NOTION: TAVR in low-risk patients

The aim of this study was to compare the results of transcatheter aortic valve replacement (TAVR) versus surgery in unselected patients with severe degenerative aortic stenosis. Patients were randomized 1:1 to TAVR (n = 145) or surgical replacement (n = 135). Those of TAVR group received Medtronic CoreValve self-expanding valve. The femoral access was used in 96.5% of the population and the crossover to surgery was 2.1%. The score of the Society of Thoracic Surgeons (STS) predicted mortality of 3% (81.8% with one STS <3%) and logistic EuroSCORE was 8.6.

The combined primary end point of death from any cause, myocardial infarction or stroke was 13.1% for TAVR and 16.3% for surgery (p = 0.43). Mortality was 4.9% and 7.5% respectively (p = 0.38). Moderate to severe aortic regurgitation favored surgery with 15.7% versus 0.9% (p <0.001) as well as symptomatic relief and the need for pacemakers. The surgery had more bleeding complications rate and atrial fibrillation. The rate of stroke was similar.

Conclusion

The results of this study indicate that patients with degenerative aortic stenosis and low risk receiving CoreValve self-expanding valve have similar rate of events to those receiving surgery.

Dharam J. Kumbhani
2015-03-17

Original title: Transcatheter Versus Surgical Aortic Valve Replacement in Patients with Severe Aortic Valve Stenosis: One-year Results from the All-comers Nordic Aortic Valve Intervention (NOTION) Randomized Clinical Trial.

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