title: Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Severe Aortic Valve Stenosis: 1-Year Results From the All-Comers NOTION Randomized Clinical Trial.
abstract: BACKGROUND
  Transcatheter aortic valve replacement (TAVR) is an option in certain high-risk surgical patients with severe aortic valve stenosis. It is unknown whether TAVR can be safely introduced to lower-risk patients.
  
  
  OBJECTIVE
  The NOTION (Nordic Aortic Valve Intervention Trial) randomized clinical trial compared TAVR with surgical aortic valve replacement (SAVR) in an all-comers patient cohort.
  
  
  METHODS
  Patients ≥ 70 years old with severe aortic valve stenosis and no significant coronary artery disease were randomized 1:1 to TAVR using a self-expanding bioprosthesis versus SAVR. The primary outcome was the composite rate of death from any cause, stroke, or myocardial infarction (MI) at 1 year.
  
  
  RESULTS
  A total of 280 patients were randomized at 3 Nordic centers. Mean age was 79.1 years, and 81.8% were considered low-risk patients. In the intention-to-treat population, no significant difference in the primary endpoint was found (13.1% vs. 16.3%; p = 0.43 for superiority). The result did not change in the as-treated population. No difference in the rate of cardiovascular death or prosthesis reintervention was found. Compared with SAVR-treated patients, TAVR-treated patients had more conduction abnormalities requiring pacemaker implantation, larger improvement in effective orifice area, more total aortic valve regurgitation, and higher New York Heart Association functional class at 1 year. SAVR-treated patients had more major or life-threatening bleeding, cardiogenic shock, acute kidney injury (stage II or III), and new-onset or worsening atrial fibrillation at 30 days than did TAVR-treated patients.
  
  
  CONCLUSIONS
  In the NOTION trial, no significant difference between TAVR and SAVR was found for the composite rate of death from any cause, stroke, or MI after 1 year. (Nordic Aortic Valve Intervention Trial [NOTION]; NCT01057173).
authors: Department of Cardiothoracic Surgery, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. Electronic address: hans.gustav.thyregod@regionh.dk.
authors: Hans Gustav Hørsted
authors: HG
authors: Thyregod
authors: Department of Cardiothoracic Surgery, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors: Daniel Andreas
authors: DA
authors: Steinbrüchel
authors: Department of Cardiology, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors: Nikolaj
authors: N
authors: Ihlemann
authors: Department of Cardiology, Odense University Hospital, Odense, Denmark.
authors: Henrik
authors: H
authors: Nissen
authors: Department of Cardiothoracic and Vascular Surgery, Odense University Hospital, Odense, Denmark.
authors: Bo Juel
authors: BJ
authors: Kjeldsen
authors: Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden.
authors: Petur
authors: P
authors: Petursson
authors: Department of Statistics, Medtronic Inc., Mounds View, Minnesota.
authors: Yanping
authors: Y
authors: Chang
authors: Department of Cardiology, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors: Olaf Walter
authors: OW
authors: Franzen
authors: Department of Cardiology, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors: Thomas
authors: T
authors: Engstrøm
authors: Department of Cardiology, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors: Peter
authors: P
authors: Clemmensen
authors: Department of Cardiac Anesthesia, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors: Peter Bo
authors: PB
authors: Hansen
authors: Department of Cardiac Anesthesia, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors: Lars Willy
authors: LW
authors: Andersen
authors: Department of Cardiothoracic Surgery, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors: Peter Skov
authors: PS
authors: Olsen
authors: Department of Cardiology, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors: Lars
authors: L
authors: Søndergaard
mesh_terms: D000368:Aged; D001021:Aortic Valve / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000601:surgery*; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000379:methods*; D006801:Humans; D008297:Male; D012720:Severity of Illness Index; D013997:Time Factors; D065467:Transcatheter Aortic Valve Replacement; D016896:Treatment Outcome
keywords: aortic valve prosthesis; mortality; myocardial infarction; stroke