Key Points:
- Complete revascularization is recommended in patients with multivessel CAD who present with ACS without cardiogenic shock, but the optimal timing of non-culprit lesion revascularization is unknown.
- The BIOVASC study was a randomized, open-label, non-inferiority clinical trial which sought to determine whether an immediate complete revascularization strategy was inferior to a staged complete revascularization strategy in patients with ACS and multivessel disease (MVD). The primary outcome was a composite of all-cause death, MI, unscheduled ischemia-driven revascularization, or cerebrovascular events at 1 year.
- At one year of follow-up, immediate complete revascularization was non-inferior to staged complete revascularization for the primary composite outcome. Patients who underwent immediate complete revascularization had fewer MIs and required fewer unplanned revascularizations.
Patients who present with acute coronary syndrome (ACS) frequently have multivessel coronary artery disease. Current guidelines recommend complete revascularization in patients with multivessel disease who present with ACS without cardiogenic shock, but the optimal timing of non-culprit lesion revascularization remains unclear. In a breaking presentation at the 2023 ACC Scientific Sessions today, Dr. Roberto Diletti (Erasmus Medical Center, Rotterdam) and his team presented their study: “Complete Revascularization Strategies In Patients Presenting With Acute Coronary Syndromes And Multivessel Coronary Disease.” When discussing the aims of the study, Dr. Diletti noted: “The purpose of the international, randomized BIOVASC trial was to compare outcomes for immediate and staged complete revascularization for patients with multivessel heart disease who have suffered a heart attack. The goal was not to determine which approach was superior but rather to establish whether immediate complete vascularization was ‘not inferior’ to the staged approach, which needed to be answered first.”
The BIOVASC study was a multicenter, randomized, non-inferiority open-label clinical trial conducted across 29 sites in Europe which evaluated whether an immediate complete revascularization strategy (ICR) was inferior to a staged complete revascularization (SCR) strategy. Patients aged 18-85 years who presented with ST-elevation myocardial infarction (STEMI) or non-ST-elevation ACS and multivessel disease with a clearly identifiable culprit lesion were included in the trial, where multivessel disease was defined as having two or more coronary arteries with a diameter of ³ 2.5mm and at least 70% stenosis or positive physiology testing. Relevant exclusions included absence of a clearly identifiable culprit lesion, previous coronary artery bypass surgery, cardiogenic shock, single-vessel coronary disease, and present of a coronary chronic total occlusion. A total of 1,525 patients were enrolled in the study; 765 were randomized to the ICR arm and 760 to the SCR arm. The mean age was 65.1 years, 78% were male, and 21% had diabetes. Forty percent presented with STEMI, 52% presented with non-ST elevation myocardial infarction (NSTEMI), and 8% presented with unstable angina (UA). Of the patients who underwent SCR, 30% underwent staged revascularization during the index hospitalization and the median interval between procedures was 15 days.
The primary outcome was a composite of all-cause death, myocardial infarction (MI), unscheduled ischemia-driven revascularization, or cerebrovascular events at 1 year following the initial procedure. At one year, the primary outcome occurred in 7.6% of patients in the ICR group and in 9.4% of patients in the SCR group; there was no difference in the primary composite outcome (HR 0.78; 95% CI 0.55-1.11; p noninferiority = 0.0011). Superiority of the immediate over the staged complete revascularization strategy was not met at1-year follow-up (p superiority=0.17). No difference was seen
in all-cause death (HR 1.56; 95% CI 0.68-3.61, p = 0.30) between the ICR and SCR groups. In secondary analyses, MI occurred less often (HR 0.41; 95% CI 0.22-0.76; p – 0.0045) and fewer unplanned ischemia-driven revascularizations were performed (HR 0.61; CI 0.39-0.95, p = 0.030) in the ICR group compared to the SCR group.
In describing the clinical implications of this study, Dr. Diletti stated: “We showed that, at one year of follow-up, immediate complete revascularization is not inferior to staged complete revascularization for the study’s primary endpoint… Moreover, immediate complete treatment offered reassurance that patients would not suffer a second heart attack while waiting for their second procedure.” Future studies are planned to investigate the impact of ICR versus SCR on patient quality of life.
