Results of acuity clinical trial
Significant advances have been made over the last several years in the treatment of patients with acute coronary syndromes including the introduction and approval of new antithrombin and antiplatelet agents. Results from a number of studies have impacted treatment strategies of patients with and without percutaneous coronary intervention. The study design and results of five trials: OASIS-5 PCI, PCI-ACUITY, TRITON–TIMI-38, FINESSE, and CARESS-in-AMI will be reviewed, and implications for clinical practice presented.Keywords
Significant advances have been made over the last several years in the treatment of patients with acute coronary syndromes (ACS), including the introduction and approval of new antithrombin and antiplatelet agents. Clinical trials to assess these new agents can be arbitrarily divided into studies to prevent ischaemic events, studies of treatment before percutaneous coronary intervention (PCI) to prevent complications, and studies after PCI to prevent stent thrombosis and thrombotic events unrelated to the PCI. This article reviews the clinical implications of a number of recently completed and published atherothrombotic trials with relevance to practicing and interventional cardiologists.
The OASIS-5 PCI trial
The Fifth Organization to Assess Strategies for Ischemic Syndromes–Percutaneous Coronary Intervention (OASIS-5 PCI) trial was a substudy of the main OASIS-5 trial, which had compared fondaparinux and enoxaparin in 20 018 patients. The substudy included 6177 patients undergoing PCI. The study drugs were tailored according to the time when each patient received his or her last subcutaneous dose of fondaparinux or enoxaparin and according to the concomitant use of glycoprotein (GP) IIb/IIIa inhibitors (GPIs). The results showed no differences in mortality, incidence of myocardial infarction (MI), or stroke at 9 days, but the administration of fondaparinux was associated with a 50% reduction in major bleeding. However, fondaparinux caused an increase in the rate of guiding-catheter thrombus formation.
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The conference will focus on issues such as design and analysis of clinical trials, methods in biostatistics and development of clinical prediction models.