Transcatheter or Surgical Treatment of Aortic Valve Stenosis

The DEDICATE-DZHK6 is a non-industry sponsored randomized noninferiority trial conducted at 38 sites in Germany, where patients with severe aortic stenosis who were at low or intermediate surgical risk were randomly assigned to undergo either transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR). TAVI and SAVR prostheses were selected at the operator's discretion. The primary outcome was a composite of death from any cause or fatal or nonfatal stroke at one year. A total of 1,414 patients underwent randomization, 701 to the TAVI group and 713 to the SAVR group). The mean age was 74±4 years, 57 percent were men, and the median Society of Thoracic Surgeons risk score was 1.8 percent. The Kaplan–Meier estimate of the primary outcome at one year was 5.4 percent in the TAVI group and 10 percent in the SAVR group (hazard ratio (HR) for death or stroke, 0.53; 95 percent confidence interval [CI], 0.35 to 0.79; P <0.001 for noninferiority). The incidence of death from any cause was 2.6 percent in the TAVI group and 6.2 percent in the SAVR group (HR 0.43; 95 percent CI, 0.24 to 0.73). The incidence of stroke was 2.9 percent and 4.7 percent in the TAVI and SAVR groups, respectively (HR 0.61; 95 percent CI, 0.35 to 1.06). The authors concluded that 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 one year.