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

Coronary Artery Disease Clinical Trial

— COMPLETE  

Official title:

Randomized Comparative Effectiveness Study of Complete vs Culprit-only Revascularization Strategies to Treat Multi-vessel Disease After Early Percutaneous Coronary Intervention (PCI) for ST-segment Elevation Myocardial (STEMI) Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01740479
• Other study ID #: COMPLETE-2012
• Status: Completed
• Phase: N/A
• Start date: February 1, 2013
• Est. completion date: June 7, 2019

Study information

• Verified date: February 2021
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4042
• Est. completion date: June 7, 2019
• Est. primary completion date: June 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Coronary Artery Disease
• Infarction
• Myocardial Infarction

Intervention

Procedure:
• Complete Revascularization Strategy
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 plus optimal medical therapy.

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Population Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Major Bleeding		Over duration of follow-up (average of approximately 4 years)
Primary	Composite of Cardiovascular death or new myocardial Infarction	Co-primary outcome: CV death or new MI	over duration of follow-up (average of approximately 4 years)
Primary	Composite of cardiovascular death, new myocardial infarction or ischemia-driven revascularization	Co-primary outcome: CV death, new MI or IDR	over duration of follow-up (average of approximately 4 years)
Secondary	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)