Lotus and CoreValve TAVR Systems Compared in 100-Patient Study

June 25, 2015—Findings from a study that aimed to determine whether transcatheter aortic valve replacement (TAVR) with the mechanically expanded Lotus valve (Boston Scientific Corporation) offers potential benefits over treatment with the self-expanding CoreValve (Medtronic plc) were published by Robert P. Gooley, MD, et al in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions (2015;8:962–971).

The investigators assessed 100 patients (83.4 ± 4.8 years of age, 44% men, Society of Thoracic Surgeons predicted risk of mortality score of 5.5 ± 2.4). Fifty consecutive patients undergoing Lotus TAVR were enrolled and compared with 50 matched patients treated with a CoreValve. An independent core laboratory reviewed all echocardiographic data, and an independent clinical events committee adjudicated all events.

As summarized in JACC: Cardiovascular Interventions, Valve Academic Research Consortium (VARC) 2–defined device success was 84% in the Lotus cohort and 64% in the CoreValve cohort. This difference was driven by lower rates of moderate or greater aortic regurgitation in the Lotus group versus the CoreValve group (4% vs 16.7%) and higher rates of successfully implanting a single device in the correct anatomic position (100% vs 86%). Cardiovascular mortality rate (0% vs 4%), major stroke rate (4% vs 2%), and permanent pacemaker insertion rate (28% vs 18%) were not different at 30 days in the Lotus and CoreValve cohorts, reported the investigators.

The investigators concluded that in this matched comparison of high-surgical-risk patients undergoing TAVR, the use of the Lotus device was associated with higher rates of VARC 2–defined device success compared with the CoreValve, which was driven by higher rates of correct anatomic positioning and lower incidences of moderate paraprosthetic regurgitation.

The investigators advised that the clinical significance of these differences needs to be tested in a large randomized, controlled trial, such as the currently recruiting REPRISE III study, which is Boston Scientific’s pivotal study to evaluate the safety and effectiveness of the Lotus TAVR system in patients with severe aortic stenosis who are considered to be at either high or extreme risk for surgical valve replacement. The company announced the beginning of REPRISE III enrollment in September 2014.