Bivalirudin and Provisional Glycoprotein IIb/IIIa Blockade Compared With Heparin and Planned Glycoprotein IIb/IIIa Blockade During Percutaneous Coronary Intervention

JAMA - Journal of the American Medical Association - Tập 289 Số 7 - Trang 853 - 2003
A. Michael Lincoff1, John A. Bittl2, Robert A. Harrington3, Frederick Feit4, Neal S. Kleiman5, J. Daniel Jackman, Ian J. Sarembock6, David B. Seder7, Douglas Spriggs8, Ramin Ebrahimi9, Gadi Keren10, J. Jeffrey Carr11, Eric A. Cohen12, Amadeo Betriu13, Walter Desmet14, Dean J. Kereiakes15, Wolfgang Rutsch16, Robert G. Wilcox17, Pim J. de Feyter18, Alec Vahanian19, Eric J. Topol1
1[Cleveland Clinic Foundation]
2Munroe Regional Med Center
3Duke Clinical Research Institute
4New York University School of Medicine
5Academic Institute
6University of Virginia Health System;
7Harvard University
8Clearwater Cardiovasc. Consultants
9Veterans Affairs Medical Center
10Tel-Aviv Sourasky Medical Center;
11TEXAS MEDICAL CENTER
12Sunnybrook Health Sciences Centre
13Hospital Clínic
14Belgium
15Ohio Heart and Vascular Center
16Rudolf Virchow Hospital
17Nottingham University Hospitals
18Thoraxcenter
19Hôpital Bichat

Tóm tắt

ContextThe direct thrombin inhibitor bivalirudin has been associated with better efficacy and less bleeding than heparin during coronary balloon angioplasty but has not been widely tested during contemporary percutaneous coronary intervention (PCI).ObjectiveTo determine the efficacy of bivalirudin, with glycoprotein IIb/IIIa (Gp IIb/IIIa) inhibition on a provisional basis for complications during PCI, compared with heparin plus planned Gp IIb/IIIa blockade with regard to protection from periprocedural ischemic and hemorrhagic complications.Design, Setting, and ParticipantsThe Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE)–2 trial, a randomized, double-blind, active-controlled 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.InterventionsPatients were randomly assigned to receive intravenous bivalirudin (0.75-mg/kg bolus plus 1.75 mg/kg per hour for the duration of PCI), with provisional Gp IIb/IIIa inhibition (n = 2999), or heparin (65-U/kg bolus) with planned Gp IIb/IIIa inhibition (abciximab or eptifibatide) (n = 3011). Both groups received daily aspirin and a thienopyridine for at least 30 days after PCI.Main Outcome MeasuresThe primary composite end point was 30-day incidence of death, myocardial infarction, urgent repeat revascularization, or in-hospital major bleeding; the secondary composite end point was 30-day incidence of death, myocardial infarction, or urgent repeat revascularization.ResultsProvisional Gp IIb/IIIa blockade was administered to 7.2% of patients in the bivalirudin group. By 30 days, the primary composite end point had occurred among 9.2% of patients in the bivalirudin group vs 10.0% of patients in the heparin-plus-Gp IIb/IIIa group (odds ratio, 0.92; 95% confidence interval, 0.77-1.09; P = .32). The secondary composite end point occurred in 7.6% of patients in the bivalirudin vs 7.1% of patients in the heparin-plus-Gp IIb/IIIa groups (odds ratio, 1.09; 95% confidence interval 0.90-1.32; P = .40). Prespecified statistical criteria for noninferiority to heparin plus Gp IIb/IIIa were satisfied for both end points. In-hospital major bleeding rates were significantly reduced by bivalirudin (2.4% vs 4.1%; P<.001).ConclusionsBivalirudin with provisional Gp IIb/IIIa blockade is statistically not inferior to heparin plus planned Gp IIb/IIIa blockade during contemporary PCI with regard to suppression of acute ischemic end points and is associated with less bleeding.

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JAMA - Journal of the American Medical Association

Tập 289 Số 7

853

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