Diseño y justificación del estudio clínico aleatorizado BA-SCAD (bloqueadores beta y agentes antiplaquetarios en pacientes con disección arterial coronaria espontánea)

Translated title of the contribution: Rationale and design of the BA-SCAD (Beta-blockers and Antiplatelet agents in patients with Spontaneous Coronary Artery Dissection) randomized clinical trial

Fernando Alfonso, José M. de la Torre Hernández, Borja Ibáñez, Manel Sabaté, Manuel Pan, Rajiv Gulati, Jacqueline Saw, Dominick J. Angiolillo, David Adlam, Francisco Sánchez-Madrid

Research output: Contribution to journalArticlepeer-review

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).

Translated title of the contributionRationale and design of the BA-SCAD (Beta-blockers and Antiplatelet agents in patients with Spontaneous Coronary Artery Dissection) randomized clinical trial
Original languageSpanish
JournalRevista Espanola de Cardiologia
DOIs
StateAccepted/In press - 2021

Keywords

  • Acute coronary syndrome
  • Biomarkers
  • Fibromuscular dysplasia
  • Intracoronary imaging
  • Myocardial infarction
  • Spontaneous coronary artery dissection

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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