Bleeding after antithrombotic therapy in patients with acute ischemic heart disease
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Definitions of bleeding must be considered when evaluating results of clinical trials. Assessments of bleeding impact based on clinical criteria may be more relevant to patient outcomes than those based on simple laboratory measures like an isolated change in hemoglobin, that do not appear to affect patient care. The risk of excessive bleeding in patients who receive antiplatelet and antithrombotic therapy is related to a combination of patient characteristics (older age, female sex, impaired renal function), and delivery factors (excessive dosing, stacking of anticoagulants). Investigators should justify components of bleeding endpoints as being clinically meaningful, sufficiently frequent in the study population, and affected by the intervention.
KeywordsBleeding Acute coronary syndrome Hemorrhage Percutaneous coronary intervention
Editorial assistance for this manuscript was provided by Adelphi, Inc., and funded by Schering-Plough Corporation.
Conflict of interest
Dr. Cohen has received grant/research support from Bayer, Sanofi Aventis. He is a consultant to Datascope and Schering-Plough. He is a member of the speakers’ bureau for Schering-Plough, Sanofi Aventis, Merck, and BMS.
Dr. Rao is a consultant to Sanofi Aventis and The Medicines Company. He is on the Speakers’ Bureaus of Sanofi Aventis, The Medicines Company, and Cordis Corporation. He receives research funding from The Medicines Company and Cordis Corporation.
Dr. Alexander is a consultant to Schering-Plough and receives research funding from Merck, Schering-Plough, and BMS.
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