The challenge of defining bleeding among patients with acute coronary syndromes.
Journal Article (Journal Article;Review)
Advances in the management of patients with acute coronary syndromes (ACS), specifically, the use of combined pharmacotherapy with antithrombotic and antiplatelet therapies and routine percutaneous coronary intervention (PCI), have greatly reduced rates of thrombotic outcomes and mortality in these patients. However, these same therapies also can increase the risk of bleeding and transfusion use, which are predictive of poor outcomes in patients with ACS. Accurate assessment of the risk-to-benefit ratio for any therapy depends on the use of clinically relevant, preferably standardized, definitions of endpoint events. Unfortunately, clinical trials of antithrombotic therapies have used various definitions for bleeding, most of which were originally developed for trials of fibrinolytic therapy in acute myocardial infarction (MI). These variations in bleeding definitions have complicated cross-study comparisons and assessments of drug class effects. Further, it is unclear whether these definitions remain clinically relevant in the era of routine PCI and aggressive antithrombotic therapy for ACS. Although an argument can be made for development of a standardized bleeding definition, a more prudent approach may be to develop standardized data elements, which can then be used to tailor bleeding definitions according to the goals of future clinical investigations.
Full Text
Duke Authors
Cited Authors
- Wallace, TW; Rao, SV
Published Date
- October 2007
Published In
Volume / Issue
- 30 / 10 Suppl 2
Start / End Page
- II16 - II23
PubMed ID
- 18228648
Pubmed Central ID
- PMC6653169
International Standard Serial Number (ISSN)
- 0160-9289
Digital Object Identifier (DOI)
- 10.1002/clc.20229
Language
- eng
Conference Location
- United States