Immediate complete revascularisation non-inferior to staged complete revascularisation

In patients with acute coronary syndrome (ACS) and multivessel coronary disease, an immediate complete revascularisation strategy was non-inferior to staged complete revascularisation for the composite primary outcome in the BIOVASC trial. Furthermore, it was associated with lower rates of myocardial infarction (MI) and unplanned ischaemia-driven revascularisation at 1-year follow-up.

This was the overall conclusion from the results of the randomised BIOVASC trial (NCT03621501), which were presented by Dr Roberto Diletti (Erasmus MC, the Netherlands) [1,2]. He explained that multiple studies have established the clinical benefit of complete revascularisation by percutaneous coronary intervention (PCI) compared with a culprit lesion-only PCI. The BIOVASC study aimed to establish the optimal timing for non-culprit lesion revascularisation. Enrolled were 1,525 patients from 4 European countries, who were randomised to immediate revascularisation (n=764) or staged complete revascularisation (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 ischaemia-driven revascularisation, or cerebrovascular events in the first year following the procedure.

In the immediate treatment group, 7.6% had a primary endpoint event at 1 year versus 9.4% in the staged group, meeting the non-inferiority criteria (HR 0.78; P_{non-inferiority} =0.0011). However, in the prespecified analysis of clinical events at 30 days, immediate complete revascularisation 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 ischaemia-driven revascularisations (4.2% vs 6.7%; HR 0.61; P=0.030).

Dr Diletti offered 2 possible explanations for the high rate of MIs in the staged group (4.5%). The operator may have misjudged the culprit lesion, or there are more unstable plaques so treating only the culprit lesion “does not do the job.”

1. 
   
   1. Diletti R, et al. Complete revascularization strategies in patients presenting with acute coronary syndromes and multivessel coronary disease. Session 405-16, ACC Scientific Session 2023, 4–6 March, New Orleans, USA.
   2. Diletti R, et al. The Lancet. 2023; March 5. DOI: 10.1016/S0140-6736(23)00351–3.

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Posted on 7 June 202313 June 2024