Abstract | CONTEXT: OBJECTIVE: To determine whether the efficacy of bivalirudin remains comparable with that of heparin plus Gp IIb/IIIa blockade over 6 months and 1 year. DESIGN, SETTING, AND PARTICIPANTS: Follow-up study to 1 year of a randomized, double-blind trial conducted among 6010 patients undergoing urgent or elective PCI at 233 community or referral hospitals in 9 countries from October 2001 through August 2002. INTERVENTIONS: Patients were randomly assigned to receive intravenously bivalirudin (0.75 mg/kg bolus, 1.75 mg/kg per hour for the duration of PCI), with provisional Gp IIb/IIIa inhibition, or to receive heparin (65 U/kg bolus), with planned Gp IIb/IIIa inhibition ( abciximab or eptifibatide). Both groups received daily aspirin and a thienopyridine for at least 30 days after PCI. MAIN OUTCOME MEASURES: Incidence of death, myocardial infarction, or repeat revascularization by 6 months and death by 12 months after enrollment. RESULTS: At 6 months, death occurred in 1.4% of patients in the heparin plus Gp IIb/IIIa group and in 1.0% of patients in the bivalirudin group (hazard ratio [HR], 0.70; 95% confidence interval [CI], 0.43-1.14; P =.15). Myocardial infarction occurred in 7.4% and 8.2% of patients, respectively (HR, 1.12; 95% CI, 0.93-1.34; P =.24), and repeat revascularization was required in 11.4% and 12.1% of patients, respectively (HR, 1.06; 95% CI, 0.91-1.23; P =.45). By 1 year, death occurred in 2.46% of patients treated with heparin plus Gp IIb/IIIa blockade and in 1.89% of patients treated with bivalirudin (HR, 0.78; 95% CI, 0.55-1.11; P =.16). Nonsignificant trends toward lower 1-year mortality with bivalirudin were present in all patient subgroups analyzed and were of greatest magnitude among high-risk patients. CONCLUSION: Long-term clinical outcome with bivalirudin and provisional Gp IIb/IIIa blockade is comparable with that of heparin plus planned Gp IIb/IIIa inhibition during contemporary PCI.
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Authors | A Michael Lincoff, Neal S Kleiman, Dean J Kereiakes, Frederick Feit, John A Bittl, J Daniel Jackman, Ian J Sarembock, David J Cohen, Douglas Spriggs, Ramin Ebrahimi, Gadi Keren, Jeffrey Carr, Eric A Cohen, Amadeo Betriu, Walter Desmet, Wolfgang Rutsch, Robert G Wilcox, Pim J de Feyter, Alec Vahanian, Eric J Topol, REPLACE-2 Investigators |
Journal | JAMA
(JAMA)
Vol. 292
Issue 6
Pg. 696-703
(Aug 11 2004)
ISSN: 1538-3598 [Electronic] United States |
PMID | 15304466
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antibodies, Monoclonal
- Anticoagulants
- Hirudins
- Immunoglobulin Fab Fragments
- Peptide Fragments
- Peptides
- Platelet Aggregation Inhibitors
- Platelet Glycoprotein GPIIb-IIIa Complex
- Recombinant Proteins
- Heparin
- Eptifibatide
- bivalirudin
- Abciximab
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Topics |
- Abciximab
- Aged
- Angioplasty, Balloon, Coronary
- Antibodies, Monoclonal
(therapeutic use)
- Anticoagulants
(therapeutic use)
- Double-Blind Method
- Eptifibatide
- Female
- Follow-Up Studies
- Heparin
(therapeutic use)
- Hirudins
- Humans
- Immunoglobulin Fab Fragments
(therapeutic use)
- Male
- Middle Aged
- Peptide Fragments
(therapeutic use)
- Peptides
(therapeutic use)
- Platelet Aggregation Inhibitors
(therapeutic use)
- Platelet Glycoprotein GPIIb-IIIa Complex
(antagonists & inhibitors)
- Recombinant Proteins
(therapeutic use)
- Survival Analysis
- Treatment Outcome
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