Deferral of routine percutaneous coronary intervention in patients undergoing transcatheter aortic valve implantation: Rationale and design of the PRO-TAVI trial
Hugo M. AartsKimberley HemelrijkGijs M BroezeDirk Jan van GinkelGeert A. A. VersteegDaniël C. OverduinJan G.P. TijssenMarcel A.M. BeijkJan BaanMarije M. VisJorrit S. LemkesRobbert J. de WinterMichael G. DickinsonAdriaan O. KraaijeveldMostafa M. MokhlesThomas C. DessingMaik J. GrundekenBimmer E. ClaessenPim A.L. ToninoCarl E. SchotborghMartijn MeuwissenGert K. van HouwelingenJoanna J. WykrzykowskaGiovanni AmorosoTessel VossenbergPieter A. VriesendorpNiels van RoyenJurriën M. ten BergRonak DelewiMichiel Voskuil
Key result
Routine PCI deferral before TAVI tested for non-inferiority against pre-TAVI PCI on 12-month events.
- n=466
Why the study?
The optimal treatment strategy for concomitant coronary artery disease in patients undergoing TAVI is debated, and randomized controlled trials are warranted to assess the benefit of routine PCI before TAVI.
Does deferral of routine PCI prevent a composite of all-cause mortality, myocardial infarction, stroke, or bleeding in patients with severe aortic stenosis and concomitant CAD undergoing TAVI?
Key Points
- To evaluate whether deferring routine percutaneous coronary intervention is non-inferior to preprocedural revascularization in patients with concomitant coronary artery disease undergoing transcatheter aortic valve implantation.
- Investigator-initiated, multicenter, open-label, randomized controlled trial (NCT05078619) enrolling 466 patients undergoing transcatheter aortic valve implantation with concomitant coronary artery disease.
- Participants are randomized 1:1 to preprocedural percutaneous coronary intervention (reference group) or deferral of routine revascularization (index group).
- The primary endpoint is a composite of all-cause mortality, myocardial infarction, stroke, or type 2–4 bleeding at 12 months, assessed against a prespecified non-inferiority margin of 11 percentage points.
- Formal clinical outcomes are currently pending, with primary trial results anticipated in early 2026.
- The statistical framework evaluates non-inferiority of routine revascularization deferral based on a 12-month composite endpoint using Valve Academic Research Consortium-3 criteria.
Study Design
Type
RCT (n=466)
Blinding
Open-label
Randomization
1:1
Multicenter
Yes
Structured PICO
Does deferral of routine PCI prevent a composite of all-cause mortality, myocardial infarction, stroke, or bleeding in patients with severe aortic stenosis and concomitant CAD undergoing TAVI?
P
Population
466 patients with severe aortic stenosis and concomitant coronary artery disease undergoing TAVI, followed for 12 months.
I
Intervention
Deferral of routine preprocedural percutaneous coronary intervention (PCI)
C
Comparator
Routine preprocedural percutaneous coronary intervention (PCI)
O
Outcome
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 criteriacomposite
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“For elderly TAVR patients with concomitant coronary artery disease, I think it's safe to first do TAVR and see if patients will still have complaints about chest pain or tightness. We can wait, and—if they still have complaints afterward—only then do PCI.”
“By performing PCI, the blood vessel opens up again, but PCI in these patients is burdensome and not without risk. In the PRO-TAVI study, we wanted to know if it is safe to omit the standard PCI before the TAVI procedure. We now see that it is possible: it is less burdensome for the patient and reduces the risk of bleeding.”
PGPhilippe GarotInterventional cardiologist, Institut Cardiovasculaire Paris Sud
“In a population with a mean age above 80 years, this reduction in hemorrhagic events is clinically meaningful. Nevertheless, PRO-TAVI should not be interpreted as evidence that PCI is unnecessary in all patients undergoing TAVR.”
Implication
The PRO-TAVI trial is designed to investigate whether deferral of routine PCI is non-inferior to TAVI with preceding PCI in patients with severe aortic stenosis and concomitant CAD.
Abstract
• Coronary artery disease is highly prevalent in patients undergoing TAVI. • PCI before TAVI is recommended, but randomized controlled trials are warranted. • The PRO-TAVI trial investigates the non-inferiority of deferral of routine PCI. • The results of the PRO-TAVI trial are expected in early 2026. 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. 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. 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. clinicaltrials.gov. Unique identifier NCT05078619 Study flowchart. CAD, coronary artery disease; DAPT, dual antiplatelet therapy; PCI, percutaneous coronary intervention; TAVI, transcatheter aortic valve implantation; VARC, valve academic research consortium.
Discussion
No takes yet. Share an insight, caveat, or question.
Cite This Study
Aarts et al. (2024) conducted an RCT in Severe aortic stenosis with concomitant coronary artery disease (n=466). Deferral of routine PCI vs. Routine preprocedural PCI was evaluated on Composite of all-cause mortality, myocardial infarction, stroke, or type 2 - 4 bleeding at 12 months. Deferral of routine PCI before TAVI will be evaluated for non-inferiority against preceding PCI with an 11 percentage point margin for mortality, MI, stroke, or bleeding at 12 months.