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Six-Month Results Confirm Non-Inferiority of Bivalirudin (Angiomax®) to Heparin Plus Glycoprotein IIb/IIIa Blockers: Presented at TCT

By M. M. Pennell

WASHINGTON, DC -- September 29, 2003 -- Recent 30-month trial results demonstrated the non-inferiority of bivalirudin (Angiomax®) when compared with heparin plus glycoprotein (GP) IIb/IIIa blockers in patients undergoing percutaneous coronary intervention (PCI), researchers reported here at the 15^th Annual Transcatheter Cardiovascular Therapeutics symposium.

"Most importantly, the non-significant excess of early non-Q-wave myocardial infarction (MI) reported at 30 days did not translate into higher mortality rate at 6 months," said A. Michael Lincoff, MD, Cleveland Clinic Foundation, Ohio, United States, who presented the results on September 17^th for the investigators of the Randomized Evaluation in PCI Linking Angiomax® to Reduced Clinical Events (REPLACE-2) trial.

"At 6 months, there is no evidence of excess death in the bivalirudin group," said Dr. Lincoff. "In fact, mortality rates were lower in the bivalirudin group, with a difference established at 30 days with 5 excess deaths and then, if anything, a slight broadening of the survival curves. These differences are not statistically significant, and we look forward to follow-up at 1-year to see if these trends continue."

Dr. Lincoff added that he is cautiously optimistic about those 1-year results. "The survival curves are separating and favoring the bivalirudin regimen. It is hard to imagine a statistical scenario where those would turn the other way," he said.

The REPLACE-2 trial was a randomized, double-blind, active controlled study in 6,010 patients undergoing PCI in 233 centers, in 9 countries during 2001 and 2002.

Patients received either bivalirudin plus GP IIb/IIIa blocker at the discretion of the investigator or heparin plus planned GP IIb/IIIa blocker (abciximab or eptifibatide). The objective of the trial was to establish whether it would be possible to use GP IIb/IIIa blockers selectively rather than routinely if heparin were replaced by bivalirudin.

The primary end point of REPLACE-2 was a composite of death/MI/urgent revascularization at 30 days and major in-hospital bleeding episodes. The secondary end point was a triple composite of death/MI/urgent revascularization. The primary composite end point at 30 days suggested a slight advantage for bivalirudin over heparin plus IIb/IIIa inhibitor, but the secondary end point trended in the other direction. The 30-day results, which were published in the Journal of the American Medical Association, included the notation that a non-significant 0.5% excess in ischemic events occurred in the bivalirudin arm.

At 6 months, death, MI, and revascularization rates were not significantly different between either treatment group. "Death rates trended slightly in favor of treatment with bivalirudin, while MI and revascularization trended slightly in favor of the heparin plus IIb/IIIa inhibitor," said Dr/ Lincoff.


[Study title: REPLACE-2. 6-month Results: Late Outcomes of a Prospective, Randomized, Multicenter Trial of Procedural Anticoagulation With the Direct Thrombin Inhibitor Bivalirudin vs. Unfractionated Heparin and IIb/IIIa Inhibition During Percutaneous Coronary Intervention.]

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