MULTivessel Immediate Versus STAged RevaScularization in Acute Myocardial Infarction -The MULTISTARS AMI Trial

University of Zurich (UZH)

Status: Completed

Conditions: ST-elevation Myocardial Infarction; Multivessel Coronary Disease

Treatments: Device: Synergy™ stent; Procedure: Staged complete PCI; Procedure: Immediate complete PCI

Study type: Interventional

Funder types: Other

Identifiers

NCT03135275

MULTISTARS_USZ

Details and patient eligibility

About

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.

Full 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.

Enrollment: 840 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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840 participants in 2 patient groups

Staged complete PCI

Active Comparator group

Description:

Patients randomized to staged complete PCI will have treated during the index admission only the culprit lesion and they will be hospitalized after 19-45 days, to complete the coronary revascularization on all the other significant coronary lesions. All the revascularizations will be performed with Synergy™ stent.

Treatment:

Procedure: Staged complete PCI

Device: Synergy™ stent

Immediate complete PCI

Experimental group

Description:

Patients randomized to immediate complete PCI will have treated immediately after the revascularization of the culprit lesion during the index procedure all the other significant coronary lesions. All the revascularizations will be performed with Synergy™ stent.

Treatment:

Device: Synergy™ stent

Procedure: Immediate complete PCI