title: Network meta-analysis on the comparative effectiveness and safety of transcatheter aortic valve implantation with CoreValve or Sapien devices versus surgical replacement.
abstract: BACKGROUND
  Surgical replacement for aortic stenosis is fraught with complications in high-risk patients. Transcatheter techniques may offer a minimally invasive solution, but their comparative effectiveness and safety is uncertain. We performed a network meta-analysis on this topic.
  
  
  METHODS
  Randomized trials on transcatheter aortic valve replacement vs surgery were searched. The primary outcome was all cause death. Risk estimates were obtained with Bayesian network meta-analytic methods.
  
  
  RESULTS
  Four trials with 1,805 patients were included. After a median of 8 months, risk of death and myocardial infarction was not different when comparing surgery versus transcatheter procedures, irrespective of device or access. Conversely, surgery was associated with higher rates of major bleeding (odds ratio vs CoreValve=3.03 [95% credible interval: 2.23-4.17]; odds ratio vs transfemoral Sapien =1.82 [1.21-2.70]; odds ratio vs transapical Sapien =2.08 [1.20-3.70]), and acute kidney injury (odds ratio vs CoreValve =2.08 [1.33-3.32]; odds ratio vs transapical Sapien =2.78 [2.21-99.80]), but lower rates of pacemaker implantation (odds ratio vs CoreValve =0.41 [0.28-0.59]), and moderate or severe aortic regurgitation (odds ratio vs CoreValve =0.06 [0.02-0.27]; odds ratio vs Sapien=0.17 [0.02-0.76]). Strokes were less frequent with CoreValve than with transfemoral Sapien (odds ratio =0.32 [0.13-0.73]) or transapical Sapien (odds ratio =0.33 [0.10-0.93]), whereas pacemaker implantation was more common with CoreValve (odds ratio vs surgery =2.46 [1.69-3.61]; odds ratio vs transfemoral Sapien =2.22 [1.27-3.85]).
  
  
  CONCLUSIONS
  Survival after transcatheter or surgical aortic valve replacement is similar, but there might be differences in the individual safety and effectiveness profile between the treatment strategies and the individual devices used in transcatheter aortic valve implantation.
authors.affiliation: Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy ; VCU Pauley Heart Center, Virginia Commonwealth University, Richmond, VA, USA.
authors.forename: G
authors.initials: G
authors.lastname: Biondi-Zoccai
authors.affiliation: Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Peruzzi
authors.affiliation: VCU Pauley Heart Center, Virginia Commonwealth University, Richmond, VA, USA.
authors.forename: A
authors.initials: A
authors.lastname: Abbate
authors.affiliation: VCU Pauley Heart Center, Virginia Commonwealth University, Richmond, VA, USA.
authors.forename: Z M
authors.initials: ZM
authors.lastname: Gertz
authors.affiliation: Department of Cardiac Surgery, Harefield Hospital, London, UK.
authors.forename: U
authors.initials: U
authors.lastname: Benedetto
authors.affiliation: Department of Clinical and Molecular Medicine, Sapienza University of Rome, Rome, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Tonelli
authors.affiliation: Division of Cardiology, Department of Internal Medicine, University of Turin, Turin, Italy.
authors.forename: F
authors.initials: F
authors.lastname: D'Ascenzo
authors.affiliation: Unità Operativa di Interventistica Cardiovascolare, Presidio Ospedaliero Pineta Grande, Castel Volturno, and Unità Operativa di Emodinamica, Casa di Salute Santa Lucia, San Giuseppe Vesuviano, both in Italy.
authors.forename: A
authors.initials: A
authors.lastname: Giordano
authors.affiliation: Division of Cardiology, Utrecht University Medical Center, Utrecht, The Netherlands.
authors.forename: P
authors.initials: P
authors.lastname: Agostoni
authors.affiliation: Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy ; Department of AngioCardioNeurology, IRCCS Neuromed, Pozzilli, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Frati
keywords: TAVI; TAVR; aortic stenosis; mixed treatment comparison; network meta-analysis; transcatheter aortic valve implantation; transcatheter aortic valve replacement