Trial Outcomes & Findings for ABSORB FIRST is a Registry Designed to Evaluate the Safety and Performance of Absorb Bioresorbable Vascular Scaffold (Absorb BVS) Used in Real-world Patients. (NCT NCT01759290)
NCT ID: NCT01759290
Last Updated: 2016-10-19
Results Overview
Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
COMPLETED
1800 participants
0 to 407 days
2016-10-19
Participant Flow
A total of 1800 subjects were enrolled at 87 outside US (OUS) study sites across 21 counties worldwide. The first patient registered on January 21, 2013. The patient registration was complete on Aug 30, 2014, and the last patient completed the 1-year clinical follow-up on Sep 09, 2015. The database has been closed on Oct 30, 2015.
A total of 81 subjects are discontinued from the study population (1800) due to death:17, withdrawal of consent:5, withdrawn by physician:2, loss to follow-up:53 and unknown reasons:4. A total of 28 subjects with MI/revascularization events or reached 1-year follow-up window were included in the clinical outcome analysis.
Participant milestones
| Measure |
Absorb Bioresorbable Vascular Scaffold
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Overall Study
STARTED
|
1800
|
|
Overall Study
COMPLETED
|
1719
|
|
Overall Study
NOT COMPLETED
|
81
|
Reasons for withdrawal
| Measure |
Absorb Bioresorbable Vascular Scaffold
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Overall Study
Subjects withdrawn consent
|
5
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Death
|
17
|
|
Overall Study
Lost to Follow-up
|
53
|
|
Overall Study
Unknown reason
|
4
|
Baseline Characteristics
ABSORB FIRST is a Registry Designed to Evaluate the Safety and Performance of Absorb Bioresorbable Vascular Scaffold (Absorb BVS) Used in Real-world Patients.
Baseline characteristics by cohort
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1800 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Age, Continuous
|
58.8 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
362 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1438 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
378 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
308 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
144 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
119 participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
93 participants
n=5 Participants
|
|
Region of Enrollment
Malaysia
|
88 participants
n=5 Participants
|
|
Region of Enrollment
Thailand
|
75 participants
n=5 Participants
|
|
Region of Enrollment
Colombia
|
74 participants
n=5 Participants
|
|
Region of Enrollment
United Arab Emirates
|
65 participants
n=5 Participants
|
|
Region of Enrollment
Indonesia
|
64 participants
n=5 Participants
|
|
Region of Enrollment
France
|
59 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
59 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
51 participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
42 participants
n=5 Participants
|
|
Region of Enrollment
Saudi Arabia
|
39 participants
n=5 Participants
|
|
Region of Enrollment
Jordan
|
37 participants
n=5 Participants
|
|
Region of Enrollment
Bahrain
|
33 participants
n=5 Participants
|
|
Region of Enrollment
Vietnam
|
33 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
22 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
12 participants
n=5 Participants
|
|
Region of Enrollment
Philippines
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 to 407 daysPopulation: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1764 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))
|
2.8 percentage of participants
Interval 2.11 to 3.72
|
SECONDARY outcome
Timeframe: < or = 1 dayDevice success was defined as the achievement of a final in-scaffold residual diameter stenosis of \<50% assessed by online quantitative angiography or visual estimation, using Absorb BVS and without a device deficiency. A device was considered to have failed if it did not meet the requirements of the definition for clinical device success.
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=2183 Target Lesions
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Acute Success: Clinical Device Success (Lesion Level Analysis)
|
98.0 percentage of lesions
Interval 97.3 to 98.53
|
SECONDARY outcome
Timeframe: During the hospital stay with a maximum of 3 days post index procedureProcedure success was defined as the achievement of a final in-scaffold diameter stenosis of \<50% by online quantitative coronary angiography (QCA) or visual estimation using Absorb BVS, with or without any adjunctive devices, and without the occurrence of cardiac death, target vessel MI (Q-wave and non-Q-wave MI), or repeat revascularization of the target lesion within 3 days of the index procedure.
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1800 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Acute Success: Clinical Procedure Success (Per Subject Analysis)
|
97.0 percentage of participants
Interval 96.1 to 97.74
|
SECONDARY outcome
Timeframe: <1 dayPopulation: Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Scaffold Thrombosis event.
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1770 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Acute Scaffold Thrombosis
Definite
|
0 percentage of participants
|
|
Acute Scaffold Thrombosis
Probable
|
1 percentage of participants
|
|
Acute Scaffold Thrombosis
Definite/Probable
|
1 percentage of participants
|
SECONDARY outcome
Timeframe: 1 to 30 daysPopulation: Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Scaffold Thrombosis event.
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1770 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Subacute ScaffoldThrombosis
Definite
|
9 percentage of participants
|
|
Subacute ScaffoldThrombosis
Probable
|
2 percentage of participants
|
|
Subacute ScaffoldThrombosis
Definite/Probable
|
11 percentage of participants
|
SECONDARY outcome
Timeframe: 31 to 365 DaysPopulation: Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Scaffold Thrombosis event.
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1756 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Late Scaffold Thrombosis
Definite
|
5 percentage of participants
|
|
Late Scaffold Thrombosis
Probable
|
2 percentage of participants
|
|
Late Scaffold Thrombosis
Definite/Probable
|
7 percentage of participants
|
SECONDARY outcome
Timeframe: 0 to 7 days (In-hospital)Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1771 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
All Death, All MI, All Revascularization (DMR)
|
1.9 percentage of participants
Interval 1.33 to 2.67
|
SECONDARY outcome
Timeframe: 0 to 7 days (In-hospital)Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1771 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)
|
1.0 percentage of participants
Interval 0.56 to 1.53
|
SECONDARY outcome
Timeframe: 0 to 7 days (In-hospital)Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1771 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Major Adverse Cardiac Event (MACE)
|
0.9 percentage of participants
Interval 0.52 to 1.46
|
SECONDARY outcome
Timeframe: 0 to 7 days (In-hospital)Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1771 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))
|
0.8 percentage of participants
Interval 0.43 to 1.32
|
SECONDARY outcome
Timeframe: 0 to 7 days (In-hospital)Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1771 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Cardiac Death/All MI
|
0.8 percentage of participants
Interval 0.43 to 1.32
|
SECONDARY outcome
Timeframe: 0 to 7 days (In-hospital)Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1771 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
All Death/All MI
|
0.8 percentage of participants
Interval 0.43 to 1.32
|
SECONDARY outcome
Timeframe: 0 to 37 daysPopulation: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1771 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
All Death, All MI, All Revascularization (DMR)
|
3.0 percentage of participants
Interval 2.3 to 3.96
|
SECONDARY outcome
Timeframe: 0 to 37 daysPopulation: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1771 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)
|
1.4 percentage of participants
Interval 0.87 to 2.01
|
SECONDARY outcome
Timeframe: 0 - 37 DaysPopulation: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1771 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Major Adverse Cardiac Event (MACE)
|
1.2 percentage of participants
Interval 0.78 to 1.87
|
SECONDARY outcome
Timeframe: 0 to 37 DaysPopulation: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1771 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))
|
1.1 percentage of participants
Interval 0.65 to 1.67
|
SECONDARY outcome
Timeframe: 0 to 37 daysPopulation: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1771 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Cardiac Death/All MI
|
1.1 percentage of participants
Interval 0.69 to 1.74
|
SECONDARY outcome
Timeframe: 0 to 37 daysPopulation: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1771 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
All Death/All MI
|
1.1 percentage of participants
Interval 0.69 to 1.74
|
SECONDARY outcome
Timeframe: 0 to 180 daysPopulation: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1768 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
All Death, All MI, All Revascularization (DMR)
|
6.5 percentage of participants
Interval 5.4 to 7.76
|
SECONDARY outcome
Timeframe: 0 to 180 daysPopulation: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1768 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)
|
2.8 percentage of participants
Interval 2.06 to 3.65
|
SECONDARY outcome
Timeframe: 0 to 180 DaysPopulation: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1768 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Major Adverse Cardiac Event (MACE)
|
2.4 percentage of participants
Interval 1.77 to 3.26
|
SECONDARY outcome
Timeframe: 0 to 180 DaysPopulation: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1768 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))
|
2.1 percentage of participants
Interval 1.53 to 2.94
|
SECONDARY outcome
Timeframe: 0 to 180 daysPopulation: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1768 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Cardiac Death/All MI
|
1.9 percentage of participants
Interval 1.29 to 2.61
|
SECONDARY outcome
Timeframe: 0 to 180 daysPopulation: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1768 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
All Death/All MI
|
2.0 percentage of participants
Interval 1.43 to 2.81
|
SECONDARY outcome
Timeframe: 0 to 407 daysPopulation: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1764 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
All Death, All MI, All Revascularization (DMR)
|
8.4 percentage of participants
Interval 7.14 to 9.78
|
SECONDARY outcome
Timeframe: 0 to 407 daysPopulation: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1764 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)
|
3.7 percentage of participants
Interval 2.86 to 4.67
|
SECONDARY outcome
Timeframe: 0 to 407 DaysPopulation: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1764 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Major Adverse Cardiac Event (MACE)
|
3.1 percentage of participants
Interval 2.36 to 4.04
|
SECONDARY outcome
Timeframe: 0 to 407 daysPopulation: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1764 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Cardiac Death/All MI
|
2.1 percentage of participants
Interval 1.48 to 2.88
|
SECONDARY outcome
Timeframe: 0 to 407 daysPopulation: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1764 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
All Death/All MI
|
2.3 percentage of participants
Interval 1.67 to 3.14
|
SECONDARY outcome
Timeframe: 0 to 7 days (In-hospital)Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
This is one of the Safety Component (non-hierarchical) endpoints.
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1771 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Death (Cardiovascular, Non-Cardiovascular)
|
0.1 percentage of participants
Interval 0.01 to 0.41
|
SECONDARY outcome
Timeframe: 0 to 7 days (In-hospital)Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
This is one of the Safety Component (non-hierarchical) endpoints.
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1771 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).
|
0.7 percentage of participants
Interval 0.35 to 1.18
|
SECONDARY outcome
Timeframe: 0 to 7 days (In-hospital)Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
This is one of the Efficacy Component (non-hierarchical) endpoints.
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1771 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Target Lesion Revascularization (TLR): All TLR
|
0.4 percentage of participants
Interval 0.16 to 0.81
|
SECONDARY outcome
Timeframe: 0 to 7 days (In-hospital)Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
This is one of the Efficacy Component (non-hierarchical) endpoints.
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1771 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Target Lesion Revascularization : Ischemia-Driven (ID-TLR)
|
0.4 percentage of participants
Interval 0.16 to 0.81
|
SECONDARY outcome
Timeframe: 0 to 7 days (In-hospital)Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
This is one of the Efficacy Component (non-hierarchical) endpoints.
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1771 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Target Vessel Revascularization (TVR): All TVR
|
0.5 percentage of participants
Interval 0.2 to 0.89
|
SECONDARY outcome
Timeframe: 0 to 7 days (In-hospital)Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
This is one of the Efficacy Component (non-hierarchical) endpoints.
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1771 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Target Vessel Revascularization : Ischemic-driven (ID-TVR)
|
0.5 percentage of participants
Interval 0.2 to 0.89
|
SECONDARY outcome
Timeframe: 0 to 7 days (In-hospital)Population: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
This is one of the Efficacy Component (non-hierarchical) endpoints.
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1771 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
All Revascularization
|
1.4 percentage of participants
Interval 0.92 to 2.08
|
SECONDARY outcome
Timeframe: 0 to 37 daysPopulation: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
This is one of the Safety Component (non-hierarchical) endpoints.
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1771 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Death (Cardiovascular, Non-Cardiovascular)
|
0.1 percentage of participants
Interval 0.01 to 0.41
|
SECONDARY outcome
Timeframe: 0 to 37 daysPopulation: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
This is one of the Safety Component (non-hierarchical) endpoints.
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1771 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).
|
1.0 percentage of participants
Interval 0.6 to 1.6
|
SECONDARY outcome
Timeframe: 0 to 37 daysPopulation: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
This is one of the Efficacy Component (non-hierarchical) endpoints.
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1771 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Target Lesion Revascularization (TLR): All TLR
|
0.6 percentage of participants
Interval 0.31 to 1.11
|
SECONDARY outcome
Timeframe: 0 to 37 daysPopulation: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
This is one of the Efficacy Component (non-hierarchical) endpoints.
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1771 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Target Lesion Revascularization : Ischemia-Driven (ID-TLR)
|
0.6 percentage of participants
Interval 0.31 to 1.11
|
SECONDARY outcome
Timeframe: 0 to 37 daysPopulation: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
This is one of the Efficacy Component (non-hierarchical) endpoints.
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1771 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Target Vessel Revascularization (TVR): All TVR
|
0.8 percentage of participants
Interval 0.47 to 1.39
|
SECONDARY outcome
Timeframe: 0 to 37 daysPopulation: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
This is one of the Efficacy Component (non-hierarchical) endpoints.
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1771 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Target Vessel Revascularization : Ischemic-driven (ID-TVR)
|
0.8 percentage of participants
Interval 0.43 to 1.32
|
SECONDARY outcome
Timeframe: 0 to 37 daysPopulation: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
This is one of the Efficacy Component (non-hierarchical) endpoints.
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1771 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
All Revascularization
|
2.5 percentage of participants
Interval 1.86 to 3.39
|
SECONDARY outcome
Timeframe: 0 to 180 daysPopulation: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
This is one of the Safety Component (non-hierarchical) endpoints.
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1768 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Death (Cardiovascular, Non-Cardiovascular)
|
0.7 percentage of participants
Interval 0.39 to 1.25
|
SECONDARY outcome
Timeframe: 0 to 180 daysPopulation: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
This is one of the Safety Component (non-hierarchical) endpoints.
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1768 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).
|
1.3 percentage of participants
Interval 0.83 to 1.95
|
SECONDARY outcome
Timeframe: 0 to 180 daysPopulation: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
This is one of the Efficacy Component (non-hierarchical) endpoints.
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1768 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Target Lesion Revascularization (TLR): All TLR
|
1.3 percentage of participants
Interval 0.83 to 1.95
|
SECONDARY outcome
Timeframe: 0 to 180 daysPopulation: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
This is one of the Efficacy Component (non-hierarchical) endpoints.
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1768 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Target Lesion Revascularization : Ischemia-Driven (ID-TLR)
|
1.3 percentage of participants
Interval 0.83 to 1.95
|
SECONDARY outcome
Timeframe: 0 to 180 daysPopulation: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
This is one of the Efficacy Component (non-hierarchical) endpoints.
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1768 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Target Vessel Revascularization (TVR): All TVR
|
1.9 percentage of participants
Interval 1.34 to 2.68
|
SECONDARY outcome
Timeframe: 0 to 180 daysPopulation: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
This is one of the Efficacy Component (non-hierarchical) endpoints.
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1768 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Target Vessel Revascularization : Ischemic-driven (ID-TVR)
|
1.8 percentage of participants
Interval 1.19 to 2.48
|
SECONDARY outcome
Timeframe: 0 to 180 daysPopulation: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
This is one of the Efficacy Component (non-hierarchical) endpoints.
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1768 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
All Revascularization
|
5.5 percentage of participants
Interval 4.47 to 6.65
|
SECONDARY outcome
Timeframe: 0 to 407 daysPopulation: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
This is one of the Safety Component (non-hierarchical) endpoints.
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1764 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Death (Cardiovascular, Non-Cardiovascular)
|
1.0 percentage of participants
Interval 0.56 to 1.54
|
SECONDARY outcome
Timeframe: 0 to 407 daysPopulation: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
This is one of the Safety Component (non-hierarchical) endpoints.
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1764 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).
|
1.4 percentage of participants
Interval 0.92 to 2.09
|
SECONDARY outcome
Timeframe: 0 to 407 daysPopulation: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
This is one of the Efficacy Component (non-hierarchical) endpoints.
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1764 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Target Lesion Revascularization (TLR): All TLR
|
2.0 percentage of participants
Interval 1.43 to 2.81
|
SECONDARY outcome
Timeframe: 0 to 407 daysPopulation: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
This is one of the Efficacy Component (non-hierarchical) endpoints.
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1764 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Target Lesion Revascularization : Ischemia-Driven (ID-TLR)
|
1.9 percentage of participants
Interval 1.29 to 2.62
|
SECONDARY outcome
Timeframe: 0 to 407 daysPopulation: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
This is one of the Efficacy Component (non-hierarchical) endpoints.
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1764 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Target Vessel Revascularization (TVR): All TVR
|
2.9 percentage of participants
Interval 2.21 to 3.85
|
SECONDARY outcome
Timeframe: 0 to 407 daysPopulation: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
This is one of the Efficacy Component (non-hierarchical) endpoints.
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1764 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Target Vessel Revascularization : Ischemic-driven (ID-TVR)
|
2.6 percentage of participants
Interval 1.87 to 3.4
|
SECONDARY outcome
Timeframe: 0 to 407 daysPopulation: Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).
This is one of the Efficacy Component (non-hierarchical) endpoints.
Outcome measures
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1764 Participants
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
All Revascularization
|
7.3 percentage of participants
Interval 6.09 to 8.57
|
Adverse Events
Absorb Bioresorbable Vascular Scaffold
Serious adverse events
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1800 participants at risk
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.39%
7/1800 • Number of events 7 • 1 year
|
|
Cardiac disorders
Acute myocardial infarction
|
1.2%
22/1800 • Number of events 22 • 1 year
|
|
Cardiac disorders
Angina pectoris
|
2.6%
47/1800 • Number of events 52 • 1 year
|
|
Cardiac disorders
Angina unstable
|
0.83%
15/1800 • Number of events 15 • 1 year
|
|
Cardiac disorders
Aortic valve disease mixed
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Cardiac disorders
Arrhythmia
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
0.50%
9/1800 • Number of events 9 • 1 year
|
|
Cardiac disorders
Bradycardia
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiac arrest
|
0.11%
2/1800 • Number of events 2 • 1 year
|
|
Cardiac disorders
Cardiac failure
|
0.33%
6/1800 • Number of events 6 • 1 year
|
|
Cardiac disorders
Cardiac failure acute
|
0.06%
1/1800 • Number of events 2 • 1 year
|
|
Cardiac disorders
Cardiac failure congestive
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiogenic shock
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Cardiac disorders
Coronary artery disease
|
0.83%
15/1800 • Number of events 17 • 1 year
|
|
Cardiac disorders
Coronary artery dissection
|
0.33%
6/1800 • Number of events 6 • 1 year
|
|
Cardiac disorders
Coronary artery occlusion
|
0.11%
2/1800 • Number of events 2 • 1 year
|
|
Cardiac disorders
Coronary artery perforation
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Cardiac disorders
Coronary artery stenosis
|
1.1%
20/1800 • Number of events 21 • 1 year
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Cardiac disorders
Dressler's syndrome
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.11%
2/1800 • Number of events 2 • 1 year
|
|
Cardiac disorders
Mitral valve incompetence
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Cardiac disorders
Myocardial infarction
|
0.22%
4/1800 • Number of events 5 • 1 year
|
|
Cardiac disorders
Myocarditis
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Cardiac disorders
Palpitations
|
0.28%
5/1800 • Number of events 5 • 1 year
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Cardiac disorders
Sick sinus syndrome
|
0.11%
2/1800 • Number of events 2 • 1 year
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Cardiac disorders
Ventricular fibrillation
|
0.17%
3/1800 • Number of events 3 • 1 year
|
|
Cardiac disorders
Ventricular tachycardia
|
0.22%
4/1800 • Number of events 4 • 1 year
|
|
Ear and labyrinth disorders
Vertigo
|
0.17%
3/1800 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.11%
2/1800 • Number of events 2 • 1 year
|
|
General disorders
Chest discomfort
|
0.17%
3/1800 • Number of events 3 • 1 year
|
|
General disorders
Chest pain
|
0.67%
12/1800 • Number of events 13 • 1 year
|
|
General disorders
Death
|
0.11%
2/1800 • Number of events 2 • 1 year
|
|
General disorders
Device malfunction
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
General disorders
Fatigue
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
General disorders
Malaise
|
0.11%
2/1800 • Number of events 2 • 1 year
|
|
General disorders
Multi-organ failure
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
General disorders
Non-cardiac chest pain
|
0.94%
17/1800 • Number of events 18 • 1 year
|
|
General disorders
Sudden cardiac death
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
General disorders
Thrombosis in device
|
0.50%
9/1800 • Number of events 11 • 1 year
|
|
Hepatobiliary disorders
Jaundice
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Immune system disorders
Drug hypersensitivity
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Immune system disorders
Primary amyloidosis
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Infections and infestations
Diverticulitis
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Infections and infestations
Febrile infection
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Infections and infestations
Meningitis
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Infections and infestations
Pneumonia
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Infections and infestations
Postoperative abscess
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Infections and infestations
Prostatic abscess
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Infections and infestations
Sepsis
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Infections and infestations
Septic shock
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Cardiac function disturbance postoperative
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Cardiac procedure complication
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.17%
3/1800 • Number of events 3 • 1 year
|
|
Injury, poisoning and procedural complications
Renal haematoma
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Investigations
Cardiac enzymes increased
|
0.33%
6/1800 • Number of events 6 • 1 year
|
|
Investigations
Cardiac stress test abnormal
|
0.11%
2/1800 • Number of events 2 • 1 year
|
|
Investigations
Electrocardiogram change
|
0.11%
2/1800 • Number of events 2 • 1 year
|
|
Investigations
Exercise electrocardiogram abnormal
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Investigations
Stress echocardiogram abnormal
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Investigations
Troponin increased
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle necrosis
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Nervous system disorders
Cerebrovascular accident
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Nervous system disorders
Headache
|
0.11%
2/1800 • Number of events 2 • 1 year
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Nervous system disorders
Syncope
|
0.17%
3/1800 • Number of events 3 • 1 year
|
|
Psychiatric disorders
Depression
|
0.06%
1/1800 • Number of events 2 • 1 year
|
|
Psychiatric disorders
Personality disorder
|
0.11%
2/1800 • Number of events 2 • 1 year
|
|
Renal and urinary disorders
Renal failure acute
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.67%
12/1800 • Number of events 13 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.33%
6/1800 • Number of events 6 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.11%
2/1800 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.11%
2/1800 • Number of events 2 • 1 year
|
|
Vascular disorders
Aneurysm
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Vascular disorders
Aortic stenosis
|
0.17%
3/1800 • Number of events 3 • 1 year
|
|
Vascular disorders
Arterial stenosis
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Vascular disorders
Arteriosclerosis
|
0.28%
5/1800 • Number of events 5 • 1 year
|
|
Vascular disorders
Hypertension
|
0.11%
2/1800 • Number of events 2 • 1 year
|
|
Vascular disorders
Hypertensive crisis
|
0.33%
6/1800 • Number of events 6 • 1 year
|
|
Vascular disorders
Ischaemia
|
0.11%
2/1800 • Number of events 2 • 1 year
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Vascular disorders
Peripheral ischaemia
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Vascular disorders
Peripheral vascular disorder
|
0.06%
1/1800 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Absorb Bioresorbable Vascular Scaffold
n=1800 participants at risk
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
|
|---|---|
|
Cardiac disorders
Accelerated idioventricular rhythm
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Cardiac disorders
Acute coronary syndrome
|
0.44%
8/1800 • Number of events 10 • 1 year
|
|
Cardiac disorders
Acute myocardial infarction
|
1.2%
22/1800 • Number of events 22 • 1 year
|
|
Cardiac disorders
Angina pectoris
|
3.8%
69/1800 • Number of events 76 • 1 year
|
|
Cardiac disorders
Angina unstable
|
0.94%
17/1800 • Number of events 17 • 1 year
|
|
Cardiac disorders
Aortic valve disease mixed
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Cardiac disorders
Arrhythmia
|
0.11%
2/1800 • Number of events 2 • 1 year
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Cardiac disorders
Arteriospasm coronary
|
0.11%
2/1800 • Number of events 2 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
0.89%
16/1800 • Number of events 16 • 1 year
|
|
Cardiac disorders
Atrial flutter
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Cardiac disorders
Bradycardia
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiac arrest
|
0.11%
2/1800 • Number of events 2 • 1 year
|
|
Cardiac disorders
Cardiac failure
|
0.39%
7/1800 • Number of events 7 • 1 year
|
|
Cardiac disorders
Cardiac failure acute
|
0.06%
1/1800 • Number of events 2 • 1 year
|
|
Cardiac disorders
Cardiac failure congestive
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiogenic shock
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Cardiac disorders
Coronary artery disease
|
1.1%
19/1800 • Number of events 21 • 1 year
|
|
Cardiac disorders
Coronary artery dissection
|
0.56%
10/1800 • Number of events 10 • 1 year
|
|
Cardiac disorders
Coronary artery occlusion
|
0.28%
5/1800 • Number of events 5 • 1 year
|
|
Cardiac disorders
Coronary artery perforation
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Cardiac disorders
Coronary artery stenosis
|
1.8%
33/1800 • Number of events 35 • 1 year
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Cardiac disorders
Dressler's syndrome
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Cardiac disorders
Extrasystoles
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.17%
3/1800 • Number of events 3 • 1 year
|
|
Cardiac disorders
Mitral valve incompetence
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Cardiac disorders
Myocardial infarction
|
0.22%
4/1800 • Number of events 5 • 1 year
|
|
Cardiac disorders
Myocardial ischaemia
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Cardiac disorders
Myocarditis
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Cardiac disorders
Palpitations
|
0.56%
10/1800 • Number of events 10 • 1 year
|
|
Cardiac disorders
Pericardial effusion
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Cardiac disorders
Sick sinus syndrome
|
0.11%
2/1800 • Number of events 2 • 1 year
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Cardiac disorders
Tachycardia
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Cardiac disorders
Ventricular dysfunction
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.11%
2/1800 • Number of events 2 • 1 year
|
|
Cardiac disorders
Ventricular fibrillation
|
0.17%
3/1800 • Number of events 3 • 1 year
|
|
Cardiac disorders
Ventricular tachycardia
|
0.33%
6/1800 • Number of events 6 • 1 year
|
|
Ear and labyrinth disorders
Vertigo
|
0.17%
3/1800 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.11%
2/1800 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Diarrhoea
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
General disorders
Chest discomfort
|
0.17%
3/1800 • Number of events 3 • 1 year
|
|
General disorders
Chest pain
|
0.89%
16/1800 • Number of events 17 • 1 year
|
|
General disorders
Death
|
0.11%
2/1800 • Number of events 2 • 1 year
|
|
General disorders
Device failure
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
General disorders
Device malfunction
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
General disorders
Fatigue
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
General disorders
Feeling abnormal
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
General disorders
Malaise
|
0.17%
3/1800 • Number of events 3 • 1 year
|
|
General disorders
Multi-organ failure
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
General disorders
Non-cardiac chest pain
|
1.9%
34/1800 • Number of events 40 • 1 year
|
|
General disorders
Oedema peripheral
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
General disorders
Sudden cardiac death
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
General disorders
Thrombosis in device
|
0.50%
9/1800 • Number of events 11 • 1 year
|
|
Hepatobiliary disorders
Jaundice
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Immune system disorders
Drug hypersensitivity
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Immune system disorders
Primary amyloidosis
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Infections and infestations
Diverticulitis
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Infections and infestations
Febrile infection
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Infections and infestations
Meningitis
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Infections and infestations
Pneumonia
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Infections and infestations
Postoperative abscess
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Infections and infestations
Prostatic abscess
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Infections and infestations
Sepsis
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Infections and infestations
Septic shock
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Cardiac function disturbance postoperative
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Cardiac procedure complication
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.17%
3/1800 • Number of events 3 • 1 year
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.11%
2/1800 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Renal haematoma
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.17%
3/1800 • Number of events 3 • 1 year
|
|
Investigations
Blood creatine phosphokinase increased
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Investigations
Blood creatinine increased
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Investigations
Blood pressure increased
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Investigations
Cardiac enzymes increased
|
3.8%
69/1800 • Number of events 69 • 1 year
|
|
Investigations
Cardiac stress test abnormal
|
0.11%
2/1800 • Number of events 2 • 1 year
|
|
Investigations
Electrocardiogram change
|
0.17%
3/1800 • Number of events 3 • 1 year
|
|
Investigations
Exercise electrocardiogram abnormal
|
0.17%
3/1800 • Number of events 3 • 1 year
|
|
Investigations
Stress echocardiogram abnormal
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Investigations
Troponin I increased
|
0.44%
8/1800 • Number of events 8 • 1 year
|
|
Investigations
Troponin T increased
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Investigations
Troponin increased
|
0.78%
14/1800 • Number of events 14 • 1 year
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle necrosis
|
0.11%
2/1800 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Nervous system disorders
Cerebellar embolism
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Nervous system disorders
Cerebrovascular accident
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Nervous system disorders
Dizziness
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Nervous system disorders
Headache
|
0.11%
2/1800 • Number of events 2 • 1 year
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Nervous system disorders
Syncope
|
0.39%
7/1800 • Number of events 7 • 1 year
|
|
Nervous system disorders
Transient ischaemic attack
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Depression
|
0.06%
1/1800 • Number of events 2 • 1 year
|
|
Psychiatric disorders
Panic attack
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Personality disorder
|
0.11%
2/1800 • Number of events 2 • 1 year
|
|
Renal and urinary disorders
Renal colic
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Renal failure acute
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.0%
18/1800 • Number of events 19 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.39%
7/1800 • Number of events 7 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.11%
2/1800 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.11%
2/1800 • Number of events 2 • 1 year
|
|
Surgical and medical procedures
Hospitalisation
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Vascular disorders
Aneurysm
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Vascular disorders
Aortic stenosis
|
0.17%
3/1800 • Number of events 3 • 1 year
|
|
Vascular disorders
Arterial stenosis
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Vascular disorders
Arteriosclerosis
|
0.28%
5/1800 • Number of events 5 • 1 year
|
|
Vascular disorders
Haematoma
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Vascular disorders
Hypertension
|
0.22%
4/1800 • Number of events 4 • 1 year
|
|
Vascular disorders
Hypertensive crisis
|
0.33%
6/1800 • Number of events 6 • 1 year
|
|
Vascular disorders
Ischaemia
|
0.11%
2/1800 • Number of events 2 • 1 year
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Vascular disorders
Peripheral ischaemia
|
0.06%
1/1800 • Number of events 1 • 1 year
|
|
Vascular disorders
Peripheral vascular disorder
|
0.06%
1/1800 • Number of events 1 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60