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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease; Aortic Valve Stenosis; Valvular Heart Disease
• Intervention / Treatment: Procedure: No PCI

• Study Type: Interventional
• Enrollment (Actual): 466
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands
    • UMC Groningen
  • Utrecht, Netherlands, 3508GA
    • UMC Utrecht
  • Friesland
    • Leeuwarden, Friesland, Netherlands
      • Medisch Centrum Leeuwarden
  • Gelderland
    • Nijmegen, Gelderland, Netherlands
      • Radboudumc
  • Limburg
    • Maastricht, Limburg, Netherlands
      • Maastricht UMC+
  • Noord-Brabant
    • Breda, Noord-Brabant, Netherlands
      • Amphia Ziekenhuis Breda
    • Eindhoven, Noord-Brabant, Netherlands
      • Catharina Ziekenhuis Eindhoven
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands
      • Amsterdam UMC
    • Amsterdam, Noord-Holland, Netherlands
      • OLVG
  • Overijssel
    • Enschede, Overijssel, Netherlands
      • Medisch Spectrum Twente
  • Utrecht
    • Nieuwegein, Utrecht, Netherlands
      • Antonius Ziekenhuis Nieuwegein
  • Zuid-Holland
    • Den Haag, Zuid-Holland, Netherlands
      • Haga Ziekenhuis Den Haag

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAVI without routine PCI; Patients who are randomized to the experimental or index group undergo TAVI without routine PCI	Procedure: No PCI; Omission of PCI of significant coronary artery disease prior to TAVI
No Intervention: TAVI with routine PCI; Patients who are randomized to the control or reference group undergo TAVI with routine PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
composite of all-cause mortality, myocardial infarction, stroke and type 2-4 bleeding, in accordance to VARC-3 criteria	12 months from randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	4 months - 12 months
Quality of life assessed by SF-36 Questionnaire	Questionnaire consists of eight sections. Each section is transformed into a 0 - 100 scale. The lower the score the more disability.	4 months - 12 months
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	VARC-3	4 months - 12 months - total follow up 5 years
myocardial infarction	VARC-3	4 months - 12 months - total follow up 5 years
stroke	VARC-3	4 months - 12 months - total follow up 5 years
VARC-3 bleeding		4 months - 12 months - total follow up 5 years
BARC bleeding	BARC bleeding > type 1	4 months - 12 months - total follow up 5 years
urgent and elective revascularization	ACC/AHA Key Data Elements and Definitions for Cardiovascular Endpoint Events in Clinical Trials & ARC-2	4 months - 12 months - total follow up 5 years
Target lesion revascularization	ARC-2	4 months - 12 months - total follow up 5 years
Target vessel revascularization	ARC-2	4 months - 12 months - total follow up 5 years
rehospitalization	VARC-3	4 months - 12 months - total follow up 5 years
Anginal status (CCS)		4 months - 12 months
NYHA classification		4 months - 12 months
Acute kidney injury stage 3 and 4	VARC-3	4 months - 12 months - total follow up 5 years

Collaborators and Investigators

• Sponsor: UMC Utrecht
• Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
• Investigators: Principal Investigator: Michiel Voskuil, MD PhD, UMC Utrecht

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2021
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: September 21, 2021
• First Submitted That Met QC Criteria: October 4, 2021
• First Posted (Actual): October 14, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Percutaneous coronary intervention; Transcatheter aortic valve implantation
• Additional Relevant MeSH Terms: Aortic Valve Disease; Vascular Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Aortic Valve Stenosis; Heart Diseases; Coronary Artery Disease; Heart Valve Diseases
• Other Study ID Numbers: NL77915.041.21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No