Immediate versus staged complete revascularisation in patients presenting with acute coronary syndrome and multivessel coronary disease (BIOVASC): a prospective, open-label, non-inferiority, randomised trial

• Published in: The Lancet (British edition) 2023-04, Vol.401 (10383), p.1172-1182
• Main Authors: Diletti, Roberto, den Dekker, Wijnand K, Bennett, Johan, Schotborgh, Carl E, van der Schaaf, Rene, Sabaté, Manel, Moreno, Raúl, Ameloot, Koen, van Bommel, Rutger, Forlani, Daniele, van Reet, Bert, Esposito, Giovanni, Dirksen, Maurits T, Ruifrok, Willem P T, Everaert, Bert R C, Van Mieghem, Carlos, Elscot, Jacob J, Cummins, Paul, Lenzen, Mattie, Brugaletta, Salvatore, Boersma, Eric, Van Mieghem, Nicolas M
• Format: Article
• Language: English
• Subjects: Acute Coronary Syndrome - etiology; Acute Coronary Syndrome - surgery; Acute coronary syndromes; Aged; Angina pectoris; Angioplasty; Arteries; Cardiology; Cardiovascular disease; Clinical outcomes; Clinical significance; Consortia; Coronary Artery Disease; Coronary vessels; Female; Health care facilities; Heart attacks; Heart diseases; Humans; Informed consent; Ischemia; Lesions; Male; Males; Mortality; Myocardial infarction; Myocardial Infarction - etiology; Patients; Percutaneous Coronary Intervention - methods; Physiology; Prospective Studies; Randomization; Segments; Stenosis; Stents; Thoracic surgery; Treatment Outcome; Vein & artery diseases
• ISSN: 0140-6736; 1474-547X
• DOI: 10.1016/S0140-6736(23)00351-3

In patients with acute coronary syndrome and multivessel coronary disease, complete revascularisation by percutaneous coronary intervention (PCI) is associated with improved clinical outcomes. We aimed to investigate whether PCI for non-culprit lesions should be attempted during the index procedure or staged. This prospective, open-label, non-inferiority, randomised trial was done at 29 hospitals across Belgium, Italy, the Netherlands, and Spain. We included patients aged 18–85 years presenting with ST-segment elevation myocardial infarction or non-ST-segment elevation acute coronary syndrome and multivessel (ie, two or more coronary arteries with a diameter of 2·5 mm or more and ≥70% stenosis based on visual estimation or positive coronary physiology testing) coronary artery disease with a clearly identifiable culprit lesion. A web-based randomisation module was used to randomly assign patients (1:1), with a random block size of four to eight, stratified by study centre, to undergo immediate complete revascularisation (PCI of the culprit lesion first, followed by other non-culprit lesions deemed to be clinically significant by the operator during the index procedure) or staged complete revascularisation (PCI of only the culprit lesion during the index procedure and PCI of all non-culprit lesions deemed to be clinically significant by the operator within 6 weeks after the index procedure). The primary outcome was the composite of all-cause mortality, myocardial infarction, any unplanned ischaemia-driven revascularisation, or cerebrovascular events at 1 year after the index procedure. Secondary outcomes included all-cause mortality, myocardial infarction, and unplanned ischaemia-driven revascularisation at 1 year after the index procedure. Primary and secondary outcomes were assessed in all randomly assigned patients by intention to treat. Non-inferiority of immediate to staged complete revascularisation was considered to be met if the upper boundary of the 95% CI of the hazard ratio (HR) for the primary outcome did not exceed 1·39. This trial is registered with ClinicalTrials.gov, NCT03621501. Between June 26, 2018, and Oct 21, 2021, 764 patients (median age 65·7 years [IQR 57·2–72·9] and 598 [78·3%] males) were randomly assigned to the immediate complete revascularisation group and 761 patients (median age 65·3 years [58·6–72·9] and 589 [77·4%] males) were randomly assigned to the staged complete revascularisation group, and were included in the intention