FDA OKs antiplatelet for use during heart procedure

FDA has approved cangrelor (Kengreal, The Medicines Company) for reducing the risk of periprocedural thrombotic events in patients undergoing percutaneous coronary intervention.

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Percutaneous coronary intervention (PCI) is a non-surgical procedure used to open narrowed arteries commonly found in coronary heart disease in order to improve blood flow to the heart. In the United States, more than 700,000 PCI procedures require effective antithrombin and antiplatelet therapy.

Kengreal is the first and only intravenous, reversible P2Y12 platelet inhibitor. Its intravenous administration allows an immediate onset of action for patients undergoing PCI. The drug is indicated as an adjunct to PCI to reduce the risk of periprocedural myocardial infarction, repeat coronary revascularization, and stent thrombosis in patients who have not been treated with a P2Y12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor. Once Kengreal is discontinued, there is no antiplatelet effect after 1 hour.

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The approval of Kengreal was primarily based on the results of a phase 3 randomized, double-blind clinical trial that included 11,145 patients. The study compared Kengreal to oral clopidogrel in patients undergoing PCI and was shown to reduce the occurrence of myocardial infarction, stent thrombosis, and the need for repeat revascularization. In the trial, bleeding complications were consistently more common with Kengreal than clopidogrel.

“I believe that intravenous cangrelor has the potential to substantially improve outcomes for patients with cardiovascular disease because of its immediate onset of near complete platelet inhibition with rapid reversibility,” said Gregg Stone, MD, director of Cardiovascular Research and Education, Columbia University Medical Center, New York-Presbyterian Hospital, in a press release. “With decreasing door-to-procedure times and the limitations of all oral antiplatelet agents, I believe cangrelor will be widely embraced by the interventional community.”

Bleeding is the most common adverse effect associated with the use of Kengreal. It is contraindicated in patients with significant active bleeding because it inhibits platelet function.

The drug is expected to be available in the United States in July.

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