Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease, Coronary Artery Disease, Coronary Restenosis, Cardiovascular Disease
Conditions
Keywords
Drug eluting stent, Stents, Angioplasty, Bioabsorbable, Bioresorbable, Scaffold
Brief summary
The ABSORB EXTEND trial is to continue the assessment of the safety and performance of the ABSORB Bioresorbable Vascular Scaffold (BVS) System ABSORB BVS is currently in development at Abbott Vascular.
Interventions
DEVICEABSORB BVS
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Up to two de novo lesions can be treated, each located in a separate native epicardial vessel. * Target lesion(s) must be located in a native coronary artery where target vessel(s) diameter is ≥ 2.0 mm and ≤ 3.3 mm and target lesion length is ≤ 28 mm, both assessed by on-line Quantitative Coronary Analysis (QCA). * Target lesion(s) must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and \< 100% with a TIMI flow of ≥ 1. * If two treatable lesions meet the inclusion criteria they must be in separate major epicardial vessels (LAD with septal and diagonal branches, left circumflex artery (LCX) with obtuse marginal and/or ramus intermedius branches and right coronary artery (RCA) and any of its branches). * Percutaneous interventions for lesions in a non-target vessel are allowed if done ≥ 30 days prior to or if planned to be done 6 months after the index procedure. * Percutaneous intervention for lesions in the target vessel are allowed if done \> 6 months prior to or if planned to be done 6 months after the index procedure.
Exclusion criteria
* Lesion(s) located within an arterial or saphenous vein graft or distal to a diseased (defined as vessel irregularity per angiogram and \> 20% stenosed lesion by visual estimation) arterial or saphenous vein graft. * Lesion(s) involving a bifurcation with side branch vessel ≥ 2 mm in diameter and/or ostial lesion \> 40% stenosed by visual estimation or side branch requiring predilatation. * Total occlusion (TIMI flow 0), prior to wire passing. * Target vessel(s) contains visible thrombus. * Another clinically significant lesion is located in the same epicardial vessel (including side branch) as the target lesion(s). * Subject has received brachytherapy in any epicardial vessel (including side branches).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) | ≤ 7 days post index procedure (In hospital) | The composite endpoint composed of * Cardiac death, * Myocardial infarction (MI, classified as Q-wave and Non-Q wave MI), * Ischemia-driven target lesion revascularization (TLR) by Coronary artery bypass grafting (CABG) or Percutaneous Coronary Intervention (PCI). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Procedure Success | On day 0 (immediate post-index procedure) | Defined as successful delivery and deployment of the Clinical Investigation scaffold at the target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of \< 50% by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure. In a dual lesion setting both lesions must meet clinical procedure success. |
| Number of Participants With Cardiac Death | ≤ 7 days post index procedure (In-hospital ) | 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. |
| Number of Participants With Myocardial Infarction (MI) - Per Protocol | ≤ 7 days post index procedure (In-hospital ) | Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves |
| Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) | ≤ 7 days post index procedure (In-hospital ) | Revascularization at the target lesion associated with any of the following: * Positive functional ischemia study. * Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). * Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study. |
| Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) | ≤ 7 days post index procedure (In-hospital ) | Revascularization in the target vessel associated with any of the following: * Positive functional ischemia study. * Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). * Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study. |
| Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) | ≤ 7 days post index procedure (In-hospital ) | — |
| Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) | ≤ 7 days post index procedure (In hospital) | The composite endpoint composed of * Cardiac death, * Myocardial infarction (Q wave and Non-Q wave), * Ischemia-driven target vessel revascularization by CABG or PCI. |
| Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) | 0 to 2 years | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR). |
| Number of Participants With Scaffold Thrombosis (Early) | 0 to 30 days | According to the Academic Research Consortium (ARC) Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing: Acute stent thrombosis\*: 0 - 24 hours post stent implantation Subacute stent thrombosis\*: \>24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: \>1 year post stent implantation \*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days). †Including primary as well as secondary late stent thrombosis; secondary late stent thrombosis is a stent thrombosis after a target segment revascularization. |
| Number of Participants With Scaffold Thrombosis | 0 to 180 days | According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing: Acute stent thrombosis\*: 0 - 24 hours post stent implantation Subacute stent thrombosis\*: \>24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: \>1 year post stent implantation \*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days). †Including primary as well as secondary late stent thrombosis; secondary late stent thrombosis is a stent thrombosis after a target segment revascularization. |
| Number of Participants With Scaffold Thrombosis (Late) | 31 - 365 days | According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing: Acute stent thrombosis\*: 0 - 24 hours post stent implantation Subacute stent thrombosis\*: \>24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: \>1 year post stent implantation \*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days). †Including primary as well as secondary late stent thrombosis; secondary late stent thrombosis is a stent thrombosis after a target segment revascularization. |
| Number of Participants With Scaffold Thrombosis (Very Late) | 366 days to 2 years | According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing: Acute stent thrombosis\*: 0 - 24 hours post stent implantation Subacute stent thrombosis\*: \>24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: \>1 year post stent implantation \*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days). †Including primary as well as secondary late stent thrombosis; secondary late stent thrombosis is a stent thrombosis after a target segment revascularization. |
| Clinical Device Success | On day 0 (immediate post-index procedure) | Defined as successful delivery and deployment of the Clinical Investigation scaffold at the target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis \< 50% by QCA (by visual estimation if QCA is unavailable). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout subjects will be included as device success only if the above criteria for clinical device success are met. |
| Minimum Lumen Area | 18 months | — |
| Mean Vessel Area | 18 months | — |
| Minimum Vessel Area | 18 months | — |
| Maximum Vessel Area | 18 months | — |
| Mean Lumen Area | 18 months | — |
| Maximum Lumen Area | 18 months | — |
| Mean Plaque Area | 18 months | — |
| Minimum Plaque Area | 18 months | — |
| Maximum Plaque Area | 18 months | — |
| Mean Reference Area | 18 months | — |
| Calculated Minimum Lumen Diameter | 18 months | The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - treated lesion, treated site or treated segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab. |
| Calculated Diameter Stenosis | 18 months | The value calculated as 100 \* (1 - Minimum Lumen Diameter (MLD) / reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). |
| Area Stenosis (%) | 18 months | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Denmark, France, Germany, India, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Poland, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom
Participant flow
Recruitment details
A total of 812 subjects (Intent-to-treat population) have been registered in 25 countries across the globe in compliance with the study Clinical Investigation Plan (CIP).
Pre-assignment details
Out of the 812 subjects registered, a total of 43 subjects discontinued the study due to death (n=29) , withdrawal of consent (n=1) and lost-to-follow-up or missed the final 3 year follow-up visit (n=13).
Participants by arm
| Arm | Count |
|---|---|
| ABSORB BVS Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease | 812 |
| Total | 812 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 3 - Year Visit | Death | 29 |
| 3 - Year Visit | Lost to Follow-up | 13 |
| 3 - Year Visit | Withdrawal of consent | 1 |
Baseline characteristics
| Characteristic | ABSORB BVS |
|---|---|
| Age, Continuous | 61.12 years STANDARD_DEVIATION 10.75 |
| Region of Enrollment Argentina | 20 participants |
| Region of Enrollment Australia | 62 participants |
| Region of Enrollment Austria | 24 participants |
| Region of Enrollment Belgium | 21 participants |
| Region of Enrollment Brazil | 97 participants |
| Region of Enrollment Canada | 27 participants |
| Region of Enrollment Denmark | 15 participants |
| Region of Enrollment France | 57 participants |
| Region of Enrollment Germany | 29 participants |
| Region of Enrollment Hong Kong | 21 participants |
| Region of Enrollment India | 100 participants |
| Region of Enrollment Israel | 13 participants |
| Region of Enrollment Italy | 21 participants |
| Region of Enrollment Japan | 40 participants |
| Region of Enrollment Malaysia | 23 participants |
| Region of Enrollment Netherlands | 67 participants |
| Region of Enrollment New Zealand | 23 participants |
| Region of Enrollment Poland | 13 participants |
| Region of Enrollment Singapore | 20 participants |
| Region of Enrollment South Africa | 4 participants |
| Region of Enrollment Spain | 13 participants |
| Region of Enrollment Sweden | 3 participants |
| Region of Enrollment Switzerland | 13 participants |
| Region of Enrollment Taiwan | 74 participants |
| Region of Enrollment United Kingdom | 12 participants |
| Sex: Female, Male Female | 209 Participants |
| Sex: Female, Male Male | 603 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 812 |
| other Total, other adverse events | 808 / 812 |
| serious Total, serious adverse events | 295 / 812 |
Outcome results
Primary
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
The composite endpoint composed of * Cardiac death, * Myocardial infarction (MI, classified as Q-wave and Non-Q wave MI), * Ischemia-driven target lesion revascularization (TLR) by CABG or PCI.
Time frame: 0 to 30 days
Population: ITT population (per subject analysis).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABSORB BVS | Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) | 21 Participants |
Primary
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
The composite endpoint composed of * Cardiac death, * Myocardial infarction (MI, classified as Q-wave and Non-Q wave MI), * Ischemia-driven target lesion revascularization (TLR) by Coronary artery bypass grafting (CABG) or Percutaneous Coronary Intervention (PCI).
Time frame: ≤ 7 days post index procedure (In hospital)
Population: ITT population (per subject analysis).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABSORB BVS | Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) | 14 Participants |
Primary
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).
Time frame: 0 to 1 year
Population: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABSORB BVS | Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) | 41 Participants |
Primary
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).
Time frame: 0 to 180 days
Population: ITT population (per subject analysis).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABSORB BVS | Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) | 28 Participants |
Secondary
Area Stenosis (%)
Time frame: 18 months
Population: Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABSORB BVS | Area Stenosis (%) | 24.71 Percentage | Standard Deviation 20.55 |
Secondary
Calculated Diameter Stenosis
The value calculated as 100 \* (1 - Minimum Lumen Diameter (MLD) / reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Time frame: 18 months
Population: Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABSORB BVS | Calculated Diameter Stenosis | 14.05 Percent Diameter stenosis | Standard Deviation 11.96 |
Secondary
Calculated Minimum Lumen Diameter
The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - treated lesion, treated site or treated segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.
Time frame: 18 months
Population: Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABSORB BVS | Calculated Minimum Lumen Diameter | 2.08 mm | Standard Deviation 0.32 |
Secondary
Clinical Device Success
Defined as successful delivery and deployment of the Clinical Investigation scaffold at the target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis \< 50% by QCA (by visual estimation if QCA is unavailable). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout subjects will be included as device success only if the above criteria for clinical device success are met.
Time frame: On day 0 (immediate post-index procedure)
Population: ITT population (Per Lesion analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABSORB BVS | Clinical Device Success | 98.9 percentage of lesions |
Secondary
Clinical Procedure Success
Defined as successful delivery and deployment of the Clinical Investigation scaffold at the target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of \< 50% by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure. In a dual lesion setting both lesions must meet clinical procedure success.
Time frame: On day 0 (immediate post-index procedure)
Population: ITT population (Per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABSORB BVS | Clinical Procedure Success | 97.0 percentage of participants |
Secondary
Maximum Lumen Area
Time frame: 18 months
Population: Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABSORB BVS | Maximum Lumen Area | 6.59 mm^2 | Standard Deviation 1.53 |
Secondary
Maximum Plaque Area
Time frame: 18 months
Population: Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABSORB BVS | Maximum Plaque Area | 13.18 mm^2 | Standard Deviation 5.39 |
Secondary
Maximum Vessel Area
Time frame: 18 months
Population: Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABSORB BVS | Maximum Vessel Area | 18.3 mm^2 | Standard Deviation 5.3 |
Secondary
Mean Lumen Area
Time frame: 18 months
Population: Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABSORB BVS | Mean Lumen Area | 4.92 mm^2 | Standard Deviation 1.14 |
Secondary
Mean Plaque Area
Time frame: 18 months
Population: Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABSORB BVS | Mean Plaque Area | 8.85 mm^2 | Standard Deviation 3.73 |
Secondary
Mean Reference Area
Time frame: 18 months
Population: Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABSORB BVS | Mean Reference Area | 4.78 mm^2 | Standard Deviation 1.45 |
Secondary
Mean Vessel Area
Time frame: 18 months
Population: Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABSORB BVS | Mean Vessel Area | 13.77 mm^2 | Standard Deviation 3.78 |
Secondary
Minimum Lumen Area
Time frame: 18 months
Population: Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABSORB BVS | Minimum Lumen Area | 3.47 mm^2 | Standard Deviation 1.04 |
Secondary
Minimum Plaque Area
Time frame: 18 months
Population: Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABSORB BVS | Minimum Plaque Area | 5.41 mm^2 | Standard Deviation 2.59 |
Secondary
Minimum Vessel Area
Time frame: 18 months
Population: Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABSORB BVS | Minimum Vessel Area | 9.9 mm^2 | Standard Deviation 3 |
Secondary
Number of Participants With 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.
Time frame: 0 to 180 days
Population: ITT population (per subject analysis).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABSORB BVS | Number of Participants With Cardiac Death | 4 Participants |
Secondary
Number of Participants With 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.
Time frame: ≤ 7 days post index procedure (In-hospital )
Population: ITT population (per subject analysis).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABSORB BVS | Number of Participants With Cardiac Death | 0 Participants |
Secondary
Number of Participants With 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.
Time frame: 0 to 30 days
Population: ITT population (per subject analysis).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABSORB BVS | Number of Participants With Cardiac Death | 2 Participants |
Secondary
Number of Participants With 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.
Time frame: 0 to 1 year
Population: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABSORB BVS | Number of Participants With Cardiac Death | 6 Participants |
Secondary
Number of Participants With 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.
Time frame: 0 to 2 year
Population: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABSORB BVS | Number of Participants With Cardiac Death | 10 Participants |
Secondary
Number of Participants With 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.
Time frame: 0 to 3 years
Population: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABSORB BVS | Number of Participants With Cardiac Death | 17 Participants |
Secondary
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Revascularization at the target lesion associated with any of the following: * Positive functional ischemia study. * Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). * Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time frame: 0 to 180 days
Population: ITT population (per subject analysis).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABSORB BVS | Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) | 9 Participants |
Secondary
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Revascularization at the target lesion associated with any of the following: * Positive functional ischemia study. * Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). * Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time frame: 0 to 3 years
Population: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABSORB BVS | Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) | 41 Participants |
Secondary
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Revascularization at the target lesion associated with any of the following: * Positive functional ischemia study. * Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). * Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time frame: ≤ 7 days post index procedure (In-hospital )
Population: ITT population (per subject analysis).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABSORB BVS | Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) | 0 Participants |
Secondary
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Revascularization at the target lesion associated with any of the following: * Positive functional ischemia study. * Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). * Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time frame: 0 to 30 days
Population: ITT population (per subject analysis).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABSORB BVS | Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) | 4 Participants |
Secondary
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Revascularization at the target lesion associated with any of the following: * Positive functional ischemia study. * Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). * Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time frame: 0 to 2 year
Population: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABSORB BVS | Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) | 34 Participants |
Secondary
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Revascularization at the target lesion associated with any of the following: * Positive functional ischemia study. * Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). * Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time frame: 0 to 1 year
Population: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABSORB BVS | Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) | 19 Participants |
Secondary
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Revascularization in the target vessel associated with any of the following: * Positive functional ischemia study. * Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). * Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time frame: 0 to 1 year
Population: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABSORB BVS | Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) | 23 Participants |
Secondary
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Revascularization in the target vessel associated with any of the following: * Positive functional ischemia study. * Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). * Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time frame: 0 to 2 year
Population: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABSORB BVS | Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) | 46 Participants |
Secondary
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Revascularization in the target vessel associated with any of the following: * Positive functional ischemia study. * Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). * Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time frame: 0 to 3 years
Population: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABSORB BVS | Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) | 41 Participants |
Secondary
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Revascularization in the target vessel associated with any of the following: * Positive functional ischemia study. * Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). * Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time frame: 0 to 180 days
Population: ITT population (per subject analysis).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABSORB BVS | Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) | 11 Participants |
Secondary
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Revascularization in the target vessel associated with any of the following: * Positive functional ischemia study. * Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). * Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time frame: 0 to 30 days
Population: ITT population (per subject analysis).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABSORB BVS | Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) | 4 Participants |
Secondary
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Revascularization in the target vessel associated with any of the following: * Positive functional ischemia study. * Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). * Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time frame: ≤ 7 days post index procedure (In-hospital )
Population: ITT population (per subject analysis).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABSORB BVS | Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) | 0 Participants |
Secondary
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Time frame: 0 to 30 days
Population: ITT population (per subject analysis).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABSORB BVS | Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) | 0 Participants |
Secondary
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Time frame: 0 to 1 year
Population: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABSORB BVS | Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) | 10 Participants |
Secondary
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Time frame: 0 to 180 days
Population: ITT population (per subject analysis).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABSORB BVS | Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) | 4 Participants |
Secondary
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Time frame: ≤ 7 days post index procedure (In-hospital )
Population: ITT population (per subject analysis).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABSORB BVS | Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) | 0 Participants |
Secondary
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Time frame: 0 to 3 years
Population: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABSORB BVS | Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) | 23 Participants |
Secondary
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Time frame: 0 to 2 year
Population: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABSORB BVS | Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) | 20 Participants |
Secondary
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).
Time frame: 0 to 2 years
Population: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABSORB BVS | Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) | 58 Participants |
Secondary
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).
Time frame: 0 to 3 years
Population: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABSORB BVS | Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) | 74 Participants |
Secondary
Number of Participants With Myocardial Infarction (MI) - Per Protocol
Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Time frame: 0 to 2 year
Population: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABSORB BVS | Number of Participants With Myocardial Infarction (MI) - Per Protocol | 35 Participants |
Secondary
Number of Participants With Myocardial Infarction (MI) - Per Protocol
Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Time frame: 0 to 30 days
Population: ITT population (per subject analysis).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABSORB BVS | Number of Participants With Myocardial Infarction (MI) - Per Protocol | 20 Participants |
Secondary
Number of Participants With Myocardial Infarction (MI) - Per Protocol
Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Time frame: ≤ 7 days post index procedure (In-hospital )
Population: ITT population (per subject analysis).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABSORB BVS | Number of Participants With Myocardial Infarction (MI) - Per Protocol | 14 Participants |
Secondary
Number of Participants With Myocardial Infarction (MI) - Per Protocol
Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Time frame: 0 to 180 days
Population: ITT population (per subject analysis).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABSORB BVS | Number of Participants With Myocardial Infarction (MI) - Per Protocol | 24 Participants |
Secondary
Number of Participants With Myocardial Infarction (MI) - Per Protocol
Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Time frame: 0 to 3 years
Population: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABSORB BVS | Number of Participants With Myocardial Infarction (MI) - Per Protocol | 39 percentage of participants |
Secondary
Number of Participants With Myocardial Infarction (MI) - Per Protocol
Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Time frame: 0 to 1 year
Population: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABSORB BVS | Number of Participants With Myocardial Infarction (MI) - Per Protocol | 27 Participants |
Secondary
Number of Participants With Scaffold Thrombosis
According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing: Acute stent thrombosis\*: 0 - 24 hours post stent implantation Subacute stent thrombosis\*: \>24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: \>1 year post stent implantation \*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days). †Including primary as well as secondary late stent thrombosis; secondary late stent thrombosis is a stent thrombosis after a target segment revascularization.
Time frame: 0 to 2 years
Population: ITT population (Per Subject Analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ABSORB BVS | Number of Participants With Scaffold Thrombosis | Definite | 11 Participants |
| ABSORB BVS | Number of Participants With Scaffold Thrombosis | Probable | 1 Participants |
| ABSORB BVS | Number of Participants With Scaffold Thrombosis | Possible | 6 Participants |
Secondary
Number of Participants With Scaffold Thrombosis
According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing: Acute stent thrombosis\*: 0 - 24 hours post stent implantation Subacute stent thrombosis\*: \>24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: \>1 year post stent implantation \*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days). †Including primary as well as secondary late stent thrombosis; secondary late stent thrombosis is a stent thrombosis after a target segment revascularization.
Time frame: 0 to 3 years
Population: ITT population (Per Subject Analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ABSORB BVS | Number of Participants With Scaffold Thrombosis | Definite | 13 Participants |
| ABSORB BVS | Number of Participants With Scaffold Thrombosis | Probable | 4 Participants |
| ABSORB BVS | Number of Participants With Scaffold Thrombosis | Possible | 11 Participants |
Secondary
Number of Participants With Scaffold Thrombosis
According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing: Acute stent thrombosis\*: 0 - 24 hours post stent implantation Subacute stent thrombosis\*: \>24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: \>1 year post stent implantation \*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days). †Including primary as well as secondary late stent thrombosis; secondary late stent thrombosis is a stent thrombosis after a target segment revascularization.
Time frame: 0 to 180 days
Population: ITT population (Per Subject Analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ABSORB BVS | Number of Participants With Scaffold Thrombosis | Definite | 6 Participants |
| ABSORB BVS | Number of Participants With Scaffold Thrombosis | Probable | 1 Participants |
| ABSORB BVS | Number of Participants With Scaffold Thrombosis | Possible | 2 Participants |
Secondary
Number of Participants With Scaffold Thrombosis
According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing: Acute stent thrombosis\*: 0 - 24 hours post stent implantation Subacute stent thrombosis\*: \>24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: \>1 year post stent implantation \*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days). †Including primary as well as secondary late stent thrombosis; secondary late stent thrombosis is a stent thrombosis after a target segment revascularization.
Time frame: 0 to 1 year
Population: ITT population (Per Subject Analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ABSORB BVS | Number of Participants With Scaffold Thrombosis | Definite | 7 Participants |
| ABSORB BVS | Number of Participants With Scaffold Thrombosis | Probable | 1 Participants |
| ABSORB BVS | Number of Participants With Scaffold Thrombosis | Possible | 3 Participants |
Secondary
Number of Participants With Scaffold Thrombosis (Early)
According to the Academic Research Consortium (ARC) Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing: Acute stent thrombosis\*: 0 - 24 hours post stent implantation Subacute stent thrombosis\*: \>24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: \>1 year post stent implantation \*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days). †Including primary as well as secondary late stent thrombosis; secondary late stent thrombosis is a stent thrombosis after a target segment revascularization.
Time frame: 0 to 30 days
Population: ITT population (Per Subject Analysis)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ABSORB BVS | Number of Participants With Scaffold Thrombosis (Early) | Definite | 4 Participants |
| ABSORB BVS | Number of Participants With Scaffold Thrombosis (Early) | Probable | 1 Participants |
| ABSORB BVS | Number of Participants With Scaffold Thrombosis (Early) | Possible | 0 Participants |
Secondary
Number of Participants With Scaffold Thrombosis (Late)
According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing: Acute stent thrombosis\*: 0 - 24 hours post stent implantation Subacute stent thrombosis\*: \>24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: \>1 year post stent implantation \*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days). †Including primary as well as secondary late stent thrombosis; secondary late stent thrombosis is a stent thrombosis after a target segment revascularization.
Time frame: 31 - 365 days
Population: ITT population (Per Subject Analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ABSORB BVS | Number of Participants With Scaffold Thrombosis (Late) | Definite | 3 Participants |
| ABSORB BVS | Number of Participants With Scaffold Thrombosis (Late) | Probable | 0 Participants |
| ABSORB BVS | Number of Participants With Scaffold Thrombosis (Late) | Possible | 3 Participants |
Secondary
Number of Participants With Scaffold Thrombosis (Very Late)
According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing: Acute stent thrombosis\*: 0 - 24 hours post stent implantation Subacute stent thrombosis\*: \>24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: \>1 year post stent implantation \*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days). †Including primary as well as secondary late stent thrombosis; secondary late stent thrombosis is a stent thrombosis after a target segment revascularization.
Time frame: 366 days to 2 years
Population: ITT population (Per Subject Analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ABSORB BVS | Number of Participants With Scaffold Thrombosis (Very Late) | Definite | 4 Participants |
| ABSORB BVS | Number of Participants With Scaffold Thrombosis (Very Late) | Probable | 0 Participants |
| ABSORB BVS | Number of Participants With Scaffold Thrombosis (Very Late) | Possible | 3 Participants |
Secondary
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
The composite endpoint composed of * Cardiac death, * Myocardial infarction (Q wave and Non-Q wave), * Ischemia-driven target vessel revascularization by CABG or PCI.
Time frame: ≤ 7 days post index procedure (In hospital)
Population: ITT population (per subject analysis).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABSORB BVS | Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) | 14 Participants |
Secondary
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
The composite endpoint composed of * Cardiac death, * Myocardial infarction (Q wave and Non-Q wave), * Ischemia-driven target vessel revascularization by CABG or PCI.
Time frame: 0 to 180 days
Population: ITT population (per subject analysis).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABSORB BVS | Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) | 30 Participants |
Secondary
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
The composite endpoint composed of * Cardiac death, * Myocardial infarction (Q wave and Non-Q wave), * Ischemia-driven target vessel revascularization by CABG or PCI.
Time frame: 0 to 1 year
Population: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABSORB BVS | Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) | 45 Participants |
Secondary
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
The composite endpoint composed of * Cardiac death, * Myocardial infarction (Q wave and Non-Q wave), * Ischemia-driven target vessel revascularization by CABG or PCI.
Time frame: 0 to 2 years
Population: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABSORB BVS | Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) | 68 Participants |
Secondary
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
The composite endpoint composed of * Cardiac death, * Myocardial infarction (Q wave and Non-Q wave), * Ischemia-driven target vessel revascularization by CABG or PCI.
Time frame: 0 to 3 years
Population: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABSORB BVS | Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) | 85 Participants |
Secondary
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
The composite endpoint composed of * Cardiac death, * Myocardial infarction (Q wave and Non-Q wave), * Ischemia-driven target vessel revascularization by CABG or PCI.
Time frame: 0 to 30 days
Population: ITT population (per subject analysis).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABSORB BVS | Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) | 21 Participants |