MULTISTARS AMI Trial: Immediate Complete Multivessel PCI non-inferior to staged approach in patients with STEMI and MVD

By John Vitarello on

Key Points:

  • It is well known that patients with STEMI often have multivessel disease (MVD) and those with MVD have worse outcomes compared to patients without it.
  • Current US and European guidelines support complete revascularization in a staged fashion but trials examining immediate versus staged percutaneous coronary intervention (PCI) are lacking.
  • The MULTISTARS AMI trial demonstrated that immediate revascularization with PCI was associated with a reduction in non-fatal myocardial infarction and unplanned revascularization compared to staged revascularization at 1 year.

About half of all patients presenting with STEMI have MVD disease with significant non-culprit lesions. Numerous randomized clinical trials have demonstrated a reduction in major cardiovascular adverse events with complete revascularization performed during the index hospitalization or shortly after discharge, compared to culprit-lesion-only PCI. What is less well understood is whether immediate complete revascularization is safe and effective.

The MULTISTARS AMI trial presented by Dr. Barbara Stähli of the University Hospital Zurich, Switzerland sought to address whether immediate complete revascularization is non-inferior to staged PCI in patients presenting with STEMI with at least one other coronary lesion with a ≥70%. The results were presented at the European Society of Cardiology annual conference.

MULTISTARS-AMI was a multi-national, open label, randomized clinical trial that included patients with acute STEMI (presenting within 24 hours of symptom onset) and multivessel coronary artery disease (defined as at least one coronary lesion with ≥70% diameter stenosis on coronary angiography based on visual estimation in a non-culprit coronary artery of ≥2.25 mm and ≤5.75 mm in diameter), who were hemodynamically stable after successful primary PCI of the infarct-related coronary artery. The primary endpoint was a composite of all-cause death, non-fatal myocardial infarction, ischemia-driven revascularization, hospitalization for heart failure, and stroke at 1 year. A non-inferiority ratio of 1.46 was chosen and an additional superiority analysis on a two-sided alpha of 0.05 was performed.

A total of 840 patients with STEMI were included within a median 37 days (19-45 following successful PCI of the culprit lesion. The average patient was 65 years old and mostly male (79%). Exclusion criteria included patients in cardiogenic shock, prior CABG, left main disease, in-stent restenosis or thrombosis, or an eGFR < 30ml/min/m2 were excluded.

At 1 year, the primary endpoint occurred in 8.5% of the immediate revascularization group, compared to 16.3% in the staged group (p<0.001 for non-inferiority; p<0.001 for superiority). Non-fatal myocardial infarction and unplanned revascularization occurred more frequently in the staged group (5.3%, 9.3% respectively) compared to the immediate group (2%, 4.1% respectively) [HR 0.36; 95% CI 0.16 to 0.80 for infarction, HR 0.42, 95%CI 0.24 to 0.74 for revascularization]. However, rates of all-cause death, stroke, or hospitalization for heart failure did not differ between groups.

Staged PCI for stable patients with STEMI and MVD has a class 1 recommendation based on the 2021 AHA/ACC/SCAI guidelines for coronary revascularization. This recommendation is largely based on the results of COMPLETE trial published in 2022 that demonstrated complete revascularization performed during or after index hospitalization was associated with a reduction in cardiovascular death or myocardial infarction. The FIRE trial presented during this year’s conference helped solidify this recommendation by demonstrating that staged PCI was safe and effective in patients who were 75 years or older. The results of the MULTISTARS AMI trial have implications for clinical practice, as it demonstrated that immediate PCI of non-culprit lesions is as effective and safe as a staged procedure. Results were consistent across prespecified key subgroups, particularly among women and men, young and older patients, and patients with or without diabetes.