Complete vs Culprit-only Revascularization to Treat Multi-vessel Disease After Early PCI for STEMI

Not Applicable

Completed

• Conditions: Acute Myocardial Infarction; Coronary Artery Disease
• Interventions: Procedure: Complete Revascularization Strategy

• Registration Number: NCT01740479
• Lead Sponsor: Population Health Research Institute

Brief Summary

To determine whether, on a background of optimal medical therapy, including ticagrelor, opening of all suitable narrowings or blockages found at the time of primary PCI for an acute heart attack is better than treating only the culprit lesion in patients with multi-vessel disease.

Detailed Description

To determine if a strategy of multivessel revascularization involving PCI of all suitable non-infarct related artery lesions plus optimal medical therapy is superior to a strategy of optimal medical therapy alone in reducing (1) the composite outcome of cardiovascular (CV) death or new myocardial infarction (MI), or (2) the composite of CV death, new MI or ischemia driven revascularization (IDR) in patients with multivessel disease who have undergone early successful culprit lesion PCI for STEMI.

Study Timeline

• Study First Submitted: 2012-11-27
• Study First Submitted QC: 2012-12-03
• Study First Posted: 2012-12-04
• Study Start: 2013-02-01
• Primary Completion: 2019-06-07
• Study Completion: 2019-06-07
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-05
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4042

Inclusion Criteria

1. Men and women within 72 hours after successful PCI (preferably using a drug eluting stent) to the culprit lesion for STEMI. PCI for STEMI can be either primary PCI or rescue PCI for failed fibrinolysis or a combination strategy where PCI is performed routinely 3-12 hours after fibrinolysis AND

2. Multi-vessel disease defined as at least 1 additional non-infarct related coronary artery lesion that is at least 2.5 mm in diameter that has not been stented as part of the primary PCI and that is amenable to successful treatment with PCI and has:

   • At least 70% diameter stenosis (visual estimation) or
   • At least 50% diameter stenosis (visual estimation) with fractional flow reserve (FFR) ≤ 0.80

Exclusion Criteria

1. Planned revascularization of non-culprit lesion
2. Planned surgical revascularization
3. Non-cardiovascular co-morbidity reducing life expectancy to < 5 years
4. Any factor precluding 5 year follow-up
5. Prior Coronary Artery Bypass Graft (CABG) Surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Complete Revascularization Strategy	Complete Revascularization Strategy	Complete Revascularization Strategy (Staged Non-Culprit Lesion PCI plus Optimal Medical Therapy): Staged PCI using second generation drug eluting stents (Promus Element Plus drug-eluting stent or newer version in this series is strongly recommended) of all suitable non-culprit lesions. All patients, regardless of randomized treatment allocation will receive optimal medical therapy consisting of risk factor modification and use of evidence-based therapies (including low dose acetylsalicylic acid (ASA) and ticagrelor).

Primary Outcome Measures

Name	Time	Method
Composite of Cardiovascular death or new myocardial Infarction	over duration of follow-up (average of approximately 4 years)	Co-primary outcome: CV death or new MI
Composite of cardiovascular death, new myocardial infarction or ischemia-driven revascularization	over duration of follow-up (average of approximately 4 years)	Co-primary outcome: CV death, new MI or IDR

Secondary Outcome Measures

Name	Time	Method
Composite of CV death, new MI, ischemia-driven revascularization or hospitalization for unstable angina or heart failure	Over duration of follow-up (average of approximately 4 years)

Trial Locations

Locations (1)

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada