Boston Scientific Lotus valve demonstrated superior efficacy in a head-to-head study against Medtronic's CoreValve, but more Lotus patients needed a permanent pacemaker compared to the CoreValve patients.

Amanda Pedersen

Needham & Company's Mike Matson said he sees potential for Boston Scientific's TAVR sales to eventually exceed $1 billion. The global TAVR market is expected to reach $4 billion by 2020.

It hasn't been easy for Boston Scientific to find its place in the fertile soil otherwise known as the transcatheter aortic valve replacement  (TAVR) market. Earlier this year the Marlborough, MA-based company pulled all its Lotus valves from the market after getting reports of a mechanical problem with a pin that connects the valve to the delivery system. The problem was similar to an earlier issue the company had with its Lotus Edge valve system that received a CE mark last September.

But the company caught a fresh break this week with results from a head-to-head pivotal study in which the Lotus valve system demonstrated superior efficacy to Medtronic's CoreValve platform at one year.

The REPRISE III trial compared the Lotus valve to CoreValve (roughly half CoreValve Classic, and half CoreValve Evolut R). It is the first head-to-head pivotal study comparing two different TAVR platforms, Boston Scientific said. The multicenter, randomized controlled trial included 912 patients from the United States, Europe, Canada, and Australia with severe aortic stenosis who were considered to be at high or extreme risk for surgical valve replacement.

On the primary effectiveness endpoint, which was a composite of all-cause death, disabling stroke, and moderate or greater paravalvular aortic leakage (PVL) at one year, Lotus was superior compared to CoreValve (16.7% vs. 29.0%, p<0.0001). More specifically, moderate or greater PVL rate was 2.0% with Lotus compared to CoreValve at 11.1%, and the disabling stroke rate with Lotus was 3.6% compared to CoreValve at 7.1%. The rest of the efficacy endpoint components (all-cause mortality, cardiac death, and stroke) were non-inferior.

The study's primary safety endpoint was a composite of all-cause mortality, stroke, life-threatening and major bleeding events, stage two/three acute kidney injury, or major vascular complications through 30 days. In that regard, the results showed Lotus was non-inferior to CoreValve.

On the downside for Boston Scientific, 29.1% of Lotus patients had a permanent pacemaker implanted after their TAVR procedure, whereas only 15.8% of CoreValve patients needed a permanent pacemaker following TAVR. Analysts following the space noted that the higher pacemaker rate was expected based on earlier trials, and that design and technique changes seem to be significantly reducing the permanent pacemaker rate, likely to the 8% to 12% range.

Data presented for 21 Lotus Edge patients at the Transcatheter Cardiovascular Therapeutics meeting last November showed a permanent pacemaker rate of 9.5%. Analysts are also expecting the RESPOND extension study of Lotus with Depth Guard, which will be presented later this week at EuroPCR, to show a lower rate of permanent pacemakers.

Boston Scientific said it expects to bring the Lotus valve platform back to the market in Europe and other regions where the device is approved in the fourth quarter. The company could also file for FDA approval of the Lotus system as early as the fourth quarter.

Mike Matson, an analyst at Needham & Company, said the REPRISE III results are positive for Boston Scientific because they should support FDA approval and lead to significant market share gains. Matson said the TAVR market is on track to exceed $4 billion by 2020.

The company also completed its acquisition of Symetis, which gives it two additional TAVR products (Acurate TA and Acurate neo/TF) that are currently on the market in Europe.

Matson said he sees potential for Lotus sales to exceed $500 million, and for Boston Scientific's overall TAVR sales to eventually exceed $1 billion.

Ian Meredith, MD, executive vice president and global chief medical officer for Boston Scientific, said the REPRISE III trial results represents a crucial piece of clinical evidence for the Lotus platform. He said the data, along with findings from the RESPOND and RESPOND Extension studies that will be released over the next few days, should further illustrate the clinical benefits that the system offers.

"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," said Ted Feldman, MD, director of the cardiac catheterization laboratory at Evanston, IL-based NorthShore University HealthSystem.

Feldman served as a co-investigator of the REPRISE III trial. "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," he said.

Amanda Pedersen is Qmed's news editor. Contact her at [email protected].

[Image courtesy of Pixabay]