Aortic Valve Stenosis, Coronary Artery Disease, Valvular Heart Disease
Conditions
Keywords
Transcatheter aortic valve implantation, Percutaneous coronary intervention
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.
Interventions
PROCEDURENo PCI
Omission of PCI of significant coronary artery disease prior to TAVI
Sponsors
ZonMw: The Netherlands Organisation for Health Research and Development
UMC Utrecht
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| myocardial infarction | 4 months - 12 months - total follow up 5 years | VARC-3 |
| stroke | 4 months - 12 months - total follow up 5 years | VARC-3 |
| VARC-3 bleeding | 4 months - 12 months - total follow up 5 years | — |
| BARC bleeding | 4 months - 12 months - total follow up 5 years | BARC bleeding \> type 1 |
| 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 |
| Target vessel revascularization | 4 months - 12 months - total follow up 5 years | ARC-2 |
| Target lesion revascularization | 4 months - 12 months - total follow up 5 years | ARC-2 |
| 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 (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 |
| rehospitalization | 4 months - 12 months - total follow up 5 years | VARC-3 |
Countries
Netherlands
Outcome results
None listed