Boston Scientific (NYSE:BSX) shares fell over 3% following the release of SCOPE II trial data at TCT Connect 2020. The data showed that patients using its Acurate Neo heart valve had rates of cardiac arrest significantly higher than those who received Medtronic’s (NYSE:MDT) CoreValve Evolut valve.
The SCOPE II trial is a randomized, 23-site study of 796 patients ages 75 years or older with the primary endpoint of death or stroke at 1 year. 15.8% of patients with the Boston Scientific Accurate Neo and 13.9% of patients who received the Medtronic reached the primary endpoint of death or stroke at 1 year (P = 0.0549).
There was no difference between the two devices in all-cause mortality, but moderate or severe levels of aortic regurgitation at 1 month was greater in patients who received the Acurate Neo device than those that received the CoreValve Evolut (10.0% with Accurate Neo vs 3.0% with CoreValve Evolut; P = 0.002).
Lead investigator Dr. Corrado Tamburino of the University of Catania, Italy, told TCTMD: “Cardiac death is a secondary endpoint and as always it may suffer from lack of power and also misclassification in the absence of autopsy 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.”
During last year’s TCT Connect Conference, Boston Scientific expressed optimism that the FDA would approve the Acurate Neo device in 2021, but at this year’s event, the Company stated that it now expects to start selling in the US in 2024.