Dual antiplatelet therapy versus oral anticoagulation plus dual antiplatelet therapy in patients with atrial fibrillation and low-to-moderate thromboembolic risk undergoing coronary stenting: Design of the MUSICA-2 randomized trial

• Published in: The American heart journal Vol. 166; no. 4; pp. 669 - 675
• Main Authors: Sambola, Antonia, MD, FESC, Montoro, J. Bruno, MD, del Blanco, Bruno García, MD, Llavero, Nadia, PhD, Barrabés, José A., MD, Alfonso, Fernando, MD, FESC, Bueno, Héctor, MD, FESC, Cequier, Angel, MD, FESC, Serra, Antonio, MD, Zueco, Javier, MD, Sabaté, Manel, MD, Rodríguez-Leor, Oriol, MD, García-Dorado, David, MD, FESC, FACC
• Format: Journal Article
• Language: English
• Published: United States Mosby, Inc 01.10.2013; Elsevier Limited
• Subjects: Administration, Oral; Anticoagulants - administration & dosage; Atrial Fibrillation - complications; Atrial Fibrillation - drug therapy; Cardiovascular; Dose-Response Relationship, Drug; Double-Blind Method; Drug therapy; Female; Follow-Up Studies; Heart attacks; Humans; Incidence; Male; Mortality; Myocardial Infarction - epidemiology; Myocardial Infarction - etiology; Myocardial Infarction - prevention & control; Platelet Aggregation Inhibitors - administration & dosage; Retrospective Studies; Risk Factors; Spain - epidemiology; Stents; Stroke; Stroke - epidemiology; Stroke - etiology; Stroke - prevention & control; Survival Rate - trends; Thromboembolism - complications; Thromboembolism - epidemiology; Thromboembolism - prevention & control; Time Factors; Treatment Outcome; Spain
• ISSN: 0002-8703; 1097-6744
• DOI: 10.1016/j.ahj.2013.07.028

Background Oral anticoagulation (OAC) is the recommended therapy for patients with atrial fibrillation (AF) because it reduces the risk of stroke and other thromboembolic events. Dual antiplatelet therapy (DAPT) is required after percutaneous coronary intervention and stenting (PCI-S). In patients with AF requiring PCI-S, the association of DAPT and OAC carries an increased risk of bleeding, whereas OAC therapy or DAPT alone may not protect against the risk of developing new ischemic or thromboembolic events. Objective The MUSICA-2 study will test the hypothesis that DAPT compared with triple therapy (TT) in patients with nonvalvular AF at low-to-moderate risk of stroke (CHADS2 score ≤2) after PCI-S reduces the risk of bleeding and is not inferior to TT for preventing thromboembolic complications. Design The MUSICA-2 is a multicenter, open-label randomized trial that will compare TT with DAPT in patients with AF and CHADS2 score ≤2 undergoing PCI-S. The primary end point is the incidence of stroke or any systemic embolism or major adverse cardiac events: death, myocardial infarction, stent thrombosis, or target vessel revascularization at 1 year of PCI-S. The secondary end point is the combination of any cardiovascular event with major or minor bleeding at 1 year of PCI-S. The calculated sample size is 304 patients. Conclusions The MUSICA-2 will attempt to determine the most effective and safe treatment in patients with nonvalvular AF and CHADS2 score ≤2 after PCI-S. Restricting TT for AF patients at high risk for stroke may reduce the incidence of bleeding without increasing the risk of thromboembolic complications.