants
|
|
Region of Enrollment
Belgium
|
64 participants
n=963 Participants
|
|
Region of Enrollment
China
|
7 participants
n=963 Participants
|
|
Region of Enrollment
Taiwan
|
48 participants
n=963 Participants
|
|
Region of Enrollment
Italy
|
231 participants
n=963 Participants
|
|
Region of Enrollment
Germany
|
327 participants
n=963 Participants
|
|
Prior Percutaneous Coronary Intervention (PCI)
|
276 participants
n=963 Participants
|
|
History of Major Bleeding
|
26 participants
n=961 Participants • The number of participants analyzed includes subjects who were available at that time of analysis
|
PRIMARY outcome
Timeframe: From 1 to 6 monthsPopulation: 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.
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)
Outcome measures
| Measure |
XIENCE
n=828 Participants
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.
|
|---|---|
|
Number of Participants With Composite of Net Adverse Clinical Endpoint (NACE), by Propensity Score Quintiles
Q1
|
2 Participants
|
|
Number of Participants With Composite of Net Adverse Clinical Endpoint (NACE), by Propensity Score Quintiles
Q2
|
5 Participants
|
|
Number of Participants With Composite of Net Adverse Clinical Endpoint (NACE), by Propensity Score Quintiles
Q3
|
10 Participants
|
|
Number of Participants With Composite of Net Adverse Clinical Endpoint (NACE), by Propensity Score Quintiles
Q4
|
15 Participants
|
|
Number of Participants With Composite of Net Adverse Clinical Endpoint (NACE), by Propensity Score Quintiles
Q5
|
40 Participants
|
SECONDARY outcome
Timeframe: From 6 to 12 monthsPopulation: 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.
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)
Outcome measures
| Measure |
XIENCE
n=811 Participants
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.
|
|---|---|
|
Number of Participants With Composite of Net Adverse Clinical Endpoint (NACE)
|
55 Participants
|
SECONDARY outcome
Timeframe: From 1 to 12 monthsPopulation: 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.
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)
Outcome measures
| Measure |
XIENCE
n=825 Participants
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.
|
|---|---|
|
Number of Participants With Composite of Net Adverse Clinical Endpoint (NACE)
|
121 Participants
|
SECONDARY outcome
Timeframe: From 1 to 6 monthsPopulation: 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.
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
| Measure |
XIENCE
n=816 Participants
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.
|
|---|---|
|
Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)
|
4 Participants
|
SECONDARY outcome
Timeframe: From 6 to 12 monthsPopulation: 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.
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
| Measure |
XIENCE
n=791 Participants
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.
|
|---|---|
|
Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)
|
0 Participants
|
SECONDARY outcome
Timeframe: From 1 to 12 monthsPopulation: 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.
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
| Measure |
XIENCE
n=793 Participants
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.
|
|---|---|
|
Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)
|
4 Participants
|
SECONDARY outcome
Timeframe: From 1 to 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
XIENCE
n=828 Participants
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.
|
|---|---|
|
Number of Participants With All Death, Cardiac Death, Vascular Death, Non-cardiovascular Death
|
13 Participants
|
SECONDARY outcome
Timeframe: From 6 to 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
XIENCE
n=811 Participants
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.
|
|---|---|
|
Number of Participants With All Death, Cardiac Death, Vascular Death, Non-cardiovascular Death
|
30 Participants
|
SECONDARY outcome
Timeframe: From 1 to 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
XIENCE
n=825 Participants
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.
|
|---|---|
|
Number of Participants With All Death, Cardiac Death, Vascular Death, Non-cardiovascular Death
|
43 Participants
|
SECONDARY outcome
Timeframe: From 1 to 6 monthsPopulation: 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.
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
Outcome measures
| Measure |
XIENCE
n=828 Participants
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.
|
|---|---|
|
Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)
|
16 Participants
|
SECONDARY outcome
Timeframe: From 6 to 12 monthsPopulation: 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.
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
Outcome measures
| Measure |
XIENCE
n=811 Participants
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.
|
|---|---|
|
Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)
|
11 Participants
|
SECONDARY outcome
Timeframe: From 1 to 12 monthsPopulation: 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.
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
Outcome measures
| Measure |
XIENCE
n=825 Participants
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.
|
|---|---|
|
Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)
|
27 Participants
|
SECONDARY outcome
Timeframe: From 1 to 6 monthsPopulation: 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.
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
Outcome measures
| Measure |
XIENCE
n=828 Participants
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.
|
|---|---|
|
Number of Participants With Composite of Cardiac Death or MI (Modified ARC)
|
22 Participants
|
SECONDARY outcome
Timeframe: From 6 to 12 monthsPopulation: 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.
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
Outcome measures
| Measure |
XIENCE
n=811 Participants
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.
|
|---|---|
|
Number of Participants With Composite of Cardiac Death or MI (Modified ARC)
|
23 Participants
|
SECONDARY outcome
Timeframe: From 1 to 12 monthsPopulation: 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.
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
Outcome measures
| Measure |
XIENCE
n=825 Participants
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.
|
|---|---|
|
Number of Participants With Composite of Cardiac Death or MI (Modified ARC)
|
45 Participants
|
SECONDARY outcome
Timeframe: From 1 to 6 monthsPopulation: 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.
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
| Measure |
XIENCE
n=828 Participants
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.
|
|---|---|
|
Number of Participants With Composite of All Death or All MI (Modified ARC)
|
29 Participants
|
SECONDARY outcome
Timeframe: From 6 to 12 monthsPopulation: 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.
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
| Measure |
XIENCE
n=811 Participants
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.
|
|---|---|
|
Number of Participants With Composite of All Death or All MI (Modified ARC)
|
41 Participants
|
SECONDARY outcome
Timeframe: From 1 to 12 monthsPopulation: 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.
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
| Measure |
XIENCE
n=825 Participants
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.
|
|---|---|
|
Number of Participants With Composite of All Death or All MI (Modified ARC)
|
70 Participants
|
SECONDARY outcome
Timeframe: From 1 to 6 monthsPopulation: 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.
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
| Measure |
XIENCE
n=815 Participants
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.
|
|---|---|
|
Number of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke
|
3 Participants
|
SECONDARY outcome
Timeframe: From 6 to 12 monthsPopulation: 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.
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
| Measure |
XIENCE
n=784 Participants
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.
|
|---|---|
|
Number of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke
|
3 Participants
|
SECONDARY outcome
Timeframe: From 1 to 12 monthsPopulation: 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.
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
| Measure |
XIENCE
n=785 Participants
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.
|
|---|---|
|
Number of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke
|
6 Participants
|
SECONDARY outcome
Timeframe: From 1 to 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
XIENCE
n=828 Participants
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.
|
|---|---|
|
Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)
|
7 Participants
|
SECONDARY outcome
Timeframe: From 6 to 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
XIENCE
n=811 Participants
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.
|
|---|---|
|
Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)
|
3 Participants
|
SECONDARY outcome
Timeframe: From 1 to 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
XIENCE
n=825 Participants
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.
|
|---|---|
|
Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)
|
10 Participants
|
SECONDARY outcome
Timeframe: From 1 to 6 monthsPopulation: 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.
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
| Measure |
XIENCE
n=828 Participants
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.
|
|---|---|
|
Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR)
|
5 Participants
|
SECONDARY outcome
Timeframe: From 6 to 12 monthsPopulation: 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.
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
| Measure |
XIENCE
n=811 Participants
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.
|
|---|---|
|
Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR)
|
4 Participants
|
SECONDARY outcome
Timeframe: From 1 to 12 monthsPopulation: 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.
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
| Measure |
XIENCE
n=825 Participants
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.
|
|---|---|
|
Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR)
|
9 Participants
|
SECONDARY outcome
Timeframe: From 1 to 6 monthsPopulation: 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.
TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.
Outcome measures
| Measure |
XIENCE
n=828 Participants
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.
|
|---|---|
|
Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)
|
21 Participants
|
SECONDARY outcome
Timeframe: From 6 to 12 monthsPopulation: 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.
TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.
Outcome measures
| Measure |
XIENCE
n=811 Participants
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.
|
|---|---|
|
Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)
|
21 Participants
|
SECONDARY outcome
Timeframe: From 1 to 12 monthsPopulation: 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.
TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.
Outcome measures
| Measure |
XIENCE
n=825 Participants
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.
|
|---|---|
|
Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)
|
42 Participants
|
SECONDARY outcome
Timeframe: From 1 to 6 monthsPopulation: 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.
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
| Measure |
XIENCE
n=828 Participants
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.
|
|---|---|
|
Number of Participants With Target Vessel Failure (TVF, a Composite of Cardiac Death, TV-MI and CI-TVR)
|
22 Participants
|
SECONDARY outcome
Timeframe: From 6 to 12 monthsPopulation: 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.
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
| Measure |
XIENCE
n=811 Participants
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.
|
|---|---|
|
Number of Participants With Target Vessel Failure (TVF, a Composite of Cardiac Death, TV-MI and CI-TVR)
|
22 Participants
|
SECONDARY outcome
Timeframe: From 1 to 12 monthsPopulation: 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.
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
| Measure |
XIENCE
n=825 Participants
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.
|
|---|---|
|
Number of Participants With Target Vessel Failure (TVF, a Composite of Cardiac Death, TV-MI and CI-TVR)
|
44 Participants
|
SECONDARY outcome
Timeframe: From 1 to 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
XIENCE
n=817 Participants
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.
|
|---|---|
|
Number of Participants With Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 2-5 and Type 3-5
BARC Type 2-5
|
44 Participants
|
|
Number of Participants With Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 2-5 and Type 3-5
BARC Type 3-5
|
20 Participants
|
SECONDARY outcome
Timeframe: From 6 to 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
XIENCE
n=789 Participants
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.
|
|---|---|
|
Number of Participants With Bleeding Defined by the BARC, Type 2-5 and Type 3-5
BARC Type 2-5
|
19 Participants
|
|
Number of Participants With Bleeding Defined by the BARC, Type 2-5 and Type 3-5
BARC Type 3-5
|
7 Participants
|
SECONDARY outcome
Timeframe: From 1 to 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
XIENCE
n=792 Participants
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.
|
|---|---|
|
Number of Participants With Bleeding Defined by BARC, Type 2-5 and Type 3-5
BARC Type 2-5
|
61 Participants
|
|
Number of Participants With Bleeding Defined by BARC, Type 2-5 and Type 3-5
BARC Type 3-5
|
27 Participants
|
Adverse Events
XIENCE
Serious adverse events
| Measure |
XIENCE
n=963 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
11/963 • 1 Year
|
|
Blood and lymphatic system disorders
Bicytopenia
|
0.10%
1/963 • 1 Year
|
|
Blood and lymphatic system disorders
Hypochromic Anaemia
|
0.10%
1/963 • 1 Year
|
|
Blood and lymphatic system disorders
Nephrogenic Anaemia
|
0.10%
1/963 • 1 Year
|
|
Blood and lymphatic system disorders
Normochromic Normocytic Anaemia
|
0.10%
1/963 • 1 Year
|
|
Cardiac disorders
Angina Pectoris
|
5.7%
55/963 • 1 Year
|
|
Cardiac disorders
Angina Unstable
|
0.10%
1/963 • 1 Year
|
|
Cardiac disorders
Aortic Valve Incompetence
|
0.21%
2/963 • 1 Year
|
|
Cardiac disorders
Aortic Valve Stenosis
|
0.31%
3/963 • 1 Year
|
|
Cardiac disorders
Arrhythmia
|
0.21%
2/963 • 1 Year
|
|
Cardiac disorders
Atrial Fibrillation
|
2.8%
27/963 • 1 Year
|
|
Cardiac disorders
Atrial Flutter
|
0.31%
3/963 • 1 Year
|
|
Cardiac disorders
Atrial Tachycardia
|
0.10%
1/963 • 1 Year
|
|
Cardiac disorders
Atrioventricular Block
|
0.21%
2/963 • 1 Year
|
|
Cardiac disorders
Atrioventricular Block Complete
|
0.31%
3/963 • 1 Year
|
|
Cardiac disorders
Atrioventricular Block Second Degree
|
0.10%
1/963 • 1 Year
|
|
Cardiac disorders
Bifascicular Block
|
0.10%
1/963 • 1 Year
|
|
Cardiac disorders
Bradycardia
|
0.31%
3/963 • 1 Year
|
|
Cardiac disorders
Cardiac Failure
|
3.1%
30/963 • 1 Year
|
|
Cardiac disorders
Cardiac Failure Acute
|
0.62%
6/963 • 1 Year
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.42%
4/963 • 1 Year
|
|
Cardiac disorders
Cardiac Tamponade
|
0.10%
1/963 • 1 Year
|
|
Cardiac disorders
Cardiomyopathy
|
0.10%
1/963 • 1 Year
|
|
Cardiac disorders
Congestive Cardiomyopathy
|
0.10%
1/963 • 1 Year
|
|
Cardiac disorders
Coronary Artery Disease
|
0.73%
7/963 • 1 Year
|
|
Cardiac disorders
Dressler's Syndrome
|
0.10%
1/963 • 1 Year
|
|
Cardiac disorders
Mitral Valve Incompetence
|
0.52%
5/963 • 1 Year
|
|
Cardiac disorders
Myocardial Infarction
|
1.9%
18/963 • 1 Year
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.10%
1/963 • 1 Year
|
|
Cardiac disorders
Myopericarditis
|
0.10%
1/963 • 1 Year
|
|
Cardiac disorders
Palpitations
|
0.10%
1/963 • 1 Year
|
|
Cardiac disorders
Pericarditis
|
0.10%
1/963 • 1 Year
|
|
Cardiac disorders
Pleuropericarditis
|
0.10%
1/963 • 1 Year
|
|
Cardiac disorders
Right Ventricular Failure
|
0.10%
1/963 • 1 Year
|
|
Cardiac disorders
Sick Sinus Syndrome
|
0.31%
3/963 • 1 Year
|
|
Cardiac disorders
Sinoatrial Block
|
0.10%
1/963 • 1 Year
|
|
Cardiac disorders
Sinus Bradycardia
|
0.21%
2/963 • 1 Year
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.21%
2/963 • 1 Year
|
|
Cardiac disorders
Tachyarrhythmia
|
0.42%
4/963 • 1 Year
|
|
Cardiac disorders
Tricuspid Valve Incompetence
|
0.21%
2/963 • 1 Year
|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.31%
3/963 • 1 Year
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.10%
1/963 • 1 Year
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.52%
5/963 • 1 Year
|
|
Ear and labyrinth disorders
Vertigo
|
0.31%
3/963 • 1 Year
|
|
Ear and labyrinth disorders
Vertigo Positional
|
0.21%
2/963 • 1 Year
|
|
Endocrine disorders
Hypothyroidism
|
0.10%
1/963 • 1 Year
|
|
Eye disorders
Retinal Artery Occlusion
|
0.10%
1/963 • 1 Year
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.42%
4/963 • 1 Year
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.10%
1/963 • 1 Year
|
|
Gastrointestinal disorders
Colonic Polyp
|
0.21%
2/963 • 1 Year
|
|
Gastrointestinal disorders
Constipation
|
0.10%
1/963 • 1 Year
|
|
Gastrointestinal disorders
Diarrhoea
|
0.10%
1/963 • 1 Year
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
0.10%
1/963 • 1 Year
|
|
Gastrointestinal disorders
Enteritis
|
0.21%
2/963 • 1 Year
|
|
Gastrointestinal disorders
Faeces Discoloured
|
0.10%
1/963 • 1 Year
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.10%
1/963 • 1 Year
|
|
Gastrointestinal disorders
Gastritis
|
0.10%
1/963 • 1 Year
|
|
Gastrointestinal disorders
Gastritis Erosive
|
0.21%
2/963 • 1 Year
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.10%
1/963 • 1 Year
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.21%
2/963 • 1 Year
|
|
Gastrointestinal disorders
Intestinal Ischaemia
|
0.10%
1/963 • 1 Year
|
|
Gastrointestinal disorders
Nausea
|
0.10%
1/963 • 1 Year
|
|
Gastrointestinal disorders
Peritoneal Haemorrhage
|
0.10%
1/963 • 1 Year
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.10%
1/963 • 1 Year
|
|
Gastrointestinal disorders
Vomiting
|
0.10%
1/963 • 1 Year
|
|
General disorders
Chest Pain
|
0.52%
5/963 • 1 Year
|
|
General disorders
Death
|
1.6%
15/963 • 1 Year
|
|
General disorders
General Physical Health Deterioration
|
0.10%
1/963 • 1 Year
|
|
General disorders
Hernia Obstructive
|
0.10%
1/963 • 1 Year
|
|
General disorders
Impaired Healing
|
0.10%
1/963 • 1 Year
|
|
General disorders
Multi-Organ Failure
|
0.21%
2/963 • 1 Year
|
|
General disorders
Pain
|
0.21%
2/963 • 1 Year
|
|
General disorders
Pyrexia
|
0.31%
3/963 • 1 Year
|
|
Hepatobiliary disorders
Cholangitis
|
0.42%
4/963 • 1 Year
|
|
Hepatobiliary disorders
Cholecystitis
|
0.21%
2/963 • 1 Year
|
|
Hepatobiliary disorders
Hepatic Cirrhosis
|
0.10%
1/963 • 1 Year
|
|
Hepatobiliary disorders
Jaundice Cholestatic
|
0.10%
1/963 • 1 Year
|
|
Infections and infestations
Abscess Limb
|
0.21%
2/963 • 1 Year
|
|
Infections and infestations
Arthritis Infective
|
0.10%
1/963 • 1 Year
|
|
Infections and infestations
Bronchitis
|
0.42%
4/963 • 1 Year
|
|
Infections and infestations
Bronchopneumonia
|
0.10%
1/963 • 1 Year
|
|
Infections and infestations
Cellulitis
|
0.31%
3/963 • 1 Year
|
|
Infections and infestations
Cholecystitis Infective
|
0.10%
1/963 • 1 Year
|
|
Infections and infestations
Diverticulitis
|
0.10%
1/963 • 1 Year
|
|
Infections and infestations
Endocarditis
|
0.10%
1/963 • 1 Year
|
|
Infections and infestations
Erysipelas
|
0.21%
2/963 • 1 Year
|
|
Infections and infestations
Gangrene
|
0.10%
1/963 • 1 Year
|
|
Infections and infestations
Gastroenteritis
|
0.52%
5/963 • 1 Year
|
|
Infections and infestations
Haematoma Infection
|
0.10%
1/963 • 1 Year
|
|
Infections and infestations
Herpes Zoster
|
0.10%
1/963 • 1 Year
|
|
Infections and infestations
Infection
|
0.42%
4/963 • 1 Year
|
|
Infections and infestations
Infectious Pleural Effusion
|
0.10%
1/963 • 1 Year
|
|
Infections and infestations
Influenza
|
0.10%
1/963 • 1 Year
|
|
Infections and infestations
Lobar Pneumonia
|
0.10%
1/963 • 1 Year
|
|
Infections and infestations
Localised Infection
|
0.10%
1/963 • 1 Year
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.10%
1/963 • 1 Year
|
|
Infections and infestations
Lung Abscess
|
0.10%
1/963 • 1 Year
|
|
Infections and infestations
Muscle Abscess
|
0.10%
1/963 • 1 Year
|
|
Infections and infestations
Osteomyelitis
|
0.10%
1/963 • 1 Year
|
|
Infections and infestations
Otitis Externa
|
0.10%
1/963 • 1 Year
|
|
Infections and infestations
Peritonitis
|
0.10%
1/963 • 1 Year
|
|
Infections and infestations
Pneumonia
|
2.3%
22/963 • 1 Year
|
|
Infections and infestations
Pyelonephritis Acute
|
0.10%
1/963 • 1 Year
|
|
Infections and infestations
Respiratory Tract Infection
|
0.62%
6/963 • 1 Year
|
|
Infections and infestations
Sepsis
|
0.62%
6/963 • 1 Year
|
|
Infections and infestations
Septic Shock
|
0.42%
4/963 • 1 Year
|
|
Infections and infestations
Sinusitis
|
0.10%
1/963 • 1 Year
|
|
Infections and infestations
Soft Tissue Infection
|
0.10%
1/963 • 1 Year
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.21%
2/963 • 1 Year
|
|
Infections and infestations
Urinary Tract Infection
|
1.0%
10/963 • 1 Year
|
|
Infections and infestations
Vulval Abscess
|
0.10%
1/963 • 1 Year
|
|
Infections and infestations
Wound Infection
|
0.21%
2/963 • 1 Year
|
|
Injury, poisoning and procedural complications
Clavicle Fracture
|
0.10%
1/963 • 1 Year
|
|
Injury, poisoning and procedural complications
Compression Fracture
|
0.10%
1/963 • 1 Year
|
|
Injury, poisoning and procedural complications
Cranial Nerve Injury
|
0.10%
1/963 • 1 Year
|
|
Injury, poisoning and procedural complications
Fall
|
0.52%
5/963 • 1 Year
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.10%
1/963 • 1 Year
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.52%
5/963 • 1 Year
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.10%
1/963 • 1 Year
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.10%
1/963 • 1 Year
|
|
Injury, poisoning and procedural complications
Patella Fracture
|
0.21%
2/963 • 1 Year
|
|
Injury, poisoning and procedural complications
Pelvic Fracture
|
0.21%
2/963 • 1 Year
|
|
Injury, poisoning and procedural complications
Pubis Fracture
|
0.10%
1/963 • 1 Year
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.10%
1/963 • 1 Year
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.10%
1/963 • 1 Year
|
|
Injury, poisoning and procedural complications
Vascular Pseudoaneurysm
|
0.10%
1/963 • 1 Year
|
|
Investigations
Arteriogram Coronary
|
0.10%
1/963 • 1 Year
|
|
Investigations
Blood Pressure Abnormal
|
0.10%
1/963 • 1 Year
|
|
Investigations
Ejection Fraction Decreased
|
0.10%
1/963 • 1 Year
|
|
Investigations
Electrocardiogram Abnormal
|
0.10%
1/963 • 1 Year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.10%
1/963 • 1 Year
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.31%
3/963 • 1 Year
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.10%
1/963 • 1 Year
|
|
Metabolism and nutrition disorders
Fluid Overload
|
0.42%
4/963 • 1 Year
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.10%
1/963 • 1 Year
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.21%
2/963 • 1 Year
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.10%
1/963 • 1 Year
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
0.10%
1/963 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.10%
1/963 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.21%
2/963 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.10%
1/963 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.10%
1/963 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Joint Effusion
|
0.10%
1/963 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
0.10%
1/963 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.10%
1/963 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Disorder
|
0.10%
1/963 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.0%
10/963 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.10%
1/963 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.10%
1/963 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.10%
1/963 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Systemic Lupus Erythematosus
|
0.10%
1/963 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Lymphocytic Leukaemia Re
|
0.10%
1/963 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Biliary Neoplasm
|
0.21%
2/963 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
0.21%
2/963 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Transitional Cell Carc
|
0.10%
1/963 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.10%
1/963 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial Cancer
|
0.10%
1/963 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer
|
0.10%
1/963 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal Tract Adenoma
|
0.10%
1/963 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Neoplasm Malignant
|
0.10%
1/963 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.10%
1/963 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Cancer Metastatic
|
0.10%
1/963 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm
|
0.21%
2/963 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.21%
2/963 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple Myeloma
|
0.10%
1/963 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic Syndrome
|
0.10%
1/963 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelofibrosis
|
0.10%
1/963 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm Malignant
|
0.10%
1/963 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal Adenocarcinoma
|
0.10%
1/963 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma
|
0.10%
1/963 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Neoplasm
|
0.10%
1/963 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleural Mesothelioma
|
0.10%
1/963 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.21%
2/963 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer Metastatic
|
0.10%
1/963 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cancer
|
0.10%
1/963 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.21%
2/963 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional Cell Carcinoma
|
0.10%
1/963 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Urethral Cancer
|
0.10%
1/963 • 1 Year
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.10%
1/963 • 1 Year
|
|
Nervous system disorders
Cauda Equina Syndrome
|
0.10%
1/963 • 1 Year
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.73%
7/963 • 1 Year
|
|
Nervous system disorders
Cognitive Disorder
|
0.10%
1/963 • 1 Year
|
|
Nervous system disorders
Complex Regional Pain Syndrome
|
0.10%
1/963 • 1 Year
|
|
Nervous system disorders
Dementia
|
0.21%
2/963 • 1 Year
|
|
Nervous system disorders
Dizziness Postural
|
0.10%
1/963 • 1 Year
|
|
Nervous system disorders
Epilepsy
|
0.10%
1/963 • 1 Year
|
|
Nervous system disorders
Headache
|
0.21%
2/963 • 1 Year
|
|
Nervous system disorders
Hepatic Encephalopathy
|
0.10%
1/963 • 1 Year
|
|
Nervous system disorders
Loss Of Consciousness
|
0.10%
1/963 • 1 Year
|
|
Nervous system disorders
Neurodegenerative Disorder
|
0.10%
1/963 • 1 Year
|
|
Nervous system disorders
Syncope
|
0.52%
5/963 • 1 Year
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.21%
2/963 • 1 Year
|
|
Nervous system disorders
Viith Nerve Paralysis
|
0.10%
1/963 • 1 Year
|
|
Psychiatric disorders
Confusional State
|
0.10%
1/963 • 1 Year
|
|
Psychiatric disorders
Delirium
|
0.10%
1/963 • 1 Year
|
|
Psychiatric disorders
Mental Disorder
|
0.10%
1/963 • 1 Year
|
|
Renal and urinary disorders
Diabetic Nephropathy
|
0.10%
1/963 • 1 Year
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.10%
1/963 • 1 Year
|
|
Renal and urinary disorders
Prerenal Failure
|
0.10%
1/963 • 1 Year
|
|
Renal and urinary disorders
Renal Failure
|
0.62%
6/963 • 1 Year
|
|
Renal and urinary disorders
Renal Failure Acute
|
1.3%
13/963 • 1 Year
|
|
Renal and urinary disorders
Renal Failure Chronic
|
0.31%
3/963 • 1 Year
|
|
Renal and urinary disorders
Urinary Retention
|
0.21%
2/963 • 1 Year
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.21%
2/963 • 1 Year
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.10%
1/963 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
0.21%
2/963 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.10%
1/963 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.10%
1/963 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Hyperreactivity
|
0.10%
1/963 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.93%
9/963 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.10%
1/963 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.0%
10/963 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.10%
1/963 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic Pulmonary Fibrosis
|
0.10%
1/963 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.42%
4/963 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.31%
3/963 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.21%
2/963 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.21%
2/963 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Fibrosis
|
0.10%
1/963 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.10%
1/963 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.10%
1/963 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Diabetic Foot
|
0.21%
2/963 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.21%
2/963 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Subcutaneous Emphysema
|
0.10%
1/963 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
0.10%
1/963 • 1 Year
|
|
Surgical and medical procedures
Arteriovenous Fistula Operation
|
0.10%
1/963 • 1 Year
|
|
Surgical and medical procedures
Cardiac Pacemaker Insertion
|
0.10%
1/963 • 1 Year
|
|
Surgical and medical procedures
Cataract Operation
|
0.10%
1/963 • 1 Year
|
|
Surgical and medical procedures
Colon Polypectomy
|
0.10%
1/963 • 1 Year
|
|
Surgical and medical procedures
Hip Arthroplasty
|
0.10%
1/963 • 1 Year
|
|
Surgical and medical procedures
Hospitalisation
|
0.10%
1/963 • 1 Year
|
|
Surgical and medical procedures
Limb Immobilisation
|
0.10%
1/963 • 1 Year
|
|
Vascular disorders
Aortic Stenosis
|
0.62%
6/963 • 1 Year
|
|
Vascular disorders
Arteriovenous Fistula
|
0.21%
2/963 • 1 Year
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.10%
1/963 • 1 Year
|
|
Vascular disorders
Femoral Arterial Stenosis
|
0.10%
1/963 • 1 Year
|
|
Vascular disorders
Haemorrhage
|
5.6%
54/963 • 1 Year
|
|
Vascular disorders
Hypertension
|
0.21%
2/963 • 1 Year
|
|
Vascular disorders
Hypertensive Crisis
|
0.62%
6/963 • 1 Year
|
|
Vascular disorders
Hypotension
|
0.10%
1/963 • 1 Year
|
|
Vascular disorders
Orthostatic Hypotension
|
0.10%
1/963 • 1 Year
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.21%
2/963 • 1 Year
|
|
Vascular disorders
Peripheral Ischaemia
|
0.21%
2/963 • 1 Year
|
|
Vascular disorders
Thrombosis
|
0.10%
1/963 • 1 Year
|
|
Vascular disorders
Vascular Stenosis
|
0.10%
1/963 • 1 Year
|
Other adverse events
| Measure |
XIENCE
n=963 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.62%
6/963 • 1 Year
|
|
Blood and lymphatic system disorders
Hypochromic Anaemia
|
0.10%
1/963 • 1 Year
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.21%
2/963 • 1 Year
|
|
Blood and lymphatic system disorders
Microcytic Anaemia
|
0.10%
1/963 • 1 Year
|
|
Blood and lymphatic system disorders
Normochromic Normocytic Anaemia
|
0.10%
1/963 • 1 Year
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.10%
1/963 • 1 Year
|
|
Blood and lymphatic system disorders
Spontaneous Haematoma
|
0.10%
1/963 • 1 Year
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.10%
1/963 • 1 Year
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.10%
1/963 • 1 Year
|
|
Cardiac disorders
Angina Pectoris
|
5.6%
54/963 • 1 Year
|
|
Cardiac disorders
Atrial Fibrillation
|
1.6%
15/963 • 1 Year
|
|
Cardiac disorders
Atrial Flutter
|
0.10%
1/963 • 1 Year
|
|
Cardiac disorders
Atrial Thrombosis
|
0.10%
1/963 • 1 Year
|
|
Cardiac disorders
Atrioventricular Block Complete
|
0.10%
1/963 • 1 Year
|
|
Cardiac disorders
Atrioventricular Block First Degree
|
0.31%
3/963 • 1 Year
|
|
Cardiac disorders
Atrioventricular Block Second Degree
|
0.10%
1/963 • 1 Year
|
|
Cardiac disorders
Bradyarrhythmia
|
0.10%
1/963 • 1 Year
|
|
Cardiac disorders
Bradycardia
|
0.42%
4/963 • 1 Year
|
|
Cardiac disorders
Bundle Branch Block Left
|
0.21%
2/963 • 1 Year
|
|
Cardiac disorders
Bundle Branch Block Right
|
0.10%
1/963 • 1 Year
|
|
Cardiac disorders
Cardiac Arrest
|
0.10%
1/963 • 1 Year
|
|
Cardiac disorders
Cardiac Failure
|
0.73%
7/963 • 1 Year
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.10%
1/963 • 1 Year
|
|
Cardiac disorders
Coronary Artery Dissection
|
0.10%
1/963 • 1 Year
|
|
Cardiac disorders
Myocardial Infarction
|
0.21%
2/963 • 1 Year
|
|
Cardiac disorders
Palpitations
|
0.83%
8/963 • 1 Year
|
|
Cardiac disorders
Pericardial Effusion
|
0.10%
1/963 • 1 Year
|
|
Cardiac disorders
Pericarditis
|
0.10%
1/963 • 1 Year
|
|
Cardiac disorders
Tachyarrhythmia
|
0.10%
1/963 • 1 Year
|
|
Cardiac disorders
Tachycardia
|
0.21%
2/963 • 1 Year
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.10%
1/963 • 1 Year
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.10%
1/963 • 1 Year
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.10%
1/963 • 1 Year
|
|
Ear and labyrinth disorders
Vertigo
|
0.83%
8/963 • 1 Year
|
|
Eye disorders
Cataract
|
0.10%
1/963 • 1 Year
|
|
Eye disorders
Conjunctivitis
|
0.10%
1/963 • 1 Year
|
|
Eye disorders
Visual Impairment
|
0.10%
1/963 • 1 Year
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.10%
1/963 • 1 Year
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.31%
3/963 • 1 Year
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.42%
4/963 • 1 Year
|
|
Gastrointestinal disorders
Aphthous Stomatitis
|
0.10%
1/963 • 1 Year
|
|
Gastrointestinal disorders
Constipation
|
0.10%
1/963 • 1 Year
|
|
Gastrointestinal disorders
Diarrhoea
|
0.62%
6/963 • 1 Year
|
|
Gastrointestinal disorders
Diverticulum
|
0.21%
2/963 • 1 Year
|
|
Gastrointestinal disorders
Dry Mouth
|
0.10%
1/963 • 1 Year
|
|
Gastrointestinal disorders
Dyspepsia
|
0.21%
2/963 • 1 Year
|
|
Gastrointestinal disorders
Epigastric Discomfort
|
0.10%
1/963 • 1 Year
|
|
Gastrointestinal disorders
Gastric Disorder
|
0.10%
1/963 • 1 Year
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.10%
1/963 • 1 Year
|
|
Gastrointestinal disorders
Gastritis
|
0.83%
8/963 • 1 Year
|
|
Gastrointestinal disorders
Gastritis Erosive
|
0.10%
1/963 • 1 Year
|
|
Gastrointestinal disorders
Gingival Bleeding
|
0.10%
1/963 • 1 Year
|
|
Gastrointestinal disorders
Haematochezia
|
0.10%
1/963 • 1 Year
|
|
Gastrointestinal disorders
Hiatus Hernia
|
0.10%
1/963 • 1 Year
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.10%
1/963 • 1 Year
|
|
Gastrointestinal disorders
Nausea
|
0.10%
1/963 • 1 Year
|
|
Gastrointestinal disorders
Peptic Ulcer
|
0.10%
1/963 • 1 Year
|
|
Gastrointestinal disorders
Tooth Loss
|
0.10%
1/963 • 1 Year
|
|
Gastrointestinal disorders
Toothache
|
0.21%
2/963 • 1 Year
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.10%
1/963 • 1 Year
|
|
Gastrointestinal disorders
Vomiting
|
0.42%
4/963 • 1 Year
|
|
General disorders
Chest Discomfort
|
0.42%
4/963 • 1 Year
|
|
General disorders
Chest Pain
|
0.52%
5/963 • 1 Year
|
|
General disorders
Fatigue
|
0.31%
3/963 • 1 Year
|
|
General disorders
Impaired Healing
|
0.10%
1/963 • 1 Year
|
|
General disorders
Nodule
|
0.10%
1/963 • 1 Year
|
|
General disorders
Non-Cardiac Chest Pain
|
0.42%
4/963 • 1 Year
|
|
General disorders
Oedema
|
0.31%
3/963 • 1 Year
|
|
General disorders
Oedema Peripheral
|
0.93%
9/963 • 1 Year
|
|
General disorders
Pacemaker Generated Arrhythmia
|
0.10%
1/963 • 1 Year
|
|
General disorders
Pain
|
0.21%
2/963 • 1 Year
|
|
General disorders
Pyrexia
|
0.21%
2/963 • 1 Year
|
|
General disorders
Spinal Pain
|
0.10%
1/963 • 1 Year
|
|
General disorders
Ulcer
|
0.21%
2/963 • 1 Year
|
|
Hepatobiliary disorders
Biliary Colic
|
0.10%
1/963 • 1 Year
|
|
Hepatobiliary disorders
Hepatic Cirrhosis
|
0.10%
1/963 • 1 Year
|
|
Hepatobiliary disorders
Hepatic Steatosis
|
0.31%
3/963 • 1 Year
|
|
Hepatobiliary disorders
Liver Disorder
|
0.10%
1/963 • 1 Year
|
|
Infections and infestations
Asymptomatic Bacteriuria
|
0.10%
1/963 • 1 Year
|
|
Infections and infestations
Bronchitis
|
0.21%
2/963 • 1 Year
|
|
Infections and infestations
Bronchopneumonia
|
0.10%
1/963 • 1 Year
|
|
Infections and infestations
Cellulitis
|
0.10%
1/963 • 1 Year
|
|
Infections and infestations
Cystitis
|
0.21%
2/963 • 1 Year
|
|
Infections and infestations
Enterobiasis
|
0.10%
1/963 • 1 Year
|
|
Infections and infestations
Erysipelas
|
0.10%
1/963 • 1 Year
|
|
Infections and infestations
Gastroenteritis
|
0.10%
1/963 • 1 Year
|
|
Infections and infestations
Gastroenteritis Viral
|
0.10%
1/963 • 1 Year
|
|
Infections and infestations
Herpes Zoster
|
0.10%
1/963 • 1 Year
|
|
Infections and infestations
Influenza
|
0.21%
2/963 • 1 Year
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.10%
1/963 • 1 Year
|
|
Infections and infestations
Lung Infection
|
0.10%
1/963 • 1 Year
|
|
Infections and infestations
Nasopharyngitis
|
0.52%
5/963 • 1 Year
|
|
Infections and infestations
Osteomyelitis
|
0.10%
1/963 • 1 Year
|
|
Infections and infestations
Paronychia
|
0.10%
1/963 • 1 Year
|
|
Infections and infestations
Pneumonia
|
0.73%
7/963 • 1 Year
|
|
Infections and infestations
Respiratory Tract Infection
|
0.10%
1/963 • 1 Year
|
|
Infections and infestations
Sinusitis
|
0.10%
1/963 • 1 Year
|
|
Infections and infestations
Tinea Cruris
|
0.10%
1/963 • 1 Year
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.21%
2/963 • 1 Year
|
|
Infections and infestations
Urethritis
|
0.21%
2/963 • 1 Year
|
|
Infections and infestations
Urinary Tract Infection
|
1.6%
15/963 • 1 Year
|
|
Infections and infestations
Vaginal Infection
|
0.10%
1/963 • 1 Year
|
|
Infections and infestations
Viral Infection
|
0.10%
1/963 • 1 Year
|
|
Injury, poisoning and procedural complications
Cardiac Procedure Complication
|
0.21%
2/963 • 1 Year
|
|
Injury, poisoning and procedural complications
Contusion
|
0.31%
3/963 • 1 Year
|
|
Injury, poisoning and procedural complications
Fall
|
0.62%
6/963 • 1 Year
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.10%
1/963 • 1 Year
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.10%
1/963 • 1 Year
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.10%
1/963 • 1 Year
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.10%
1/963 • 1 Year
|
|
Injury, poisoning and procedural complications
Vascular Pseudoaneurysm
|
0.42%
4/963 • 1 Year
|
|
Injury, poisoning and procedural complications
Wound
|
0.10%
1/963 • 1 Year
|
|
Injury, poisoning and procedural complications
Wound Complication
|
0.10%
1/963 • 1 Year
|
|
Investigations
Blood Calcium Increased
|
0.10%
1/963 • 1 Year
|
|
Investigations
Blood Creatinine Increased
|
0.21%
2/963 • 1 Year
|
|
Investigations
Blood Glucose Abnormal
|
0.10%
1/963 • 1 Year
|
|
Investigations
Blood Thyroid Stimulating Hormone Increased
|
0.10%
1/963 • 1 Year
|
|
Investigations
Cardiac Enzymes Increased
|
0.10%
1/963 • 1 Year
|
|
Investigations
Ejection Fraction Decreased
|
0.21%
2/963 • 1 Year
|
|
Investigations
Glycosylated Haemoglobin Increased
|
0.10%
1/963 • 1 Year
|
|
Investigations
Haemoglobin Decreased
|
0.10%
1/963 • 1 Year
|
|
Investigations
Prostatic Specific Antigen Increased
|
0.10%
1/963 • 1 Year
|
|
Investigations
Troponin I Increased
|
0.10%
1/963 • 1 Year
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.10%
1/963 • 1 Year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.10%
1/963 • 1 Year
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.42%
4/963 • 1 Year
|
|
Metabolism and nutrition disorders
Diabetes Mellitus Inadequate Control
|
0.10%
1/963 • 1 Year
|
|
Metabolism and nutrition disorders
Gout
|
0.10%
1/963 • 1 Year
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.10%
1/963 • 1 Year
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.21%
2/963 • 1 Year
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.10%
1/963 • 1 Year
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.10%
1/963 • 1 Year
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.42%
4/963 • 1 Year
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.31%
3/963 • 1 Year
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.10%
1/963 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.31%
3/963 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.10%
1/963 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.31%
3/963 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.10%
1/963 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.10%
1/963 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Foot Deformity
|
0.10%
1/963 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.10%
1/963 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.31%
3/963 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Muscle Fatigue
|
0.10%
1/963 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.10%
1/963 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.10%
1/963 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.21%
2/963 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.52%
5/963 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.21%
2/963 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.21%
2/963 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.62%
6/963 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.10%
1/963 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Systemic Sclerosis
|
0.10%
1/963 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.10%
1/963 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Neoplasm
|
0.10%
1/963 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.10%
1/963 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm Malignant
|
0.10%
1/963 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal Papilloma
|
0.10%
1/963 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.10%
1/963 • 1 Year
|
|
Nervous system disorders
Amnesia
|
0.10%
1/963 • 1 Year
|
|
Nervous system disorders
Balance Disorder
|
0.10%
1/963 • 1 Year
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.31%
3/963 • 1 Year
|
|
Nervous system disorders
Cervicogenic Headache
|
0.10%
1/963 • 1 Year
|
|
Nervous system disorders
Dizziness
|
0.93%
9/963 • 1 Year
|
|
Nervous system disorders
Dizziness Postural
|
0.10%
1/963 • 1 Year
|
|
Nervous system disorders
Headache
|
0.42%
4/963 • 1 Year
|
|
Nervous system disorders
Paraesthesia
|
0.10%
1/963 • 1 Year
|
|
Nervous system disorders
Petit Mal Epilepsy
|
0.10%
1/963 • 1 Year
|
|
Nervous system disorders
Polyneuropathy
|
0.21%
2/963 • 1 Year
|
|
Nervous system disorders
Presyncope
|
0.21%
2/963 • 1 Year
|
|
Nervous system disorders
Restless Legs Syndrome
|
0.10%
1/963 • 1 Year
|
|
Nervous system disorders
Sciatica
|
0.10%
1/963 • 1 Year
|
|
Nervous system disorders
Syncope
|
0.42%
4/963 • 1 Year
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.21%
2/963 • 1 Year
|
|
Nervous system disorders
Tunnel Vision
|
0.10%
1/963 • 1 Year
|
|
Psychiatric disorders
Delirium
|
0.10%
1/963 • 1 Year
|
|
Psychiatric disorders
Depression
|
0.21%
2/963 • 1 Year
|
|
Psychiatric disorders
Listless
|
0.10%
1/963 • 1 Year
|
|
Psychiatric disorders
Sleep Disorder
|
0.10%
1/963 • 1 Year
|
|
Renal and urinary disorders
Cystitis Haemorrhagic
|
0.10%
1/963 • 1 Year
|
|
Renal and urinary disorders
Dysuria
|
0.10%
1/963 • 1 Year
|
|
Renal and urinary disorders
Haematuria
|
0.31%
3/963 • 1 Year
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.10%
1/963 • 1 Year
|
|
Renal and urinary disorders
Renal Failure
|
0.21%
2/963 • 1 Year
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.62%
6/963 • 1 Year
|
|
Renal and urinary disorders
Renal Failure Chronic
|
0.31%
3/963 • 1 Year
|
|
Renal and urinary disorders
Renal Impairment
|
0.10%
1/963 • 1 Year
|
|
Renal and urinary disorders
Urinary Retention
|
0.21%
2/963 • 1 Year
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.10%
1/963 • 1 Year
|
|
Reproductive system and breast disorders
Vaginismus
|
0.10%
1/963 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.31%
3/963 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.62%
6/963 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.0%
29/963 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.21%
2/963 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.21%
2/963 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.10%
1/963 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.10%
1/963 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.10%
1/963 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.21%
2/963 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.21%
2/963 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.10%
1/963 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
0.10%
1/963 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.21%
2/963 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.31%
3/963 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.52%
5/963 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.52%
5/963 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Rash Generalised
|
0.10%
1/963 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.10%
1/963 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.21%
2/963 • 1 Year
|
|
Surgical and medical procedures
Cardiac Ablation
|
0.10%
1/963 • 1 Year
|
|
Vascular disorders
Aortic Aneurysm
|
0.21%
2/963 • 1 Year
|
|
Vascular disorders
Arteriosclerosis
|
0.10%
1/963 • 1 Year
|
|
Vascular disorders
Femoral Arterial Stenosis
|
0.10%
1/963 • 1 Year
|
|
Vascular disorders
Haematoma
|
0.83%
8/963 • 1 Year
|
|
Vascular disorders
Haemorrhage
|
10.4%
100/963 • 1 Year
|
|
Vascular disorders
Hypertension
|
1.8%
17/963 • 1 Year
|
|
Vascular disorders
Hypertensive Crisis
|
0.42%
4/963 • 1 Year
|
|
Vascular disorders
Hypotension
|
0.52%
5/963 • 1 Year
|
|
Vascular disorders
Intermittent Claudication
|
0.10%
1/963 • 1 Year
|
|
Vascular disorders
Orthostatic Hypotension
|
0.10%
1/963 • 1 Year
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.21%
2/963 • 1 Year
|
|
Vascular disorders
Vascular Dissection
|
0.10%
1/963 • 1 Year
|
|
Vascular disorders
Vascular Stenosis
|
0.10%
1/963 • 1 Year
|
Additional Information
Siok Hwee Tan, PhD, Principal Clinical Research Scientist
Clinical Affairs, Abbott Vascular
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place