BIOVASC trial in perspective: complete revascularization strategies in patients presenting with acute coronary syndromes and multi-vessel coronary disease

Abstract

In patients hospitalized with acute myocardial infarction, multi-vessel coronary artery disease (MVD) is common (50-60%) and is associated with an increased risk of post-discharge mortality and recurrent myo-cardial infarction. 1,2 Multiple randomized controlled trials (PRAMI, DANAMI-3-PRIMULTI, CvLPRIT, Compare-Acute, and COMPLETE) have demonstrated that complete revascularization (CR) is superior to culprit-only recalculation in patients presenting with stent thrombosis (ST)-segment elevation myocardial infarction (STEMI). 3-6 The largest study (COMPLETE trial) randomized n = 4041 patients presenting with STEMI and MVD to culprit-only or separate staged CR procedure with 45 days of randomization. 7 It found that CR reduced death or myocardial infarction [hazard ratio (HR) 0.74; 95% confidence interval (CI) 0.60-0.91]. As of today, the optimal timing of CR in this population remains unclear with studies have protocolized immediate, in-hospital staged, or post-discharged staged CR. 3,4,7 Contribution to the literature Data considering the optimal timing in CR of the non-culprit lesion(s) are scarce or conflicting. Aim of the study The goal of the Percutaneous Complete Revascularization Strategies Using Sirolimus-Eluting Biodegradable Polymer-Coated Stents in Patients Prenting with Acute Coronary Syndrome and Multivessel Disease (BIOVASC) trial was to evaluate the optimal timing for a CR strategy in patients with acute coronary syndromes (ACS) and MVD. Study design The BIOVASC trial was a prospective, investigator-initiated, multi-center, open label, randomized non-inferiority trial that randomized patients to either (i) immediate complete revascularization (ICR) at the time of the index-PCI or (ii) staged complete revascularization (SCR) with PCI of the non-infarct related lesions within 6 weeks of the index procedure. 8 Coronary physiological assessment was used at the discretion of the operator. The primary end point was a composite of all-cause mortality, non-fatal myocardial infarction, unplanned ischaemia-driven revasculariza-tion, and cerebrovascular events (MACCE) through 1-year post-index procedure. The study planned to enrol 1525 patients at 30 sites in Belgium, Italy, Netherlands, and Spain. It had an 80% power with a non-inferiority α of 0.5 assuming an event rate of 10.5% in the immediate CR and 11% in the staged arm. Study patients The study included patients 18-85 years with ST-segment elevation and non-ST-segment elevation ACS with MVD with identifiable culprit le-sion and aimable for PCI using the Orsiro platform (Biotronik AG, Bűlach, Switzerland) stent platform. The significant coronary disease was defined as a 70% stenosis in a vessel ≥ 2.5 mm by visual estimation or positive coronary physiological testing. Selected exclusion criteria included cardiogenic shock, PCI within 30 days, presence of a chronic total occlusion, and previous coronary artery bypass grafting. Principle findings The study enrolled 1525 patients (764 in the ICR-arm and 761 in the SCR-arm) at 29 sites. The mean patient age was 65 years, 22% female, 21% with diabetes, and 40% presented with a STEMI. 9 The 1-year primary outcome The 1-year primary MACCE outcome occurred in 7.6% of the ICR-arm and 9.4% in the SCR-arm (HR 0.78, 95% CI 0.55-1.11, P = 0.001 for non-inferiority; P = 0.166 for superiority).