WASHINGTON — Transcatheter aortic valve replacement with a self-expanding transcatheter valve was associated with a higher rate of survival at 1 year compared with surgical aortic valve replacement in high-risk patients, according to new research.
TAVR with the self-expanding CoreValve (Medtronic) was compared with surgical AVR in patients with severe aortic stenosis at increased surgical risk as determined by a heart team. The findings were presented at the American College of Cardiology Scientific Sessions.
After reviewing the results of the trial, the FDA determined that it has enough information to evaluate the safety and efficacy of CoreValve for high-risk patients without convening an advisory panel, according to a Medtronic press release. CoreValve is already approved for use in extreme-risk patients.
The primary endpoint was all-cause mortality at 1 year, evaluated with noninferiority and superiority testing.
David H. Adams
Lower mortality with TAVR
David H. Adams, MD, of Mount Sinai Medical Center, and on behalf of the CoreValve US investigators, reported that for the as-treated population (n=747; mean age, 83.2 years; 52.7% men), the mortality rate at 1 year was 14.2% for the TAVR group vs. 19.1% for the surgical group (absolute risk reduction, 4.9 percentage points; upper boundary of the 95% CI, –0.4; P<.001 for noninferiority; P=.04 for superiority).
Results were similar for the intention-to-treat population (n=795) and the TAVR benefit was consistent across nine subgroups.
Results beyond 1 year have are also encouraging, Adams said at a press conference.
“We are just starting to see patients at 2 years,” he said. “We don’t have statistical power yet, but we are certainly encouraged by the continued separation of these two curves.”
Additionally, the researchers performed a hierarchical testing procedure and found that TAVR was noninferior to surgical AVR in mean aortic valve gradient from baseline to 1 year (TAVR group, –39.04 mm Hg; surgical group, –35.42 mm Hg; P<.001 for noninferiority); change in effective orifice area from baseline to 1 year (TAVR group, 1.2 cm2; surgical group, 0.81 cm2; P<.001 for noninferiority), change in NYHA class (P<.01) and change in Kansas City Cardiomyopathy Questionnaire score (P<.01). For the fifth test in the hierarchy, rate of major adverse cardiovascular and cerebrovascular events at 30 days, there was no difference between the groups (TAVR group, 8.2%; surgical group, 10.9%; P=.1 for superiority).
No increase in stroke risk
Exploratory analyses indicated that the TAVR group had a lower rate than the surgical group of major adverse cardiovascular and cerebrovascular events at 1 year (TAVR group, 20.4%; surgical group, 27.3%; P=.03) and no difference between the groups in stroke rates at 30 days (TAVR group, 4.9%; surgical group, 6.2%; P=.46) and 1 year (TAVR group, 8.8%; surgical group, 12.6%; P=.1).
The following conditions were more prevalent in the TAVR group than the surgical group: major vascular complications, permanent pacemaker implantations, cardiac perforation and paravalvular regurgitation. The following conditions were more prevalent in the surgical group than the TAVR group: bleeding, acute kidney injury, new-onset atrial fibrillation and worsening AF.
“With regard to 1-year mortality: Even in the worst-case scenario, in which it is assumed that all surgical patients lost to follow-up lived and all TAVR patients lost to follow up died, we still met our primary endpoint,” Adams said. – by Erik Swain
For more information:
Adams DH. ACC.14 Opening Showcase and the Joint ACC/JACC Late-Breaking Clinical Trials. Presented at: American College of Cardiology Scientific Sessions; March 29-31, 2014; Washington, D.C.
Adams DH. New Engl J Med. 2014;doi:10.1056/NEJMoa1400590.
Disclosure: The study was funded by Medtronic. Adams reports receiving royalties through his institution for patents from Edwards Lifesciences and Medtronic. See the full study for the other researchers’ relevant financial disclosures.