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

Primary Purpose

ST-elevation Myocardial Infarction, Multivessel Coronary Disease

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Staged complete PCI
Immediate complete PCI
Synergy™ stent
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST-elevation Myocardial Infarction focused on measuring ST-elevation Myocardial Infarction, Multivessel coronary disease, Immediate complete coronary revascularization, Staged complete coronary revascularization, Percutaneous coronary intervention, Biodegradable-polymer everolimus-eluting stent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital Zürich, Cardiology Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Staged complete PCI

Immediate complete PCI

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 10, 2017
Last Updated
June 15, 2023
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT03135275
Brief Title
MULTivessel Immediate Versus STAged RevaScularization in Acute Myocardial Infarction -The MULTISTARS AMI Trial
Acronym
MULTISTARS AMI
Official Title
MULTivessel Immediate Versus STAged RevaScularization in Acute Myocardial Infarction - The MULTISTARS AMI Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
May 2023 (Actual)
Study Completion Date
May 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
840 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Staged complete PCI
Arm Type
Active Comparator
Arm 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.
Arm Title
Immediate complete PCI
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Staged complete PCI
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Immediate complete PCI
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Synergy™ stent
Intervention Description
Bioabsorbable Polymer Drug-Eluting Stent
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
All-cause death, non-fatal myocardial infarction, unplanned ischemia-driven revascularization, hospitalization for heart failure, and stroke
Description
Primary endpoint
Time Frame
6 months
Title
All-cause death
Description
Single components of the primary endpoint
Time Frame
6 months, 1 year
Title
Non-fatal myocardial infarction
Description
Single components of the primary endpoint
Time Frame
6 months, 1 year
Title
Unplanned ischemia-driven revascularization
Description
Single components of the primary endpoint
Time Frame
6 months, 1 year
Title
Hospitalization for heart failure
Description
Single components of the primary endpoint
Time Frame
6 months, 1 year
Title
Stroke
Description
Single components of the primary endpoint
Time Frame
6 months, 1 year
Title
Target lesion revascularization (TLR)
Time Frame
6 months, 1 year
Title
Target vessel revascularization (TVR)
Time Frame
6 months, 1 year
Title
Non-cardiovascular death
Time Frame
6 months, 1 year
Title
Cardiac death
Time Frame
6 months, 1 year
Title
Cardiovascular death
Time Frame
6 months, 1 year
Title
Cardiac death or myocardial infarction
Time Frame
6 months, 1 year
Title
All-cause death or myocardial infarction
Time Frame
6 months, 1 year
Title
Stent thrombosis
Time Frame
6 months, 1 year
Title
Acute renal insufficiency or dialysis
Time Frame
6 months, 1 year
Title
Procedural success
Time Frame
6 months, 1 year
Title
Bleeding event (BARC definition)
Time Frame
6 months, 1 year
Title
Quality of life (EQ-5D questionnaire)
Time Frame
6 months, 1 year
Other Pre-specified Outcome Measures:
Title
Cost-effectiveness analysis
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara E. Stähli, MD, eMBA
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zürich, Cardiology Department
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
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MULTivessel Immediate Versus STAged RevaScularization in Acute Myocardial Infarction -The MULTISTARS AMI Trial

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