Percutaneous Coronary Intervention Before Transcatheter Aortic Valve Implantation

NCT05078619 | Active Not Recruiting DMC

• 1 other identifier: NL77915.041.21
• Study Type: interventional
• Target: 466
• Locations: 1 country
• Sites: 12

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.

Conditions

Valvular Heart Disease; Aortic Valve Stenosis; Coronary Artery Disease

Keywords

Transcatheter aortic valve implantation; Percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

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

  12 months from randomization

Secondary Outcomes (18)

• 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

• myocardial infarction

  4 months - 12 months - total follow up 5 years

• stroke

  4 months - 12 months - total follow up 5 years

• VARC-3 bleeding

  4 months - 12 months - total follow up 5 years

Study Arms (2)

TAVI without routine PCI

EXPERIMENTAL

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

Procedure: No PCI

TAVI with routine PCI

NO INTERVENTION

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

Interventions

No PCI PROCEDURE

Omission of PCI of significant coronary artery disease prior to TAVI

TAVI without routine PCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• UMC Utrecht: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (12)

RadboudUMC

Nijmegen, Gelderland, Netherlands

Location

Maastricht UMC+

Maastricht, Limburg, Netherlands

Location

Amphia Ziekenhuis Breda

Breda, North Brabant, Netherlands

Location

Catharina Ziekenhuis Eindhoven

Eindhoven, North Brabant, Netherlands

Location

Amsterdam UMC

Amsterdam, North Holland, Netherlands

Location

OLVG

Amsterdam, North Holland, Netherlands

Location

Medisch Spectrum Twente

Enschede, Overijssel, Netherlands

Location

Medisch Centrum Leeuwarden

Leeuwarden, Provincie Friesland, Netherlands

Location

UMC Groningen

Groningen, Provincie Groningen, Netherlands

Location

Haga Ziekenhuis Den Haag

The Hague, South Holland, Netherlands

Location

Antonius Ziekenhuis Nieuwegein

Nieuwegein, Utrecht, Netherlands

Location

UMC Utrecht

Utrecht, Utrecht, 3508GA, Netherlands

Location

Related Publications (1)

• Aarts HM, Hemelrijk KI, Broeze GM, van Ginkel DJ, Versteeg GAA, Overduin DC, Tijssen JG, Beijk MAM, Baan J, Vis MM, Lemkes JS, de Winter RJ, Dickinson MG, Kraaijeveld AO, Mokhles MM, Dessing TC, Grundeken MJ, Claessen BEPM, Tonino PAL, Schotborgh CE, Meuwissen M, van Houwelingen GK, Wykrzykowska JJ, Amoroso G, Vossenberg TN, Vriesendorp PA, van Royen N, Ten Berg JM, Delewi R, Voskuil M. Deferral of routine percutaneous coronary intervention in patients undergoing transcatheter aortic valve implantation: Rationale and design of the PRO-TAVI trial. Am Heart J. 2025 Mar;281:133-139. doi: 10.1016/j.ahj.2024.12.003. Epub 2024 Dec 16.

  PMID: 39674524 DERIVED

MeSH Terms

Conditions

Heart Valve Diseases; Aortic Valve Stenosis; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Ventricular Outflow Obstruction; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Michiel Voskuil, MD PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Cardiology

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: October 14, 2021
• Study Start: October 5, 2021
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2029
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (12)