BIOVASC: Immediate complete revascularization as safe and effective as staged procedure in treating multi-vessel disease

Reported from ACC 2023

Rationale

In patients with acute myocardial infarction (MI) treating the culprit artery is the standard of care. Nevertheless, about half of patients who have acute MI have multi-vessel coronary artery disease (CAD). Previous studies have shown that patients with multi-vessel heart disease have better outcomes when they undergo complete revascularization compared with stenting of the culprit artery alone. Data regarding the timing (immediate vs. delayed) of treating other “non-culprit lesions” is lacking. Hence, the purpose of the international, randomized BIOVASC trial was to compare outcomes for immediate and staged complete revascularization for patients with multi-vessel CAD who have suffered an acute MI.

Design

The study was conducted in four European countries (Belgium, Italy, the Netherlands and Spain). A total of 1,525 patients were randomly assigned to receive either immediate or staged complete revascularization.

In the staged treatment group, the second procedure could be performed later during the same hospital stay or at any time up to 6 weeks after the initial procedure.

The study’s primary endpoint was a combination of death from any cause, recurrent MI, any unplanned additional stenting procedures or cerebrovascular events at one year of follow-up.

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.

Endpoints

Among 1,506 patients at one year of follow-up, 7.6% vs. 9.4% of patients in the immediate complete vs. stage procedure revascularization, respectively, had a primary endpoint event.

Recurrent acute MI occurred more than twice as many in patients in the staged treatment group as compared with the immediate treatment group (4.5% vs. 1.9%, respectively). Over 40% of the recurrent acute MI’s occurred in patients in the staged treatment group during the interval before their second stenting procedure.

Unplanned additional stenting procedures were more frequent among patients in the staged treatment group as compared with the immediate treatment group (6.7% vs. 4.2%, respectively).

The stroke rate was similar in both groups (1.5% in the immediate treatment group versus 1.6% in the staged treatment group).

The median hospital stay was one day shorter for patients in the immediate complete revascularization group than for those whose procedure was staged.

The study findings were consistent across subgroups of patients, such as women versus men, younger versus older patients and patients with obesity versus those with weight in the normal range.

The authors concluded that in patients with multi-vessel CAD who have had acute MI, immediate treatment with stents in all diseased arteries was found to be as safe and effective at one year of follow-up as staged treatment.

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