（英文原文）FDA approves new antiplatelet drug used during heart procedure
The U.S. Food and Drug Administration todayapproved Kengreal (cangrelor), an intravenous antiplatelet drug that preventsformation of harmful blood clots in the coronary arteries, the blood vesselsthat supply blood to the heart. It is approved for adult patients undergoingpercutaneous coronary intervention (PCI), a procedure used to open a blocked ornarrowed coronary artery to improve blood flow to the heart muscle.
According to the Centers for DiseaseControl and Prevention, PCI is performed onapproximately500,000 people in the United States each year. The coronaryarteries 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 theartery open.
By preventing platelets from accumulating,Kengreal reduces the risk of serious clotting complications related to theprocedure, including heart attack and clotting of the stent (stentthrombosis).
「For patients undergoing percutaneouscoronary intervention, blood clotting can cause serious problems,」 said NormanStockbridge, M.D., Ph.D., director of the Division of Cardiovascular and RenalDrugs in the FDA’s Center for Drug Evaluation and Research. 「The approval ofKengreal provides another treatment option for patients.」
As with other FDA-approved anti-platelet drugs,bleeding, including life-threatening bleeding, is the most serious risk ofKengreal.
In a clinical trial that compared Kengrealto Plavix (clopidogrel) in more than 10,000 participants, Kengrealsignificantly reduced the occurrence of heart attack, the need for furtherprocedures to open the artery and stent thrombosis. The overall occurrence ofserious bleeding was low but more common with Kengreal than with clopidogrel.Approximately one in every 170 Kengreal patients had a serious bleed versus approximatelyone in every 275 clopidogrel patients.
來源：ACC CV News Digest（June 23，2015）
【163】FDA批准抗血小板新藥坎格雷洛（Kengreal）用於PCI成年患者（中文摘要）
美國FDA於當地時間6月22日宣布，批准坎格雷洛（一種預防冠狀動脈血栓形成的靜脈用抗血小板藥物）用於接受PCI的成年患者。
據CDC報告，在美國每年有大約50萬人接受PCI。坎格雷洛可通過防止血小板聚集來降低與介入治療相關的嚴重凝血併發症，包括心臟病發作和支架內血栓形成。FDA藥物評估和研究中心心血管與腎病藥物部主任Stockbridge認為，對於接受PCI的患者，凝血可引發嚴重問題。坎格雷洛的獲批可為這些患者提供另一種治療選擇。
正如其他獲得FDA批准的抗血小板藥物一樣，出血（包括危及生命的出血）是坎格雷洛最嚴重的不良反應。在超過1萬例患者中對坎格雷洛和氯吡格雷進行比較的臨床試驗顯示，坎格雷洛顯著減少了心臟病發作、需要再次血運重建以及支架內血栓形成的發生。嚴重出血的總發生率低，但坎格雷洛組高於氯吡格雷組（約為1例/170例患者對比1例/275例患者）。
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