Transcatheter or surgical treatment of aortic stenosis

Transcatheter or Surgical Treatment of Aortic-Valve Stenosis

(The New England Journal of Medicine, IF:158.50)

• S. Blankenberg, M. Seiffert, R. Vonthein, H. Baumgartner, S. Bleiziffer, M.A. Borger, Y.-H. Choi, P. Clemmensen, J. Cremer, M. Czerny, N. Diercks, I. Eitel, S. Ensminger, D. Frank, N. Frey, A. Hagendorff, C. Hagl, C. Hamm, U. Kappert, M. Karck, W.-K. Kim, I.R. König, M. Krane, U. Landmesser, A. Linke, L.S. Maier, S. Massberg, F.-J. Neumann, H. Reichenspurner, T.K. Rudolph, C. Schmid, H. Thiele, R. Twerenbold, T. Walther, D. Westermann, E. Xhepa, A. Ziegler, and V. Falk, for the DEDICATE-DZHK6 Trial Investigators
• CORRESPONDENCE TO: [email protected]

BACKGROUND 背景

Among low-risk patients with severe, symptomatic aortic stenosis who are eligible for both transcatheter aortic-valve implantation (TAVI) and surgical aortic-valve replacement (SAVR), data are lacking on the appropriate treatment strategy in routine clinical practice.

Low-risk patients with severe aortic stenosis, who are candidates for both transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR), lack data on the selection of appropriate treatment strategies in routine clinical practice.

METHODS 方法

In this randomized noninferiority trial conducted at 38 sites in Germany, we assigned patients with severe aortic stenosis who were at low or intermediate surgical risk to undergo either TAVI or SAVR. Percutaneous- and surgical-valve prostheses were selected according to operator discretion. The primary outcome was a composite of death from any cause or fatal or nonfatal stroke at 1 year.

In this randomized, non-inferiority trial conducted at 38 sites in Germany, we assigned patients with severe aortic stenosis with low or moderate surgical risk to receive either TAVI or SAVR. Percutaneous and surgical valve prostheses are selected at the discretion of the surgeon. The primary outcome was a composite of death from any cause or fatal or non-fatal stroke within one year.

RESULTS 结果

A total of 1414 patients underwent randomization (701 to the TAVI group and 713 to the SAVR group). The mean (±SD) age of the patients was 74±4 years; 57% were men, and the median Society of Thoracic Surgeons risk score was 1.8% (low surgical risk). The Kaplan–Meier estimate of the primary outcome at 1 year was 5.4% in the TAVI group and 10.0% in the SAVR group (hazard ratio for death or stroke, 0.53; 95% confidence interval [CI], 0.35 to 0.79; P<0.001 for noninferiority). The incidence of death from any cause was 2.6% in the TAVI group and 6.2% in the SAVR group (hazard ratio, 0.43; 95% CI, 0.24 to 0.73); the incidence of stroke was 2.9% and 4.7%, respectively (hazard ratio, 0.61; 95% CI, 0.35 to 1.06). Procedural complications occurred in 1.5% and 1.0% of patients in the TAVI and SAVR groups, respectively.

A total of 1414 patients were randomized (701 patients were assigned to TAVI and 713 patients to SAVR). The mean age (±SD) of patients was 74±4 years, 57% were male, and the median risk score of the Society of Thoracic Surgeons was 1.8% (low risk of surgery). Kaplan–Meier estimated the proportion of primary outcomes at one year to be 5.4% in the TAVI arm and 10.0% in the SAVR arm (hazard ratio for death or stroke 0.53; 95% confidence interval [CI] 0.35 to 0.79; non-inferiority P). <0.001）。 The incidence of death from any cause was 2.6% in the TAVI group, 6.2% in the SAVR group (hazard ratio 0.43; 95% confidence interval [CI] 0.24 to 0.73), and stroke in 2.9% and 4.7%, respectively (hazard ratio 0.61; 95% confidence interval [CI] 0.35 to 1.06). Surgical complications occurred in 1.5% and 1.0% of patients in the TAVI and SAVR groups, respectively.

CONCLUSIONS 结论

Among patients with severe aortic stenosis at low or intermediate surgical risk, TAVI was noninferior to SAVR with respect to death from any cause or stroke at 1 year. (Funded by the German Center for Cardiovascular Research and the German Heart Foundation; DEDICATE-DZHK6 ClinicalTrials.gov number, NCT03112980.)

In patients with severe aortic stenosis with low or intermediate surgical risk, TAVI is non-inferior to SAVR in terms of death or stroke from any cause within 1 year. (Funded by the German Center for Cardiovascular Research and the German Heart Foundation; DEDICATE-ZHK6 ClinicalTrials.gov number, NCT03112980.) ）