title: Transcatheter aortic valve implantation with the Edwards SAPIEN versus the Medtronic CoreValve Revalving system devices: a multicenter collaborative study: the PRAGMATIC Plus Initiative (Pooled-RotterdAm-Milano-Toulouse In Collaboration).
abstract: OBJECTIVE
  The aim of this study was to compare outcomes after transfemoral transcatheter aortic valve implantation with the Medtronic CoreValve (MCV) versus the Edwards SAPIEN/SAPIEN XT transcatheter heart valve (ESV) for severe aortic stenosis.
  
  
  BACKGROUND
  No large matched comparison study has been conducted so far evaluating both commercially available devices.
  
  
  METHODS
  The data from databases of 4 experienced European centers were pooled and analyzed. Due to differences in baseline clinical characteristics, propensity score matching was performed. Study objectives were Valve Academic Research Consortium outcomes at 30 days and 1 year.
  
  
  RESULTS
  In total, 793 patients were included: 453 (57.1%) treated with the MCV and 340 (42.9%) with the ESV. After propensity matching, 204 patients were identified in each group. At 30 days, there were no differences in all-cause mortality (MCV, 8.8% vs. ESV, 6.4%; hazard ratio [HR]: 1.422; 95% confidence interval [CI]: 0.677 to 2.984; p = 0.352), cardiovascular mortality (MCV, 6.9% vs. ESV, 6.4%; HR: 1.083; 95% CI: 0.496 to 2.364; p = 0.842), myocardial infarction (MCV, 0.5% vs. ESV, 1.5%; HR: 0.330; 95% CI: 0.034 to 3.200; p = 0.339), stroke (MCV, 2.9% vs. ESV, 1.0%; HR: 3.061; 95% CI: 0.610 to 15.346; p = 0.174), or device success (MCV, 95.6% vs. ESV, 96.6%; HR: 0.770; 95% CI: 0.281 to 2.108; p = 0.611). Additionally, there were no differences in major vascular complications (MCV, 9.3% vs. ESV, 12.3%; HR: 0.735; 95% CI: 0.391 to 1.382; p = 0.340) or life-threatening bleeding (MCV, 13.7% vs. ESV, 8.8%; HR: 1.644; 95% CI: 0.878 to 3.077; p = 0.120). MCV was associated with more permanent pacemakers (22.5% vs. 5.9%; HR: 4.634; 95% CI: 2.373 to 9.050; p < 0.001). At 1 year, there were no differences in all-cause (MCV, 16.2% vs. ESV, 12.3%; HR: 1.374; 95% CI: 0.785 to 2.407; p = 0.266) or cardiovascular (MCV, 8.3% vs. ESV, 7.4%; HR: 1.145; 95% CI: 0.556 to 12.361; p = 0.713) mortality.
  
  
  CONCLUSIONS
  No differences between the 2 commercially available transfemoral transcatheter aortic valve implantation devices were observed at the adjusted analysis in Valve Academic Research Consortium outcomes except for the need for permanent pacemakers with the MCV.
authors: San Raffaele Scientific Institute, Milan, Italy.
authors: Alaide
authors: A
authors: Chieffo
authors: Gill Louise
authors: GL
authors: Buchanan
authors: Nicolas M
authors: NM
authors: Van Mieghem
authors: Didier
authors: D
authors: Tchetche
authors: Nicolas
authors: N
authors: Dumonteil
authors: Azeem
authors: A
authors: Latib
authors: Robert M A
authors: RM
authors: van der Boon
authors: Olivier
authors: O
authors: Vahdat
authors: Bertrand
authors: B
authors: Marcheix
authors: Bruno
authors: B
authors: Farah
authors: Patrick W
authors: PW
authors: Serruys
authors: Jean
authors: J
authors: Fajadet
authors: Didier
authors: D
authors: Carrié
authors: Peter P T
authors: PP
authors: de Jaegere
authors: Antonio
authors: A
authors: Colombo
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D006328:Cardiac Catheterization / Q000379:methods*; D057186:Comparative Effectiveness Research; D005260:Female; D006334:Heart Function Tests; D006350:Heart Valve Prosthesis / Q000009:adverse effects / Q000706:statistics & numerical data; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods / Q000401:mortality; D006801:Humans; D008297:Male; D017063:Outcome Assessment, Health Care; D011183:Postoperative Complications / Q000453:epidemiology*; D011358:Product Surveillance, Postmarketing; D057216:Propensity Score; D011474:Prosthesis Design; D012189:Retrospective Studies; D012720:Severity of Illness Index; D016019:Survival Analysis; D015996:Survival Rate; D014652:Vascular Diseases / Q000453:epidemiology / Q000209:etiology