Percutaneous complete revascularization strategies using sirolimus-eluting biodegradable polymer-coated stents in patients presenting with acute coronary syndrome and multivessel disease: Rationale and design of the BIOVASC trial - 25/08/20
, Nicolas M. Van Mieghem, MD PhD a, Johan Bennett, MD PhD b, Manel Sabate, MD PhD c, Giovanni Esposito, MD PhD d, Rutger J. van Bommel, MD PhD e, Joost Daemen, MD PhD a, Matthias Vrolix, MD PhD f, Paul A. Cummins, RN a, Mattie J. Lenzen, PhD a, Eric Boersma, MD PhD a, Felix Zijlstra, MD PhD a, Roberto Diletti, MD PhD aon Behalf of the BioVasc Trial Investigators
Abstract |
Background |
Complete revascularization in patients with an acute coronary syndrome and multivessel disease is superior compared to culprit-only treatment. However, it is unknown whether direct complete or staged complete revascularization should be pursued.
Methods |
The BIOVASC study is an investigator-initiated, prospective, multicenter, randomized, 2-arm, international, open-label, noninferiority trial. We will randomize 1,525 patients 1:1 to immediate complete revascularization (experimental arm) or culprit-only plus staged complete revascularization (control arm). Patients will be enrolled in approximately 30 sites in Belgium, Italy, the Netherlands, and Spain. The primary end point is a composite of all-cause mortality, nonfatal myocardial infarction, any unplanned ischemia-driven revascularization (excluding staged procedures in the control arm at the predetermined time), and cerebrovascular events (MACCE) at 1 year post index procedure.
Conclusions |
The BIOVASC study aims to further refine the treatment algorithm for acute coronary syndrome patients with multivessel disease in terms of optimal timing for complete revascularization (Clinicaltrials.gov NCT03621501).
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Vol 227
P. 111-117 - septembre 2020 Retour au numéro
Article précédent
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