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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Complete Revascularization Strategy | Active Comparator | 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). |
|
| Optimal Medical Therapy Alone | No Intervention | 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Complete Revascularization Strategy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Major Bleeding | Over duration of follow-up (average of approximately 4 years) |
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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shamir R Mehta, MD, MSc | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton General Hospital | Hamilton | Ontario | L8L2X2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42233186 | Derived | Madanchi M, Pinilla-Echeverri N, Wood DA, Sheth T, Storey RF, Kunadian V, Campo G, Moreno R, Mehran R, Rao SV, Bainey KR, Cieza T, Nguyen H, Mani T, Cairns JA, Mehta SR. Impact of Revascularization Completeness on Cardiovascular Outcomes in STEMI With Multivessel Disease. Circ Cardiovasc Interv. 2026 Jun 3:e016515. doi: 10.1161/CIRCINTERVENTIONS.126.016515. Online ahead of print. | |
| 34320839 |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| Derived |
| Dehghani P, Cantor WJ, Wang J, Wood DA, Storey RF, Mehran R, Bainey KR, Welsh RC, Rodes-Cabau J, Rao S, Lavi S, Velianou JL, Natarajan MK, Ziakas A, Guiducci V, Fernandez-Aviles F, Cairns JA, Mehta SR. Complete Revascularization in Patients Undergoing a Pharmacoinvasive Strategy for ST-Segment-Elevation Myocardial Infarction: Insights From the COMPLETE Trial. Circ Cardiovasc Interv. 2021 Aug;14(8):e010458. doi: 10.1161/CIRCINTERVENTIONS.120.010458. Epub 2021 Jul 29. |
| 32646305 | Derived | Pinilla-Echeverri N, Mehta SR, Wang J, Lavi S, Schampaert E, Cantor WJ, Bainey KR, Welsh RC, Kassam S, Mehran R, Storey RF, Nguyen H, Meeks B, Wood DA, Cairns JA, Sheth T. Nonculprit Lesion Plaque Morphology in Patients With ST-Segment-Elevation Myocardial Infarction: Results From the COMPLETE Trial Optical Coherence Tomography Substudys. Circ Cardiovasc Interv. 2020 Jul;13(7):e008768. doi: 10.1161/CIRCINTERVENTIONS.119.008768. Epub 2020 Jul 10. |
| 31475795 | Derived | Mehta SR, Wood DA, Storey RF, Mehran R, Bainey KR, Nguyen H, Meeks B, Di Pasquale G, Lopez-Sendon J, Faxon DP, Mauri L, Rao SV, Feldman L, Steg PG, Avezum A, Sheth T, Pinilla-Echeverri N, Moreno R, Campo G, Wrigley B, Kedev S, Sutton A, Oliver R, Rodes-Cabau J, Stankovic G, Welsh R, Lavi S, Cantor WJ, Wang J, Nakamya J, Bangdiwala SI, Cairns JA; COMPLETE Trial Steering Committee and Investigators. Complete Revascularization with Multivessel PCI for Myocardial Infarction. N Engl J Med. 2019 Oct 10;381(15):1411-1421. doi: 10.1056/NEJMoa1907775. Epub 2019 Sep 1. |
| 31326681 | Derived | Mehta SR, Wood DA, Meeks B, Storey RF, Mehran R, Bainey KR, Nguyen H, Bangdiwala SI, Cairns JA; COMPLETE Trial Steering Committee and Investigators. Design and rationale of the COMPLETE trial: A randomized, comparative effectiveness study of complete versus culprit-only percutaneous coronary intervention to treat multivessel coronary artery disease in patients presenting with ST-segment elevation myocardial infarction. Am Heart J. 2019 Sep;215:157-166. doi: 10.1016/j.ahj.2019.06.006. Epub 2019 Jun 18. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D009203 | Myocardial Infarction |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |