Chicago, IL - Six- and 12-month results from the REPLACE-2 trialnow published in the August 11, 2004 issue of the Journal of the American Medical Associationsupport the efficacy of bivalirudin in patients undergoing PCI, with no evidence of an increased mortality risk over the long term.1

Presentations at international meetings of the 30-day primary end point of REPLACE 2, as well as six- and 12-month follow-up studies, have all been previously reported by heartwire. The 30-day results were also published in JAMA last year.2 The trial enrolled 6010 patients undergoing urgent or elective PCI at 233 centers in nine countries and compared bivalirudin plus provisional GP IIb/IIIa inhibition with heparin plus planned GP IIb/IIIa blockade. At 30 days, bivalirudin was found to have comparable efficacy, with slightly less bleeding.

By six months, fewer patients in the bivalirudin group had died, but more of the same group had had MIs, both nonsignificant differences. By one year, however, this increase in MI did not appear to translate into increased mortality rates in the bivalirudin-treated patients. Indeed, the trend toward decreased mortality persisted in the bivalirudin group at one year and held true for all subsets analyzed, including patients older than 75, women, and diabetics.

"The one-year findings of the REPLACE-2 trial...validate the durable efficacy of bivalirudin," Dr A Michael Lincoff (Cleveland Clinic, OH) and his coinvestigators write. "Not only was there no excess mortality with bivalirudin therapy, but death rates actually trended to be better in the bivalirudin group."