BIOVASC Compares Immediate Complete Revascularization Versus Staged Procedure in Treating Multivessel Disease

March 5, 2023—The American College of Cardiology (ACC) announced that the BIOVASC study demonstrated that immediate treatment with stents in all diseased arteries was found to be as safe and effective at 1 year of follow-up as staged treatment in patients with multivessel heart disease who have had a heart attack.

The BIOVASC findings were presented at ACC.23/WCC, the ACC’s annual scientific session together with the World Congress of Cardiology held March 4-6, 2023, in New Orleans, Louisiana. The study was simultaneously published online by Roberto Diletti, MD, et al in The Lancet. The study was funded by a grant from Biotronik.

“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,” commented Dr. Diletti in the ACC press release. “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.”

Dr. Diletti, who is an interventional cardiologist at Erasmus Medical Center in Rotterdam, the Netherlands, continued, “We show that, at 1 year of follow-up, immediate complete revascularization is not inferior to staged complete revascularization for the study’s primary endpoint—that means that patients had similar rate of the composite of all-cause mortality, myocardial infarction, any unplanned ischemia-driven revascularization, and cerebrovascular events. Moreover, immediate complete treatment offered reassurance that patients would not suffer a second heart attack while waiting for their second procedure.”

As noted in the ACC press release, previous studies have shown that patients with multivessel heart disease have better outcomes when they undergo complete revascularization compared with stenting of the culprit artery alone.

An unanswered question, however, has been whether outcomes are better when patients undergo immediate complete revascularization or staged complete revascularization.

Dr. Diletti stated that clinicians have tended to favor the staged approach because some observational studies have suggested that patients treated with immediate complete revascularization had worse outcomes. However, a risk of the staged approach is that the patient could have a second heart attack during the period before the second procedure.

Expert guidelines currently state that the optimal timing for performing complete revascularization is unknown, advised Dr. Diletti.

The ACC press release summarized the findings from the BIOVASC study, which enrolled a total of 1,525 patients (median age 65 years; 78% male) in four European countries (Belgium, Italy, the Netherlands, and Spain).

Patients were randomly assigned to receive either immediate or staged complete revascularization. Among patients assigned to 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, another heart attack, any unplanned additional stenting procedures, or cerebrovascular events at 1 year of follow-up. “Unplanned procedures” excluded staged stenting procedures in patients assigned to that arm of the study.

Dr. Diletti reported that the investigators found the following results among the 1,506 patients at 1 year of follow-up:

• 7.6% of patients in the immediate complete revascularization group had a primary endpoint event compared with 9.4% of those who received a staged procedure.
• More than twice as many patients in the staged treatment group (4.5%) had a second heart attack than in the immediate treatment group (1.9%).
• More than 40% of the heart attacks in patients in the staged treatment group occurred during the interval before their second stenting procedure. The median interval between procedures for patients in the staged treatment group was 15 days.
• Unplanned additional stenting procedures were more frequent among patients in the staged treatment group (6.7%) compared with the immediate treatment group (4.2%), a significant difference.
• The rate of stroke was similar in the two groups (1.5% in the immediate treatment group versus 1.6% in the staged treatment group).
• The median hospital stay was 1 day shorter for patients in the immediate complete revascularization group than for those in the staged treatment group.

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, noted the ACC press release.

A limitation of the study is that both patients and their clinicians knew what treatment they were assigned to receive. In addition, a “real world” concern relates to clinicians’ willingness to perform immediate complete revascularization on patients hospitalized with an acute heart attack during “off” hours, said Dr. Diletti. He further stated that stenting of a patient’s nonculprit arteries could take anywhere from a few minutes to an hour and a half longer than treating the culprit artery alone, depending on how many additional arteries need treatment and the complexity of the arterial blockages.

The BIOVASC investigators are currently analyzing data on patients’ quality of life after immediate or staged treatment. This analysis will be published when completed.

In addition, the investigators will continue to follow the patients in the BIOVASC study for 5 years.