Patrice Wendling

May 17, 2017

PARIS, FRANCE — The first head-to-head comparison of two transcatheter aortic values shows the recently recalled Lotus Valve System (Boston Scientific) is noninferior for safety and looks superior for efficacy against the first-generation CoreValve and second-generation Evolut R valves (Medtronic) in patients at extreme or high surgical risk[1].

"The Lotus Valve is safe and effective compared with a commercially available self-expanding TAVI valve," co–principal investigator Dr Ted Feldman (NorthShore University Health System, Evanston, IL) said in a late-breaking clinical-trials session at EuroPCR 2017.

The positive results for the repositionable TAVI device, which is approved in Europe but investigational in the US, come just months after Boston Scientific recalled its Lotus values globally after reports of premature release of a pin connecting the valve to the delivery system. Following revisions to the manufacturing process to address the defect, testing has verified that tension on the pin wires is now correct, Feldman said during a press briefing.

Based on how the Safety and Efficacy Study of the Lotus Valve for Transcatheter Aortic Valve Replacement (REPRISE III) data are received by the FDA, he said there is still the potential for US approval "sometime next year."

Commenting to heartwire from Medscape, session moderator Dr Davide Capodanno (Ferrarotto Hospital, University of Catania, Italy) said the results mark a turning point in how TAVI safety and efficacy are determined.

"Before it was always comparisons of TAVI vs surgery, and now that TAVI is an established therapy, we will see more and more of these head-to-head comparisons, and what was interesting to see was that it is obvious that these valves are not equal to each other; there are some pros and some cons with each."

He added, "This is good news for doctors and means that when you have a patient you select the valve that is preferable to that specific scenario, clinically and anatomically."

Safety Details

REPRISE III enrolled 912 extreme- or high-risk patients from 55 centers and randomly assigned them 2:1 to the Lotus Valve or CoreValve, with roughly half receiving the CoreValve Classic and half the Evolut R valve.

The primary safety end point—a composite of all-cause mortality, stroke, life-threatening/major bleeding, stage 2/3 acute kidney injury, and major vascular complications at 30 days—was seen in 20.3% of 576 patients implanted with the Lotus valve and 17.2% of 297 patients implanted with the self-expanding CoreValve (noninferiority P=0.003).

The Lotus and CoreValve groups were also similar for the primary safety end point in an intention-to-treat analysis at 30 days (19.0% vs 16.2% P=0.001) and at 1 year (30.7% vs 30.2%; P=0.83).

What the composite safety end point didn't take into account, however, was the rate of pacemaker implants, which was roughly double in the Lotus vs the CoreValve group, whether measured as any new pacemaker (29.1% vs 15.8%;) or in patients with no prior pacemaker (35.5% vs 19.6%; both P<0.001).

The next-generation Lotus valve has been reengineered to shorten it from the top down, and early experience shows pacemaker rates have fallen to under 20%, Feldman said in an interview.

Of note, other 30-day outcomes favored the Lotus valve over the CoreValve, including less valve-in-valve deployment (0% vs 3%) and less valve malpositioning (0% vs 2.6%; both P<0.001).

Efficacy End Points

The rate of the primary effectiveness end point—a composite of all-cause death, disabling stroke, and moderate or greater paravalvular aortic leakage (PVL) at 1 year—was superior among the Lotus-treated patients to the CoreValve-treated patients in intention-to-treat (16.7% vs 29%) and as-treated (16.4% vs 28.6%; both P<0.001) analyses.

This was due to fewer disabling strokes but largely driven by less moderate or severe PVL (2.0% vs 11.1%; P<0.001 for superiority). Although not part of the primary end point in other TAVR trials, Feldman told reporters it was important to include because moderate and severe leak is associated with increased mortality, and the Lotus system's adaptive seal is specifically designed to minimize PVL.

Invited panelist Dr Robert Byrne (Deutsches Herzzentrum, Munich, Germany) said in an interview that the safety end point appears robust and that ultimately physicians will have to balance the risks and benefits of the two systems.

"Of course you have to figure in this efficacy end point, which was in favor of the Lotus device but included different composites, including, for example, moderate valvular regurgitation, which we all agree is not something that's desirable, but whether it should be a component of a primary end point is probably something you could discuss back and forward."

Feldman told reporters one of the most important findings of REPRISE III is the rate of disabling stroke at 3.6% for Lotus and 7.3% for CoreValve (P=0.02), which is among the lowest for Lotus but unexplainably high for CoreValve compared with prior trials.

"We are reassured by the low stroke rate in this high-risk group; there is no penalty for repositioning of the device," he said.

The study was sponsored and funded by Boston Scientific. Feldman reports institutional grant/research support and honoraria/consultation fees from Abbott, Boston Scientific, and Edwards Lifesciences.

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