Clinical trial NCT05078619: Percutaneous Coronary Intervention Before Transcatheter Aortic Valve Implantation
Official title: Percutaneous Coronary Intervention Before Transcatheter Aortic Valve Implantation: the PRO-TAVI Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Valvular Heart Disease
Aortic Valve Stenosis
Coronary Artery Disease
Keywords: Transcatheter aortic valve implantation
Percutaneous coronary intervention
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2021-10-14
Enrollment: 466
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: composite of all-cause mortality, myocardial infarction, stroke and type 2-4 bleeding, in accordance to VARC-3 criteria
timeFrame: 12 months from randomization
Secondary outcomes:
measure: Composite of all-cause mortality, myocardial infarction, stroke, in accordance with VARC-3 criteria
timeFrame: 4 months - 12 months - total follow up 5 years
measure: all-cause mortality
timeFrame: 4 months - 12 months - total follow up 5 years
measure: myocardial infarction
timeFrame: 4 months - 12 months - total follow up 5 years
measure: stroke
timeFrame: 4 months - 12 months - total follow up 5 years
measure: VARC-3 bleeding
timeFrame: 4 months - 12 months - total follow up 5 years
measure: BARC bleeding
timeFrame: 4 months - 12 months - total follow up 5 years
measure: urgent and elective revascularization
timeFrame: 4 months - 12 months - total follow up 5 years
measure: Target lesion revascularization
timeFrame: 4 months - 12 months - total follow up 5 years
measure: Target vessel revascularization
timeFrame: 4 months - 12 months - total follow up 5 years
measure: rehospitalization
timeFrame: 4 months - 12 months - total follow up 5 years
measure: Left ventricular function measured by echocardiography
timeFrame: 12 months
measure: Cost-effectiveness of omission of PCI using QALYs
timeFrame: 4 months - 12 months
measure: Cost-effectiveness of omission of PCI using Incremental Cost Effectiveness Ratios
timeFrame: 4 months - 12 months
measure: Quality of life assessed by Euro Quality of Life 5D Questionnaire
timeFrame: 4 months - 12 months
measure: Quality of life assessed by SF-36 Questionnaire
timeFrame: 4 months - 12 months
measure: Anginal status (CCS)
timeFrame: 4 months - 12 months
measure: NYHA classification
timeFrame: 4 months - 12 months
measure: Acute kidney injury stage 3 and 4
timeFrame: 4 months - 12 months - total follow up 5 years
Other outcomes:
Locations:
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
state: Friesland
city: Nijmegen
country: Netherlands
facility: RadboudUMC
state: Gelderland
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
state: Limburg
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis Breda
state: Noord-Brabant
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis Eindhoven
state: Noord-Brabant
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: OLVG
state: Noord-Holland
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
state: Overijssel
city: Nieuwegein
country: Netherlands
facility: Antonius Ziekenhuis Nieuwegein
state: Utrecht
city: Den Haag
country: Netherlands
facility: Haga Ziekenhuis Den Haag
state: Zuid-Holland
city: Groningen
country: Netherlands
facility: UMC Groningen
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
affiliation: UMC Utrecht
name: Michiel Voskuil, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: