Standardized reporting of bleeding complications for clinical investigations in acute coronary syndromes: A proposal from the Academic Bleeding Consensus (ABC) Multidisciplinary Working Group

Sunil V. Rao, John Eikelboom, Ph Gabriel Steg, A. Michael Lincoff, William S. Weintraub, Jean Pierre Bassand, A. Koneti Rao, C. Michael Gibson, John L. Petersen, Roxana Mehran, Steven V. Manoukian, Richard Charnigo, Kerry L. Lee, Mauro Moscucci, Robert A. Harrington

Research output: Contribution to journalArticle

35 Citations (Scopus)

Abstract

Background: Clinical trials of antithrombotic agents for the treatment of ACS routinely assess bleeding as a safety endpoint, but variation in bleeding definitions makes comparison of the relative safety of these agents difficult. Methods: The ABC Multidisciplinary Working Group, an informal working group comprising clinical researchers and representatives from the US Food and Drug Administration, the National Institutes of Health, and the pharmaceutical industry, sought to develop a consensus approach to measuring the incidence and severity of bleeding complications during clinical trials of acute coronary syndromes (ACS). A meeting of the ABC was convened in April 2008 in Washington, DC, with the goal of developing a consensus approach to measuring the incidence and severity of hemorrhagic complications during clinical trials of ACS. Relevant literature on bleeding was reviewed through a series of short lectures and intensive group discussion. Results: Using existing evidence on bleeding and outcomes as well as clinical judgment, criteria for the assessment of bleeding were developed through expert consensus. This consensus statement divides bleeding-related data elements into three categories: essential, recommended, and optional. Conclusions: The ABC Group recommendations for collection and reporting of bleeding complications provide a framework for consistency in the collection of information on hemorrhagic complications in trials of ACS. Widespread adoption of the statement recommendations will facilitate understanding of the mechanisms of adverse outcomes after bleeding and comparisons of the relative safety of antithrombotic agents, as well as the interpretation of safety results from future studies.

Original languageEnglish
JournalAmerican Heart Journal
Volume158
Issue number6
DOIs
StatePublished - Dec 1 2009

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Acute Coronary Syndrome
Consensus
Hemorrhage
Safety
Fibrinolytic Agents
Clinical Trials
Incidence
National Institutes of Health (U.S.)
Drug Industry
United States Food and Drug Administration
Research Personnel

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Standardized reporting of bleeding complications for clinical investigations in acute coronary syndromes : A proposal from the Academic Bleeding Consensus (ABC) Multidisciplinary Working Group. / Rao, Sunil V.; Eikelboom, John; Steg, Ph Gabriel; Lincoff, A. Michael; Weintraub, William S.; Bassand, Jean Pierre; Rao, A. Koneti; Gibson, C. Michael; Petersen, John L.; Mehran, Roxana; Manoukian, Steven V.; Charnigo, Richard; Lee, Kerry L.; Moscucci, Mauro; Harrington, Robert A.

In: American Heart Journal, Vol. 158, No. 6, 01.12.2009.

Research output: Contribution to journalArticle

Rao, SV, Eikelboom, J, Steg, PG, Lincoff, AM, Weintraub, WS, Bassand, JP, Rao, AK, Gibson, CM, Petersen, JL, Mehran, R, Manoukian, SV, Charnigo, R, Lee, KL, Moscucci, M & Harrington, RA 2009, 'Standardized reporting of bleeding complications for clinical investigations in acute coronary syndromes: A proposal from the Academic Bleeding Consensus (ABC) Multidisciplinary Working Group', American Heart Journal, vol. 158, no. 6. https://doi.org/10.1016/j.ahj.2009.10.008
Rao, Sunil V. ; Eikelboom, John ; Steg, Ph Gabriel ; Lincoff, A. Michael ; Weintraub, William S. ; Bassand, Jean Pierre ; Rao, A. Koneti ; Gibson, C. Michael ; Petersen, John L. ; Mehran, Roxana ; Manoukian, Steven V. ; Charnigo, Richard ; Lee, Kerry L. ; Moscucci, Mauro ; Harrington, Robert A. / Standardized reporting of bleeding complications for clinical investigations in acute coronary syndromes : A proposal from the Academic Bleeding Consensus (ABC) Multidisciplinary Working Group. In: American Heart Journal. 2009 ; Vol. 158, No. 6.
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