Clinical trial NCT03135275: MULTivessel Immediate Versus STAged RevaScularization in Acute Myocardial Infarction -The MULTISTARS AMI Trial
Official title: MULTivessel Immediate Versus STAged RevaScularization in Acute Myocardial Infarction - The MULTISTARS AMI Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ST-elevation Myocardial Infarction
Multivessel Coronary Disease
Keywords: ST-elevation Myocardial Infarction
Multivessel coronary disease
Immediate complete coronary revascularization
Staged complete coronary revascularization
Percutaneous coronary intervention
Biodegradable-polymer everolimus-eluting stent
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2017-05-01
Enrollment: 840
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* Severe mechanical complication of acute myocardial infarction
* Pre-existing severe renal failure (eGFR \<30 mL/min) or renal replacement therapy
* Chronic total occlusion of a major coronary artery
* Left main stem stenosis ≥50% or left main stem equivalent (ostial left anterior descending and ostial circumflex stenosis ≥70%)
* In-stent restenosis
* Panned coronary, cerebrovascular, or peripheral arterial revascularization
* Planned cardiac or major surgery
* Any contraindications for dual antiplatelet therapy with aspirin and a P2Y12 Inhibitor for at least 90 days, except for patients on oral anticoagulation
* Known pregnancy at the time of inclusion
* Participation in another clinical study with an investigational product
* Life expectancy \<1 year

Primary outcomes:
measure: 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
timeFrame: 1-year
Secondary outcomes:
measure: All-cause death, non-fatal myocardial infarction, unplanned ischemia-driven revascularization, hospitalization for heart failure, and stroke
timeFrame: 6 months
measure: All-cause death
timeFrame: 6 months, 1 year
measure: Non-fatal myocardial infarction
timeFrame: 6 months, 1 year
measure: Unplanned ischemia-driven revascularization
timeFrame: 6 months, 1 year
measure: Hospitalization for heart failure
timeFrame: 6 months, 1 year
measure: Stroke
timeFrame: 6 months, 1 year
measure: Target lesion revascularization (TLR)
timeFrame: 6 months, 1 year
measure: Target vessel revascularization (TVR)
timeFrame: 6 months, 1 year
measure: Non-cardiovascular death
timeFrame: 6 months, 1 year
measure: Cardiac death
timeFrame: 6 months, 1 year
measure: Cardiovascular death
timeFrame: 6 months, 1 year
measure: Cardiac death or myocardial infarction
timeFrame: 6 months, 1 year
measure: All-cause death or myocardial infarction
timeFrame: 6 months, 1 year
measure: Stent thrombosis
timeFrame: 6 months, 1 year
measure: Acute renal insufficiency or dialysis
timeFrame: 6 months, 1 year
measure: Procedural success
timeFrame: 6 months, 1 year
measure: Bleeding event (BARC definition)
timeFrame: 6 months, 1 year
measure: Quality of life (EQ-5D questionnaire)
timeFrame: 6 months, 1 year
Other outcomes:
measure: Cost-effectiveness analysis
timeFrame: 1 year
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zürich, Cardiology Department
Study officials:
affiliation: University of Zurich
name: Barbara E. Stähli, MD, eMBA
role: PRINCIPAL_INVESTIGATOR
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