n engl j med 364;23 nejm.org june 9, 20112187The new england journal of medicineestablished in 1812 june 9, 2011 vol. 364 no. 23Transcatheter versus Surgical Aortic-Valve Replacement in High-Risk PatientsCraig R. Smith, M.D., Martin B. Leon, M.D., Michael J. Mack, M.D., D. Craig Miller, M.D., Jeffrey W. Moses, M.D., Lars G. Svensson, M.D., Ph.D., E. Murat Tuzcu, M.D., John G. Webb, M.D., Gregory P. Fontana, M.D., Raj R. Makkar, M.D., Mathew Williams, M.D., Todd Dewey, M.D., Samir Kapadia, M.D., Vasilis Babaliaros, M.D., Vinod H. Thourani, M.D., Paul Corso, M.D., Augusto D. Pichard, M.D., Joseph E. Bavaria, M.D., Howard C. Herrmann, M.D., Jodi J. Akin, M.S., William N. Anderson, Ph.D., Duolao Wang, Ph.D., and Stuart J. Pocock, Ph.D., for the PARTNER Trial Investigators*Abstr actThe authors’ affiliations are listed in the Appendix. Address reprint requests to Dr. Smith at Columbia University Medi-cal Center–New York Presbyterian Hos-pital, 177 Fort Washington Ave., Milstein Bldg. 7-435, New York, NY 10032, or at [email protected].*The investigators, institutions, and re-search organizations participating in the Placement of Aortic Transcatheter Valves (PARTNER) trial are in the Supplementary Appendix, available at NEJM.org.N Engl J Med 2011;364:2187-98.Copyright © 2011 Massachusetts Medical Society.BackgroundThe use of transcatheter aortic-valve replacement has been shown to reduce mortality among high-risk patients with aortic stenosis who are not candidates for surgical replacement. However, the two procedures have not been compared in a randomized trial involving high-risk patients who are still candidates for surgical replacement.MethodsAt 25 centers, we randomly assigned 699 high-risk patients with severe aortic stenosis to undergo either transcatheter aortic-valve replacement with a balloon-expandable bovine pericardial valve (either a transfemoral or a transapical approach) or surgical replacement. The primary end point was death from any cause at 1 year. The primary hypothesis was that transcatheter replacement is not inferior to surgical replacement.ResultsThe rates of death from any cause were 3.4% in the transcatheter group and 6.5% in the surgical group at 30 days (P = 0.07) and 24.2% and 26.8%, respectively, at 1 year (P = 0.44), a reduction of 2.6 percentage points in the transcatheter group (upper limit of the 95% confidence interval, 3.0 percentage points; predefined margin, 7.5 percentage points; P = 0.001 for noninferiority). The rates of major stroke were 3.8% in the transcatheter group and 2.1% in the surgical group at 30 days (P = 0.20) and 5.1% and 2.4%, respectively, at 1 year (P = 0.07). At 30 days, major vascular compli-cations were significantly more frequent with transcatheter replacement (11.0% vs. 3.2%, P<0.001); adverse events that were more frequent after surgical replacement included major bleeding (9.3% vs. 19.5%, P<0.001) and new-onset atrial fibrillation (8.6% vs. 16.0%, P = 0.006). More patients undergoing transcatheter replacement had an improvement in symptoms at 30 days, but by 1 year, there was not a significant between-group difference.ConclusionsIn high-risk patients with severe aortic stenosis, transcatheter and surgical proce-dures for aortic-valve replacement were associated with similar rates of survival at 1 year, although there were important differences in periprocedural risks. (Funded by Edwards Lifesciences; Clinical Trials.gov number, NCT00530894.)The New England Journal of Medicine Downloaded from nejm.org at WEILL CORNELL MEDICAL LIBRARY on September 9, 2014. For personal use only. No other uses without permission. Copyright © 2011 Massachusetts Medical Society. All rights reserved.The new engl a nd journa l o f medicinen engl j med 364;23 nejm.org june 9, 20112188A fter the appearance of symptoms, aortic stenosis is associated with a high rate of death if left untreated.1-10 Although surgical aortic-valve replacement improves symp-toms and survival,11-15 observational studies have identified various subgroups of patients (i.e., those with an advanced age and those with poor left ventricular function or other coexisting disorders) who are at increased risk for operative complica-tions or death.16-21 In such patients, a less invasive treatment may be a desirable alternative.Transcatheter aortic-valve replacement treats aortic stenosis by displacing and functionally re-placing the native valve with a bioprosthetic valve delivered on a catheter through the femoral artery (transfemoral placement) or the left ventricular apex (transapical placement).22-34 In the random-ized Placement of Aortic Transcatheter Valves (PARTNER) trial, a subgroup of patients with aor-tic stenosis who were not candidates for surgical aortic-valve replacement and who underwent trans-femoral placement had an improvement of 20% in the 1-year survival rate and also had reduced symp-toms.35 This report describes results for the high-risk subgroup of patients in the PARTNER trial who were still candidates for surgical valve replace-ment and who were randomly assigned to undergo either transcatheter or surgical replacement of the aortic valve.MethodsPatientsFrom May 11, 2007, through August 28, 2009, we enrolled 699 patients with severe aortic stenosis and cardiac symptoms (New York Heart Associa-tion [NYHA] class II function or worse) at 22 cen-ters in the United States, 2 centers in Canada, and 1 center in Germany. All the patients were consid-ered to be candidates for conventional surgical aor-tic-valve repair. Severe aortic stenosis was defined as an aortic-valve area of less than 0.8 cm2 plus either a mean valve gradient of at least 40 mm Hg or a peak velocity of at least 4.0 m per second. Pa-tients were deemed to be at high risk for operative complications or death on the basis of coexisting conditions that were associated with a risk of death of at least 15% by 30 days after the procedure. The final determination of high operative risk was made by surgeons at each study center, but we used as a guideline a score of at least 10% on the risk model developed by the Society for Thoracic Surgeons, which uses an algorithm that is based on the presence of coexisting illnesses in order to estimate the 30-day operative mortality. Less than 5% of patients in the population from which the algorithm was derived had a predicted operative risk (risk score) of more than 10%.36Exclusion criteria were a bicuspid or noncalci-fied valve,
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