Timi bleeding trial#
An optimal bleeding score would not only be applicable to large groups as in a clinical trial but would also be applicable to an individual patient and help define transfusion thresholds. Ultimately, patients could benefit from tailored antithrombotic therapy, which optimizes their individual risk/benefit ratio.
Timi bleeding verification#
It would also facilitate detection and verification of factors that differentially affect a patient’s bleeding risk and risk of ischemic complications and/or that differentially affect the prognostic impact of bleeding and ischemia. Examples include analyses from the SYNERGY (Superior Yield of the New Strategy of Enoxaparin, Revascularization and Glycoprotein IIb/IIIa Inhibitors) and CURE (Clopidogrel in Unstable Angina to Prevent Recurrent Events) trials in which significant between-group differences in bleeding risk were observed using one bleeding score, but not using others (8,9).Ĭonsistent use of a meaningful bleeding classification in cardiovascular trials would allow more reliable comparisons of different antithrombotic drugs across trials. It is also possible to reach different conclusions regarding the bleeding risk or the prognostic impact of bleeding within a trial depending on which bleeding definition is used. Because these definitions differ considerably, it is difficult to compare results across trials and studies. Unfortunately, bleeding definitions in pivotal contemporary multicenter clinical trials have not been consistent (2,6,7). How bleeding is assessed and treated may also vary across geographies and individual practitioners. An elderly patient with residual coronary disease, for example, may have a markedly different response to an acute drop in hemoglobin compared with a young patient without significant residual coronary disease. Bleeding is therefore a central safety outcome in cardiovascular clinical trials.Īssessing bleeding is not straightforward, however, and involves multiple factors: absolute amount of blood loss, rate of blood loss, hemodilution effects of fluids, effect of transfusion, as well as varying hemodynamic and ischemic effects of the bleeding episode itself, which depend to a large extent on the patient’s underlying comorbidities and baseline hemoglobin levels. In fact, observational studies have suggested that bleeding complications are as dangerous as a recurrent myocardial infarction (5). Both in-hospital and post-discharge bleeding are associated with increased risk of death (3,4). However, this benefit comes at the expense of increased bleeding (2).
Percutaneous coronary intervention and antithrombotic drugs reduce the risk of ischemic events and improve prognosis for patients with acute coronary syndromes (1,2).
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