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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
466
Omission of PCI of significant coronary artery disease prior to TAVI
RadboudUMC
Nijmegen, Gelderland, Netherlands
Maastricht UMC+
Maastricht, Limburg, Netherlands
Amphia Ziekenhuis Breda
Breda, North Brabant, Netherlands
composite of all-cause mortality, myocardial infarction, stroke and type 2-4 bleeding, in accordance to VARC-3 criteria
Time frame: 12 months from randomization
Composite of all-cause mortality, myocardial infarction, stroke, in accordance with VARC-3 criteria
Time frame: 4 months - 12 months - total follow up 5 years
all-cause mortality
VARC-3
Time frame: 4 months - 12 months - total follow up 5 years
myocardial infarction
VARC-3
Time frame: 4 months - 12 months - total follow up 5 years
stroke
VARC-3
Time frame: 4 months - 12 months - total follow up 5 years
VARC-3 bleeding
Time frame: 4 months - 12 months - total follow up 5 years
BARC bleeding
BARC bleeding \> type 1
Time frame: 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
Time frame: 4 months - 12 months - total follow up 5 years
Target lesion revascularization
ARC-2
Time frame: 4 months - 12 months - total follow up 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Catharina Ziekenhuis Eindhoven
Eindhoven, North Brabant, Netherlands
Amsterdam UMC
Amsterdam, North Holland, Netherlands
OLVG
Amsterdam, North Holland, Netherlands
Medisch Spectrum Twente
Enschede, Overijssel, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, Provincie Friesland, Netherlands
UMC Groningen
Groningen, Provincie Groningen, Netherlands
Haga Ziekenhuis Den Haag
The Hague, South Holland, Netherlands
...and 2 more locations
Target vessel revascularization
ARC-2
Time frame: 4 months - 12 months - total follow up 5 years
rehospitalization
VARC-3
Time frame: 4 months - 12 months - total follow up 5 years
Left ventricular function measured by echocardiography
Time frame: 12 months
Cost-effectiveness of omission of PCI using QALYs
Time frame: 4 months - 12 months
Cost-effectiveness of omission of PCI using Incremental Cost Effectiveness Ratios
Time frame: 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.
Time frame: 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.
Time frame: 4 months - 12 months
Anginal status (CCS)
Time frame: 4 months - 12 months
NYHA classification
Time frame: 4 months - 12 months
Acute kidney injury stage 3 and 4
VARC-3
Time frame: 4 months - 12 months - total follow up 5 years