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Deferral of routine percutaneous coronary intervention in patients undergoing transcatheter aortic valve
Hugo M Aarts1, Kimberley I Hemelrijk2, Gijs M Broeze2
1Department of Cardiology, University Medical Center Utrecht, Utrecht, The Netherlands; Department of Cardiology, Amsterdam University Medical Center, Amsterdam, The Netherlands.
Insights
Deferring percutaneous coronary intervention (PCI) before transcatheter aortic valve implantation (TAVI) may be as safe as performing it. The PRO-TAVI trial investigates if delaying PCI is non-inferior to routine PCI in TAVI patients.
Area of Science:
- Cardiology
- Interventional Cardiology
- Clinical Trials
Background:
- Severe aortic stenosis patients often have concomitant coronary artery disease (CAD).
- Optimal CAD treatment strategy alongside transcatheter aortic valve implantation (TAVI) remains debated.
- Previous studies suggest PCI may not improve mortality post-TAVI, warranting further research.
Purpose of the Study:
- To evaluate the non-inferiority of deferring routine percutaneous coronary intervention (PCI) compared to performing PCI before transcatheter aortic valve implantation (TAVI).
- To assess the safety and efficacy of a conservative approach to CAD management in patients undergoing TAVI.
Main Methods:
- The PRO-TAVI trial is a multicenter, randomized controlled trial involving 466 patients undergoing TAVI.
- Patients are randomized 1:1 to receive TAVI with or without routine preprocedural PCI.
- The primary endpoint is a composite of mortality, myocardial infarction, stroke, or bleeding at 12 months, analyzed for non-inferiority.
Main Results:
- The PRO-TAVI trial is designed to determine if deferring PCI is non-inferior to preceding PCI.
- Analysis will focus on a composite endpoint including mortality, MI, stroke, and bleeding.
- Key secondary endpoints include individual component analysis, revascularization rates, quality of life, and cost-effectiveness.
Conclusions:
- The PRO-TAVI trial aims to provide crucial data on the optimal management of CAD in TAVI patients.
- Findings will inform clinical practice regarding the necessity of routine PCI before TAVI.
- The study hypothesizes that deferring routine PCI is non-inferior to performing it prior to TAVI.
Background:
Concomitant coronary artery disease (CAD) is highly prevalent in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI). The optimal treatment strategy for CAD is a topic of debate. An initial conservative strategy for CAD in patients undergoing TAVI may be favorable as multiple studies have failed to show an evident beneficial effect of percutaneous coronary intervention (PCI) on mortality after TAVI. However, more randomized, controlled trials are warranted.
Methods:
The PeRcutaneous cOronary Intervention before Transcatheter Aortic Valve Implantation (PRO-TAVI) trial is an investigator-initiated, multicenter, open-label, randomized controlled trial comparing TAVI with or without routine preprocedural PCI. A total of 466 patients undergoing TAVI will be randomized in a 1:1 ratio to PCI (reference group) or no PCI (index group). Concomitant CAD is defined as at least 1 stenosis of 70% to 99%, or at least 1 stenosis between 40% and 70% combined with positive physiological measurement in a coronary artery with a minimal diameter of 2.5 mm or bypass graft. The primary endpoint is a composite of all-cause mortality, myocardial infarction, stroke, or type 2 - 4 bleeding at 12 months after randomization, in accordance with Valve Academic Research Consortium-3 criteria. Key secondary endpoints include the individual components of the primary endpoint, revascularization, quality of life and cost-effectiveness. The primary endpoint will be analyzed to assess non-inferiority of deferral of routine PCI in patients undergoing TAVI against the prespecified margin of 11 percentage points.
Conclusion:
The PeRcutaneous cOronary intervention before Transcatheter Aortic Valve Implantation (PRO-TAVI) trial is designed to investigate the hypothesis that deferral of routine PCI in patients undergoing TAVI is non-inferior to TAVI with preceding PCI.
Clinical Trial Registration:
clinicaltrials.gov. Unique identifier NCT05078619.
