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Transcatheter Aortic-Valve Replacement for Inoperable Severe Aortic Stenosis.
Makkar, Raj R. M.D.; Fontana, Gregory P. M.D.; Jilaihawi, Hasan M.D.; Kapadia, Samir M.D.; Pichard, Augusto D. M.D.; Douglas, Pamela S. M.D.; Thourani, Vinod H. M.D.; Babaliaros, Vasilis C. M.D.; Webb, John G. M.D.; Herrmann, Howard C. M.D.; Bavaria, Joseph E. M.D.; Kodali, Susheel M.D.; Brown, David L. M.D.; Bowers, Bruce M.D.; Dewey, Todd M. M.D.; Svensson, Lars G. M.D., Ph.D.; Tuzcu, Murat M.D.; Moses, Jeffrey W. M.D.; Williams, Matthew R. M.D.; Siegel, Robert J. M.D.; Akin, Jodi J. M.S.; Anderson, William N. Ph.D.; Pocock, Stuart Ph.D.; Smith, Craig R. M.D.; Leon, Martin B. M.D.; the PARTNER Trial Investigators *
[Article] New England Journal of Medicine. 366(18):1696-1704, May 3, 2012.

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Background: Transcatheter aortic-valve replacement (TAVR) is the recommended therapy for patients with severe aortic stenosis who are not suitable candidates for surgery. The outcomes beyond 1 year in such patients are not known.

Methods: We randomly assigned patients to transfemoral TAVR or to standard therapy (which often included balloon aortic valvuloplasty). Data on 2-year outcomes were analyzed.

Results: A total of 358 patients underwent randomization at 21 centers. The rates of death at 2 years were 43.3% in the TAVR group and 68.0% in the standard-therapy group (P<0.001), and the corresponding rates of cardiac death were 31.0% and 62.4% (P<0.001). The survival advantage associated with TAVR that was seen at 1 year remained significant among patients who survived beyond the first year (hazard ratio, 0.58; 95% confidence interval [CI], 0.36 to 0.92; P=0.02 with the use of the log-rank test). The rate of stroke was higher after TAVR than with standard therapy (13.8% vs. 5.5%, P=0.01), owing, in the first 30 days, to the occurrence of more ischemic events in the TAVR group (6.7% vs. 1.7%, P=0.02) and, beyond 30 days, to the occurrence of more hemorrhagic strokes in the TAVR group (2.2% vs. 0.6%, P=0.16). At 2 years, the rate of rehospitalization was 35.0% in the TAVR group and 72.5% in the standard-therapy group (P<0.001). TAVR, as compared with standard therapy, was also associated with improved functional status (P<0.001). The data suggest that the mortality benefit after TAVR may be limited to patients who do not have extensive coexisting conditions. Echocardiographic analysis showed a sustained increase in aortic-valve area and a decrease in aortic-valve gradient, with no worsening of paravalvular aortic regurgitation.

Conclusions: Among appropriately selected patients with severe aortic stenosis who were not suitable candidates for surgery, TAVR reduced the rates of death and hospitalization, with a decrease in symptoms and an improvement in valve hemodynamics that were sustained at 2 years of follow-up. The presence of extensive coexisting conditions may attenuate the survival benefit of TAVR. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.)