Immediate revascularisation non-inferior to staged procedure in acute coronary syndrome and multivessel disease

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,” operators performing PCI in officebased laboratories (OBLs) and ambulatory surgery centres (ASCs) with positive outcomes. Thanks to improvement in PCI safety and several global studies in recent years, we now know that PCI at ASCs may improve access, patient satisfaction, and reduce costs.”

This expert consensus statement was endorsed by the American College of Cardiology (ACC), American Heart Association (AHA), British Cardiovascular Intervention Society (BCIS), Canadian Association of Interventional Cardiologists (CAIC), and Outpatient Endovascular and Interventional Society (OEIS).

According to SCAI:

● Elective PCI in settings with no-SOS has increased in volume and complexity (extending beyond the simple lesion recommendations in the 2014 document). In addition, PCI is now being performed outside of the hospital setting, in office-based laboratories and ambulatory surgery centres.

● Several new studies in the USA and abroad have demonstrated that PCIs performed at no-SOS centres have very low rates of complications and similar outcomes to PCIs performed at surgical centres.

● Despite increase in age, comorbidities, and lesion complexity, the rate of periprocedural complications has remained constant, or declined, with rates of emergency surgery as low as 0.1% in many series.

● Complex PCI, including unprotected left main, is being performed in some no-SOS centres, with no increase in major adverse cardiovascular events or emergency coronary artery bypass graft surgery (CABG) compared with PCI at surgical centres. The SCAI writing group proposes a new PCI treatment algorithm that expands the type of cases that can be performed with noSOS compared with its 2014 document, with consideration of the patients’ clinical and lesion risk, the operator experience (both recent and accumulated), and the experience and rescue capabilities of the site. In the USA, there are considerable financial savings (to insurers and Medicare) for PCI to be performed in ASC and OBL settings, thus out-migration of procedures from hospitals should be anticipated.

Diletti commented in his presentation, noting that the optimal timing for treatment remains unknown.

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.

“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.

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 important”, Itchhaporia asked Diletti to reflect on the disparity in rates of MI reported in the two arms, to which Diletti offered up two 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”.