TAVI: Boston Scientific’s Lotus valve tops Medtronic’s CoreValve – study

Data from a study of Boston Scientific‘s (NYSE:BSX) Lotus Valve showed a greater device success rate than Medtronic‘s (NYSE:MDT) CoreValve in high-risk transcatheter aortic valve replacement patients.

The single-center, non-randomized study, published this month in the journal JACC: Cardiovascular Interventions, compared outcomes from 50 high-risk TAVI patients treated with the Lotus valve and 50 similar patients treated with Medtronic’s self-expanding CoreValve device.

Success rates were higher at 30 days in the Lotus group, at 84%, versus 64% with CoreValve, according to the study.  These results were driven by higher rates of correct positioning and no more than mild aortic regurgitation, according to the study.

Cardiovascular mortality rates were 0% for the Lotus and 4% for the CoreValve, though the CoreValve had a 2% rate of major stroke, compared to 4% with Lotus.

“In this matched comparison of high surgical risk patients undergoing transcatheter aortic valve replacement, the use of the Lotus device was associated with higher rates of Valve Academic Research Consortium 2–defined device success compared with the CoreValve. This was driven by higher rates of correct anatomic positioning and lower incidences of moderate paraprosthetic regurgitation. The clinical significance of these differences needs to be tested in a large randomized, controlled trial,” the authors wrote.

Marlborough, Mass.-based Boston Scientific’s ongoing Reprise III trial, launched in 2014 with a planned enrollment of just more than 1,000 patients, is slated to compare the Lotus and CoreValve out to 1 year.

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