Trial Outcomes & Findings for Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (NCT NCT00433966)
NCT ID: NCT00433966
Last Updated: 2017-12-04
Results Overview
Number of participants with major adverse cardiovascular events (death, reinfarction, target-vessel revascularization for ischemia, and stroke) and major bleeding (bleeding adjudicated as not related to coronary artery bypass grafting).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
3602 participants
Primary outcome timeframe
30 Days
Results posted on
2017-12-04
Participant Flow
Between March 25, 2005, and May 7, 2007, 3602 patients with STEMI undergoing primary percutaneous coronary intervention were enrolled at 123 academic or community-based medical centers in 11 countries.
Random, open-label assignment (1:1 ratio) to unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor or bivalirudin alone. After emergency angiography and triage to PCI, CABG, or GDMT, eligible patients were randomly assigned (3:1 ratio) to either paclitaxel-eluting stents or uncoated, bare-metal stents.
Participant milestones
| Measure |
Pharmacology Arm - Bivalirudin
To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:
1. reduced rates of major bleeding events at 30 days
2. similar rates of major adverse ischemic cardiac events at 30 days
3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.
Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).
Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).
|
Pharmacology Arm - Unfractionated Heparin
To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:
1. reduced rates of major bleeding events at 30 days
2. similar rates of major adverse ischemic cardiac events at 30 days
3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.
Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).
Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).
|
Stent Arm - Paclitaxel-Eluting Stent
To establish the safety and efficacy of the paclitaxel-eluting TAXUS™ stent by showing that compared to an otherwise identical bare metal EXPRESS2™ stent, the TAXUS™ stent results in:
1. reduced rates of target lesion revascularization for ischemia at 1 year
2. similar rates of death, reinfarction, stroke or stent thrombosis at 1 year
3. lower rates of analysis segment binary angiographic restenosis at 13 months
Bare metal stent: Uncoated bare metal stent
Paclitaxel-eluting stent: slow rate-release paclitaxel-eluting stent
|
Stent Arm - Bare Metal Stent
To establish the safety and efficacy of the paclitaxel-eluting TAXUS™ stent by showing that compared to an otherwise identical bare metal EXPRESS2™ stent, the TAXUS™ stent results in:
1. reduced rates of target lesion revascularization for ischemia at 1 year
2. similar rates of death, reinfarction, stroke or stent thrombosis at 1 year
3. lower rates of analysis segment binary angiographic restenosis at 13 months
Bare metal stent: Uncoated bare metal stent
Paclitaxel-eluting stent: slow rate-release paclitaxel-eluting stent
|
|---|---|---|---|---|
|
Pharmacology Intervention/Randomization
STARTED
|
1800
|
1802
|
0
|
0
|
|
Pharmacology Intervention/Randomization
30-Day Follow-up
|
1787
|
1791
|
0
|
0
|
|
Pharmacology Intervention/Randomization
1-Year Follow-up
|
1696
|
1702
|
0
|
0
|
|
Pharmacology Intervention/Randomization
3-Year Follow-up
|
1634
|
1628
|
0
|
0
|
|
Pharmacology Intervention/Randomization
COMPLETED
|
1634
|
1628
|
0
|
0
|
|
Pharmacology Intervention/Randomization
NOT COMPLETED
|
166
|
174
|
0
|
0
|
|
Stent Intervention/Randomization
STARTED
|
0
|
0
|
2257
|
749
|
|
Stent Intervention/Randomization
1-Year Follow-up
|
0
|
0
|
2186
|
715
|
|
Stent Intervention/Randomization
3-Year Follow-up
|
0
|
0
|
2103
|
687
|
|
Stent Intervention/Randomization
COMPLETED
|
0
|
0
|
2103
|
687
|
|
Stent Intervention/Randomization
NOT COMPLETED
|
0
|
0
|
154
|
62
|
Reasons for withdrawal
| Measure |
Pharmacology Arm - Bivalirudin
To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:
1. reduced rates of major bleeding events at 30 days
2. similar rates of major adverse ischemic cardiac events at 30 days
3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.
Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).
Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).
|
Pharmacology Arm - Unfractionated Heparin
To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:
1. reduced rates of major bleeding events at 30 days
2. similar rates of major adverse ischemic cardiac events at 30 days
3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.
Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).
Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).
|
Stent Arm - Paclitaxel-Eluting Stent
To establish the safety and efficacy of the paclitaxel-eluting TAXUS™ stent by showing that compared to an otherwise identical bare metal EXPRESS2™ stent, the TAXUS™ stent results in:
1. reduced rates of target lesion revascularization for ischemia at 1 year
2. similar rates of death, reinfarction, stroke or stent thrombosis at 1 year
3. lower rates of analysis segment binary angiographic restenosis at 13 months
Bare metal stent: Uncoated bare metal stent
Paclitaxel-eluting stent: slow rate-release paclitaxel-eluting stent
|
Stent Arm - Bare Metal Stent
To establish the safety and efficacy of the paclitaxel-eluting TAXUS™ stent by showing that compared to an otherwise identical bare metal EXPRESS2™ stent, the TAXUS™ stent results in:
1. reduced rates of target lesion revascularization for ischemia at 1 year
2. similar rates of death, reinfarction, stroke or stent thrombosis at 1 year
3. lower rates of analysis segment binary angiographic restenosis at 13 months
Bare metal stent: Uncoated bare metal stent
Paclitaxel-eluting stent: slow rate-release paclitaxel-eluting stent
|
|---|---|---|---|---|
|
Pharmacology Intervention/Randomization
Withdrawal by Subject
|
40
|
43
|
0
|
0
|
|
Pharmacology Intervention/Randomization
Lost to Follow-up
|
97
|
103
|
0
|
0
|
|
Pharmacology Intervention/Randomization
Not true myocardial infarction
|
29
|
28
|
0
|
0
|
|
Stent Intervention/Randomization
Withdrawal by Subject
|
0
|
0
|
41
|
15
|
|
Stent Intervention/Randomization
Lost to Follow-up
|
0
|
0
|
113
|
47
|
Baseline Characteristics
Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction
Baseline characteristics by cohort
| Measure |
Pharmacology Arm - Bivalirudin
n=1800 Participants
To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:
1. reduced rates of major bleeding events at 30 days
2. similar rates of major adverse ischemic cardiac events at 30 days
3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.
Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).
Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).
|
Pharmacology Arm - Unfractionated Heparin
n=1802 Participants
To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:
1. reduced rates of major bleeding events at 30 days
2. similar rates of major adverse ischemic cardiac events at 30 days
3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.
Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).
Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).
|
Total
n=3602 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.8 years
n=5 Participants
|
60.7 years
n=7 Participants
|
60.2 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
412 Participants
n=5 Participants
|
430 Participants
n=7 Participants
|
842 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1388 Participants
n=5 Participants
|
1372 Participants
n=7 Participants
|
2760 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 DaysNumber of participants with major adverse cardiovascular events (death, reinfarction, target-vessel revascularization for ischemia, and stroke) and major bleeding (bleeding adjudicated as not related to coronary artery bypass grafting).
Outcome measures
| Measure |
Pharmacology Arm - Bivalirudin
n=1800 Participants
To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:
1. reduced rates of major bleeding events at 30 days
2. similar rates of major adverse ischemic cardiac events at 30 days
3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.
Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).
Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).
|
Pharmacology Arm - Unfractionated Heparin
n=1802 Participants
To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:
1. reduced rates of major bleeding events at 30 days
2. similar rates of major adverse ischemic cardiac events at 30 days
3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.
Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).
Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).
|
|---|---|---|
|
Pharmacology Arm - Major Adverse Ischemic Cardiac Events and Major Bleeding Events
|
166 Participants
|
218 Participants
|
PRIMARY outcome
Timeframe: 1 yearNumber of Participants With Ischemic Target Lesion Revascularization
Outcome measures
| Measure |
Pharmacology Arm - Bivalirudin
n=2257 Participants
To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:
1. reduced rates of major bleeding events at 30 days
2. similar rates of major adverse ischemic cardiac events at 30 days
3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.
Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).
Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).
|
Pharmacology Arm - Unfractionated Heparin
n=749 Participants
To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:
1. reduced rates of major bleeding events at 30 days
2. similar rates of major adverse ischemic cardiac events at 30 days
3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.
Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).
Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).
|
|---|---|---|
|
Stent Arm - Ischemic Target Lesion Revascularization
|
98 Participants
|
54 Participants
|
PRIMARY outcome
Timeframe: 1 yearNumber of Participants With Death, Reinfarction, Stroke, or Stent Thrombosis
Outcome measures
| Measure |
Pharmacology Arm - Bivalirudin
n=2257 Participants
To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:
1. reduced rates of major bleeding events at 30 days
2. similar rates of major adverse ischemic cardiac events at 30 days
3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.
Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).
Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).
|
Pharmacology Arm - Unfractionated Heparin
n=749 Participants
To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:
1. reduced rates of major bleeding events at 30 days
2. similar rates of major adverse ischemic cardiac events at 30 days
3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.
Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).
Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).
|
|---|---|---|
|
Stent Arm - Death, Reinfarction, Stroke, or Stent Thrombosis
|
181 Participants
|
59 Participants
|
SECONDARY outcome
Timeframe: 30 daysNumber of participants with major adverse cardiovascular events (death, reinfarction, target-vessel revascularization for ischemia, and stroke)
Outcome measures
| Measure |
Pharmacology Arm - Bivalirudin
n=1800 Participants
To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:
1. reduced rates of major bleeding events at 30 days
2. similar rates of major adverse ischemic cardiac events at 30 days
3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.
Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).
Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).
|
Pharmacology Arm - Unfractionated Heparin
n=1802 Participants
To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:
1. reduced rates of major bleeding events at 30 days
2. similar rates of major adverse ischemic cardiac events at 30 days
3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.
Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).
Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).
|
|---|---|---|
|
Pharmacology Arm - Major Adverse Cardiovascular Events
|
98 Participants
|
99 Participants
|
SECONDARY outcome
Timeframe: 30 daysNumber of participants with major bleeding (bleeding adjudicated as not related to coronary artery bypass grafting)
Outcome measures
| Measure |
Pharmacology Arm - Bivalirudin
n=1800 Participants
To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:
1. reduced rates of major bleeding events at 30 days
2. similar rates of major adverse ischemic cardiac events at 30 days
3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.
Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).
Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).
|
Pharmacology Arm - Unfractionated Heparin
n=1802 Participants
To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:
1. reduced rates of major bleeding events at 30 days
2. similar rates of major adverse ischemic cardiac events at 30 days
3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.
Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).
Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).
|
|---|---|---|
|
Pharmacology Arm - Non-Coronary Artery Bypass Grafting-Related Major Bleeding
|
89 Participants
|
149 Participants
|
SECONDARY outcome
Timeframe: 13 monthsNumber of Participants With Segment Binary Angiographic Restenosis (13-month Angiographic Subset).
Outcome measures
| Measure |
Pharmacology Arm - Bivalirudin
n=1062 Participants
To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:
1. reduced rates of major bleeding events at 30 days
2. similar rates of major adverse ischemic cardiac events at 30 days
3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.
Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).
Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).
|
Pharmacology Arm - Unfractionated Heparin
n=328 Participants
To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:
1. reduced rates of major bleeding events at 30 days
2. similar rates of major adverse ischemic cardiac events at 30 days
3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.
Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).
Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).
|
|---|---|---|
|
Stent Arm - Segment Binary Angiographic Restenosis
|
102 Participants
|
76 Participants
|
SECONDARY outcome
Timeframe: 3 yearsNumber of participants with major adverse cardiovascular events (death, reinfarction, target-vessel revascularization for ischemia, and stroke)
Outcome measures
| Measure |
Pharmacology Arm - Bivalirudin
n=1800 Participants
To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:
1. reduced rates of major bleeding events at 30 days
2. similar rates of major adverse ischemic cardiac events at 30 days
3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.
Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).
Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).
|
Pharmacology Arm - Unfractionated Heparin
n=1802 Participants
To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:
1. reduced rates of major bleeding events at 30 days
2. similar rates of major adverse ischemic cardiac events at 30 days
3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.
Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).
Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).
|
|---|---|---|
|
Pharmacology Arm - Major Adverse Cardiovascular Events
|
379 Participants
|
377 Participants
|
Adverse Events
Pharmacology Arm - Bivalirudin
Serious events: 397 serious events
Other events: 81 other events
Deaths: 102 deaths
Pharmacology Arm - Unfractionated Heparin
Serious events: 439 serious events
Other events: 132 other events
Deaths: 134 deaths
Stent Arm - Paclitaxel-Eluting Stent
Serious events: 473 serious events
Other events: 122 other events
Deaths: 123 deaths
Stent Arm - Bare Metal Stent
Serious events: 185 serious events
Other events: 32 other events
Deaths: 48 deaths
Serious adverse events
| Measure |
Pharmacology Arm - Bivalirudin
n=1800 participants at risk
To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:
1. reduced rates of major bleeding events at 30 days
2. similar rates of major adverse ischemic cardiac events at 30 days
3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.
Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).
Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).
|
Pharmacology Arm - Unfractionated Heparin
n=1802 participants at risk
To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:
1. reduced rates of major bleeding events at 30 days
2. similar rates of major adverse ischemic cardiac events at 30 days
3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.
Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).
Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).
|
Stent Arm - Paclitaxel-Eluting Stent
n=2257 participants at risk
To establish the safety and efficacy of the paclitaxel-eluting TAXUS™ stent by showing that compared to an otherwise identical bare metal EXPRESS2™ stent, the TAXUS™ stent results in:
1. reduced rates of target lesion revascularization for ischemia at 1 year
2. similar rates of death, reinfarction, stroke or stent thrombosis at 1 year
3. lower rates of analysis segment binary angiographic restenosis at 13 months
Bare metal stent: Uncoated bare metal stent
Paclitaxel-eluting stent: slow rate-release paclitaxel-eluting stent
|
Stent Arm - Bare Metal Stent
n=749 participants at risk
To establish the safety and efficacy of the paclitaxel-eluting TAXUS™ stent by showing that compared to an otherwise identical bare metal EXPRESS2™ stent, the TAXUS™ stent results in:
1. reduced rates of target lesion revascularization for ischemia at 1 year
2. similar rates of death, reinfarction, stroke or stent thrombosis at 1 year
3. lower rates of analysis segment binary angiographic restenosis at 13 months
Bare metal stent: Uncoated bare metal stent
Paclitaxel-eluting stent: slow rate-release paclitaxel-eluting stent
|
|---|---|---|---|---|
|
Cardiac disorders
Death (cardiac)
|
2.8%
50/1800 • Number of events 50 • 3 Years
|
4.9%
88/1802 • Number of events 88 • 3 Years
|
3.1%
71/2257 • Number of events 71 • 3 Years
|
3.7%
28/749 • Number of events 28 • 3 Years
|
|
Cardiac disorders
Stent thrombosis (definite or probable)
|
4.2%
75/1800 • Number of events 83 • 3 Years
|
4.5%
81/1802 • Number of events 88 • 3 Years
|
4.9%
110/2257 • Number of events 121 • 3 Years
|
4.3%
32/749 • Number of events 34 • 3 Years
|
|
Cardiac disorders
Ischemia-driven target vessel revascularization (TVR)
|
13.3%
239/1800 • Number of events 272 • 3 Years
|
11.1%
200/1802 • Number of events 238 • 3 Years
|
11.9%
268/2257 • Number of events 303 • 3 Years
|
16.8%
126/749 • Number of events 150 • 3 Years
|
|
Cardiac disorders
Ischemia-driven target lesion revascularization (TLR)
|
10.6%
190/1800 • Number of events 215 • 3 Years
|
8.9%
160/1802 • Number of events 181 • 3 Years
|
9.0%
204/2257 • Number of events 228 • 3 Years
|
14.4%
108/749 • Number of events 126 • 3 Years
|
|
Cardiac disorders
Ischemia-driven TVR, non-TLR
|
4.8%
86/1800 • Number of events 94 • 3 Years
|
3.8%
68/1802 • Number of events 76 • 3 Years
|
4.4%
100/2257 • Number of events 105 • 3 Years
|
5.1%
38/749 • Number of events 44 • 3 Years
|
|
Cardiac disorders
Major bleeing (protocol), non-coronary artery bypass grafting-related
|
6.7%
121/1800 • Number of events 149 • 3 Years
|
10.3%
185/1802 • Number of events 207 • 3 Years
|
8.4%
189/2257 • Number of events 213 • 3 Years
|
7.5%
56/749 • Number of events 68 • 3 Years
|
|
Cardiac disorders
Blood transfusion
|
5.1%
91/1800 • Number of events 132 • 3 Years
|
6.9%
124/1802 • Number of events 150 • 3 Years
|
4.7%
105/2257 • Number of events 123 • 3 Years
|
4.3%
32/749 • Number of events 43 • 3 Years
|
|
Cardiac disorders
Thrombolysis in Myocardial Infarction (TIMI) major or minor bleeding
|
6.9%
124/1800 • Number of events 156 • 3 Years
|
10.7%
193/1802 • Number of events 212 • 3 Years
|
7.3%
165/2257 • Number of events 179 • 3 Years
|
6.1%
46/749 • Number of events 55 • 3 Years
|
|
Cardiac disorders
Global Use of Strategies to Open Occluded Arteries (GUSTO) Moderate Bleeding
|
4.5%
81/1800 • Number of events 120 • 3 Years
|
6.1%
110/1802 • Number of events 136 • 3 Years
|
4.2%
95/2257 • Number of events 112 • 3 Years
|
3.9%
29/749 • Number of events 41 • 3 Years
|
Other adverse events
| Measure |
Pharmacology Arm - Bivalirudin
n=1800 participants at risk
To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:
1. reduced rates of major bleeding events at 30 days
2. similar rates of major adverse ischemic cardiac events at 30 days
3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.
Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).
Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).
|
Pharmacology Arm - Unfractionated Heparin
n=1802 participants at risk
To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:
1. reduced rates of major bleeding events at 30 days
2. similar rates of major adverse ischemic cardiac events at 30 days
3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.
Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).
Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).
|
Stent Arm - Paclitaxel-Eluting Stent
n=2257 participants at risk
To establish the safety and efficacy of the paclitaxel-eluting TAXUS™ stent by showing that compared to an otherwise identical bare metal EXPRESS2™ stent, the TAXUS™ stent results in:
1. reduced rates of target lesion revascularization for ischemia at 1 year
2. similar rates of death, reinfarction, stroke or stent thrombosis at 1 year
3. lower rates of analysis segment binary angiographic restenosis at 13 months
Bare metal stent: Uncoated bare metal stent
Paclitaxel-eluting stent: slow rate-release paclitaxel-eluting stent
|
Stent Arm - Bare Metal Stent
n=749 participants at risk
To establish the safety and efficacy of the paclitaxel-eluting TAXUS™ stent by showing that compared to an otherwise identical bare metal EXPRESS2™ stent, the TAXUS™ stent results in:
1. reduced rates of target lesion revascularization for ischemia at 1 year
2. similar rates of death, reinfarction, stroke or stent thrombosis at 1 year
3. lower rates of analysis segment binary angiographic restenosis at 13 months
Bare metal stent: Uncoated bare metal stent
Paclitaxel-eluting stent: slow rate-release paclitaxel-eluting stent
|
|---|---|---|---|---|
|
Cardiac disorders
Thrombolysis in Myocardial Infarction Minor Bleeding
|
3.2%
57/1800 • Number of events 64 • 3 Years
|
4.9%
89/1802 • Number of events 91 • 3 Years
|
3.8%
85/2257 • Number of events 87 • 3 Years
|
3.2%
24/749 • Number of events 26 • 3 Years
|
|
Cardiac disorders
Global Use of Strategies to Open Occluded Arteries Mild Bleeding
|
3.9%
71/1800 • Number of events 71 • 3 Years
|
6.1%
110/1802 • Number of events 113 • 3 Years
|
4.7%
106/2257 • Number of events 109 • 3 Years
|
3.7%
28/749 • Number of events 28 • 3 Years
|
Additional Information
Ori Ben-Yehuda, MD, Executive Director, Clinical Trials Center
Cardiovascular Research Foundation
Phone: 646-434-4123
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place