جهت دسترسی به کاربرگه ی زیر، از این لینک استفاده کنید. http://dl.kums.ac.ir/handle/Hannan/259346
Title: Surgical or Transcatheter Aortic Valve Replacement in Intermediate Risk Patients
Authors: Reardon, Michael J.;Van Mieghem, Nicolas M.;Popma, Jeffrey J.;Kleiman, Neal S.;Søndergaard, Lars;Mumtaz, Mubashir;Adams, David H.;Deeb, G. Michael;Maini, Brijeshwar;Gada, Hemal;Chetcuti, Stanley;Gleason, Thomas;Heiser, John;Lange, Rüdiger;Merhi, William;O
Year: 2017
Publisher: 
Abstract: BACKGROUND Previous trials have shown that among high-risk patients with aortic stenosis, survival rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical aorticvalve replacement. We evaluated the two procedures in a randomized trial involving intermediate-risk patients. METHODS We randomly assigned 2032 intermediate-risk patients with severe aortic stenosis, at 57 centers, to undergo either TAVR or surgical replacement. The primary end point was death from any cause or disabling stroke at 2 years. The primary hypothesis was that TAVR would not be inferior to surgical replacement. Before randomization, patients were entered into one of two cohorts on the basis of clinical and imaging findings; 76.3% of the patients were included in the transfemoral-access cohort and 23.7% in the transthoracic-access cohort. RESULTS The rate of death from any cause or disabling stroke was similar in the TAVR group and the surgery group (P=0.001 for noninferiority). At 2 years, the Kaplan–Meier event rates were 19.3% in the TAVR group and 21.1% in the surgery group (hazard ratio in the TAVR group, 0.89; 95% confidence interval [CI], 0.73 to 1.09; P=0.25). In the transfemoralaccess cohort, TAVR resulted in a lower rate of death or disabling stroke than surgery (hazard ratio, 0.79; 95% CI, 0.62 to 1.00; P=0.05), whereas in the transthoracic-access cohort, outcomes were similar in the two groups. TAVR resulted in larger aortic-valve areas than did surgery and also resulted in lower rates of acute kidney injury, severe bleeding, and new-onset atrial fibrillation; surgery resulted in fewer major vascular complications and less paravalvular aortic regurgitation. CONCLUSIONS In intermediate-risk patients, TAVR was similar to surgical aortic-valve replacement with respect to the primary end point of death or disabling stroke. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.)
URI: http://www.nejm.org/doi/10.1056/NEJMoa1700456
http://dl.kums.ac.ir/handle/Hannan/259346
ISSN: 1533-4406 (Electronic)\r0028-4793 (Linking)
volume: Volume 376
Issue: Issue 14
month: April
More Information: START PAGE : NEJMoa1700456 END PAGES : NEJMoa1700456
Appears in Collections:New England Journal of Medicine

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