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
| Autor: | Nikolaj Ihlemann, Peter Clemmensen, Lars Søndergaard, Thomas Engstrøm, Peter Skov Olsen, Bo Juel Kjeldsen, Petur Petursson, Daniel A Steinbrüchel, Henrik Nissen, Olaf Walter Franzen, Anh Thuc Ngo, Hans Gustav Hørsted Thyregod, Yanping Chang, Niels Thue Olsen |
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| Rok vydání: | 2015 |
| Předmět: |
Aortic valve
medicine.medical_specialty Time Factors medicine.medical_treatment Denmark Myocardial Infarction Kaplan-Meier Estimate 030204 cardiovascular system & hematology hemodynamics Risk Assessment Severity of Illness Index law.invention Transcatheter Aortic Valve Replacement 03 medical and health sciences 0302 clinical medicine Valve replacement Aortic valve replacement Randomized controlled trial law Risk Factors Internal medicine medicine Risk of mortality Humans 030212 general & internal medicine Proportional Hazards Models Heart Valve Prosthesis Implantation Sweden bioprosthesis business.industry Hemodynamics Aortic Valve Stenosis medicine.disease stroke Confidence interval Surgery Clinical trial Stroke myocardial infarction medicine.anatomical_structure Treatment Outcome Echocardiography Aortic valve stenosis Aortic Valve Heart Valve Prosthesis Cardiology transcatheter aortic valve replacement Cardiology and Cardiovascular Medicine business |
| Zdroj: | Søndergaard, L, Steinbrüchel, D A, Ihlemann, N, Nissen, H, Kjeldsen, B J, Petursson, P, Ngo, A T, Olsen, N T, Chang, Y, Franzen, O W, Engstrøm, T, Clemmensen, P, Olsen, P S & Thyregod, H G H 2016, ' 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 ', Circulation: Cardiovascular Interventions, vol. 9, no. 6, e003665 . https://doi.org/10.1161/CIRCINTERVENTIONS.115.003665 |
| ISSN: | 1941-7632 |
| DOI: | 10.1161/CIRCINTERVENTIONS.115.003665 |
| Popis: | Background— 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. Methods and Results— 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) (P =0.58) or intermediate-risk patients (21.1% versus 27.1%; P =0.59). Conclusions— 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. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01057173. |
| Databáze: | OpenAIRE |
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