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June 26, 2015 – The following is good news for patients who will need percutaneous coronary intervention (PCI), however, bleeding problems are not completely resolved. But see for yourself.
The U.S. Food and Drug Administration just approved Cangrelor (Kengreal), 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 percutaneous coronary intervention (PCI), a procedure in interventional cardiology used to open a blocked or narrowed coronary artery to improve blood flow to the heart muscle. According to the Centers for Disease Control and Prevention, PCI is performed on approximately 500’000 people in the United States each year. 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. By preventing platelets from accumulating, Cangrelor (Kengreal), reduces the risk of serious clotting complications related to the procedure, including heart attack and clotting of the stent (stent thrombosis).
“For patients undergoing percutaneous coronary intervention, blood clotting can cause serious problems,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Drugs in the FDA’s Center for Drug Evaluation and Research. “The approval of Cangrelor (Kengreal), provides another treatment option for patients.”
Unfortunately, as with other FDA-approved anti-platelet drugs, bleeding, including life-threatening bleeding, is the most serious risk of Cangrelor (Kengreal), . In a clinical trial that compared Cangrelor (Kengreal), to Clopidogrel (Plavix) in more than 10,000 participants, Cangrelor (Kengreal), significantly reduced the occurrence of heart attack, the need for further procedures to open the artery and stent thrombosis. The overall occurrence of serious bleeding was low but more common with Cangrelor (Kengreal), than with Clopidogrel (Plavix). Approximately one in every 170 Kengreal patients had a serious bleed versus approximately one in every 275 clopidogrel patients. The treatment with Clopidogrel itself may pose difficulties in patients that are of the poor metabolizer phenotype at the CYP2C19 gene locus. This complication has already been discussed earlier on in thasso post