麻豆传媒

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SAN FRANCISCO -- Bivalirudin (Angiomax) isn't any better than unfractionated heparin (UFH) in transcatheter aortic valve replacement (TAVR), the BRAVO 3 trial showed.

Anticoagulation with the newer, more expensive agent did not significantly lower rates of major bleeding at 48 hours (6.9% versus 9.0% with heparin, relative risk 0.77, P=0.27), , of Institut Hospitalier Jacques Cartier in Massy, France, and colleagues reported here at the Transcatheter Cardiovascular Therapeutics (TCT) meeting.

Nor did it lower the composite of all-cause mortality, myocardial infarction, and stroke at 48 hours (3.5% bivalirudin versus 4.8% heparin, relative risk 0.73, P=0.35) the group reported simultaneously online in the Journal of the American College of Cardiology.

The net effect -- cardiovascular events and major bleeding considered together -- at 30 days likewise came out similar (14.4% versus 16.1%, respectively, relative risk 0.89, P=0.50), which met non-inferiority criteria.

"Bivalirudin may be used as an alternative anticoagulant during TAVR in patients who cannot be treated with UFH," Lefevre concluded.

, of the Duke Clinical Research Institute in Durham, N.C., agreed in an editorial accompanying the JACC paper.

All else being equal, "the cost difference between the two agents begs the question of when bivalirudin should be considered," he cautioned.

One good reason to use the more expensive drug would be heparin-induced thrombocytopenia, which affects maybe 2% of patients, , conference co-director said at a press conference he moderated where the findings were presented.

"Another clinical scenario in which bivalirudin can be considered is when very large doses or repeated doses of UFH may be necessary to maintain therapeutic ACT values, such as in patients who are overweight or obese," Rao added. "The predictable anticoagulant effect of bivalirudin could provide an advantage in this context."

"Other than these specific conditions, there is no question that until further data are available, UFH is the preferred agent for TAVR," Rao concluded.

Already, though, an informal hand-raising poll at the press conference showed that every member of the eight-person panel of leading interventionalists uses heparin instead of bivalirudin in this setting.

Perhaps illustrating why, , director of the Sones Cardiac Catheterization Laboratory at the Cleveland Clinic, raised the issue of how to treat patients who do bleed.

The trial didn't specify use of protamine for heparin reversal, but about half of U.S. centers do use it at the end of the procedure, Kapadia noted. All on the panel said they do.

"There has been a hypothesis about bivalirudin that it could reduce bleeding compared to heparin alone in PCI patients," said Kirtane, of New York-Presbyterian Hospital/Columbia University Medical Center in New York City. "While this is a much bigger access site, you won't necessarily see these trends. On the other hand, when you have a bigger access site there's a potential for increased signal. But this study is still somewhat underpowered."

Roxana Mehran, MD, of Mount Sinai School of Medicine in New York City and also a co-director of the conference, cautioned against generalizing to all PCI settings.

"This really doesn't change all the decades of data of thousands of patients showing that bivalirudin reduces bleeding complications," she said at the press conference. "There's no question about that."

However, this is a little different because there was no use of glycoprotein IIb/IIIa agents to confound bleeding risk as in those trials, making BRAVO 3 a pure comparison that may be more informative, Kirtane countered.