Netherlands: Revascularisation Study

A recent study in The Lancet has revealed that immediate complete revascularisation is non-inferior to staged complete revascularization for the primary outcome in patients presenting with multivessel disease and acute coronary syndrome.

Primary Outcome

The primary outcome was the composite of myocardial infarction, all-cause mortality, unplanned ischaemia-driven revascularisation, or cerebrovascular events one year after the index procedure.

Study Details

Complete revascularisation by PCI (percutaneous coronary intervention) is linked with improved clinical outcomes in patients with multivessel coronary disease and acute coronary syndrome. Complete revascularization involves treating all significant blockages in the coronary arteries, including those not causing symptoms (non-culprit lesions).

Roberto Diletti, Erasmus University Medical Center, Rotterdam, Netherlands, and colleagues set out to examine whether PCI for non-culprit lesions should be strived during the index procedure or staged in BIOVASC, a prospective, open-label, non-inferiority, randomized trial.

The trial was conducted at 29 hospitals across Italy, Belgium, the Netherlands, and Spain. Patients aged 18–85 years with ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation acute coronary syndrome and multivessel coronary artery disease with an identifiable culprit lesion were included.

Patients were randomly assigned in a ratio of 1:1 to undergo immediate or staged complete revascularization. In immediate complete revascularization, PCI of the culprit lesion first was followed by other non-culprit lesions deemed clinically significant by the operator during the index procedure. In staged complete revascularization, PCI of only the culprit lesion during the index procedure and PCI of all non-culprit lesions deemed clinically significant within six weeks after the index procedure.

Secondary Outcomes

Secondary outcomes included unplanned ischaemia-driven revascularization, myocardial infarction, and all-cause mortality one year after the index procedure.

Study Findings

• 764 patients were randomly allocated to the immediate complete revascularisation group and 761 patients to the staged complete revascularisation group.
• The primary outcome at one year occurred in 9.4% of 761 patients in the staged group and 7.6% of 764 patients in the immediate complete revascularisation group.
• The investigators did not observe any difference in all-cause death between the staged and immediate complete revascularisation groups (1.2% versus 1.9%).
• Myocardial infarction occurred in 1.9% of patients in the immediate complete revascularisation group and 4.5% of patients in the staged complete revascularisation group (HR 0.41).
• In the staged complete revascularisation group, more unplanned ischaemia-driven revascularisations were performed than in the immediate complete revascularisation group (6.7% patients vs 4.2% patients).

In patients with multivessel disease and acute coronary syndrome, immediate complete revascularisation was non-inferior to staged complete revascularisation for the primary composite outcome. It was linked with a reduction in unplanned ischaemia-driven revascularisation and myocardial infarction.

Reference

The study titled, "Immediate versus staged complete revascularisation in patients presenting with acute coronary syndrome and multivessel coronary disease (BIOVASC): a prospective, open-label, non-inferiority, randomized trial", was published in The Lancet. DOI: https://doi.org/10.1016/S0140-6736(23)00351-3