ISSN: 1885-5857 Impact factor 2023 5.9
Vol. 75. Num. 6.
Pages 515-522 (June 2022)

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

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

Fernando AlfonsoabJosé M. de la Torre HernándezcBorja IbáñezbdManel SabatébeManuel PanfRajiv GulatigJacqueline SawhDominick J. AngiolilloiDavid AdlamjFrancisco Sánchez-Madridbk

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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).

Keywords

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

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