Valvular & structural heart disease
TransCatheter aortic valve implantation and fractional flow reserve-guided percutaneous coronary intervention versus conventional surgical aortic valve replacement and coronary bypass grafting for treatment of patients with aortic valve stenosis and multivessel or advanced coronary disease: The transcatheter valve and vessels trial (TCW trial): Design and rationale
Study context
- Population
- Patients ≥ 70 years with severe aortic stenosis (AS) and multivessel (≥ 2 vessels) or advanced coronary artery disease (CAD), deemed feasible by the heart team for both full percutaneous and surgical treatmentplanned sample size
- Participants
- 328 patients
- Planned comparison
- Fractional-flow reserve (FFR)-guided percutaneous coronary intervention (PCI) followed by transcatheter aortic valve implantation (TAVI) vs coronary artery bypass grafting (CABG) and surgical aortic valve replacement (SAVR)
- Primary endpoint
- Composite of:
- All-cause mortality
- MI
- Disabling stroke
- Unscheduled clinically-driven target vessel revascularization
- Valve reintervention
- Life threatening or disabling bleeding
- Follow-up
- 1 year
Methodological detailsdesign and rationale, prospective, open label, international, non-inferiority, 1:1 randomisation
- Design and rationale
- Prospective
- Open label
- International
- Non-inferiority
- 1:1 randomisation
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
TransCatheter aortic valve implantation and fractional flow reserve-guided percutaneous coronary intervention versus conventional surgical aortic valve replacement and coronary bypass grafting for treatment of patients with aortic valve stenosis and multivessel or advanced coronary disease: The transcatheter valve and vessels trial (TCW trial): Design and rationale. Am Heart J. Published 1 February 2024. doi:10. 1016/ j. ahj. 2024. 01. 010
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