Fernando Alfonso1, José M de la Torre Hernández2, Borja Ibáñez3, Manel Sabaté4, Manuel Pan5, Rajiv Gulati6, Jacqueline Saw7, Dominick J Angiolillo8, David Adlam9, Francisco Sánchez-Madrid10. 1. Departamento de Cardiología, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid, Madrid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain. Electronic address: falf@hotmail.com. 2. Departamento de Cardiología, Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Cantabria, Spain. 3. Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain; Departamento de Cardiología, IIS-Fundación Jiménez Díaz, Centro Nacional Investigaciones Cardiovasculares (CNIC), Madrid, Spain. 4. Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain; Departamento de Cardiología, Instituto Cardiovascular, Hospital Clínic, IDIBAPS, Barcelona, Spain. 5. Departamento de Cardiología, Hospital Universitario Reina Sofía, Universidad de Córdoba, IMIBIC, Córdoba, Spain. 6. Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, United States. 7. Division of Cardiology, Vancouver General Hospital, University of British Columbia, Vancouver, BC, Canada. 8. Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida, United States. 9. Department of Cardiovascular Sciences and National Institute for Health Research, Leicester Biomedical Research Centre, Glenfield Hospital, United Kingdom. 10. Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain; Departamento de Inmunología, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid, Madrid, Spain.
Abstract
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).
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).
Authors: Lucas Lentini Herling de Oliveira; Vinícius Machado Correia; Pedro Felipe Gomes Nicz; Paulo Rogério Soares; Thiago Luis Scudeler Journal: J Clin Med Date: 2022-09-20 Impact factor: 4.964