In patients with acute coronary syndrome (ACS) and multivessel coronary disease, an immediate complete revascularization strategy was non-inferior to staged complete revascularization for the composite primary outcome. Furthermore, it was associated with lower rates of myocardial infarction and unplanned ischemia-driven revascularization at 1-year follow-up.
This was the overall conclusion from the results of the BIOVASC trial (NCT03621501), which were presented at the 2023 American College of Cardiology annual meeting by Dr. Roberto Diletti.1,2 He explained that multiple studies have established the clinical benefit of complete revascularization by percutaneous coronary intervention (PCI) compared with a culprit lesion-only PCI. The BIOVACS study aimed to establish the optimal timing for non-culprit lesion revascularization. A total of 1,525 patients from four European countries were randomized to immediate revascularization (N=764) or staged complete revascularization (N=761). Of the participants, 40% had ST-segment elevation myocardial infarction (STEMI), 52% had non-STEMI, and 8% had unstable angina. The primary outcome was a composite of all-cause mortality, MI, any unplanned ischemia-driven revascularization, or cerebrovascular events in the first year following the index procedure.
In the immediate treatment group, 7.6% had a primary endpoint event versus 9.4% in the staged group, meeting non-inferiority criteria (HR, 0.78; P non-inferiority 0.0011). However, in the prespecified analysis of clinical events at 30 days, immediate complete revascularization was superior (2.2% vs 5.8%; HR, 0.38; P superiority 0.0007).
After 1 year, no difference was seen in all-cause death between the 2 groups (1.9% vs 1.2%; HR, 1.56; P=0.30), but a second MI was less frequent in the immediate treatment group (1.9% vs 4.5%; HR, 0.41; P=0.0045), as were unplanned ischemia-driven revascularizations (4.2% vs 6.7%; HR, 0.61; P=0.030).
Dr. Diletti offered two possible explanations for the high rate of MI in the staged group (4.5%): the operator may have misjudged the culprit lesion, or there are more unstable plaques so that treating only the culprit lesion “does not do the job.”
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