• Elvin Kedhi, Renicus S Hermanides, DambrinkJan-Henk EJEDepartment of Cardiology, Isala Heart Center, Zwolle, Netherlands., Sandeep K Singh, Jurriën M Ten Berg, DirkJan van Ginkel, Martin Hudec, Giovanni Amoroso, Ignacio J Amat-Santos, Martin Andreas, Campante TelesRuiRHospital de Santa Cruz, Carnaxide, Portugal; Comprehensive Health Research Center, Nova Medical School, Lisbon, Portugal., Guillaume Bonnet, Eric Van Belle, Lenard Conradi, Leen van Garsse, Wojtek Wojakowski, Vassilis Voudris, Jerzy Sacha, Pavel Cervinka, Erik Lipsic, Samer Somi, Luis Nombela-Franco, Sonja Postma, Kerstin Piayda, Giuseppe De Luca, Evelien Kolkman, Krzysztof P Malinowski, Thomas Modine, and TCW study group.
• Royal Victoria Hospital, McGill University Health Center, Montreal, QC, Canada; Department of Cardiology and Structural Heart Disease, Medical University of Silesia, Katowice, Poland. Electronic address: elvin.kedhi@mcgill.ca.
• Lancet. 2024 Dec 4.

BackgroundPatients with severe aortic stenosis present frequently (∼50%) with concomitant obstructive coronary artery disease. Current guidelines recommend combined surgical aortic valve replacement (SAVR) and coronary artery bypass grafting (CABG) as the preferred treatment. Transcatheter aortic valve implantation (TAVI) and fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) represent a valid treatment alternative. We aimed to test the non-inferiority of FFR-guided PCI plus TAVI versus SAVR plus CABG in patients with severe aortic stenosis and complex coronary artery disease.MethodsThis international, multicentre, prospective, open-label, non-inferiority, randomised controlled trial was conducted at 18 tertiary medical centres across Europe. Patients (aged ≥70 years) with severe aortic stenosis and complex coronary artery disease, deemed feasible for percutaneous or surgical treatment according to the on-site Heart Team, were randomly assigned (1:1) to FFR-guided PCI plus TAVI or SAVR plus CABG according to a computer-generated sequence with random permuted blocks sizes stratified by site. The primary endpoint was a composite of all-cause mortality, myocardial infarction, disabling stroke, clinically driven target-vessel revascularisation, valve reintervention, and life-threatening or disabling bleeding at 1 year post-treatment. The trial was powered for non-inferiority (with a margin of 15%) and if met, for superiority. The primary and safety analyses were done per an intention-to-treat principle. This trial is registered with ClinicalTrials.gov (NCT03424941) and is closed.FindingsBetween May 31, 2018, and June 30, 2023, 172 patients were enrolled, of whom 91 were assigned to the FFR-guided PCI plus TAVI group and 81 to the SAVR plus CABG group. The mean age of patients was 76·5 years (SD 3·9). 118 (69%) of 172 patients were male and 54 (31%) patients were female. FFR-guided PCI plus TAVI resulted in favourable outcomes for the primary endpoint (four [4%] of 91 patients) versus SAVR plus CABG (17 [23%] of 77 patients; risk difference -18·5 [90% CI -27·8 to -9·7]), which was below the 15% prespecified non-inferiority margin (pnon-inferiority<0·001). FFR-guided PCI plus TAVI was superior to SAVR plus CABG (hazard ratio 0·17 [95% CI 0·06-0·51]; psuperiority<0·001), which was driven mainly by all-cause mortality (none [0%] of 91 patients vs seven (10%) of 77 patients; p=0·0025) and life-threatening bleeding (two [2%] vs nine [12%]; p=0·010).InterpretationThe TCW trial is the first trial to compare percutaneous treatment versus surgical treatment in patients with severe aortic stenosis and complex coronary artery disease, showing favourable primary endpoint and mortality outcomes with percutaneous treatment.FundingIsala Heart Centre and Medtronic.Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.

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