Two-Year Outcomes in Patients With Severe Aortic Valve Stenosis Randomized to Transcatheter Versus Surgical Aortic Valve Replacement: The All-Comers Nordic Aortic Valve Intervention Randomized Clinical Trial.
The Nordic Aortic Valve Intervention (NOTION) trial was the first to randomize all-comers with severe native aortic valve stenosis to either transcatheter aortic valve replacement (TAVR) with the CoreValve self-expanding bioprosthesis or surgical aortic valve replacement (SAVR), including a lower-risk patient population than previous trials. This article reports 2-year clinical and echocardiographic outcomes from the NOTION trial.



Two-hundred eighty patients from 3 centers in Denmark and Sweden were randomized to either TAVR (n=145) or SAVR (n=135) with follow-up planned for 5 years. There was no difference in all-cause mortality at 2 years between TAVR and SAVR (8.0% versus 9.8%, respectively; P=0.54) or cardiovascular mortality (6.5% versus 9.1%; P=0.40). The composite outcome of all-cause mortality, stroke, or myocardial infarction was also similar (15.8% versus 18.8%, P=0.43). Forward-flow hemodynamics were improved following both procedures, with effective orifice area significantly more improved after TAVR than SAVR (effective orifice area, 1.7 versus 1.4 cm(2) at 3 months). Mean valve gradients were similar after TAVR and SAVR. When patients were categorized according to Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) (<4% versus ≥4%), there was no statistically significant difference for TAVR and SAVR groups in the composite outcome for low-risk (14.7%, 95% confidence interval, 8.3-21.2 versus 16.8%; 95% confidence interval, 9.7-23.8; P=0.58) or intermediate-risk patients (21.1% versus 27.1%; P=0.59).



Two-year results from the NOTION trial demonstrate the continuing safety and effectiveness of TAVR in lower-risk patients. Longer-term data are needed to verify the durability of this procedure in this patient population.



URL: http://www.clinicaltrials.gov. Unique identifier: NCT01057173.
From the Departments of Cardiology (L.S., N.I., A.T.N., N.T.O., O.W.F., T.E.) and Cardiothoracic Surgery (D.A.S., P.S.O., H.G.H.T.), The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Denmark; Departments of Cardiology (H.N.) and Cardiothoracic and Vascular Surgery (B.J.K.), Odense University Hospital, Denmark; Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden (P.P.); Department of Statistics, Medtronic, Mounds View, MN (Y.C.); and Department of Medicine, Nykoebing F Hospital and University of Southern Denmark, Odense, Denmark (P.C.). Lars.Soendergaard.01@regionh.dk.
Lars
L
Søndergaard
From the Departments of Cardiology (L.S., N.I., A.T.N., N.T.O., O.W.F., T.E.) and Cardiothoracic Surgery (D.A.S., P.S.O., H.G.H.T.), The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Denmark; Departments of Cardiology (H.N.) and Cardiothoracic and Vascular Surgery (B.J.K.), Odense University Hospital, Denmark; Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden (P.P.); Department of Statistics, Medtronic, Mounds View, MN (Y.C.); and Department of Medicine, Nykoebing F Hospital and University of Southern Denmark, Odense, Denmark (P.C.).
Daniel Andreas
DA
Steinbrüchel
From the Departments of Cardiology (L.S., N.I., A.T.N., N.T.O., O.W.F., T.E.) and Cardiothoracic Surgery (D.A.S., P.S.O., H.G.H.T.), The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Denmark; Departments of Cardiology (H.N.) and Cardiothoracic and Vascular Surgery (B.J.K.), Odense University Hospital, Denmark; Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden (P.P.); Department of Statistics, Medtronic, Mounds View, MN (Y.C.); and Department of Medicine, Nykoebing F Hospital and University of Southern Denmark, Odense, Denmark (P.C.).
Nikolaj
N
Ihlemann
From the Departments of Cardiology (L.S., N.I., A.T.N., N.T.O., O.W.F., T.E.) and Cardiothoracic Surgery (D.A.S., P.S.O., H.G.H.T.), The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Denmark; Departments of Cardiology (H.N.) and Cardiothoracic and Vascular Surgery (B.J.K.), Odense University Hospital, Denmark; Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden (P.P.); Department of Statistics, Medtronic, Mounds View, MN (Y.C.); and Department of Medicine, Nykoebing F Hospital and University of Southern Denmark, Odense, Denmark (P.C.).
Henrik
H
Nissen
From the Departments of Cardiology (L.S., N.I., A.T.N., N.T.O., O.W.F., T.E.) and Cardiothoracic Surgery (D.A.S., P.S.O., H.G.H.T.), The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Denmark; Departments of Cardiology (H.N.) and Cardiothoracic and Vascular Surgery (B.J.K.), Odense University Hospital, Denmark; Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden (P.P.); Department of Statistics, Medtronic, Mounds View, MN (Y.C.); and Department of Medicine, Nykoebing F Hospital and University of Southern Denmark, Odense, Denmark (P.C.).
Bo Juel
BJ
Kjeldsen
From the Departments of Cardiology (L.S., N.I., A.T.N., N.T.O., O.W.F., T.E.) and Cardiothoracic Surgery (D.A.S., P.S.O., H.G.H.T.), The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Denmark; Departments of Cardiology (H.N.) and Cardiothoracic and Vascular Surgery (B.J.K.), Odense University Hospital, Denmark; Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden (P.P.); Department of Statistics, Medtronic, Mounds View, MN (Y.C.); and Department of Medicine, Nykoebing F Hospital and University of Southern Denmark, Odense, Denmark (P.C.).
Petur
P
Petursson
From the Departments of Cardiology (L.S., N.I., A.T.N., N.T.O., O.W.F., T.E.) and Cardiothoracic Surgery (D.A.S., P.S.O., H.G.H.T.), The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Denmark; Departments of Cardiology (H.N.) and Cardiothoracic and Vascular Surgery (B.J.K.), Odense University Hospital, Denmark; Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden (P.P.); Department of Statistics, Medtronic, Mounds View, MN (Y.C.); and Department of Medicine, Nykoebing F Hospital and University of Southern Denmark, Odense, Denmark (P.C.).
Anh Thuc
AT
Ngo
From the Departments of Cardiology (L.S., N.I., A.T.N., N.T.O., O.W.F., T.E.) and Cardiothoracic Surgery (D.A.S., P.S.O., H.G.H.T.), The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Denmark; Departments of Cardiology (H.N.) and Cardiothoracic and Vascular Surgery (B.J.K.), Odense University Hospital, Denmark; Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden (P.P.); Department of Statistics, Medtronic, Mounds View, MN (Y.C.); and Department of Medicine, Nykoebing F Hospital and University of Southern Denmark, Odense, Denmark (P.C.).
Niels Thue
NT
Olsen
From the Departments of Cardiology (L.S., N.I., A.T.N., N.T.O., O.W.F., T.E.) and Cardiothoracic Surgery (D.A.S., P.S.O., H.G.H.T.), The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Denmark; Departments of Cardiology (H.N.) and Cardiothoracic and Vascular Surgery (B.J.K.), Odense University Hospital, Denmark; Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden (P.P.); Department of Statistics, Medtronic, Mounds View, MN (Y.C.); and Department of Medicine, Nykoebing F Hospital and University of Southern Denmark, Odense, Denmark (P.C.).
Yanping
Y
Chang
From the Departments of Cardiology (L.S., N.I., A.T.N., N.T.O., O.W.F., T.E.) and Cardiothoracic Surgery (D.A.S., P.S.O., H.G.H.T.), The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Denmark; Departments of Cardiology (H.N.) and Cardiothoracic and Vascular Surgery (B.J.K.), Odense University Hospital, Denmark; Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden (P.P.); Department of Statistics, Medtronic, Mounds View, MN (Y.C.); and Department of Medicine, Nykoebing F Hospital and University of Southern Denmark, Odense, Denmark (P.C.).
Olaf Walter
OW
Franzen
From the Departments of Cardiology (L.S., N.I., A.T.N., N.T.O., O.W.F., T.E.) and Cardiothoracic Surgery (D.A.S., P.S.O., H.G.H.T.), The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Denmark; Departments of Cardiology (H.N.) and Cardiothoracic and Vascular Surgery (B.J.K.), Odense University Hospital, Denmark; Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden (P.P.); Department of Statistics, Medtronic, Mounds View, MN (Y.C.); and Department of Medicine, Nykoebing F Hospital and University of Southern Denmark, Odense, Denmark (P.C.).
Thomas
T
Engstrøm
From the Departments of Cardiology (L.S., N.I., A.T.N., N.T.O., O.W.F., T.E.) and Cardiothoracic Surgery (D.A.S., P.S.O., H.G.H.T.), The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Denmark; Departments of Cardiology (H.N.) and Cardiothoracic and Vascular Surgery (B.J.K.), Odense University Hospital, Denmark; Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden (P.P.); Department of Statistics, Medtronic, Mounds View, MN (Y.C.); and Department of Medicine, Nykoebing F Hospital and University of Southern Denmark, Odense, Denmark (P.C.).
Peter
P
Clemmensen
From the Departments of Cardiology (L.S., N.I., A.T.N., N.T.O., O.W.F., T.E.) and Cardiothoracic Surgery (D.A.S., P.S.O., H.G.H.T.), The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Denmark; Departments of Cardiology (H.N.) and Cardiothoracic and Vascular Surgery (B.J.K.), Odense University Hospital, Denmark; Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden (P.P.); Department of Statistics, Medtronic, Mounds View, MN (Y.C.); and Department of Medicine, Nykoebing F Hospital and University of Southern Denmark, Odense, Denmark (P.C.).
Peter Skov
PS
Olsen
From the Departments of Cardiology (L.S., N.I., A.T.N., N.T.O., O.W.F., T.E.) and Cardiothoracic Surgery (D.A.S., P.S.O., H.G.H.T.), The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Denmark; Departments of Cardiology (H.N.) and Cardiothoracic and Vascular Surgery (B.J.K.), Odense University Hospital, Denmark; Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden (P.P.); Department of Statistics, Medtronic, Mounds View, MN (Y.C.); and Department of Medicine, Nykoebing F Hospital and University of Southern Denmark, Odense, Denmark (P.C.).
Hans Gustav Hørsted
HG
Thyregod
D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D003718:Denmark; D004452:Echocardiography; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods* / Q000401:mortality; D006439:Hemodynamics; D006801:Humans; D053208:Kaplan-Meier Estimate; D009203:Myocardial Infarction / Q000209:etiology; D016016:Proportional Hazards Models; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D020521:Stroke / Q000209:etiology; D013548:Sweden; D013997:Time Factors; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods* / Q000401:mortality; D016896:Treatment Outcome
bioprosthesis; hemodynamics; myocardial infarction; stroke; transcatheter aortic valve replacement