NOTION: Outcomes similar for self-expanding transcatheter aortic valve, surgery at 2 years

In an all-comers population, transcatheter aortic valve replacement with a self-expanding valve produced similar outcomes as surgical aortic valve replacement at 2 years, according to new data from the NOTION trial.

The study population included patients at low and intermediate risk for surgery. The 2-year results support the safety and effectiveness of the self-expanding TAVR system (CoreValve, Medtronic) in those patients, Lars Søndergaard, MD, from The Heart Center, Rigshospitalet, Copenhagen, Denmark, said during a presentation at EuroPCR.

Lars Søndergaard

Søndergaard and colleagues randomly assigned 280 patients aged 70 years or older with severe aortic stenosis who were eligible for TAVR or surgical AVR to undergo either procedure. The mean age of the cohort was 79 years and 53% were men. Four patients died before TAVR or surgical AVR, two in the surgical AVR group were not implanted and three from the TAVR group crossed over to surgery.

At the American College of Cardiology Scientific Sessions in March, researchers reported that the primary outcome, a composite of all-cause mortality, stroke and MI at 1 year, was similar between the groups (TAVR group, 13.1%; surgical AVR group, 16.3%; absolute difference, –3.2%; P = .43 for superiority).

At 2 years, the rate of the primary outcome was 15.8% for the TAVR group vs. 18.8% for the surgical AVR group (P = .43), Søndergaard reported at EuroPCR.

Rates also were similar at 2 years for all-cause mortality (TAVR, 8%; surgical AVR, 9.8%), CV death (TAVR, 6.5%; surgical AVR, 9.1%; P = .4), stroke (TAVR, 3.6%; surgical AVR, 5.4%; P = .46), transient ischemic attack (TAVR, 6%; surgical AVR, 3.3%; P = .3) and MI (TAVR, 5.1%; surgical AVR, 6%; P = .69), he said.

However, patients assigned surgical AVR had a much higher rate of atrial fibrillation (60.2% vs. 22.7%; P < .001), and those in the TAVR group had a much higher rate of pacemaker implantation (41.3% vs. 4.2%; P < .001). There were no reported cases of aortic valve reintervention.

TAVR was associated with greater improvement in effective orifice area from baseline to 2 years (mean change, 0.9 cm² vs. 0.6 cm²; P < .001), he said. Patients who underwent TAVR were more likely to have mild (39% vs. 15.2%) or moderate (15.4% vs. 0.9%) aortic regurgitation (P < .001), he noted.

“These 2-year data support the safety and effectiveness of [TAVR] in lower-risk patients,” Søndergaard said. “Longer-term data on durability and more randomized clinical trials in lower-risk patients are necessary.”

The self-expanding TAVR system currently has FDA approval for use in patients at extreme risk or high risk for surgery. The larger SURTAVI trial evaluating the system in the intermediate-risk population is underway. – by Erik Swain

Reference:

Søndergaard L, et al. Hot Line: Late-Breaking Trials and Innovations. Presented at: EuroPCR; May 19-22, 2015; Paris.

Disclosure: The study was funded by the Danish Heart Foundation. Søndergaard reports consulting for Boston Scientific, CardiAQ Valve Technologies, Medtronic and St. Jude Medical.