Immediate Complete Revascularization Non-Inferior to Staged Procedure in BIOVASC Trial

Roberto Diletti, MD, PhD

In patients presenting with acute coronary syndrome and multi-vessel disease, immediate complete revascularization was found to be as safe and effective as staged treatment, based on findings from the BIOVASC trial.

The research, presented at the American College of Cardiology (ACC) 2023 Scientific Sessions in New Orleans, Louisiana, suggested immediate stenting, or percutaneous coronary intervention (PCI), was also associated with a reduction in myocardial infarction and unplanned ischemic-driven revascularization.

“We show that, at one 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 a similar rate of the composite of all-cause mortality, myocardial infarction, any unplanned ischemia-driven revascularization, and cerebrovascular events,” said Roberto Diletti, MD, PhD, Erasmus Medical Center, the lead author of the study. “Moreover, immediate complete treated offered reassurance that patients would not suffer a second heart attack while waiting for their second procedure.”

Approximately half of the patients who have a heart attack have multi-vessel heart disease, meaning the additional narrowed coronary arteries are at risk of becoming blocked or unstable, leading to another heart attack. The blocked artery is referred to as the “culprit lesion” and the other at-risk arteries as “non-culprit lesions”, while the placement of stents in both lesions is referred to as completed revascularization.

Prior investigations have cited better outcomes in patients with multi-vessel heart disease when after undergoing complete revascularization compared with stenting of the culprit artery alone. However, it remains unknown whether outcomes are better when patients undergo a single procedure to place stents in both culprit and no culprit arteries (immediate) or two procedures days or weeks apart (staged).

The international, randomized BIOVASC trial looked to compare outcomes for immediate and staged complete revascularization, not to determine which approach was superior, but to establish whether immediate complete vascularization was non-inferior to the staged approach. The trial enrolled approximately 1,525 patients (median age, 65 years; 78% male) in four European countries (Belgium, Italy, the Netherlands, and Spain).

Participants were randomly assigned to receive either immediate or staged complete revascularization. Among those 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 one year of follow-up. Moreover, “unplanned procedures” excluded staging stenting procedures in patients assigned to that arm of the study.

Between June 2018 and October 2021, 764 patients were randomly assigned to the immediate complete revascularization group and 761 patients were randomly assigned to the staged complete revascularization and were included in the intention-to-treat population.

The primary outcome at 1 year occurred in 57 (7.6%) of 764 patients in the immediate complete revascularization group and in 71 (9.4%) of 761 patients in the staged complete revascularization group. More than twice as many patients in the staged treatment group (4.5%) were reported to have had a second heart attack than in the immediate treatment group (1.9%).

Data showed over 40% of the heart attacks in patients in the staged treatment group occurred during the interval before their second stenting procedure. A median interval of 15 days between procedures for patients in the staged treatment group was reported by investigators.

The findings suggest no difference in all-cause death was observed between the immediate and staged complete revascularization groups (1.9% vs. 1.2%). There were more unplanned ischemia-driven stenting procedures performed in the staged complete revascularization group (6.7%) than in the immediate complete revascularization group (4.2%). The median hospital stay was one day shorter for individuals in the immediate complete revascularization group than for those whose procedure was staged, according to the results.

Investigators noted the study’s findings were consistent across subgroups, including by sex, age, and patients with obesity or body mass index (BMI) in the normal range. Quality of life following immediate or staged treatment will be analyzed in further research, and patients will be followed-up with for a total of 5 years.

References

1. R. Diletti, W. den Dekker, J. Bennett, et. al 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, The Lancet, 2023.