Noninferiority of immediate vs staged multivessel PCI shown in STEMI patients

medwireNews: Immediate multivessel percutaneous coronary intervention (PCI) is noninferior to a staged approach in patients with ST-segment elevation myocardial infarction (STEMI) with multivessel coronary artery disease (CAD), indicate trial data. The MULTISTARS AMI findings were presented at the ESC Congress 2023 in Amsterdam, the Netherlands, by Barbara Stähli (University Hospital Zurich, Switzerland) and simultaneously published in The New England Journal of Medicine. She told delegates that at the 1-year mark, a primary endpoint event – a composite of death from any cause, nonfatal myocardial infarction, stroke, unplanned ischemia-driven revascularization, or hospitalization for heart failure – occurred in 8.5% of the 418 patients with hemodynamically stable STEMI and multivessel CAD who were randomly assigned to undergo multivessel PCI during the index procedure (immediate approach). By contrast, the incidence of a primary endpoint event was 16.3% among their 422 counterparts who were assigned to the staged approach involving PCI of the culprit lesion during the index procedure, followed by PCI of the nonculprit lesions 19–45 days later (median 37 days). This corresponded to a risk ratio of 0.52 in favor of the immediate approach and met the criteria for noninferiority, reported the investigator. With respect to the individual components of the primary endpoint, there was no significant difference between the immediate and staged PCI groups in the rates of death from any cause (2.9 vs 2.6%), stroke (1.2 vs 1.7%), or hospitalization for heart failure (1.2 vs 1.4%). But the incidence of nonfatal myocardial infarction and unplanned ischemia-driven revascularization were significantly lower in the immediate than staged PCI group, at rates of 2.0% versus 5.3%, and 4.1% versus 9.3%, respectively. The researchers acknowledge, however, that “an increased risk of ascertainment bias for procedure-related myocardial infarction in the context of primary PCI as compared with staged elective PCI may have favored the immediate group.” But “there did not appear to be a substantial difference in the risk of a primary end-point event in the trial groups after exclusion of procedure-related myocardial infarctions from the analysis,” they add. The immediate and staged PCI groups were comparable with regard to the incidence of stent thrombosis (1.2 vs 1.4%), acute kidney failure (3.6 vs 2.9%), and major bleeding (3.1 vs 4.8%). Discussant Robert Byrne (Mater Private Hospital, Dublin, Ireland) also noted the possibility of ascertainment bias in identifying procedural myocardial infarctions in the immediate PCI group and highlighted that although urgent unplanned revascularizations favored the immediate group, the trial was open-label. He therefore commented that “MULTISTARS AMI provides evidence, but not strong evidence of benefit with routine immediate PCI during the index procedure as compared with staged outpatient PCI.” The discussant concluded: “Patients with STEMI and multivessel CAD should undergo complete revascularization within the first 45 days with the timing of the non-[infarct-related artery] procedure individualized according to clinical risk and logistical considerations.” medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2023 Springer Healthcare Ltd, part of the Springer Nature Group ESC Congress 2023; Amsterdam, the Netherlands: 25–28 August N Engl J Med 2023; doi:10.1056/NEJMoa2307823

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Noninferiority of immediate vs staged multivessel PCI shown in STEMI patients

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