![]() In response to the need to develop, disseminate, and ultimately adopt standardized bleeding end-point definitions for patients receiving antithrombotic therapy, the Bleeding Academic Research Consortium (BARC) convened in February 2010 at the US Food and Drug Administration (FDA) headquarters in White Oak, MD. Finally, as reflected by the various terms used to describe bleeding (serious, severe, catastrophic, major, life-threatening, etc), the heterogeneity of definitions may undermine the ability of clinical trials to meaningfully define the balance of safety and efficacy in vascular interventions. Lack of standardization makes it difficult to optimally organize key clinical trial processes such as adjudication, and even more difficult to interpret relative safety comparisons of different antithrombotic agents across studies, or even within a given trial, because results may vary according to the definition(s) used for bleeding. 15 Unlike ischemic clinical events (eg, cardiac death, MI, stent thrombosis), for which there is now general consensus on end-point definitions, 16, 17 there is substantial heterogeneity among the many bleeding definitions currently in use. 13, 14īecause prevention of major bleeding may represent an important step in improving outcomes by balancing safety and efficacy in the contemporary treatment of ACS, bleeding events have been systematically identified as a crucial end point for the assessment of the safety of drugs during the course of randomized clinical trials, and are an important aspect of the evaluation of new devices and interventional therapies. Prior randomized trials comparing antithrombotic agents suggest that a reduction in bleeding events is associated with improved survival. 11, 12 Thus, balancing the anti-ischemic benefits against the bleeding risk of antithrombotic agents and interventions is of paramount importance in assessing new therapies and in managing patients. 1 – 4 However, the combination of multiple pharmacotherapies, including aspirin, platelet P2Y 12 inhibitors, heparin plus glycoprotein IIb/IIIa inhibitors, direct thrombin inhibitors, and the increasing use of invasive procedures, has also been associated with an increased risk of bleeding.īleeding complications have been associated with an increased risk of subsequent adverse outcomes, including MI, stroke, stent thrombosis, and death, in patients with ACS and in those undergoing percutaneous coronary intervention (PCI), 5 – 10 as well as in the long-term antithrombotic setting. Customer Service and Ordering InformationĪdvances in antithrombotic therapy, along with an early invasive strategy, have reduced the incidence of recurrent ischemic events and death in patients with acute coronary syndromes (ACS unstable angina, non–ST-segment–elevation myocardial infarction, and ST-segment–elevation MI).Stroke: Vascular and Interventional Neurology.Journal of the American Heart Association (JAHA).Circ: Cardiovascular Quality & Outcomes.Arteriosclerosis, Thrombosis, and Vascular Biology (ATVB). ![]()
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