Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients

被引：2074

作者：

Reardon, M. J. ^{[1
]}

Van Mieghem, N. M. ^{[2
]}

Popma, J. J. ^{[3
]}

Kleiman, N. S. ^{[1
]}

Sondergaard, L. ^{[4
]}

Mumtaz, M. ^{[5
]}

Adams, D. H. ^{[7
]}

Deeb, G. M. ^{[9
]}

Maini, B. ^{[11
]}

Gada, H. ^{[5
]}

Chetcuti, S. ^{[9
]}

Gleason, T. ^{[6
]}

Heiser, J. ^{[10
]}

Lange, R. ^{[12
]}

Merhi, W. ^{[10
]}

Oh, J. K. ^{[14
]}

Olsen, P. S. ^{[4
]}

Piazza, N. ^{[17
]}

Williams, M. ^{[8
]}

Windecker, S. ^{[18
]}

Yakubov, S. J. ^{[19
]}

Grube, E. ^{[13
]}

Makkar, R. ^{[20
]}

Lee, J. S. ^{[6
]}

Conte, J. ^{[21
]}

Vang, E. ^{[15
]}

Nguyen, H. ^{[15
]}

Chang, Y. ^{[15
]}

Mugglin, A. S. ^{[16
]}

Serruys, P. W. J. C. ^{[2
]}

Kappetein, A. P. ^{[2
]}

机构：

[1] Methodist DeBakey Heart & Vasc Ctr, 6550 Fannin St, Houston, TX 77030 USA

[2] Erasmus Univ, Med Ctr, Rotterdam, Netherlands

[3] Beth Israel Deaconess Med Ctr, Boston, MA 02215 USA

[4] Rigshosp, Ctr Heart, Copenhagen, Denmark

[5] Pinnacle Hlth Hosp, Harrisburg, PA USA

[6] Univ Pittsburgh, Med Ctr, Pittsburgh, PA USA

[7] Mt Sinai Hlth Syst, New York, NY USA

[8] NYU, Langone Med Ctr, New York, NY USA

[9] Univ Michigan, Ann Arbor, MI 48109 USA

[10] Spectrum Hlth Hosp, Grand Rapids, MI USA

[11] Tenet Healthcare, Delray Beach, FL USA

[12] German Heart Ctr, Munich, Germany

[13] Siegburg Heart Ctr, Siegburg, Germany

[14] Mayo Clin, Rochester, MN USA

[15] Medtron, Minneapolis, MN USA

[16] Paradigm Biostat, Anoka, MN USA

[17] McGill Univ, Med Ctr, Montreal, PQ, Canada

[18] Univ Hosp Bern, Bern, Switzerland

[19] Riverside Methodist Hosp, Columbus, OH 43214 USA

[20] Cedars Sinai Med Ctr, Los Angeles, CA 90048 USA

[21] Johns Hopkins Univ, Baltimore, MD USA

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2017年 / 376卷 / 14期

关键词：

SELF-EXPANDING BIOPROSTHESIS; OUTCOMES; STENOSIS; IMPLANTATION; SURGERY; MORTALITY; US;

D O I：

10.1056/NEJMoa1700456

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.)

引用

页码：1321 / 1331

页数：11

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