Immediate, complete revascularisation with percutaneous coronary intervention (PCI) in patients presenting with acute coronary syndrome and multivessel disease was non-inferior to staged complete revascularisation both in terms of safety and efficacy, findings of the BIOVASC randomised trial have shown.
Roberto Diletti (Erasmus Medical Center, Rotterdam, The Netherlands) delivered insights from the trial at the American College of Cardiology (ACC) 2023 Scientific Session (4–6 March, New Orleans, USA), with the findings published simultaneously in The Lancet.
The trial—conducted in 29 hospitals across Belgium, Italy, The Netherlands and Spain—randomised patients to undergo either an immediate complete revascularisation, whereby PCI of the culprit lesion was performed first, followed by other non-culprit lesions deemed to be clinically significant by the operator during the procedure, or they underwent a staged procedure, whereby the non-culprit lesions were treated within six weeks of the index procedure.
“A large proportion of patients with acute coronary syndrome are presenting with multivessel coronary artery disease, and there are a number of papers already demonstrating that a complete coronary revascularisation is probably the best way to treat these patients compared with a culprit-only lesion strategy,” Diletti commented in his presentation, noting that the optimal timing for treatment of non-culprit lesions remains unknown.
Through the study, investigators randomised 1,525 patients, with 764 undergoing the immediate revascularisation strategy, and 761 the staged approach. Patients had a mean age of 65 years and there was a majority male population in both groups. Endpoints were assessed at one year after the index procedure.
Among 1,506 patients at one year of follow-up, 7.6% of patients in the immediate complete revascularisation group had a primary endpoint event compared with 9.4% of those who received a staged procedure, Diletti reported (hazard ratio [HR] 0.78, 95% confidence interval [CI] 0.55–1.11, p-non-inferiority=0·0011).
There was no difference in all-cause death between the two groups (1.9% vs. 1.2%, HR 1.56, 95% CI 0.68–3.61, p=0.30), though more than twice as many patients in the staged treatment group (4.5%) had myocardial infarction (MI) than in the immediate treatment group (1.9%, HR 0.41, 95% CI 0.22–0.76, p=0.0045). Over 40% of the MIs in patients in the staged treatment group occurred during the interval before their second stenting procedure, Diletti said. The median interval between procedures for patients in the staged treatment group was 15 days.
Furthermore, 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 (HR 0.61, 95% CI 0.39–0.95, p=0.030). The rate of cerebrovascular events was similar in the two groups (1.5% vs. 1.6%, HR 0.91, 95% CI 0.40–2.07, p=0.83). The median hospital stay was one day shorter for patients in the immediate complete revascularisation 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, Diletti noted.
“In patients with acute coronary syndrome and multivessel disease, an immediate complete revascularisation strategy was non-inferior to a staged complete revascularisation strategy in terms of the primary endpoint and was associated with a reduction in MIs and unplanned ischaemia-driven revascularisation,” Diletti told attendees of ACC in the concluding remarks of his presentation.
Limitations of the trial highlighted by the authors in their Lancet paper include that the patient population was overwhelmingly male, and that the trial was conducted in countries with populations that are “predominantly white”. “Therefore, our findings might not pertain to different demographic environments with a higher representation of females and people of different races and ethnicities,” the investigators note.
Furthermore, the authors recognise that the use of functional and imaging assessment was low, reflective of contemporary practice in Europe, and that higher adoption of invasive imaging and coronary physiology testing may have provided more comprehensive and accurate culprit lesion identification.
The latter point was picked up by Diletti during discussion that followed his presentation at ACC, where he was asked by Dipti Itchhaporia (Hoag Hospital Newport Beach, Newport Beach, USA). “In my opinion this is reducing our ability to correctly detect the culprit lesions and even to correctly treat the lesion with optimisation,” said Diletti of the adoption of functional and imaging assessment in Europe, after Itchhaporia had picked up on the low utilisation in the trial.
Describing the findings of the BIOVASC trial as “very, very important”, Itchhaporia also asked Diletti to reflect on the disparity in rates of MI reported in the two arms of the trial, to which Diletti offered up two possible explanations. “It might be possible that the operator misjudged the culprit lesion—so treated a lesion that was not the actual culprit, and the actual culprit gave a second event in the very early phase,” he commented. His second potential explanation was that “there are multiple unstable plaques during acute coronary syndrome, and then treating only the culprit does not complete the job”.