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

Sponsor

UMC Utrecht (Other)

Overall Status

Recruiting

CT.gov ID

NCT05078619

Collaborator

ZonMw: The Netherlands Organisation for Health Research and Development (Other)

466

Enrollment

Locations

Arms

82.6

Anticipated Duration (Months)

46.6

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Valvular Heart Disease Aortic Valve Stenosis Coronary Artery Disease	Procedure: No PCI	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

466 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Percutaneous Coronary Intervention Before Transcatheter Aortic Valve Implantation

Actual Study Start Date :

Oct 5, 2021

Anticipated Primary Completion Date :

Nov 5, 2024

Anticipated Study Completion Date :

Aug 22, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TAVI only Patients randomly allocated to this study arm will undergo transcatheter aortic valve implantation without preceding PCI of significant coronary artery disease	Procedure: No PCI Omission of PCI of significant coronary artery disease prior to TAVI
No Intervention: TAVI with preceding PCI Patients randomly allocated to this study arm will undergo transcatheter aortic valve implantation with preceding PCI of significant coronary artery disease which is currently the standard of care.

Arm

Intervention/Treatment

Experimental: TAVI only

Patients randomly allocated to this study arm will undergo transcatheter aortic valve implantation without preceding PCI of significant coronary artery disease

Procedure: No PCI

Omission of PCI of significant coronary artery disease prior to TAVI

No Intervention: TAVI with preceding PCI

Patients randomly allocated to this study arm will undergo transcatheter aortic valve implantation with preceding PCI of significant coronary artery disease which is currently the standard of care.

Outcome Measures

Primary Outcome Measures

composite of all-cause mortality, myocardial infarction, stroke and major bleeding [12 months]

Secondary Outcome Measures

all-cause mortality [4 months - 12 months - total follow up 5 years]
myocardial infarction [4 months - 12 months - total follow up 5 years]
stroke [4 months - 12 months - total follow up 5 years]
major bleeding [4 months - 12 months - total follow up 5 years]
minor bleeding [4 months - 12 months - total follow up 5 years]
urgent and elective revascularization [4 months - 12 months - total follow up 5 years]
rehospitalization [4 months - 12 months - total follow up 5 years]
Left ventricular function measured by echocardiography [12 months]
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]
the system produces a 5-digit health status profile to describe quality of life in a descriptive manner. Therefore, no lowest and highest value can be stated.
Quality of life assessed by SF-36 Questionnaire [4 months - 12 months]
Questionnaire consists of eight sections. Each section is transformed into a 0 - 100 scale. The lower the score the more disability.
Anginal status assessed by CCS classification [4 months - 12 months]
Anginal status assessed by Seattle Angina Questionnaire [4 months - 12 months]
Anginal status assessed by NYHA classification [4 months - 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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:

LM-stenosis or equivalent
CAD with patent bypass grafts
Contraindication for DAPT
Life expectancy < 1 year

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medisch Centrum Leeuwarden	Leeuwarden	Friesland	Netherlands
2	RadboudUMC	Nijmegen	Gelderland	Netherlands
3	Amphia Ziekenhuis Breda	Breda	Noord-Brabant	Netherlands
4	Catharina Ziekenhuis Eindhoven	Eindhoven	Noord-Brabant	Netherlands
5	Amsterdam UMC	Amsterdam	Noord-Holland	Netherlands
6	Medisch Spectrum Twente	Enschede	Overijssel	Netherlands
7	Antonius Ziekenhuis Nieuwegein	Nieuwegein	Utrecht	Netherlands
8	Haga Ziekenhuis Den Haag	Den Haag	Zuid-Holland	Netherlands
9	UMC Groningen	Groningen		Netherlands
10	UMC Utrecht	Utrecht		Netherlands	3508GA