Percutaneous Coronary Intervention Before Transcatheter Aortic Valve Implantation: the PRO-TAVI Trial

UMC Utrecht12 sites in 1 country466 target enrollmentOctober 5, 2021

ConditionsValvular Heart Disease Aortic Valve Stenosis Coronary Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Valvular Heart Disease
Sponsor: UMC Utrecht
Enrollment: 466
Locations: 12
Primary Endpoint: composite of all-cause mortality, myocardial infarction, stroke and type 2-4 bleeding, in accordance to VARC-3 criteria
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 5, 2021

End Date

December 1, 2029

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

UMC Utrecht

Responsible Party

Principal Investigator

Michiel Voskuil, MD, PhD

Professor in Cardiology

UMC Utrecht

Eligibility Criteria

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

Outcomes

Primary Outcomes

composite of all-cause mortality, myocardial infarction, stroke and type 2-4 bleeding, in accordance to VARC-3 criteria

Time Frame: 12 months from randomization

Secondary Outcomes

stroke(4 months - 12 months - total follow up 5 years)
Composite of all-cause mortality, myocardial infarction, stroke, in accordance with VARC-3 criteria(4 months - 12 months - total follow up 5 years)
all-cause mortality(4 months - 12 months - total follow up 5 years)
Target lesion revascularization(4 months - 12 months - total follow up 5 years)
Target vessel revascularization(4 months - 12 months - total follow up 5 years)
rehospitalization(4 months - 12 months - total follow up 5 years)
myocardial infarction(4 months - 12 months - total follow up 5 years)
BARC bleeding(4 months - 12 months - total follow up 5 years)
Left ventricular function measured by echocardiography(12 months)
VARC-3 bleeding(4 months - 12 months - total follow up 5 years)
urgent and elective revascularization(4 months - 12 months - total follow up 5 years)
Cost-effectiveness of omission of PCI using QALYs(4 months - 12 months)
Cost-effectiveness of omission of PCI using Incremental Cost Effectiveness Ratios(4 months - 12 months)
Quality of life assessed by Euro Quality of Life 5D Questionnaire(4 months - 12 months)
Quality of life assessed by SF-36 Questionnaire(4 months - 12 months)
Anginal status (CCS)(4 months - 12 months)
NYHA classification(4 months - 12 months)
Acute kidney injury stage 3 and 4(4 months - 12 months - total follow up 5 years)