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

Sponsor

Population Health Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT01740479

Collaborator

(none)

4,042

Enrollment

Location

Arms

76.1

Actual Duration (Months)

53.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myocardial Infarction Coronary Artery Disease	Procedure: Complete Revascularization Strategy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

4042 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Feb 1, 2013

Actual Primary Completion Date :

Jun 7, 2019

Actual Study Completion Date :

Jun 7, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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).	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. Other Names: Staged Non-Culprit Lesion PCI plus Optimal Medical Therapy
No Intervention: Optimal Medical Therapy Alone Culprit lesion only Revascularization Strategy (Optimal Medical Therapy Alone): No further revascularization of 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 ASA and ticagrelor).

Arm

Intervention/Treatment

Active Comparator: 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).

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.

Other Names:

Staged Non-Culprit Lesion PCI plus Optimal Medical Therapy

No Intervention: Optimal Medical Therapy Alone

Culprit lesion only Revascularization Strategy (Optimal Medical Therapy Alone): No further revascularization of 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 ASA and ticagrelor).

Outcome Measures

Primary Outcome Measures

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

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)]

Other Outcome Measures

Major Bleeding [Over duration of follow-up (average of approximately 4 years)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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
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: