MULTivessel Immediate Versus STAged RevaScularization in Acute Myocardial Infarction -The MULTISTARS AMI Trial (MULTISTARS AMI)
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ClinicalTrials.gov Identifier: NCT03135275 |
Recruitment Status :
Completed
First Posted : May 1, 2017
Last Update Posted : January 11, 2024
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Condition or disease | Intervention/treatment | Phase |
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ST-elevation Myocardial Infarction Multivessel Coronary Disease | Procedure: Staged complete PCI Procedure: Immediate complete PCI Device: Synergy™ stent | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 840 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | MULTivessel Immediate Versus STAged RevaScularization in Acute Myocardial Infarction - The MULTISTARS AMI Trial |
Actual Study Start Date : | October 2016 |
Actual Primary Completion Date : | May 2023 |
Actual Study Completion Date : | May 2023 |
Arm | Intervention/treatment |
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Active Comparator: Staged complete PCI
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.
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Procedure: Staged 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. Device: Synergy™ stent Bioabsorbable Polymer Drug-Eluting Stent |
Experimental: Immediate complete PCI
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.
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Procedure: Immediate 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. Device: Synergy™ stent Bioabsorbable Polymer Drug-Eluting Stent |
- 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 ]
- All-cause death, non-fatal myocardial infarction, unplanned ischemia-driven revascularization, hospitalization for heart failure, and stroke [ Time Frame: 6 months ]Primary endpoint
- All-cause death [ Time Frame: 6 months, 1 year ]Single components of the primary endpoint
- Non-fatal myocardial infarction [ Time Frame: 6 months, 1 year ]Single components of the primary endpoint
- Unplanned ischemia-driven revascularization [ Time Frame: 6 months, 1 year ]Single components of the primary endpoint
- Hospitalization for heart failure [ Time Frame: 6 months, 1 year ]Single components of the primary endpoint
- Stroke [ Time Frame: 6 months, 1 year ]Single components of the primary endpoint
- Target lesion revascularization (TLR) [ Time Frame: 6 months, 1 year ]
- Target vessel revascularization (TVR) [ Time Frame: 6 months, 1 year ]
- Non-cardiovascular death [ Time Frame: 6 months, 1 year ]
- Cardiac death [ Time Frame: 6 months, 1 year ]
- Cardiovascular death [ Time Frame: 6 months, 1 year ]
- Cardiac death or myocardial infarction [ Time Frame: 6 months, 1 year ]
- All-cause death or myocardial infarction [ Time Frame: 6 months, 1 year ]
- Stent thrombosis [ Time Frame: 6 months, 1 year ]
- Acute renal insufficiency or dialysis [ Time Frame: 6 months, 1 year ]
- Procedural success [ Time Frame: 6 months, 1 year ]
- Bleeding event (BARC definition) [ Time Frame: 6 months, 1 year ]
- Quality of life (EQ-5D questionnaire) [ Time Frame: 6 months, 1 year ]
- Cost-effectiveness analysis [ Time Frame: 1 year ]
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03135275
Switzerland | |
University Hospital Zürich, Cardiology Department | |
Zurich, Switzerland, 8091 |
Principal Investigator: | Barbara E. Stähli, MD, eMBA | University of Zurich |
Publications of Results:
Other Publications:
Responsible Party: | University of Zurich |
ClinicalTrials.gov Identifier: | NCT03135275 |
Other Study ID Numbers: |
MULTISTARS_USZ |
First Posted: | May 1, 2017 Key Record Dates |
Last Update Posted: | January 11, 2024 |
Last Verified: | January 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
ST-elevation Myocardial Infarction Multivessel coronary disease Immediate complete coronary revascularization |
Staged complete coronary revascularization Percutaneous coronary intervention Biodegradable-polymer everolimus-eluting stent |
Myocardial Infarction Coronary Disease Coronary Artery Disease ST Elevation Myocardial Infarction Infarction Ischemia Pathologic Processes |
Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases |