![]() ![]() The COMPASS (Cardiovascular Outcomes for People Using Anticoagulation Strategies) trial randomized 27 395 participants with stable atherosclerotic vascular disease to receive rivaroxaban (2.5 mg twice daily) plus aspirin (100 mg once daily), rivaroxaban (5 mg twice daily), aspirin (100 mg once daily), or placebo. 4 Subgroup analysis demonstrated greater absolute reductions in ischemic events with long-term ticagrelor (60 mg twice daily) in higher-risk post-MI patients with diabetes, peripheral arterial disease, or multivessel CAD. The rates of bleeding and dyspnea were numerically lower with 60 mg of ticagrelor than with 90 mg, resulting in a lower rate of discontinuation of the study drug and a better safety profile with the 60 mg dose. The PEGASUS-TIMI 54 (Prevention of Cardiovascular Events in Patients with Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin Thrombolysis In Myocardial Infarction 54) trial demonstrated that long-term dual antiplatelet therapy (DAPT) with aspirin (75-150 mg) and ticagrelor 60 or 90 mg twice daily, started in stable patients 1-3 years after MI, reduced ischemic events at the expense of more non-fatal bleeding. Patients who have had an acute coronary syndrome, especially myocardial infarction (MI), are at high risk for recurrent ischemic events, which suggests that this population may derive particular benefit from more intensive secondary prevention. 1Ĭoronary artery disease (CAD), a process of atherosclerotic plaque formation in the coronary arteries, can be stable for long periods, but can also become unstable at any time due to an acute atherothrombotic event, typically caused by plaque erosion and rupture. Another interesting finding in this study was the large number of patients excluded for having an indication for chronic anticoagulation (46.2% on the PEGASUS criteria and 32.1% on the COMPASS criteria), which certainly reflects the high prevalence of other clinical conditions such as atrial fibrillation among these patients at high ischemic risk. It is therefore not surprising that a large number of real-world patients do not meet the inclusion criteria for these clinical trials (about 50% in the study by Faria et al.). It must, however, be borne in mind that most patients with a higher ischemic risk also have a high bleeding risk. Hence the importance in clinical practice of determining which patients are most at risk of ischemic events without a high risk of bleeding. In the real world, the expression “there is no such thing as a free lunch” is once again applicable, since the reduction of ischemic events seen with extended antithrombotic therapy for secondary prevention of acute coronary syndrome is accompanied by an increase in bleeding events in all published antithrombotic trials. For this reason, the results of these RCTs must be complemented with real-world registries, as these are likely to have broader inclusion criteria, making it easier to validate some of the therapeutic options for the many patients who would not have been included in the trials. This becomes even more complicated when there are multiple studies on the same clinical issue, but with different inclusion and exclusion criteria, which makes it difficult to put them all into perspective. published in this issue of the Journal 1 calls attention to an important issue in medicine, which is the applicability in clinical practice of the results of published randomized clinical trials (RCTs). ![]()
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