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.

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).

• Authors: Wijnand K den Dekker, Nicolas M Van Mieghem, Johan Bennett, Manel Sabate, Giovanni Esposito, Rutger J van Bommel, Joost Daemen, Matthias Vrolix, Paul A Cummins, Mattie J Lenzen, Eric Boersma, Felix Zijlstra, Roberto Diletti, BioVasc Trial Investigators
• Journal: American heart journal (Am Heart J) Vol. 227 Pg. 111-117 (09 2020) ISSN: 1097-6744 [Electronic] United States
• PMID: 32739537 (Publication Type: Clinical Trial Protocol, Journal Article)
• Copyright: Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.

Chemical References

• Polymers
• Sirolimus

Topics

• Absorbable Implants
• Acute Coronary Syndrome (drug therapy, surgery)
• Drug-Eluting Stents
• Equivalence Trials as Topic
• Humans
• Multicenter Studies as Topic
• Percutaneous Coronary Intervention
• Polymers
• Prospective Studies
• Prosthesis Design
• Randomized Controlled Trials as Topic (methods)
• Sirolimus (administration & dosage)