TAVR equal to surgery in younger low-risk patients, but not if they have bicuspid valves
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Key takeaways:
- In younger patients with severe aortic stenosis and low surgical risk, TAVR had similar 1-year outcomes as surgery.
- However, TAVR had worse outcomes in patients with a bicuspid aortic valve.
In younger patients with severe aortic stenosis at low surgical risk, transcatheter aortic valve replacement was associated with similar outcomes to surgical AVR, except in those with bicuspid valves, researchers reported.
The results of the NOTION-2 trial were presented by Ole De Backer, MD, PhD, MBA, professor of cardiology at Copenhagen University and structural interventional cardiologist at The Heart Center – Rigshospitalet in Copenhagen, Denmark, at EuroPCR, and simultaneously published in the European Heart Journal
De Backer and colleagues randomly assigned 370 patients aged 75 years or younger with severe symptomatic aortic stenosis at low surgical risk (mean age, 71 years; 63% men; 26% with a bicuspid aortic valve; mean Society of Thoracic Surgeons Predicted Risk of Mortality score, 1.1%) to undergo TAVR or surgical AVR.
“There are already [TAVR vs. surgery] low-risk trials, but in all of these trials, typically, older patients are included, so they don’t primarily focus on younger patients, and bicuspid aortic valve stenosis has always been excluded, so this is novel about this trial,” De Backer said at a press conference.
Equipoise in overall cohort
In the overall cohort, there was no difference between the groups in the primary endpoint of death, stroke or procedure-, valve- or HF-related rehospitalization at 1 year (TAVR, 10.2%; surgery, 7.1%; absolute risk difference, 3.1 percentage points; 95% CI, –2.7 to 8.8; HR = 1.4; 95% CI, 0.7-2.9; P = .3) or the key secondary outcome of death or disabling stroke at 1 year (TAVR, 3.2%; surgery, 1.6%; absolute risk difference, 1.6 percentage points; 95% CI, –2.8 to 6.1; HR = 2; 95% CI, 0.5-7.8; P = .3), De Backer said at the press conference.
There were no differences between the groups at 1 year in any of all-cause death, disabling stroke or rehospitalization, but the TAVR group had a higher rate of nondisabling stroke than the surgery group (3.7% vs. 0.5%; HR = 7; 95% CI, 0.9-56.5; P = .03), the researchers found.
In addition, compared with the surgery group, at 1 year the TAVR group had lower rates of major or life-threatening bleeding (4.8% vs. 17.5%; HR = 0.3; 95% CI, 0.1-0.5; P < .001), new-onset atrial fibrillation (3.2% vs. 41.7%; HR = 0.1; 95% CI, 0.03-0.2; P < .001) and severe patient-prosthesis mismatch (10.1% vs. 19.4%; HR = 0.5; 95% CI, 0.3-0.9; P = .02), according to the researchers.
The TAVR group also had a shorter median length of hospital stay (3 days vs. 7 days; P < .001).
There were also no differences between the groups at 1 year in NYHA HF classification or in quality of life, according to the researchers.
Tricuspid vs. bicuspid valves
In patients with tricuspid aortic valves, there was no difference between TAVR and surgery for the primary outcome (TAVR, 8.7%; surgery, 8.3%; HR = 1; 95% CI, 0.5-2.3; P = .9), but in patients with bicuspid aortic valves, the TAVR group was more likely to experience a primary outcome event at 1 year, though the difference did not reach statistical significance (TAVR, 14.3%; surgery, 3.9%; HR = 3.8; 95% CI, 0.8-13.5; P = .07; P for interaction = .01), De Backer said, noting a similar but less pronounced disparity was observed for the key secondary outcome.
For patients with tricuspid aortic valves, “there was clinical equipoise: TAVR was as good as surgery,” De Backer said at the press conference. “Both had really good results if you look at the absolute incidence rates at 1 year. On the other hand, we see that outcomes with surgery were more favorable than TAVR in patients with bicuspid aortic valves. There were more nondisabling strokes and a higher rate of moderate or greater paravalvular leak noted in the TAVR vs. surgical treatment arm.
“We have to be modest about it, because it is a limited study population overall and especially in the subgroups, but still, we believe this may impact future randomized controlled trial designs comparing both therapies, especially in this bicuspid cohort,” he said. “Eventually it may also have impact on our practice in terms of what we would do when treating younger bicuspid patients with TAVR, being more selective on which bicuspid phenotypes to accept and considering the use of cerebral embolic protection when planning for TAVR.”
A possible explanation for the results in patients with bicuspid aortic valves is that younger patients with bicuspid aortic valves and severe aortic stenosis tend to have excessively calcified aortic valves and leaflets, De Backer said.
He said the cohort will be followed for at least 10 years.
Reference:
For more information:
Ole De Backer, MD, PhD, MBA, can be reached at ole.debacker@gmail.com.
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De Backer O, et al. Hotline: Major late-breaking trials from EuroPCR 2024. Presented at: EuroPCR; May 14-17, 2024; Paris.
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