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Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement

List of authors.
  • Raj R. Makkar, M.D.,
  • Vinod H. Thourani, M.D.,
  • Michael J. Mack, M.D.,
  • Susheel K. Kodali, M.D.,
  • Samir Kapadia, M.D.,
  • John G. Webb, M.D.,
  • Sung-Han Yoon, M.D.,
  • Alfredo Trento, M.D.,
  • Lars G. Svensson, M.D., Ph.D.,
  • Howard C. Herrmann, M.D.,
  • Wilson Y. Szeto, M.D.,
  • D. Craig Miller, M.D.,
  • Lowell Satler, M.D.,
  • David J. Cohen, M.D.,
  • Todd M. Dewey, M.D.,
  • Vasilis Babaliaros, M.D.,
  • Mathew R. Williams, M.D.,
  • Dean J. Kereiakes, M.D.,
  • Alan Zajarias, M.D.,
  • Kevin L. Greason, M.D.,
  • Brian K. Whisenant, M.D.,
  • Robert W. Hodson, M.D.,
  • David L. Brown, M.D.,
  • William F. Fearon, M.D.,
  • Mark J. Russo, M.D.,
  • Philippe Pibarot, D.V.M., Ph.D.,
  • Rebecca T. Hahn, M.D.,
  • Wael A. Jaber, M.D.,
  • Erin Rogers, M.Eng.,
  • Ke Xu, Ph.D.,
  • Jaime Wheeler, M.B.A., C.Ph.T.,
  • Maria C. Alu, M.S.,
  • Craig R. Smith, M.D.,
  • and Martin B. Leon, M.D.
  • for the PARTNER 2 Investigators*

Abstract

Background

There are scant data on long-term clinical outcomes and bioprosthetic-valve function after transcatheter aortic-valve replacement (TAVR) as compared with surgical aortic-valve replacement in patients with severe aortic stenosis and intermediate surgical risk.

Methods

We enrolled 2032 intermediate-risk patients with severe, symptomatic aortic stenosis at 57 centers. Patients were stratified according to intended transfemoral or transthoracic access (76.3% and 23.7%, respectively) and were randomly assigned to undergo either TAVR or surgical replacement. Clinical, echocardiographic, and health-status outcomes were followed for 5 years. The primary end point was death from any cause or disabling stroke.

Results

At 5 years, there was no significant difference in the incidence of death from any cause or disabling stroke between the TAVR group and the surgery group (47.9% and 43.4%, respectively; hazard ratio, 1.09; 95% confidence interval [CI], 0.95 to 1.25; P=0.21). Results were similar for the transfemoral-access cohort (44.5% and 42.0%, respectively; hazard ratio, 1.02; 95% CI, 0.87 to 1.20), but the incidence of death or disabling stroke was higher after TAVR than after surgery in the transthoracic-access cohort (59.3% vs. 48.3%; hazard ratio, 1.32; 95% CI, 1.02 to 1.71). At 5 years, more patients in the TAVR group than in the surgery group had at least mild paravalvular aortic regurgitation (33.3% vs. 6.3%). Repeat hospitalizations were more frequent after TAVR than after surgery (33.3% vs. 25.2%), as were aortic-valve reinterventions (3.2% vs. 0.8%). Improvement in health status at 5 years was similar for TAVR and surgery.

Conclusions

Among patients with aortic stenosis who were at intermediate surgical risk, there was no significant difference in the incidence of death or disabling stroke at 5 years after TAVR as compared with surgical aortic-valve replacement. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.)

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Funding and Disclosures

Supported by Edwards Lifesciences.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

This article was published on January 29, 2020, at NEJM.org.

A data sharing statement provided by the authors is available with the full text of this article at NEJM.org.

Author Affiliations

From Cedars–Sinai Medical Center, Los Angeles (R.R.M., S.-H.Y., A.T.), Stanford University, Stanford (D.C.M., W.F.F.), and Edwards Lifesciences, Irvine (E.R., K.X., J.W.) — all in California; the Department of Cardiovascular Surgery, Piedmont Heart Institute (V.H.T.), and Emory University (V.B.) — both in Atlanta; Baylor Scott and White Healthcare, Plano (M.J.M., D.L.B.), and Medical City Dallas Hospital, Dallas (T.M.D.) — both in Texas; Columbia University Medical Center/New York–Presbyterian Hospital (S.K.K., R.T.H., M.C.A., C.R.S., M.B.L.) and NYU Langone Medical Center (M.R.W.) — both in New York; Cleveland Clinic, Cleveland (S.K., L.G.S., W.A.J.); St. Paul’s Hospital, Vancouver, BC (J.G.W.), and Institut Universitaire de Cardiologie et de Pneumologie de Québec, Université Laval, Quebec, QC (P.P.) — both in Canada; University of Pennsylvania, Philadelphia (H.C.H., W.Y.S.); Medstar Washington Hospital Center, Washington, DC (L.S.); University of Missouri–Kansas City School of Medicine, Kansas City (D.J.C.); Christ Hospital, Cincinnati (D.J.K.); Barnes–Jewish Hospital, Washington University, St. Louis (A.Z.); Mayo Clinic, Rochester, MN (K.L.G.); Intermountain Medical Center, Salt Lake City (B.K.W.); Providence St. Vincent Medical Center, Portland, OR (R.W.H.); and Rutgers–Robert Wood Johnson Medical School, New Brunswick, NJ (M.J.R.).

Address reprint requests to Dr. Makkar at Cedars–Sinai Medical Center, 8700 Beverly Blvd., Los Angeles, CA 90048, or at .

A complete list of the PARTNER 2 Investigators is provided in the Supplementary Appendix, available at NEJM.org.

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