Reduced Stent Strategy Versus Conventional Percutaneous Coronary Revascularization in Patients Presenting With STEMI (COPERNICAN)

Jorge Sanz Sanchez

Status: Enrolling

Conditions: ST Elevation Myocardial Infarction

Treatments: Device: Primary PCI

Study type: Interventional

Funder types: Other

Identifiers

NCT06353594

COPERNICAN TRIAL

Details and patient eligibility

About

The objective is to compare a reduced stent strategy based on drug-coated balloon (DCB) percutaneous coronary intervention (PCI) with conventional drug-eluting stent (DES) coronary revascularization in patients presenting with ST-segment myocardial infarction (STEMI).

Randomization will be performed after successful culprit-lesion guidewire crossing and flow restoration. Random allocation in a 1:1 fashion to one of the following strategies:

• Study group: reduced stent PCI strategy (DCB-based)
• Control group: conventional PCI strategy (DES-based).

Enrollment: 1,272 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients presenting with STEMI and indication to undergo pPCI.

Exclusion criteria

• Life expectancy <1 year due 1 to non-cardiac disease.
• Inability to provide informed consent.
• Cardiogenic shock.
• Left ventricular ejection fraction <15%.
• Left main disease.
• Stent thrombosis
• Patients with prior bypass graft lesions requiring PCI (culprit or non culprit lesions).
• Patients with chronic total occlusions.
• Untreatable coronary disease.
• Non-identified culprit lesion.
• Known allergy to aspirin, ticagrelor, prasugrel, clopidogrel, paclitaxel or sirolimus.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,272 participants in 2 patient groups

DCB-based

Experimental group

Description:

Reduced stent PCI strategy: Culprit lesion revascularization with DCB will be performed after coronary predilation if residual stenosis ≤30%, lack of dissections \>type B and TIMI 3 flow. If the aforementioned culprit-lesion characteristics are not achieved after DCB-PCI, a DES will be implanted.

Treatment:

Device: Primary PCI

DES-based

No Intervention group

Description:

Control group