Complete Revascularization Versus Culprit Lesion Only PCI in NSTEMI (CompleteNSTEMI)

Leipzig Heart Science gGmbH

Status: Enrolling

Conditions: Multivessel Coronary Artery Disease; Non-ST-elevation Myocardial Infarction

Treatments: Procedure: Non-culprit-lesion revascularization; Procedure: Culprit-lesion revascularization

Study type: Interventional

Funder types: Other

Identifiers

NCT05786131

2023-019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,390 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• Non-culprit lesion located in the left main coronary artery
• Co-morbidity with life expectancy less than 6 months
• Type 2 myocardial infarction
• Pregnancy and breast feeding period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,390 participants in 2 patient groups

culprit-lesion-only revascularization

Experimental group

Description:

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.

Treatment:

Procedure: Culprit-lesion revascularization

multivessel complete revascularization

Experimental group

Description:

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.

Treatment:

Procedure: Culprit-lesion revascularization

Procedure: Non-culprit-lesion revascularization