In another major study comparing TAVR to surgery, outcomes were similar.
Results of a two-year study presented this morning at ACC showed a self-expanding transcatheter aortic valve replacement (TAVR) procedure was just as effective as surgery in intermediate risk patients.
Reporting on a trial known as SURTAVI, Michael Reardon, MD, a professor of cardiothoracic surgery at Houston Methodist Hospital, said the trial enrolled 1,746 patients at 87 centers in the United States, Europe, and Canada. It is the second randomized controlled trial to compare the two procedures in patients who were at intermediate risk.
“TAVR was just as good as surgery, but it was not statistically superior to it,” Reardon said.
“We saw the best surgical outcomes we’ve seen yet and TAVR did just as well,” he said.
The patients averaged nearly 80 years old and had symptomatic, severe aortic stenosis. Parameters were a valve area less than or equal to one, a valve index less than 0.6, and a median gradient over 40 or peak velocity over four.
Before the procedures these patients estimated mortality was 3% to 15%.
In the surgeries physicians performing the operations could choose any biologic valve or whether to enlarge the annulus or base of the valve if needed so that TAVR would be evaluated against real-world surgery.
While the TAVR arm of the trial started with the original Core-Valve, used in 84% of the cases, the rest of the patients got a newer device known as the Evolut-R system.
Overall, deaths from any cause were similar for TAVR and surgery. The TAVR patients’ mortality rate at 30 days was 2.2 % vs 1.7% for surgery patients. At one year those rates were 6.7% vs 6.8% respectively.
The team also noted that TAVR did a better job at preventing stroke with the rate at 30 days 3.4% for TAVR patients vs 5.6% for the surgical patients.
The study differed from the earlier PARTNER trial in that PARTNER researchers stratified patients by whether the catheter was placed transfemorally or using transapial access. The SURTAVI researchers stratified patients by how seriously they needed a procedure.
TAVR had more moderate-to-severe paravavular leakage seen in 5.4% of patients vs 0.4% of surgical patients. In those who got surgery there were more transfusions, strokes, acute kidney injury and atrial fibrillation at 30 days.
Next up, Reardon said, is a study of low-risk patients with aortic stenosis, a group that comprises 80% of patients with that condition.
The TAVR devices are made by Medtronic. The company sponsored the trial.
The study is described in the New England Journal of Medicine.