FDA Approves New Antiplatelet Drug Used During Heart Procedure

 

According to the Centers for Disease Control and Prevention, percutaneous coronary intervention (PCI) is performed on approximately 500,000 people in the United States each year. For this procedure, the coronary arteries are opened by inflating a balloon at the site of the narrowing, usually followed by placement of a small mesh tube, called a stent, to keep the artery open.

 

The FDA has approved Kengreal (cangrelor), an intravenous antiplatelet drug that prevents formation of harmful blood clots in the coronary arteries, the blood vessels that supply blood to the heart. It is approved for adult patients undergoing PCI. By preventing platelets from accumulating, Kengreal reduces the risk of serious clotting complications related to the procedure, including heart attack and clotting of the stent (stent thrombosis). As with other FDA-approved anti-platelet drugs, bleeding, including life-threatening bleeding, is the most serious risk of Kengreal.

 

In a clinical trial that compared Kengreal to Plavix (clopidogrel) in more than 10,000 participants, Kengreal significantly reduced the occurrence of heart attack, the need for further procedures to open the artery and stent thrombosis. However, the overall occurrence of serious bleeding was low but more common with Kengreal than with clopidogrel. Approximately one in every 170 Kengreal patients had a serious bleed versus approximately one in every 275 clopidogrel patients.

 

Kengreal is manufactured by The Medicines Company based in Parsippany, New Jersey.

 

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