Surgical or transcatheter aortic-valve replacement in intermediate-risk patients

M. J. Reardon, N. M. Van Mieghem, J. J. Popma, N. S. Kleiman, L. Sondergaard, M. Mumtaz, D. H. Adams, G. M. Deeb, B. Maini, H. Gada, S. Chetcuti, T. Gleason, J. Heiser, R. Lange, W. Merhi, J. K. Oh, P. S. Olsen, N. Piazza, M. Williams, S. Windecker & 11 others S. J. Yakubov, E. Grube, R. Makkar, J. S. Lee, J. Conte, E. Vang, H. Nguyen, Y. Chang, A. S. Mugglin, P. W.J.C. Serruys, A. P. Kappetein

Research output: Contribution to journalArticle

Abstract

BACKGROUND Although transcatheter aortic-valve replacement (TAVR) is an accepted alternative to surgery in patients with severe aortic stenosis who are at high surgical risk, less is known about comparative outcomes among patients with aortic stenosis who are at intermediate surgical risk. METHODS We evaluated the clinical outcomes in intermediate-risk patients with severe, symptomatic aortic stenosis in a randomized trial comparing TAVR (performed with the use of a self-expanding prosthesis) with surgical aortic-valve replacement. The primary end point was a composite of death from any cause or disabling stroke at 24 months in patients undergoing attempted aortic-valve replacement. We used Bayesian analytical methods (with a margin of 0.07) to evaluate the noninferiority of TAVR as compared with surgical valve replacement. RESULTS A total of 1746 patients underwent randomization at 87 centers. Of these patients, 1660 underwent an attempted TAVR or surgical procedure. The mean (?}SD) age of the patients was 79.8?}6.2 years, and all were at intermediate risk for surgery (Society of Thoracic Surgeons Predicted Risk of Mortality, 4.5?}1.6%). At 24 months, the estimated incidence of the primary end point was 12.6% in the TAVR group and 14.0% in the surgery group (95% credible interval [Bayesian analysis] for difference, -5.2 to 2.3%; posterior probability of noninferiority, >0.999). Surgery was associated with higher rates of acute kidney injury, atrial fibrillation, and transfusion requirements, whereas TAVR had higher rates of residual aortic regurgitation and need for pacemaker implantation. TAVR resulted in lower mean gradients and larger aortic-valve areas than surgery. Structural valve deterioration at 24 months did not occur in either group. CONCLUSIONS TAVR was a noninferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk, with a different pattern of adverse events associated with each procedure. (Funded by Medtronic; SURTAVI ClinicalTrials.gov number, NCT01586910.).

Original languageEnglish (US)
Pages (from-to)1321-1331
Number of pages11
JournalNew England Journal of Medicine
Volume376
Issue number14
DOIs
StatePublished - Apr 6 2017

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Aortic Valve Stenosis
Aortic Valve
Bayes Theorem
Surgical Instruments
Aortic Valve Insufficiency
Transcatheter Aortic Valve Replacement
Random Allocation
Acute Kidney Injury
Atrial Fibrillation
Prostheses and Implants
Cause of Death
Stroke
Mortality
Incidence

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Reardon, M. J., Van Mieghem, N. M., Popma, J. J., Kleiman, N. S., Sondergaard, L., Mumtaz, M., ... Kappetein, A. P. (2017). Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. New England Journal of Medicine, 376(14), 1321-1331. https://doi.org/10.1056/NEJMoa1700456

Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. / Reardon, M. J.; Van Mieghem, N. M.; Popma, J. J.; Kleiman, N. S.; Sondergaard, L.; Mumtaz, M.; Adams, D. H.; Deeb, G. M.; Maini, B.; Gada, H.; Chetcuti, S.; Gleason, T.; Heiser, J.; Lange, R.; Merhi, W.; Oh, J. K.; Olsen, P. S.; Piazza, N.; Williams, M.; Windecker, S.; Yakubov, S. J.; Grube, E.; Makkar, R.; Lee, J. S.; Conte, J.; Vang, E.; Nguyen, H.; Chang, Y.; Mugglin, A. S.; Serruys, P. W.J.C.; Kappetein, A. P.

In: New England Journal of Medicine, Vol. 376, No. 14, 06.04.2017, p. 1321-1331.

Research output: Contribution to journalArticle

Reardon, MJ, Van Mieghem, NM, Popma, JJ, Kleiman, NS, Sondergaard, L, Mumtaz, M, Adams, DH, Deeb, GM, Maini, B, Gada, H, Chetcuti, S, Gleason, T, Heiser, J, Lange, R, Merhi, W, Oh, JK, Olsen, PS, Piazza, N, Williams, M, Windecker, S, Yakubov, SJ, Grube, E, Makkar, R, Lee, JS, Conte, J, Vang, E, Nguyen, H, Chang, Y, Mugglin, AS, Serruys, PWJC & Kappetein, AP 2017, 'Surgical or transcatheter aortic-valve replacement in intermediate-risk patients', New England Journal of Medicine, vol. 376, no. 14, pp. 1321-1331. https://doi.org/10.1056/NEJMoa1700456
Reardon MJ, Van Mieghem NM, Popma JJ, Kleiman NS, Sondergaard L, Mumtaz M et al. Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. New England Journal of Medicine. 2017 Apr 6;376(14):1321-1331. https://doi.org/10.1056/NEJMoa1700456
Reardon, M. J. ; Van Mieghem, N. M. ; Popma, J. J. ; Kleiman, N. S. ; Sondergaard, L. ; Mumtaz, M. ; Adams, D. H. ; Deeb, G. M. ; Maini, B. ; Gada, H. ; Chetcuti, S. ; Gleason, T. ; Heiser, J. ; Lange, R. ; Merhi, W. ; Oh, J. K. ; Olsen, P. S. ; Piazza, N. ; Williams, M. ; Windecker, S. ; Yakubov, S. J. ; Grube, E. ; Makkar, R. ; Lee, J. S. ; Conte, J. ; Vang, E. ; Nguyen, H. ; Chang, Y. ; Mugglin, A. S. ; Serruys, P. W.J.C. ; Kappetein, A. P. / Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. In: New England Journal of Medicine. 2017 ; Vol. 376, No. 14. pp. 1321-1331.
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TY - JOUR

T1 - Surgical or transcatheter aortic-valve replacement in intermediate-risk patients

AU - Reardon, M. J.

AU - Van Mieghem, N. M.

AU - Popma, J. J.

AU - Kleiman, N. S.

AU - Sondergaard, L.

AU - Mumtaz, M.

AU - Adams, D. H.

AU - Deeb, G. M.

AU - Maini, B.

AU - Gada, H.

AU - Chetcuti, S.

AU - Gleason, T.

AU - Heiser, J.

AU - Lange, R.

AU - Merhi, W.

AU - Oh, J. K.

AU - Olsen, P. S.

AU - Piazza, N.

AU - Williams, M.

AU - Windecker, S.

AU - Yakubov, S. J.

AU - Grube, E.

AU - Makkar, R.

AU - Lee, J. S.

AU - Conte, J.

AU - Vang, E.

AU - Nguyen, H.

AU - Chang, Y.

AU - Mugglin, A. S.

AU - Serruys, P. W.J.C.

AU - Kappetein, A. P.

PY - 2017/4/6

Y1 - 2017/4/6

N2 - BACKGROUND Although transcatheter aortic-valve replacement (TAVR) is an accepted alternative to surgery in patients with severe aortic stenosis who are at high surgical risk, less is known about comparative outcomes among patients with aortic stenosis who are at intermediate surgical risk. METHODS We evaluated the clinical outcomes in intermediate-risk patients with severe, symptomatic aortic stenosis in a randomized trial comparing TAVR (performed with the use of a self-expanding prosthesis) with surgical aortic-valve replacement. The primary end point was a composite of death from any cause or disabling stroke at 24 months in patients undergoing attempted aortic-valve replacement. We used Bayesian analytical methods (with a margin of 0.07) to evaluate the noninferiority of TAVR as compared with surgical valve replacement. RESULTS A total of 1746 patients underwent randomization at 87 centers. Of these patients, 1660 underwent an attempted TAVR or surgical procedure. The mean (?}SD) age of the patients was 79.8?}6.2 years, and all were at intermediate risk for surgery (Society of Thoracic Surgeons Predicted Risk of Mortality, 4.5?}1.6%). At 24 months, the estimated incidence of the primary end point was 12.6% in the TAVR group and 14.0% in the surgery group (95% credible interval [Bayesian analysis] for difference, -5.2 to 2.3%; posterior probability of noninferiority, >0.999). Surgery was associated with higher rates of acute kidney injury, atrial fibrillation, and transfusion requirements, whereas TAVR had higher rates of residual aortic regurgitation and need for pacemaker implantation. TAVR resulted in lower mean gradients and larger aortic-valve areas than surgery. Structural valve deterioration at 24 months did not occur in either group. CONCLUSIONS TAVR was a noninferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk, with a different pattern of adverse events associated with each procedure. (Funded by Medtronic; SURTAVI ClinicalTrials.gov number, NCT01586910.).

AB - BACKGROUND Although transcatheter aortic-valve replacement (TAVR) is an accepted alternative to surgery in patients with severe aortic stenosis who are at high surgical risk, less is known about comparative outcomes among patients with aortic stenosis who are at intermediate surgical risk. METHODS We evaluated the clinical outcomes in intermediate-risk patients with severe, symptomatic aortic stenosis in a randomized trial comparing TAVR (performed with the use of a self-expanding prosthesis) with surgical aortic-valve replacement. The primary end point was a composite of death from any cause or disabling stroke at 24 months in patients undergoing attempted aortic-valve replacement. We used Bayesian analytical methods (with a margin of 0.07) to evaluate the noninferiority of TAVR as compared with surgical valve replacement. RESULTS A total of 1746 patients underwent randomization at 87 centers. Of these patients, 1660 underwent an attempted TAVR or surgical procedure. The mean (?}SD) age of the patients was 79.8?}6.2 years, and all were at intermediate risk for surgery (Society of Thoracic Surgeons Predicted Risk of Mortality, 4.5?}1.6%). At 24 months, the estimated incidence of the primary end point was 12.6% in the TAVR group and 14.0% in the surgery group (95% credible interval [Bayesian analysis] for difference, -5.2 to 2.3%; posterior probability of noninferiority, >0.999). Surgery was associated with higher rates of acute kidney injury, atrial fibrillation, and transfusion requirements, whereas TAVR had higher rates of residual aortic regurgitation and need for pacemaker implantation. TAVR resulted in lower mean gradients and larger aortic-valve areas than surgery. Structural valve deterioration at 24 months did not occur in either group. CONCLUSIONS TAVR was a noninferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk, with a different pattern of adverse events associated with each procedure. (Funded by Medtronic; SURTAVI ClinicalTrials.gov number, NCT01586910.).

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