Percutaneous Coronary Intervention Before Transcatheter Aortic Valve Implantation

Study Overview
=================
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.

Official Title
-----------------
Percutaneous Coronary Intervention Before Transcatheter Aortic Valve Implantation

Conditions
-----------------
Valvular Heart Disease, Aortic Valve Stenosis, Coronary Artery Disease

Intervention / Treatment
-----------------
* Procedure: No PCI


Participation Criteria
=================
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 CAD with patent bypass grafts Contraindication for DAPT Life expectancy < 1 year

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAVI only<br>Patients randomly allocated to this study arm will undergo transcatheter aortic valve implantation without preceding PCI of significant coronary artery disease | Procedure: No PCI<br>* Omission of PCI of significant coronary artery disease prior to TAVI<br>|
| No Intervention: TAVI with preceding PCI<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite of all-cause mortality, myocardial infarction, stroke and major bleeding |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 
| 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 | 
| Acute kidney injury stage 3 and 4 |  | 4 months - 12 months | 
| Target lesion revascularization |  | 4 months - 12 months | 
| Target vessel revascularization |  | 4 months - 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transcatheter aortic valve implantation, Percutaneous coronary intervention