RESUMEN
INTRODUCTION Y OBJECTIVES: Spontaneous coronary artery dissection (SCAD) is a rare cause of acute coronary syndrome. Most patients are empirically treated with beta-blockers and antiplatelet drugs. The Beta-blockers and Antiplatelet agents in patients with Spontaneous Coronary Artery Dissection (BA-SCAD) is an academic, pragmatic, prospective, randomized, open-label, blinded-endpoint clinical trial, performed under the auspices of the Spanish Society of Cardiology, to assess the efficacy of pharmacological therapy in patients with SCAD. METHODS: Using a 2 x 2 factorial design, 600 patients will be randomized (1:1/1:1) to: a) beta-blockers (yes/no) and b) "short" (1 month) vs "prolonged" (12 months) antiplatelet therapy. Only patients with preserved left ventricular ejection fraction will be randomized to beta-blockers (yes/no) because patients with reduced left ventricular ejection fraction will receive beta-blockers according to current guidelines. Similarly, only conservatively managed patients (ie, no coronary intervention) will be randomized to the antiplatelet stratum, as patients requiring coronary interventions will receive 1-year dual antiplatelet therapy. The primary efficacy endpoint includes a composite of death, myocardial infarction, stroke, coronary revascularization, recurrent SCAD, and unplanned hospitalization for acute coronary syndrome or heart failure at 1 year. The primary safety endpoint will be bleeding. All patients will be clinically followed up yearly. A comprehensive set of additional substudies (clinical, imaging, revascularization, biomarkers, inflammatory, immunologic, pharmacogenetics, and genetic) will be conducted to ensure a holistic view of this unique and challenging clinical entity. CONCLUSIONS: The results of the BA-SCAD randomized clinical trial will advance our knowledge in the treatment of patients with SCAD. The study was registered at ClinicalTrials.gov (Identifier: NCT04850417).
Asunto(s)
Síndrome Coronario Agudo , Anomalías de los Vasos Coronarios , Accidente Cerebrovascular , Enfermedades Vasculares , Síndrome Coronario Agudo/complicaciones , Síndrome Coronario Agudo/tratamiento farmacológico , Antagonistas Adrenérgicos beta/uso terapéutico , Angiografía Coronaria/métodos , Anomalías de los Vasos Coronarios/complicaciones , Anomalías de los Vasos Coronarios/diagnóstico , Anomalías de los Vasos Coronarios/tratamiento farmacológico , Vasos Coronarios/diagnóstico por imagen , Humanos , Inhibidores de Agregación Plaquetaria/uso terapéutico , Estudios Prospectivos , Accidente Cerebrovascular/complicaciones , Volumen Sistólico , Enfermedades Vasculares/congénito , Enfermedades Vasculares/etiología , Función Ventricular IzquierdaAsunto(s)
Síndrome Coronario Agudo , Angioplastia Coronaria con Balón/métodos , Aterectomía Coronaria/métodos , Angiografía Coronaria/métodos , Vasos Coronarios , Tomografía de Coherencia Óptica/métodos , Calcificación Vascular , Síndrome Coronario Agudo/diagnóstico , Síndrome Coronario Agudo/etiología , Síndrome Coronario Agudo/fisiopatología , Síndrome Coronario Agudo/terapia , Anciano , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/patología , Vasos Coronarios/cirugía , Femenino , Salud Holística , Humanos , Índice de Severidad de la Enfermedad , Cirugía Asistida por Computador/métodos , Resultado del Tratamiento , Calcificación Vascular/diagnóstico por imagen , Calcificación Vascular/patología , Calcificación Vascular/cirugíaRESUMEN
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.