BACKGROUND:Patients with a non-ST-elevation acute coronary syndrome and prior CABG are at high risk of a recurrent ischemic event despite aspirin therapy. This trial investigated the potential benefit of secondary prevention with warfarin. METHODS AND RESULTS: In a double-blind randomized trial, 135 patients with unstable angina or non-ST-segment elevation myocardial infarction, with prior CABG, and who were poor candidates for a revascularization procedure received therapy withaspirin and placebo+warfarin, warfarin and placebo+aspirin, or aspirin and warfarinfor 12 months. Warfarin was titrated to an international normalized ratio of 2.0 to 2.5. The primary end point (death or myocardial infarction or unstable angina requiring hospitalization 1 year after randomization) occurred in 14.6% of the patients in the warfarin-alone group, in 11.5% of patients in the aspirin-alone group, and in 11.3% of patients randomized to the combination therapy (P=0.76). Subgroup analyses by risk features provided no indications that warfarin alone or in combination with aspirin could be of benefit over aspirin alone. Bleeding was more frequent in the 2 groups of patients administered warfarin. CONCLUSIONS: Moderate-intensity oral anticoagulation alone or combined with low-dose aspirin does not appear to be superior to low-dose aspirin in the prevention of recurrent ischemic events in patients with non-ST-elevation acute coronary syndromes and previous CABG.
RCT Entities:
BACKGROUND:Patients with a non-ST-elevation acute coronary syndrome and prior CABG are at high risk of a recurrent ischemic event despite aspirin therapy. This trial investigated the potential benefit of secondary prevention with warfarin. METHODS AND RESULTS: In a double-blind randomized trial, 135 patients with unstable angina or non-ST-segment elevation myocardial infarction, with prior CABG, and who were poor candidates for a revascularization procedure received therapy with aspirin and placebo+warfarin, warfarin and placebo+aspirin, or aspirin and warfarin for 12 months. Warfarin was titrated to an international normalized ratio of 2.0 to 2.5. The primary end point (death or myocardial infarction or unstable angina requiring hospitalization 1 year after randomization) occurred in 14.6% of the patients in the warfarin-alone group, in 11.5% of patients in the aspirin-alone group, and in 11.3% of patients randomized to the combination therapy (P=0.76). Subgroup analyses by risk features provided no indications that warfarin alone or in combination with aspirin could be of benefit over aspirin alone. Bleeding was more frequent in the 2 groups of patients administered warfarin. CONCLUSIONS: Moderate-intensity oral anticoagulation alone or combined with low-dose aspirin does not appear to be superior to low-dose aspirin in the prevention of recurrent ischemic events in patients with non-ST-elevation acute coronary syndromes and previous CABG.
Authors: Thomas L Ortel; Ignacio Neumann; Walter Ageno; Rebecca Beyth; Nathan P Clark; Adam Cuker; Barbara A Hutten; Michael R Jaff; Veena Manja; Sam Schulman; Caitlin Thurston; Suresh Vedantham; Peter Verhamme; Daniel M Witt; Ivan D Florez; Ariel Izcovich; Robby Nieuwlaat; Stephanie Ross; Holger J Schünemann; Wojtek Wiercioch; Yuan Zhang; Yuqing Zhang Journal: Blood Adv Date: 2020-10-13