Percutaneous Coronary Intervention Before Transcatheter Aortic Valve Implantation (PRO-TAVI)

UMC Utrecht

Status: Active, not recruiting

Conditions: Coronary Artery Disease; Valvular Heart Disease; Aortic Valve Stenosis

Treatments: Procedure: No PCI

Study type: Interventional

Funder types: Other

Identifiers

NCT05078619

NL77915.041.21

Details and patient eligibility

About

The aim of this trial is to evaluate the safety and cost effectiveness of omission of percutaneous coronary intervention of significant coronary artery disease in patients scheduled to undergo transcatheter aortic valve implantation.

Enrollment: 466 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Severe AoS meeting the criteria stated by the ESC in the ESC/EACTS Guidelines for the management of valvular heart disease AND considered symptomatic (NYHA functional class ≥ 2);
• TAVI decided by multidisciplinary Heart Team taken into account the international standards by ESC and guidelines of Dutch Society for Cardiology (NVVC);
• ≥ 1 stenosis in epicardial coronary artery (> 2.5mm) or bypass graft. Stenosis is considered significant if angiographic 70-99% or angiographic 40-70% with positive hemodynamic parameters.
• Written informed consent.

Exclusion criteria

• Unprotected LM-stenosis or equivalent
• No PCI-eligible stenosis
• Contraindication for DAPT
• Life expectancy < 1 year

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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466 participants in 2 patient groups

TAVI without routine PCI

Experimental group

Description:

Patients who are randomized to the experimental or index group undergo TAVI without routine PCI

Treatment:

Procedure: No PCI

TAVI with routine PCI

No Intervention group

Description:

Patients who are randomized to the control or reference group undergo TAVI with routine PCI