Percutaneous Coronary Intervention Before Transcatheter Aortic Valve Implantation

Not Applicable

Active, not recruiting

• Conditions: Aortic Valve Stenosis; Valvular Heart Disease; Coronary Artery Disease
• Interventions: Procedure: No PCI

• Registration Number: NCT05078619
• Lead Sponsor: UMC Utrecht

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-21
• Study First Submitted QC: 2021-10-04
• Study Start: 2021-10-05
• Study First Posted: 2021-10-14
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-16
• Primary Completion: 2025-12-01
• Study Completion: 2029-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 466

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAVI only	No PCI	Patients randomly allocated to this study arm will undergo transcatheter aortic valve implantation without preceding PCI of significant coronary artery disease

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
stroke	4 months - 12 months - total follow up 5 years	VARC-3
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	VARC-3
Target lesion revascularization	4 months - 12 months - total follow up 5 years	ARC-2
Target vessel revascularization	4 months - 12 months - total follow up 5 years	ARC-2
rehospitalization	4 months - 12 months - total follow up 5 years	VARC-3
myocardial infarction	4 months - 12 months - total follow up 5 years	VARC-3
BARC bleeding	4 months - 12 months - total follow up 5 years	BARC bleeding \> type 1
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	ACC/AHA Key Data Elements and Definitions for Cardiovascular Endpoint Events in Clinical Trials \& ARC-2
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 (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	VARC-3

Trial Locations

Locations (12)

Maastricht UMC+; 🇳🇱 Maastricht, Limburg, Netherlands

Medisch Centrum Leeuwarden; 🇳🇱 Leeuwarden, Friesland, Netherlands

RadboudUMC; 🇳🇱 Nijmegen, Gelderland, Netherlands

Amsterdam UMC; 🇳🇱 Amsterdam, Noord-Holland, Netherlands

OLVG; 🇳🇱 Amsterdam, Noord-Holland, Netherlands

Medisch Spectrum Twente; 🇳🇱 Enschede, Overijssel, Netherlands

Antonius Ziekenhuis Nieuwegein; 🇳🇱 Nieuwegein, Utrecht, Netherlands

Haga Ziekenhuis Den Haag; 🇳🇱 Den Haag, Zuid-Holland, Netherlands

Amphia Ziekenhuis Breda; 🇳🇱 Breda, Noord-Brabant, Netherlands

Catharina Ziekenhuis Eindhoven; 🇳🇱 Eindhoven, Noord-Brabant, Netherlands

UMC Groningen; 🇳🇱 Groningen, Netherlands

UMC Utrecht; 🇳🇱 Utrecht, Netherlands