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PARTNER 2A: TAVR remains similar to surgery for 5-year outcomes in intermediate-risk population
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SAN FRANCISCO — At 5 years, transcatheter aortic valve replacement with the Sapien XT device was similar to surgical AVR for death and disabling stroke in patients with severe aortic stenosis at intermediate surgical risk, according to new data from the PARTNER 2A trial.
As Healio previously reported, TAVR with the balloon-expandable valve (Edwards Lifesciences) was noninferior to surgery at 2 years in a cohort of 2,032 intermediate-risk patients. Vinod H. Thourani, MD, FACS, FACC, chairman of the department of cardiac surgery at MedStar Heart & Vascular Institute, presented 5-year results at TCT 2019.
At 5 years, the primary outcome of death or disabling stroke occurred in 47.9% of the TAVR group compared with 43.4% of the surgery group (HR = 1.09; 95% CI, 0.95-1.25), Thourani said at a press conference.
Among those selected for transfemoral access, TAVR and surgery were similar in the primary outcome (TAVR, 44.5%; surgery, 42%; HR = 1.02; 95% CI, 0.87-1.2). But among those selected for transthoracic access, patients assigned TAVR had a higher rate of the primary outcome than patients assigned surgery (59.3% vs. 48.3%; HR = 1.32; 95% CI, 1.02-1.71), he said.
Very few patients in either group required aortic valve reintervention, with rates of freedom from reintervention at 99.4% in the surgery group compared with 96.8% in the TAVR group (HR = 3.93; 95% CI, 1.48-10.43), Thourani said.
Mean aortic valve gradient did not differ between the groups at 5 years (P = .23).
Paravalvular regurgitation severity was greater in the TAVR group at 5 years (P < .001), according to the researchers.
Of note, Thourani said, moderate-to-severe paravalvular regurgitation after the procedure led to greater odds of 5-year mortality. Among those who had moderate-to-severe paravalvular regurgitation, 64.8% had died within 5 years, compared with 48.7% of those with mild regurgitation and 41.1% of those who had no or trace regurgitation (P for moderate-to-severe vs. mild = .007).
“This shows us we have to be vigilant about not having moderate-to-severe paravalvular regurgitation,” he said. “If, for whatever reason, we leave a patient with it, we have to use adjunctive therapies to address it. With this level of moderate-to-severe paravalvular regurgitation, ejection fraction goes down and symptoms go up.”
Both groups had improved NYHA class and Kansas City Cardiomyopathy Questionnaire score at 5 years, Thourani said.
“Patients were much better after both therapies,” he said. “This was sustained at 5 years and not different.” – by Erik Swain
Reference:
Thourani VH, et al. Late-Breaking Trials 3. Presented at: TCT Scientific Symposium; Sept. 25-29, 2019; San Francisco.
Disclosures: The study was funded by Edwards Lifesciences. Thourani reports he has financial ties with Abbott Vascular, Boston Scientific, Edwards Lifesciences, CryoLife, JenaValve and W.L. Gore and Associates.
Perspective
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Dharam J. Kumbhani, MD, SM
The PARTNER 2A data are important, even though the Sapien XT valve is no longer used. The current Sapien 3 valve is very similar; the valve frame is what’s difference. That is, the biological portion of the valve leaflets is very similar. So, it is a very good message that the transcatheter valve was just as durable at 5 years as surgical valves in an intermediate-risk cohort. Hopefully, we will have 10-year data in the future, which will further help with this issue.
Also, the paravalvular leak data reflect that at the time of the trial, we did not understand sizing as well as we do now. We know that taking away paravalvular leak leads to better outcomes, but we have also learned that the patients who have paravalular leak are different from those who do not. They tend to be sicker and have more calcific disease. But there is no question, paravalvular leak is bad for these patients. The better we can reduce that, the better our long-term outcomes will be.
Perspective
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Ashish Pershad, MD
These data may be a little outdated because the valve studied is not a contemporary valve. But the findings show that what we saw in the pivotal study held true up to 5 years: TAVR is noninferior to surgery in intermediate-risk patients.
The transfemoral approach is now the default, given the lower profile of the newer devices. The skirt of these devices eliminates some of the original concerns related to transcatheter technology. Paravalvular regurgitation was higher in the TAVR arm of the older studies. That issue has almost been entirely taken care of with the newer Sapien 3 device, and the transfemoral approach is used in more than 95% of cases.
These data suggest that there is no difference in performance of surgical and transcatheter valves. I would support following these patients out to 10 years, as is being done in PARTNER 3, but this population was older and it’s unclear how many will still be alive 10 years after their implant.
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