Wijnand K den Dekker1, Nicolas M Van Mieghem2, Johan Bennett3, Manel Sabate4, Giovanni Esposito5, Rutger J van Bommel6, Joost Daemen2, Matthias Vrolix7, Paul A Cummins2, Mattie J Lenzen2, Eric Boersma2, Felix Zijlstra2, Roberto Diletti2. 1. Department of Cardiology, Erasmus MC, University Medical Center Rotterdam, Thoraxcenter, Rotterdam, the Netherlands. Electronic address: w.dendekker@erasmusmc.nl. 2. Department of Cardiology, Erasmus MC, University Medical Center Rotterdam, Thoraxcenter, Rotterdam, the Netherlands. 3. Department of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium. 4. Cardiovascular institute, Hospital Clinic University of Barcelona, IDIBAPS, Barcelona, Spain. 5. Division of Cardiology, Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy. 6. Department of Cardiology, Tergooi Blaricum, Blaricum, the Netherlands. 7. Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium.
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 toimmediate 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).
RCT Entities:
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 syndromepatients with multivessel disease in terms of optimal timing for complete revascularization (Clinicaltrials.gov NCT03621501).
Authors: P A Vriesendorp; J M Wilschut; R Diletti; J Daemen; I Kardys; F Zijlstra; N M Van Mieghem; J Bennett; G Esposito; M Sabate; W K den Dekker Journal: Neth Heart J Date: 2022-05-10 Impact factor: 2.854