MULTivessel Immediate Versus STAged RevaScularization in Acute Myocardial Infarction - The MULTISTARS AMI Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- ST-elevation Myocardial Infarction
- Sponsor
- University of Zurich
- Enrollment
- 840
- Locations
- 1
- Primary Endpoint
- The primary outcome measure is a composite of all-cause death, non-fatal myocardial infarction, unplanned ischemia-driven revascularization, hospitalization for heart failure, and stroke at 1 year
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The primary objective of the trial is to compare, in patients presenting with ST segment elevation myocardial infarction (STEMI) and multi-vessel disease (MVD), the safety and efficacy of immediate complete revascularization of all significant coronary lesions versus culprit vessel only revascularization and staged percutaneous coronary intervention (PCI) of all significant coronary lesions (within 19 to 45 days), in a non-inferiority trial using a third generation, biodegradable-polymer, everolimus-eluting stent.
Detailed Description
An investigator-initiated, randomized, multicenter, two-arm, open-label study of consecutive patients presenting with STEMI and MVD in stable hemodynamic conditions, undergoing after successful PCI of the culprit lesion either (1:1 randomization) immediate revascularization of all additional target lesions during the index procedure or staged PCI of all additional target lesions (within 19 to 45 days) using the Boston Scientific Synergy™ stent. The goal of this trial is to compare two treatment strategies that are currently performed in clinical practice: immediate complete revascularization versus staged complete revascularization in patients with STEMI and MVD. Patients randomized to immediate complete revascularization will have treated during the index procedure, after revascularization of the culprit lesion, all significant non-culprit coronary lesions. Patients randomized to staged complete revascularization will have treated during the index procedure only the culprit lesion, and they will be hospitalized after 19-45 days for complete revascularization of all significant non-culprit coronary lesions. For both groups, lesion are considered significant when causing a ≥70% diameter stenosis by visual estimation in at least two projections on the coronary angiogram.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 years
- •Spontaneous acute STEMI (patients presenting within 24 hours of symptom onset)
- •Suitability for PCI from femoral or radial access
- •Coronary anatomy suitable for complete coronary revascularization with Synergy® stent implantation
- •Identifiable culprit lesion/artery
- •At least one non-culprit coronary stenosis ≥ 70% in at least two projections, in a vessel with a lumen diameter ≥2.25 - ≤5.75 mm, other than the culprit artery
- •TIMI Flow 3 or TIMI flow 2 after revascularization of the culprit artery
- •Stable hemodynamics at the end of the culprit vessel revascularization
Exclusion Criteria
- •Inability to give informed consent
- •Cardiogenic shock
- •Prolonged resuscitation \>10 min
- •General unsuitability for PCI
- •Need for emergency CABG
- •Previous CABG
- •Planned hybrid revascularization
- •Coronary artery dissection
- •STEMI due to ST
- •Previous documented allergic reaction to everolimus or to any stent material
Outcomes
Primary Outcomes
The primary outcome measure is a composite of all-cause death, non-fatal myocardial infarction, unplanned ischemia-driven revascularization, hospitalization for heart failure, and stroke at 1 year
Time Frame: 1-year
Secondary Outcomes
- All-cause death(6 months, 1 year)
- Target vessel revascularization (TVR)(6 months, 1 year)
- Non-fatal myocardial infarction(6 months, 1 year)
- Target lesion revascularization (TLR)(6 months, 1 year)
- Hospitalization for heart failure(6 months, 1 year)
- All-cause death, non-fatal myocardial infarction, unplanned ischemia-driven revascularization, hospitalization for heart failure, and stroke(6 months)
- Cardiac death(6 months, 1 year)
- Unplanned ischemia-driven revascularization(6 months, 1 year)
- Stroke(6 months, 1 year)
- Quality of life (EQ-5D questionnaire)(6 months, 1 year)
- Non-cardiovascular death(6 months, 1 year)
- Cardiovascular death(6 months, 1 year)
- Cardiac death or myocardial infarction(6 months, 1 year)
- Acute renal insufficiency or dialysis(6 months, 1 year)
- Procedural success(6 months, 1 year)
- Bleeding event (BARC definition)(6 months, 1 year)
- All-cause death or myocardial infarction(6 months, 1 year)
- Stent thrombosis(6 months, 1 year)