Deferral of routine percutaneous coronary intervention in patients undergoing transcatheter aortic valve implantation: Rationale and design of the PRO-TAVI trial.
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Aarts Hugo M, Hemelrijk Kimberley I, Broeze Gijs M, van Ginkel Dirk Jan, Versteeg Geert A A, Overduin Daniel C, Tijssen Jan G, Beijk Marcel A M, Baan Jan, Vis Marije M, Lemkes Jorrit S, de Winter Robbert J, Dickinson Michael G, Kraaijeveld Adriaan O, Mokhles Mostafa M, Dessing Thomas C, Grundeken Maik J, Claessen Bimmer E P M, Tonino Pim A L, Schotborgh Carl E, Meuwissen Martijn, van Houwelingen Gert K, Wykrzykowska Joanna J, Amoroso Giovanni, Vossenberg Tessel N, Vriesendorp Pieter A, van Royen Niels, Ten Berg Jurriën M, Delewi Ronak, Voskuil Michiel
Аннотация
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.