Jeffrey J. Popma
SAN DIEGO — A final analysis of 24-month results from the SURTAVI trial confirmed interim findings that transcatheter aortic valve replacement with a self-expanding bioprosthesis had similar outcomes vs. surgical AVR in patients at intermediate risk for surgery.
As Cardiology Today’s Intervention previously reported, in the interim 24-month analysis published in March 2017, patients who had TAVR with a self-expanding valve (CoreValve or Evolut R, Medtronic) had similar rates of death or disabling stroke as patients who underwent surgery.
At TCT 2018, Jeffrey J. Popma, MD, director of interventional cardiology at Beth Israel Deaconess Medical Center and professor of medicine at Harvard Medical School, presented the final 24-month results of the study, in which 864 patients were assigned TAVR (mean age, 80 years; 58% men) and 796 patients were assigned surgical AVR (mean age, 80 years; 55% men).
In the entire cohort, the rate of death or disabling stroke at 24 months was 12.7% in both arms (difference, 0%; 95% CI, –3.2 to 3.3; log-rank P = .97; P for noninferiority > .999), Popma said.
The TAVR group had higher rates of early aortic valve reintervention (2.4% vs. 0.5%; P < .01), but there was no significant difference in other secondary outcomes, including death, all stroke, disabling stroke, transient ischemic attack, MI, aortic valve hospitalization and MACCE, he said.
NYHA functional class improved similarly in both groups at 24 months (P = .33), he said.
Kansas City Cardiomyopathy Questionnaire score was better in the TAVR group at 30 days (P < .01), but was almost identical between the groups at 24 months (P = .85), according to the researchers.
The TAVR group performed better vs. baseline on the 6-minute walk test than the surgery group at 30 days (P < .01), 12 months (P < .01) and 24 months (P = .04), Popma said.
The TAVR group had better improvements in aortic valve area and mean gradient at discharge, 12 months and 24 months compared with the surgery group (P < .001 for all), he said.
The results did not vary according to early or late enrollment, according to the researchers.
Among 275 patients implanted with the self-expanding valve in a continuous access study (mean age, 79 years, 46% men), all of whom were treated with the second-generation Evolut platform, the 12-month rate of death or disabling stroke was 3.8%, lower than that seen at 12 months in either SURTAVI arm (TAVR, 7.8%; surgery, 8.6%), Popma said.
“This report confirms the interim Bayesian findings that TAVR is noninferior to surgery in patients at intermediate risk,” Popma said during his presentation. “There were sustained clinical outcomes in patients enrolled earlier and later in the SURTAVI clinical trial, and improved echocardiographic and functional outcomes with TAVR were sustained at 2 years.” – by Erik Swain
Popma JJ, et al. Keynote Interventional Studies VI: Structural Heart Interventions I. Presented at: TCT Scientific Symposium; Sept. 21-25, 2018; San Diego.
Disclosure: The study was funded by Medtronic. Popma reports he has received institutional research grants from Abbott Vascular, Boston Scientific, Cook Medical, Edwards Lifesciences and Medtronic, and serves on medical advisory boards for Boston Scientific, Cordis and Edwards Lifesciences.