title: Transcatheter aortic valve implantation vs. surgical aortic valve replacement for treatment of severe aortic stenosis: a meta-analysis of randomized trials.
abstract: In view of the currently available evidence from randomized trials, we aimed to compare the collective safety and efficacy of transcatheter aortic valve implantation (TAVI) vs. surgical aortic valve replacement (SAVR) across the spectrum of risk and in important subgroups.
  
  
  
  Trials comparing TAVI vs. SAVR were identified through Medline, Embase, and Cochrane databases. The primary outcome was death from any cause at 2 years. We performed random-effects meta-analyses to combine the available evidence and to evaluate the effect in different subgroups. This systematic review and meta-analysis is registered with PROSPERO (CRD42016037273). We identified four eligible trials including 3806 participants, who were randomly assigned to undergo TAVI (n = 1898) or SAVR (n = 1908). For the primary outcome of death from any cause, TAVI when compared with SAVR was associated with a significant 13% relative risk reduction [hazard ratio (95% CI): 0.87 (0.76-0.99); P = 0.038] with homogeneity across all trials irrespective of TAVI device (Pinteraction= 0.306) and baseline risk (Pinteraction= 0.610). In subgroup analyses, TAVI showed a robust survival benefit over SAVR for patients undergoing transfemoral access [0.80 (0.69-0.93); P = 0.004], but not transthoracic access [1.17 (0.88-1.56); P = 0.293] (Pinteraction= 0.024) and in female [0.68 (0.50-0.91); P = 0.010], but not male patients [0.99 (0.77-1.28); P = 0.952] (Pinteraction= 0.050). Secondary outcomes of kidney injury, new-onset atrial fibrillation, and major bleeding favoured TAVI, while major vascular complications, incidence of permanent pacemaker implantation, and paravalvular regurgitation favoured SAVR.
  
  
  
  Compared with SAVR, TAVI is associated with a significant survival benefit throughout 2 years of follow-up. Importantly, this superiority is observed irrespective of the TAVI device across the spectrum of intermediate and high-risk patients, and is particularly pronounced among patients undergoing transfemoral TAVI and in females.
authors.affiliation: Department of Cardiology, INSELSPITAL, Bern University Hospital, University of Bern, Bern 3010, Switzerland.
authors.forename: George C M
authors.initials: GC
authors.lastname: Siontis
authors.affiliation: Department of Cardiology, INSELSPITAL, Bern University Hospital, University of Bern, Bern 3010, Switzerland.
authors.forename: Fabien
authors.initials: F
authors.lastname: Praz
authors.affiliation: Department of Cardiology, INSELSPITAL, Bern University Hospital, University of Bern, Bern 3010, Switzerland.
authors.forename: Thomas
authors.initials: T
authors.lastname: Pilgrim
authors.affiliation: Department of Hygiene and Epidemiology, University of Ioannina School of Medicine, Ioannina, Greece.
authors.forename: Dimitris
authors.initials: D
authors.lastname: Mavridis
authors.affiliation: Division of Cardiac Surgery, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Subodh
authors.initials: S
authors.lastname: Verma
authors.affiliation: Department of Hygiene and Epidemiology, University of Ioannina School of Medicine, Ioannina, Greece.|Institute of Social and Preventive Medicine and Clinical Trials Unit, University of Bern, Bern, Switzerland.|Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.
authors.forename: Georgia
authors.initials: G
authors.lastname: Salanti
authors.affiliation: Department of Cardiology, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Lars
authors.initials: L
authors.lastname: Søndergaard
authors.affiliation: Applied Health Research Centre (AHRC), Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Canada.
authors.forename: Peter
authors.initials: P
authors.lastname: Jüni
authors.affiliation: Department of Cardiology, INSELSPITAL, Bern University Hospital, University of Bern, Bern 3010, Switzerland stephan.windecker@insel.ch.
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
mesh_terms: D001021:Aortic Valve; D001024:Aortic Valve Stenosis; D005260:Female; D019918:Heart Valve Prosthesis Implantation; D006801:Humans; D008297:Male; D016032:Randomized Controlled Trials as Topic; D065467:Transcatheter Aortic Valve Replacement; D016896:Treatment Outcome
keywords: Aortic stenosis; Meta-analysis; Randomized controlled trial; Surgical aortic valve replacement; Transcatheter aortic valve implantation; Transcatheter aortic valve replacement