Complete Revascularization Versus Culprit Lesion Only PCI in NSTEMI

Study Overview
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Brief Summary
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Prospective, randomized, controlled, multicenter, open-label trial to study whether multivessel percutaneous coronary intervention (PCI) is superior over culprit-lesion only PCI in patients with non-ST-segment elevation myocardial infarction (NSTEMI) and multivessel coronary artery disease.

Detailed Description
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The complete revascularization versus culprit lesion only PCI in NSTEMI (COMPLETE-NSTEMI) trial aims to investigate whether multivessel complete PCI is superior over culprit-lesion only PCI in patients with NSTEMI and multivessel coronary artery disease.

Official Title
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Complete Revascularization Versus Culprit Lesion Only PCI in NSTEMI (-COMPLETE-NSTEMI-)

Conditions
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Non-ST-elevation Myocardial Infarction, Multivessel Coronary Artery Disease

Intervention / Treatment
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* Procedure: Culprit-lesion revascularization
* Procedure: Non-culprit-lesion revascularization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: NSTEMI as suggested by high-sensitivity troponin algorithms Multivessel coronary artery disease Identifiable culprit lesion Informed consent Exclusion Criteria: Age <18 years Cardiogenic shock Sustained ventricular tachycardia (VT) or ventricular fibrillation (VF) Contraindication for coronary revascularization Prior coronary artery bypass graft Indication for coronary artery bypass graft surgery Co-morbidity with life expectancy less than 6 months Type 2 myocardial infarction

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: culprit-lesion-only revascularization<br>Patients will receive optimal medical therapy without further revascularization of non-culprit lesions (neither during index hospitalization nor during follow-up). Angina pectoris will be treated medically as recommended in the chronic coronary syndrome guidelines. Revascularization of non-culprit lesions will only be permitted if at least one bailout criteria is met. | Procedure: Culprit-lesion revascularization<br>* Percutaneous coronary intervention of culprit-lesion<br>* Other names: Culprit-lesion PCI;|
| Experimental: multivessel complete revascularization<br>Patients will receive complete revascularization of all angiographically significant non-culprit lesions, either during the index procedure, the index hospitalization, or staged within 45 days after PCI of the culprit lesion. | Procedure: Culprit-lesion revascularization<br>* Percutaneous coronary intervention of culprit-lesion<br>* Other names: Culprit-lesion PCI;Procedure: Non-culprit-lesion revascularization<br>* Complete percutaneous coronary intervention of all angiographically significant non-culprit lesions<br>* Other names: multivessel PCI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite rate of cardiovascular death or rehospitalization for non-fatal myocardial infarction |  | During follow-up (2 years estimated average duration) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Cardiovascular death |  | During follow-up (2 years estimated average duration) | 
| Rate of Rehospitalization for non-fatal myocardial infarction |  | During follow-up (2 years estimated average duration) | 
| Rate of all-cause death |  | During follow-up (2 years estimated average duration) | 
| Rate of ischemia-driven revascularization |  | During follow-up (2 years estimated average duration) | 
| Rate of rehospitalization for heart failure |  | During follow-up (2 years estimated average duration) | 
| Composite rate of all-cause death, rehospitalization for non-fatal myocardial infarction, or rehospitalization for ischemia-driven revascularization |  | During follow-up (2 years estimated average duration) | 
| Rate of coronary artery bypass surgery |  | During follow-up (2 years estimated average duration) | 
| Quality of Life (EQ-5D-5L) | European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) Score 1-5 for each dimension, 1 means best outcome EQ VAS score between 0 and 100; higher score means better outcome | 12 months | 
| Rate of bleeding |  | 6 months | 
| Rate of stroke | Ischemic and Hemorrhagic | 6 months | 
| Rate of contrast-induced acute kidney injury | AKIN grade I-III | 6 months | 
| Rate of coronary procedure-related myocardial infarction |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSTEMI, Multivessel coronary artery disease, culprit-lesion only PCI, multivessel percutaneous coronary intervention