Does MULTISTARS shed light on the timing of complete revascularization in ST-elevation myocardial infarction?

Key points• The Multivessel Immediate versus Staged Revascularization in Acute Myocardial Infarction (MULTISTARS AMI) is an investigator-initiated, industry-funded, multicentre, open-label, randomized, non-inferiority trial aimed at assessing whether immediate multivessel percutaneous coronary intervention (PCI) at the time of the primary PCI is non-inferior to staged multivessel PCI (between 19 and 45 days after the index procedure) in patients with ST-elevation myocardial infarction (STEMI), multivessel coronary artery disease (CAD), and stable haemodynamic conditions. 1 • The trial was conducted at 37 sites in Europe, where 840 patients with STEMI admitted within 24 h from symptom onset, and found to have multivessel CAD, were randomized to either immediate (n = 418) or staged PCI (n = 422) of the non-culprit coronary lesions.The median age was 65 years [interquartile range (IQR) 55-73], with 21% females and 98% Whites.Patients had to be haemodynamically stable, defined according to CULPRIT-SHOCK trial criteria. 2Multivessel CAD was defined as at least one angiographically significant stenosis (≥70% diameter stenosis based on visual estimation) in a non-culprit coronary artery (2.25 to 5.75 mm in diameter).A third-generation everolimus-eluting stent (Synergy, Boston Scientific Corporation, Marlborough, MA) was recommended for PCI.• The primary endpoint was a heterogeneous composite of all-cause death, non-fatal myocardial infarction (MI), stroke, unplanned ischaemiadriven revascularization, or hospitalization for heart failure within 1 year after randomization.Secondary endpoints included the same composite at 6 months after randomization and the individual components of the primary endpoint at 6 months and at 1 year.Non-fatal MI was defined based on the third universal definition. 3• The median time interval from randomization to staged procedures was 37 days (IQR 30-43).Cross-over from the immediate group to the staged group occurred in 12 patients (3%), whereas no cross-over occurred from the staged group to the immediate group.The use of fractional flow reserve (FFR, 3% in the immediate group vs. 9% in the staged group), intravascular ultrasound (IVUS 2% in both groups), or optical coherence tomography (OCT, 0.5% vs. 2%) was up to the operator's discretion.The preferred access site was the radial artery both for the index (73%) and staged (77%) procedures.The presence of chronic total occlusion of a major coronary artery, left main stenosis ≥ 50% or left main equivalent, stent thrombosis, or in-stent restenosis was exclusion criteria.The total volume of contrast (250 vs. 333 mL) and the total duration of fluoroscopy (18 vs. 24 min) were lower in the immediate group than in the staged group.• The primary endpoint occurred in 35 patients (8.5%) in the immediate PCI group and in 68 patients (16.3%) in the staged PCI group [risk ratio 0.52; 95% confidence interval (CI), 0.38 to 0.72; P < .001for non-inferiority; P < .001for superiority].Non-fatal MI occurred in 8 patients (2.0%; n = 5 type I and n = 3 type 4b) in the immediate PCI group and in 22 patients (5.3%; n = 6 type 1, n = 2 type 2, n = 12 type 4a, n = 2 type 4b) in the staged group [hazard ratio (HR), 0.36; 95% CI, 0.16 to 0.80].Unplanned ischaemia-driven revascularization was performed in 17 patients (4.1%) in the immediate PCI group and 39 patients (9.3%) in the staged PCI group (HR, 0.42; 95% CI, 0.24 to 0.74).No statistically significant differences were observed between groups in all-cause death, stroke, hospitalization for heart failure, and major bleeding.Results were consistent across pre-specified subgroups.