CompleteNSTEMI: Complete Revascularization Versus Culprit Lesion Only PCI in NSTEMI

Sponsor

Leipzig Heart Science gGmbH (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05786131

Collaborator

Heart Center Leipzig at University of Leipzig (Other), German Federal Ministry of Education and Research (Other), IHF GmbH - Institut für Herzinfarktforschung (Other), Stiftung IHF - Institut für Herzinfarktforschung (Other)

3,390

Enrollment

Location

Arms

Anticipated Duration (Months)

70.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Non-ST-elevation Myocardial Infarction Multivessel Coronary Artery Disease	Procedure: Culprit-lesion revascularization Procedure: Non-culprit-lesion revascularization	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

3390 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Sep 30, 2026

Anticipated Study Completion Date :

Mar 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: culprit-lesion-only revascularization 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 Percutaneous coronary intervention of culprit-lesion Other Names: Culprit-lesion PCI
Experimental: multivessel complete revascularization 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 Percutaneous coronary intervention of culprit-lesion Other Names: Culprit-lesion PCI Procedure: Non-culprit-lesion revascularization Complete percutaneous coronary intervention of all angiographically significant non-culprit lesions Other Names: multivessel PCI

Arm

Intervention/Treatment

Experimental: culprit-lesion-only revascularization

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

Percutaneous coronary intervention of culprit-lesion

Other Names:

Culprit-lesion PCI

Experimental: multivessel complete revascularization

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

Percutaneous coronary intervention of culprit-lesion

Other Names:

Culprit-lesion PCI

Procedure: Non-culprit-lesion revascularization

Complete percutaneous coronary intervention of all angiographically significant non-culprit lesions

Other Names:

multivessel PCI

Outcome Measures

Primary Outcome Measures

Composite rate of cardiovascular death or rehospitalization for non-fatal myocardial infarction [During follow-up (2 years estimated average duration)]

Secondary Outcome Measures

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) [12 months]
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
Rate of bleeding [6 months]
Rate of stroke [6 months]
Ischemic and Hemorrhagic
Rate of contrast-induced acute kidney injury [6 months]
AKIN grade I-III
Rate of coronary procedure-related myocardial infarction [6 months]