Bivalirudin No Better Than Heparin Among MI Patients Getting PCI

By Reuters Staff

NEW YORK (Reuters Health) - In people with acute MI undergoing urgent percutaneous coronary intervention (PCI), replacing heparin with bivalirudin in a standard anticoagulant regimen does not lower the combined risk of major bleeding, myocardial infarction (MI), or death from any cause, according to results from 6,006 patients in Sweden.

The trial, known as VALIDATE-SWEDEHEART, is the latest attempt to refine therapy for patients undergoing PCI with broader use of radial-artery access and better P2Y-12 inhibitors.

Results of the trial were detailed August 27 at the European Society of Cardiology (ESC) Congress in Barcelona, Spain, and published online by the New England Journal of Medicine.

Both ST-segment elevation myocardial infarction (STEMI) patients and non-STEMI patients were enrolled in the registry-based open-label trial, which tracked volunteers for 180 days. Nine out of 10 cases used radial-artery access.

All patients were pretreated with aspirin, usually at an oral dose of 300 mg.

When the research team looked at the primary composite endpoint of major bleeding, MI, or death from any cause, the rate was 12.3% with bivalirudin and 12.8% with heparin (P=0.54), regardless of the type of heart attack.

The 2.0% MI rate with bivalirudin was a nonsignificant 0.4 percentage points lower than with heparin (2.4%), and the death rate was nearly identical in the two groups (2.9% and 2.8%, respectively).

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Definite stent thrombosis was nonsignificantly less common with bivalirudin (0.4% vs. 0.7%). Rates of major bleeding were the same in the two groups: 8.6%.

"In contrast to the results of many earlier studies, the rate of major bleeding was not significantly lower and the rate of stent thrombosis was not significantly higher with bivalirudin therapy than with heparin therapy," said Dr. Gregg Stone of New York-Presbyterian Hospital in an accompanying editorial.

For example, the 2015 BRIGHT study published in the Journal of the American Medical Association concluded that bivalirudin significantly reduced the 30-day and 1-year rates of adverse events compared to heparin.

Previous trials had suggested that bivalirudin, sold under the brand name Angiomax and manufactured by the Medicines Company, produced less bleeding, but that was before P2Y-12 inhibitors were widely adopted and radial-artery access became common.

But because of continued uncertainties in all the data, "even after VALIDATE-SWEDEHEART, there is no definitive answer to the question of whether to use bivalirudin or heparin during PCI," Dr. Stone said.

SOURCES: https://bit.ly/2xDALso and https://bit.ly/2wMgC7o

N Engl J Med 2017.

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