Relative outcomes from Lotus and CoreValve remain largely unchanged at 2 years, a post hoc analysis of the REPRISE III trial found.
Mortality occurred among 22.5% of CoreValve cases and 21.3% of Lotus cases (P=0.67), and the composite of disabling stroke and all-cause mortality was likewise similar (27.0% vs 22.8%, P=0.14)
“The 2-year survival rate of Lotus compared with a valve that was already shown to be superior to surgery at 2 years is encouraging,” reported Michael Reardon, MD, of Houston Methodist DeBakey Heart and Vascular Center, and colleagues in JAMA Cardiology.
Other clinical factors retained their positions at 1 year in REPRISE III: Lotus again at 2 years had fewer disabling strokes (4.7% vs 8.6%), less valve migration (0.0% vs 0.7%), embolization (0.0% vs 2.0%), and fewer repeated procedures (0.6% vs 2.9%). Moderate or greater paravalvular leak was less common with Lotus than CoreValve (0.3% vs 3.8%).
However, new permanent pacemaker implantation was substantially higher than with CoreValve (41.7% vs 26.1%) and there was more valve thrombosis (3.0% vs 0.0%). CoreValve’s mean gradient was lower (13.0 vs 8.1 mm Hg) and valve areas remained significantly larger (mean 1.53 vs 1.76 cm2).
Andres Pineda, MD, of the University of Florida College of Medicine in Jacksonville, wasn’t impressed.
Lotus’s permanent pacemaker rate was “unacceptably high and worse than the CoreValve in this trial, and worse than the reported incidence with Sapien 3 in other trials,” he told MedPage Today.
“Second, higher incidence of valve thrombosis, which raises questions about valve durability in the long-term; and finally, worse valve hemodynamics. It would be hard for me to offer patients treatment with Lotus over the other available transcatheter valves. Additionally, the expectations are even higher as we move forward to treat lower risk patients with TAVR,” Pineda continued.
The transcatheter valves that are currently commercially available have demonstrated excellent results among high, extreme, and intermediate risk patients with aortic stenosis, Pineda said.
“In my opinion, new transcatheter valves reaching FDA clearance and commercial use would need to at least match the performance of those already available. The main implication of the 2-year data is that the Lotus valve fails to do that,” Pineda told MedPage Today.
Randomized clinical trials have long compared surgery with transcatheter aortic valve replacement (TAVR) among high-risk aortic stenosis (AS) populations and found that at 1 and 2 years TAVR was superior or noninferior to surgery, the study authors noted.
Previously reported findings from the REPRISE III trial showed that the mechanically-expanded Lotus valve demonstrated no difference among the high risk population when it came to 30-day primary safety composite endpoints of stroke, life-threatening bleeding, major vascular complications, stage 2 or 3 acute kidney injury, and all-cause mortality. The Lotus valve was superior for the 1-year composite primary effectiveness endpoint of disabling stroke, moderate or worse paravalvular leaks, and all-cause mortality.
Reardon’s group evaluated 912 participants, with a mean age of 82.8 years and 51% were female, with extreme risk and severe, symptomatic aortic stenosis.
Patients were randomized 2:1 to the Lotus or CoreValve study arms at 55 centers in Australia, Europe, and North America. Echocardiographic and clinical evaluations were conducted through 2 years and will be ongoing on an annual basis through 5 years.
“One of the limitations is that it is a TAVR valve versus TAVR valve, not a TAVR valve versus surgery [comparison]. So it is really hard to say how this does against surgery, other than comparing it to how the CoreValve did against surgery, which is kind of a one-off comparison,” Reardon told MedPage Today–
The trial was funded by the Boston Scientific Corporation.
Reardon disclosed relationships with Medtronic and Boston Scientific.