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

Conditions

Multivessel Coronary Disease, ST-elevation Myocardial Infarction

Keywords

ST-elevation Myocardial Infarction, Multivessel coronary disease, Immediate complete coronary revascularization, Staged complete coronary revascularization, Percutaneous coronary intervention, Biodegradable-polymer everolimus-eluting stent

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.

Philipp Jakob, Ferdinando Varbella, A Linke, Stephan B. Felix, Moritz Seiffert et al. (45 authors)

Scientific Reports2026-06-26

10.1038/s41598-026-58258-8

Impact of renal dysfunction on immediate versus staged revascularization of non-culprit lesions in patients with ST segment elevation myocardial infarction: a pre-specified subgroup analysis of the randomized MULTISTARS AMI trial.

Rohla M, Huber K, Varbella F, Linke A, Schwarz B, Felix SB, Seiffert M, Kesterke R, Nordbeck P, Witzenbichler B, Lang IM, Kessler M, Valina C, Dibra A, Jakob P, Moccetti M, Vercellino M, Gaede L, Bott-Flügel L, Stehli J, Candreva A, Paneni F, Templin C, Schindler M, Wischnewsky M, Zanda G, Quadri G, Mangner N, Toma A, Magnani G, Clemmensen P, Lüscher TF, Münzel T, Schulze PC, Laugitz KL, Rottbauer W, Neumann FJ, Schneider S, Riemer T, Weidinger F, Achenbach S, Richardt G, Kastrati A, Ford I, Ruschitzka F, Stähli BE, MULTISTARS AMI Investigators.

2026-03-09

10.1007/s00392-026-02875-w

Impact of diabetes on outcomes of patients with ST-segment elevation myocardial infarction and multivessel coronary artery disease undergoing percutaneous coronary intervention

Philipp Jakob, Ferdinando Varbella, Axel Linke, Bettina Schwarz, Stephan B. Felix et al. (47 authors)

Clinical Research in Cardiology2025-09-10

10.1007/s00392-025-02745-x

Timing of Complete Revascularization with Multivessel PCI for Myocardial Infarction

Barbara E. Stähli, Ferdinando Varbella, Axel Linke, Bettina Schwarz, Stephan B. Felix et al. (45 authors)

New England Journal of Medicine2023-08-27147 citations

10.1056/nejmoa2307823

Interventions

PROCEDUREStaged complete PCI

During the index procedure, patients will have treated with primary PCI the culprit lesion only. Patients will be hospitalized again after 19-45 days to undergo PCI of all the other significant coronary lesions. All the revascularizations will be performed with Synergy™ stent.

PROCEDUREImmediate complete PCI

During the index procedure, patients will have treated with primary PCI the culprit lesion, as well as all the other significant coronary lesions. All the revascularizations will be performed with Synergy™ stent.

DEVICESynergy™ stent

Bioabsorbable Polymer Drug-Eluting Stent

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
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	1-year

Secondary

Measure	Time frame	Description
Unplanned ischemia-driven revascularization	6 months, 1 year	Single components of the primary endpoint
Hospitalization for heart failure	6 months, 1 year	Single components of the primary endpoint
Stroke	6 months, 1 year	Single components of the primary endpoint
Target lesion revascularization (TLR)	6 months, 1 year	—
Target vessel revascularization (TVR)	6 months, 1 year	—
Non-cardiovascular death	6 months, 1 year	—
Cardiac death	6 months, 1 year	—
Cardiovascular death	6 months, 1 year	—
Cardiac death or myocardial infarction	6 months, 1 year	—
Stent thrombosis	6 months, 1 year	—
All-cause death, non-fatal myocardial infarction, unplanned ischemia-driven revascularization, hospitalization for heart failure, and stroke	6 months	Primary endpoint
All-cause death	6 months, 1 year	Single components of the primary endpoint
Non-fatal myocardial infarction	6 months, 1 year	Single components of the primary endpoint
Acute renal insufficiency or dialysis	6 months, 1 year	—
Procedural success	6 months, 1 year	—
Bleeding event (BARC definition)	6 months, 1 year	—
Quality of life (EQ-5D questionnaire)	6 months, 1 year	—
All-cause death or myocardial infarction	6 months, 1 year	—

Other

Measure	Time frame
Cost-effectiveness analysis	1 year

Countries

Switzerland

Outcome results

None listed