Curriculum in CardiologyVariation in the definitions of bleeding in clinical trials of patients with acute coronary syndromes and undergoing percutaneous coronary interventions and its impact on the apparent safety of antithrombotic drugs
Section snippets
Methods
We performed searches on Medline to identify all randomized controlled trials (RCTs) published between January 2000 and September 2006 that evaluated an antithrombotic drug and enrolled more than 3000 patients with an ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI), or undergoing PCI. Searches were performed for the following drugs: dalteparin; tinzaparin; enoxaparin; fondaparinux; clopidogrel; bivalirudin; lepirudin; hirudin;
Differences in bleeding definitions in clinical trials
The trials reviewed evaluated 7 different antithrombotic drugs in over 178,000 patients. The incidence of major bleeding in these trials ranged from as low as 0.2% to as high as 9.1% (Table II).10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25 The risk of bleeding is not the same for fibrinolytics, antithrombins, or antiplatelets and is influenced by the use of glycoprotein IIb/IIIa inhibitors and the clinical situation. Notwithstanding that there are important differences between
Need for standardized bleeding definitions
A number of recent trials in patients with NSTEMI, such as the OASIS-515 and ACUITY13 trials, have shown the clinical value of antithrombotic therapies that have a lower risk of bleeding compared with older strategies and the favorable impact this has on late clinical outcome. A similar advantage of new antithrombotic regimens is seen in recent PCI trials, namely the STEEPLE17 and REPLACE-216 trials, which both demonstrated a lower bleeding risk at similar antithrombotic efficacy compared with
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Cited by (95)
Should Hemoglobin Drop Be Added to Bleeding Classifications in ACS?
2021, Journal of the American College of CardiologyRegistry of left atrial appendage closure and initial experience with intracardiac echocardiography
2018, Revista Portuguesa de CardiologiaThe role of Glycoprotein IIb/IIIa inhibitors in acute coronary syndromes and the interference with anemia
2016, International Journal of CardiologyCitation Excerpt :ACS patients with anemia were more vulnerable to bleeding than their counterparts without it [76]. Major bleeding was also related to ischemic outcomes [83–90]. A myriad of criteria were proposed to define major bleeding [83–90].
Clinical utility of new bleeding criteria: A prospective study of evaluation for the Bleeding Academic Research Consortium definition of bleeding in patients undergoing percutaneous coronary intervention
2015, Journal of CardiologyCitation Excerpt :As a result, bleeding avoidance strategies (BAS), such as radial artery approach, vascular closure device, and novel antithrombotic agents, have been developed for patients undergoing PCI, and have contributed to reducing the risk of bleeding events [11–14]. While the reduction of bleeding events has the potential to improve clinical outcomes, the variable criteria of bleeding definitions make it difficult to interpret the safety of BAS or antithrombotic drugs, and to compare inter-study outcomes [15]. Recently, a consensus effort by academics, research organizations, industry, and regulator representatives resulted in the Bleeding Academic Research Consortium (BARC) suggesting a new objective: a hierarchically graded, consensus classification for bleeding complications [16].
Disclosures: Dr Steinhubl received research support from and served as a consultant for Bristol-Myers Squibb, Sanofi-Aventis, and The Medicines Company and served as a consultant for AstraZeneca. Doctor Berger received consulting and lecture fees from Bristol-Myers Squibb, Sanofi-Aventis, Johnson & Johnson, Genentech, Guilford, Arginox, Schering-Plough, and Boston Scientific and is the medical director and owns equity in Lumen. Doctor Kastrati received lecture fees from Bristol-Myers Squibb, Lilly, and Sanofi-Aventis.
Disclosures: Financial and editorial support for this publication has been provided by Sanofi-Aventis US Inc.