Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction

• Sponsor: Cardiovascular Research Foundation, New York (Other)
• Overall Status: Completed
• CT.gov ID: NCT00433966
• Collaborator: Boston Scientific Corporation (Industry), The Medicines Company (Industry)
• Enrollment: 3,602
• Location: 1
• Arms: 2
• Duration (Months): 68
• Patients Per Site Per Month: 52.9

Study Details

Study Description

Brief Summary

The primary objectives of the trial are:

1. To establish the safety and efficacy of the use of bivalirudin (+ bail-out GP IIb/IIIa inhibitors) compared to the use of unfractionated heparin + GP IIb/IIIa inhibitors in patients with acute myocardial infarction undergoing a primary angioplasty strategy.

2. To establish the safety and efficacy of the slow rate release paclitaxel-eluting TAXUS™ stent compared to an otherwise identical uncoated bare metal EXPRESS2™ stent.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction	Drug: Bivalirudin; Drug: Unfractionated heparin; Device: Bare metal stent; Device: Paclitaxel-eluting stent	Phase 3

Detailed Description

Prospective, 2 x 2 factorial single blind, randomized, multi-center trial of 3400 patients enrolled at up to 200 centers. Patients will be randomized 1:1 in the emergency room to a) anticoagulation with unfractionated heparin plus routine GP IIb/IIIa inhibition vs. b) bivalirudin and bail-out GP IIb/IIIa inhibition. Following angiography, patients with lesions eligible for stenting will then undergo a second randomization (3:1) to stent implantation with either a) a slow rate-release paclitaxel-eluting stent (TAXUS™) or b) an otherwise identical uncoated bare metal stent (EXPRESS2™).

Study Design

• Study Type: Interventional
• Actual Enrollment: 3602 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Dual Arm Factorial Randomized Trial in Patients w/ST Segment Elevation AMI to Compare the Results of Using Anticoagulation With Either Unfractionated Heparin + Routine GP IIb/IIIa Inhibition or Bivalirudin + Bail-out GP IIb/IIIa Inhibition; and Primary Angioplasty With Stent Implantation With Either a Slow Rate-release Paclitaxel-eluting Stent (TAXUS™) or Uncoated Bare Metal Stent (EXPRESS2™)
• Study Start Date: Mar 1, 2005
• Actual Primary Completion Date: Jun 1, 2008
• Actual Study Completion Date: Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Pharmacology Arm 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: reduced rates of major bleeding events at 30 days similar rates of major adverse ischemic cardiac events at 30 days reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.	Drug: 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).; Other Names: Angiomax ; Drug: Unfractionated heparin; 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).; Other Names: Heparin Sodium
Active Comparator: Stent Arm 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: reduced rates of target lesion revascularization for ischemia at 1 year similar rates of death, reinfarction, stroke or stent thrombosis at 1 year lower rates of analysis segment binary angiographic restenosis at 13 months	Device: Bare metal stent; Uncoated bare metal stent; Other Names: EXPRESS2™ ; Device: Paclitaxel-eluting stent; slow rate-release paclitaxel-eluting stent; Other Names: TAXUS™

Outcome Measures

Primary Outcome Measures

1. Pharmacology Arm - Major Adverse Ischemic Cardiac Events and Major Bleeding Events [30 Days]

   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).

2. Stent Arm - Ischemic Target Lesion Revascularization [1 year]

   Number of Participants With Ischemic Target Lesion Revascularization

3. Stent Arm - Death, Reinfarction, Stroke, or Stent Thrombosis [1 year]

   Number of Participants With Death, Reinfarction, Stroke, or Stent Thrombosis

Secondary Outcome Measures

1. Pharmacology Arm - Major Adverse Cardiovascular Events [30 days]

   Number of participants with major adverse cardiovascular events (death, reinfarction, target-vessel revascularization for ischemia, and stroke)

2. Pharmacology Arm - Non-Coronary Artery Bypass Grafting-Related Major Bleeding [30 days]

   Number of participants with major bleeding (bleeding adjudicated as not related to coronary artery bypass grafting)

3. Stent Arm - Segment Binary Angiographic Restenosis [13 months]

   Number of Participants With Segment Binary Angiographic Restenosis (13-month Angiographic Subset).

4. Pharmacology Arm - Major Adverse Cardiovascular Events [3 years]

   Number of participants with major adverse cardiovascular events (death, reinfarction, target-vessel revascularization for ischemia, and stroke)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Must have clinical symptoms consistent with AMI (e.g., angina or anginal equivalent)lasting >20 minutes but <12 hours in duration;

• ST-segment elevation of >1 mm in >2 contiguous leads, or (presumably new) left bundle branch block, or true posterior MI with ST depression of >1 mm in >2 contiguous anterior leads;

• The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent.

Exclusion Criteria:

• The patient has a known hypersensitivity or contraindication to any of the following medications:

• Heparin, pork or pork products

• Both abciximab and eptifibatide

• Aspirin

• Both Clopidogrel and Ticlopidine

• Bivalirudin

• Paclitaxel or Taxol

• The polymer components of the TAXUS™ stent (SIBS)

• Stainless steel and/or

• Contrast media;

• Prior administration of thrombolytic therapy, bivalirudin, GP IIb/IIIa inhibitors, low molecular weight heparin or fondaparinux for this admission. Patients receiving prior unfractionated heparin may be enrolled, and treated per randomization;

• Current use of coumadin;

• Systemic (intravenous) Paclitaxel or Taxol use within 12 months;

• Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plans to become pregnant any time after enrollment into this study;

• History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions;

• History of intra-cerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke;

• Stroke or transient ischemic attack within the past 6 months, or any permanent residual neurologic defect;

• Gastrointestinal or genitourinary bleeding within the last 2 months, or major surgery within six weeks;

• Recent history or known current platelet count <100,000 cells/mm3 or Hgb <10 g/dL;

• Extensive peripheral vascular disease, such that emergent angiography and intervention in the opinion of the investigator is likely to be difficult or complicated;

• An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first six months post enrollment;

• Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance;

• Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period;

• Previous enrollment in this trial;

• Patients who underwent coronary stent implantation within the past 30 days.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	LeBauer CV Research Foundation	Greensboro	North Carolina	United States	27401

Sponsors and Collaborators

• Cardiovascular Research Foundation, New York
• Boston Scientific Corporation
• The Medicines Company

Investigators

• Principal Investigator: Gregg W Stone, MD, CardioVascular Research Foundation
• Study Director: Roxana Mehran, MD, CardioVascular Research Foundation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cardiovascular Research Foundation, New York
• ClinicalTrials.gov Identifier: NCT00433966
• Other Study ID Numbers: HORIZONS AMI
• First Posted: Feb 12, 2007
• Last Update Posted: Dec 4, 2017
• Last Verified: Nov 1, 2017

• Keywords provided by Cardiovascular Research Foundation, New York: Myocardial Infarction; Angioplasty; Myocardial Ischemia; Myocardial Reperfusion; Stents; Heart Disease
• Additional relevant MeSH terms: Myocardial Infarction; Infarction; Paclitaxel; Heparin; Calcium heparin; Bivalirudin

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	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.

Arm/Group Title	Pharmacology Arm - Bivalirudin	Pharmacology Arm - Unfractionated Heparin	Stent Arm - Paclitaxel-Eluting Stent	Stent Arm - Bare Metal Stent
Arm/Group Description	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: reduced rates of major bleeding events at 30 days similar rates of major adverse ischemic cardiac events at 30 days 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).	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: reduced rates of major bleeding events at 30 days similar rates of major adverse ischemic cardiac events at 30 days 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).	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: reduced rates of target lesion revascularization for ischemia at 1 year similar rates of death, reinfarction, stroke or stent thrombosis at 1 year 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	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: reduced rates of target lesion revascularization for ischemia at 1 year similar rates of death, reinfarction, stroke or stent thrombosis at 1 year 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
Period Title: Pharmacology Intervention/Randomization
STARTED	1800	1802	0	0
30-Day Follow-up	1787	1791	0	0
1-Year Follow-up	1696	1702	0	0
3-Year Follow-up	1634	1628	0	0
COMPLETED	1634	1628	0	0
NOT COMPLETED	166	174	0	0
Period Title: Pharmacology Intervention/Randomization
STARTED	0	0	2257	749
1-Year Follow-up	0	0	2186	715
3-Year Follow-up	0	0	2103	687
COMPLETED	0	0	2103	687
NOT COMPLETED	0	0	154	62

Baseline Characteristics

Arm/Group Title	Pharmacology Arm - Bivalirudin	Pharmacology Arm - Unfractionated Heparin	Total
Arm/Group Description	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: reduced rates of major bleeding events at 30 days similar rates of major adverse ischemic cardiac events at 30 days 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).	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: reduced rates of major bleeding events at 30 days similar rates of major adverse ischemic cardiac events at 30 days 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 of all reporting groups
Overall Participants	1800	1802	3602
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	59.8	60.7	60.2
Sex: Female, Male (Count of Participants)
Female	412 22.9%	430 23.9%	842 23.4%
Male	1388 77.1%	1372 76.1%	2760 76.6%

Outcome Measures

1. Primary Outcome

Title	Pharmacology Arm - Major Adverse Ischemic Cardiac Events and Major Bleeding Events
Description	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).
Time Frame	30 Days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pharmacology Arm - Bivalirudin	Pharmacology Arm - Unfractionated Heparin
Arm/Group Description	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: reduced rates of major bleeding events at 30 days similar rates of major adverse ischemic cardiac events at 30 days 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).	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: reduced rates of major bleeding events at 30 days similar rates of major adverse ischemic cardiac events at 30 days 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).
Measure Participants	1800	1802
Count of Participants [Participants]	166 9.2%	218 12.1%

2. Primary Outcome

Title	Stent Arm - Ischemic Target Lesion Revascularization
Description	Number of Participants With Ischemic Target Lesion Revascularization
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stent Arm - Paclitaxel-Eluting Stent	Stent Arm - Bare Metal Stent
Arm/Group Description	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: reduced rates of target lesion revascularization for ischemia at 1 year similar rates of death, reinfarction, stroke or stent thrombosis at 1 year 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	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: reduced rates of target lesion revascularization for ischemia at 1 year similar rates of death, reinfarction, stroke or stent thrombosis at 1 year 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
Measure Participants	2257	749
Count of Participants [Participants]	98 5.4%	54 3%

3. Primary Outcome

Title	Stent Arm - Death, Reinfarction, Stroke, or Stent Thrombosis
Description	Number of Participants With Death, Reinfarction, Stroke, or Stent Thrombosis
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stent Arm - Paclitaxel-Eluting Stent	Stent Arm - Bare Metal Stent
Arm/Group Description	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: reduced rates of target lesion revascularization for ischemia at 1 year similar rates of death, reinfarction, stroke or stent thrombosis at 1 year 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	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: reduced rates of target lesion revascularization for ischemia at 1 year similar rates of death, reinfarction, stroke or stent thrombosis at 1 year 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
Measure Participants	2257	749
Count of Participants [Participants]	181 10.1%	59 3.3%

4. Secondary Outcome

Title	Pharmacology Arm - Major Adverse Cardiovascular Events
Description	Number of participants with major adverse cardiovascular events (death, reinfarction, target-vessel revascularization for ischemia, and stroke)
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pharmacology Arm - Bivalirudin	Pharmacology Arm - Unfractionated Heparin
Arm/Group Description	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: reduced rates of major bleeding events at 30 days similar rates of major adverse ischemic cardiac events at 30 days 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).	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: reduced rates of major bleeding events at 30 days similar rates of major adverse ischemic cardiac events at 30 days 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).
Measure Participants	1800	1802
Count of Participants [Participants]	98 5.4%	99 5.5%

5. Secondary Outcome

Title	Pharmacology Arm - Non-Coronary Artery Bypass Grafting-Related Major Bleeding
Description	Number of participants with major bleeding (bleeding adjudicated as not related to coronary artery bypass grafting)
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pharmacology Arm - Bivalirudin	Pharmacology Arm - Unfractionated Heparin
Arm/Group Description	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: reduced rates of major bleeding events at 30 days similar rates of major adverse ischemic cardiac events at 30 days 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).	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: reduced rates of major bleeding events at 30 days similar rates of major adverse ischemic cardiac events at 30 days 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).
Measure Participants	1800	1802
Count of Participants [Participants]	89 4.9%	149 8.3%

6. Secondary Outcome

Title	Stent Arm - Segment Binary Angiographic Restenosis
Description	Number of Participants With Segment Binary Angiographic Restenosis (13-month Angiographic Subset).
Time Frame	13 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stent Arm - Paclitaxel-Eluting Stent	Stent Arm - Bare Metal Stent
Arm/Group Description	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: reduced rates of target lesion revascularization for ischemia at 1 year similar rates of death, reinfarction, stroke or stent thrombosis at 1 year 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	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: reduced rates of target lesion revascularization for ischemia at 1 year similar rates of death, reinfarction, stroke or stent thrombosis at 1 year 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
Measure Participants	1062	328
Count of Participants [Participants]	102 5.7%	76 4.2%

7. Secondary Outcome

Title	Pharmacology Arm - Major Adverse Cardiovascular Events
Description	Number of participants with major adverse cardiovascular events (death, reinfarction, target-vessel revascularization for ischemia, and stroke)
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pharmacology Arm - Bivalirudin	Pharmacology Arm - Unfractionated Heparin
Arm/Group Description	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: reduced rates of major bleeding events at 30 days similar rates of major adverse ischemic cardiac events at 30 days 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).	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: reduced rates of major bleeding events at 30 days similar rates of major adverse ischemic cardiac events at 30 days 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).
Measure Participants	1800	1802
Count of Participants [Participants]	379 21.1%	377 20.9%

Adverse Events

Time Frame	3 Years
Arm/Group Title	Pharmacology Arm - Bivalirudin		Pharmacology Arm - Unfractionated Heparin		Stent Arm - Paclitaxel-Eluting Stent		Stent Arm - Bare Metal Stent
Arm/Group Description	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: reduced rates of major bleeding events at 30 days similar rates of major adverse ischemic cardiac events at 30 days 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).		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: reduced rates of major bleeding events at 30 days similar rates of major adverse ischemic cardiac events at 30 days 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).		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: reduced rates of target lesion revascularization for ischemia at 1 year similar rates of death, reinfarction, stroke or stent thrombosis at 1 year 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		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: reduced rates of target lesion revascularization for ischemia at 1 year similar rates of death, reinfarction, stroke or stent thrombosis at 1 year 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
All Cause Mortality
	Pharmacology Arm - Bivalirudin		Pharmacology Arm - Unfractionated Heparin		Stent Arm - Paclitaxel-Eluting Stent		Stent Arm - Bare Metal Stent
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	102/1800 (5.7%)		134/1802 (7.4%)		123/2257 (5.4%)		48/749 (6.4%)
Serious Adverse Events
	Pharmacology Arm - Bivalirudin		Pharmacology Arm - Unfractionated Heparin		Stent Arm - Paclitaxel-Eluting Stent		Stent Arm - Bare Metal Stent
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	397/1800 (22.1%)		439/1802 (24.4%)		473/2257 (21%)		185/749 (24.7%)
Cardiac disorders
Death (cardiac)	50/1800 (2.8%)	50	88/1802 (4.9%)	88	71/2257 (3.1%)	71	28/749 (3.7%)	28
Stent thrombosis (definite or probable)	75/1800 (4.2%)	83	81/1802 (4.5%)	88	110/2257 (4.9%)	121	32/749 (4.3%)	34
Ischemia-driven target vessel revascularization (TVR)	239/1800 (13.3%)	272	200/1802 (11.1%)	238	268/2257 (11.9%)	303	126/749 (16.8%)	150
Ischemia-driven target lesion revascularization (TLR)	190/1800 (10.6%)	215	160/1802 (8.9%)	181	204/2257 (9%)	228	108/749 (14.4%)	126
Ischemia-driven TVR, non-TLR	86/1800 (4.8%)	94	68/1802 (3.8%)	76	100/2257 (4.4%)	105	38/749 (5.1%)	44
Major bleeing (protocol), non-coronary artery bypass grafting-related	121/1800 (6.7%)	149	185/1802 (10.3%)	207	189/2257 (8.4%)	213	56/749 (7.5%)	68
Blood transfusion	91/1800 (5.1%)	132	124/1802 (6.9%)	150	105/2257 (4.7%)	123	32/749 (4.3%)	43
Thrombolysis in Myocardial Infarction (TIMI) major or minor bleeding	124/1800 (6.9%)	156	193/1802 (10.7%)	212	165/2257 (7.3%)	179	46/749 (6.1%)	55
Global Use of Strategies to Open Occluded Arteries (GUSTO) Moderate Bleeding	81/1800 (4.5%)	120	110/1802 (6.1%)	136	95/2257 (4.2%)	112	29/749 (3.9%)	41
Other (Not Including Serious) Adverse Events
	Pharmacology Arm - Bivalirudin		Pharmacology Arm - Unfractionated Heparin		Stent Arm - Paclitaxel-Eluting Stent		Stent Arm - Bare Metal Stent
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	81/1800 (4.5%)		132/1802 (7.3%)		122/2257 (5.4%)		32/749 (4.3%)
Cardiac disorders
Thrombolysis in Myocardial Infarction Minor Bleeding	57/1800 (3.2%)	64	89/1802 (4.9%)	91	85/2257 (3.8%)	87	24/749 (3.2%)	26
Global Use of Strategies to Open Occluded Arteries Mild Bleeding	71/1800 (3.9%)	71	110/1802 (6.1%)	113	106/2257 (4.7%)	109	28/749 (3.7%)	28

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.