SAN DIEGO — Patients with severe symptomatic aortic stenosis and high operative mortality risk after transcatheter aortic valve replacement had similar 5-year survival and stroke rates compared with those who underwent surgical AVR, according to data presented at TCT 2018.
“These outcomes support TAVR as a reasonable alternative to SAVR in the high-risk population and its current Class I indication,” Thomas G. Gleason, MD, Ronald V. Pellegrini Endowed Professor of Cardiothoracic Surgery and chief of the division of cardiac surgery at University of Pittsburgh School of Medicine, and director of the Center for Thoracic Aortic Disease and co-director of the Center for Heart Valve Disease at University of Pittsburgh Medical Center, and colleagues wrote in a simultaneous publication in the Journal of the American College of Cardiology.
In the CoreValve U.S. Pivotal High-Risk Trial, researchers analyzed data from 750 patients with severe symptomatic aortic stenosis who were at high operative mortality risk, which was defined as an estimated risk for surgical mortality and major morbidity between 15% and 50% at 30 days.
Patients were assigned TAVR (n = 391; mean age, 83 years; mean STS Predicted Risk of Mortality (PROM) score, 7.3%; mean aortic valve gradient, 7.1 mm Hg) or surgical AVR (n = 359; mean age, 83 years; mean STS PROM score, 7.5%; mean aortic valve gradient, 10.9 mm Hg), which were performed at 45 centers in the U.S. Those assigned TAVR had a self-expanding system (CoreValve, Medtronic) implanted during the procedure, whereas valve selection was left to the operator’s discretion during surgical AVR.
As Cardiology Today’s Intervention previously reported, for the primary endpoint of all-cause mortality at 1 year, TAVR with the self-expanding valve was superior to surgery in high-risk patients. The trial was the first to report superiority in survival for TAVR over surgical AVR.
Patients assigned TAVR were followed up for a median of 49.9 months, and those assigned surgical AVR were followed up for a median of 41 months.
At 5 years, all-cause mortality occurred in 55.3% of patients in the TAVR group vs. 55.4% in the surgical AVR group (P = .5). Statistical differences were not seen at 5 years between both groups in subgroup analyses.
There were no differences in the rate of stroke at 5 years in patients assigned TAVR vs. surgical AVR (12.3% vs. 13.2%, respectively; P = .49). Transthoracic echocardiography did not show clinical valve thrombosis in either group.
Freedom from structural valve deterioration occurred in 99.2% of patients in the TAVR group and 98.3% in the surgical AVR group (P = .32). Freedom from valve reintervention was slightly higher in the surgery group (TAVR, 97%; surgery, 98.9%; P = .04).
At 5 years, more patients in the TAVR group had a permanent pacemaker implanted compared with those in the surgical AVR group (33% vs. 19.8%; P < .001).
“These were early CoreValve patients, some of the first patients to receive the therapy, and it’s reassuring to see that the CoreValve System has proven to be durable out to 5 years,” Gleason said in a press release. “As the technology and heart team experience continues to improve, this longer-term follow-up data is an encouraging indicator for TAVR patients in the future. Earlier concerns regarding the durability of TAVR are certainly tempered by these mid-term data.”
Regardless of treatment, predictors of all-cause mortality at 5 years were STS PROM greater than 7%, age older than 85 years, home oxygen, NYHA class III or IV symptoms, recent falls, malnutrition, post-procedural acute kidney injury and moderate or greater mitral valve regurgitation. Positive predictors of 5-year mortality in patients assigned TAVR were STS PROM greater than 7%, age older than 85 years, mild aortic regurgitation at 1 month and baseline moderate or more mitral valve regurgitation. Mortality predictors in patients assigned surgical AVR were post-procedural acute kidney injury and home oxygen.
“As longer-term data accrue from the ongoing intermediate- and low-risk randomized trials, we will gain a better understanding of the relative roles of TAVR and SAVR with respect to long-term durability and clinical impact,” Gleason and colleagues wrote in JACC. – by Darlene Dobkowski
Gleason TG, et al. Oral Abstracts: TAVR Pivotal Trials. Presented at: TCT Scientific Symposium; Sept. 21-25, 2018; San Diego.
Gleason TG, et al. J Am Coll Cardiol. 2018;doi:10.1016/j.jacc.2018.08.1090.
Disclosures: The trial was funded by Medtronic. Gleason reports he receives institutional grant support from Boston Scientific and Medtronic and serves on medical advisory boards for Abbott and Cytosorbents Corporation. Please see the study for all other authors’ relevant financial disclosures.