Data from the Reprise III study, billed as the 1st head-to-head pivotal trial comparing transcatheter aortic valve replacements, were released today at the annual EuroPCR meeting in Paris. The 912-patient study compared Lotus with the CoreValve and CoreValve Evolut devices in high- and extreme-risk patients.
The primary efficacy endpoint was the composite rate of death, disabling stroke and moderate or greater paravalvular leakage at 1 year; the primary safety endpoint was a composite rate of all-cause mortality, stroke, life-threatening and major bleeding, stage 2 or 3 acute kidney injury or major vascular complications at 30 days.
Boston Scientific said the Lotus valve showed superiority on the efficacy endpoint of 16.7%, compared with 29.0% for the CoreValve arm. On the safety endpoint, Lotus showed non-inferiority to CoreValve, the Marlborough, Mass.-based company said.
A secondary endpoint, the rate of moderate to severe PVL, was 2.0% for Lotus and 11.1% for the CoreValve-treated cohort, Boston Scientific said.
“We are very excited by the performance of the Lotus valve system in this trial as it represents a crucial piece of clinical evidence for the Lotus platform,” global CMO Dr. Ian Meredith said in prepared remarks. “We believe that these data, along with upcoming findings to be shared from the Respond and Respond Extension studies, can further illustrate the unique clinical benefits that this system offers physicians for the treatment of patients.”
“The excellent results seen in this large randomized trial, particularly the superior performance in efficacy and the continued demonstration of low PVL rates, further establish the advantages of the Lotus valve system,” added Reprise III investigator Dr. Ted Feldman of the NorthShore University HealthSystem in Evanston, Ill. “With the Lotus valve system, I have confidence that I can position the valve accurately in every case and achieve good outcomes for my patients.”
A Medtronic spokesman told MassDevice.com that it’s “difficult to draw firm conclusions from this study as it was conducted with 1st-generation technology and reported some results inconsistent with contemporary findings.”
“It should also be noted that the difference in disabling stroke is inconsistent with published data from the CoreValve and Evolut R pivotal trials: As the PI in the study stated from the podium, the stroke outcome was ‘probably a chance finding.’ Further, latest-generation Evolut Pro has shown no moderate/severe PVL (0%), low rates of disabling stroke (1.7%) and low pacemaker rate (10%) at 30 days as presented at ACC17,” he wrote. “Given all the limitations and unknowns surrounding this study right now, we trust that the physician community will further evaluate the study findings when this is published in a peer-review journal and make their own determination of the study’s clinical relevance.”