Shares in Boston Scientific (NYSE:BSX) slid nearly 4% on news that the rates of cardiac death in patients implanted with its Acurate Neo heart valve were significantly higher than those in patients who received Medtronic’s (NYSE:MDT) CoreValve Evolut.
The head-to-head SCOPE II study, presented today at TCT Connect, the 32nd annual scientific symposium of the Cardiovascular Research Foundation, pitted the two supra-annular, self-expanding TAVR devices against one another in treating patients with symptomatic severe aortic stenosis.
SCOPE II is a randomized, noninferiority study conducted at 23 high-volume centers in Europe. The study included 796 patients aged 75 years or older (mean 83.2 years; 68% women). The primary endpoint of death or stroke at 1 year occurred in 15.8% of patients treated with Acurate Neo and 13.9% of those who received CoreValve Evolut, a difference that failed to meet the trial’s statistical benchmark for noninferiority (P = 0.0549), according to a report by TCTMD.
The implants yielded no difference in all-cause mortality, but moderate or severe aortic regurgitation at 30 days was significantly higher in patients who received the Acurate Neo device (10.0% vs 3.0% with CoreValve Evolut; P = 0.002), the report said. However, the study showed Acurate Neo device was associated with significantly less need for a new permanent pacemaker at 30 days (11.% vs 18.0% with CoreValve Evolut; P = 0.0027).
“Cardiac death is a secondary endpoint and as always it may suffer from lack of power and also misclassification in the absence of autopsy,” lead investigator Dr. Corrado Tamburino of the University of Catania, Italy, told TCTMD. “Although we cannot establish a conclusive link based on our data, a hypothesis is that there was more paravalvular leak with Acurate, and the link between paravalvular leak and cardiac death is well-known in the literature. At 1 year, the most common cause of cardiac death in the study cohort was adjudicated by the clinical event committee as heart failure.”
This is the second time Acurate Neo has come up short against the competition. In 2019, Acurate Neo failed to establish noninferiority when compared with Edwards Lifesciences’ Sapien 3 in the SCOPE 1 trial.
Acurate Neo was approved in Europe in 2014, but is not available in the U.S. Dr. Howard Herrmann of the Hospital of the University of Pennsylvania in Philadelphia told TCTMD that Acurate Neo may protrude less into the ventricle than CoreValve Evolut and has less radial force, it had more adverse effects. One-year data from SCOPE I will be presented this Saturday during the late-breaking clinical science session at the virtual conference. Herrmann was not involved in either study.
At 30 days, there was a significantly increased risk of cardiac death among patients treated with Acurate Neo (3.0% vs 1.0% with CoreValve Evolut; P = 0.03), and this higher risk of cardiac death was still evident at 1 year (8.0% vs 4.0% with CoreValve Evolut; P = 0.01). As individual endpoints, there was no difference in the risk of all-cause mortality or stroke at 30 days or 1 year.
Boston Scientific recently launched the second-generation device, Acurate Neo2, to selected centers in Europe. The device has a new annular sealing technology designed to better fit irregular, calcified anatomies and prevent paravalvular regurgitation, according to the company. Both Herrmann and Tamburino suggested to TCT MD that if the sealing technology can reduce the rate of aortic regurgitation, it may influence mortality at 30-days and 1-year.
BSX closed down 3.99% at $39 per share.