Abbott Laboratories’ latest head-to-head data of its Amplatzer Amulet heart device and Boston Scientific’s Watchman show more mixed results in safety metrics for the competing products.
The Amulet left atrial appendage occluder device had lower instances of cardiovascular and all-cause death factors than Watchman at three years, according to data presented Saturday at the TCT 2022 conference. However, Amulet had higher instances of ischemic stroke and major bleeding than Watchman.
The trial showed that the rate of cardiovascular death was 6.6% with Amulet and 8.5% with Watchman, and instances of all-cause death were 14.6% with Amulet and 17.9% with Watchman.
Meanwhile, instances of major bleeding were 16.1% for patients given Amulet and 14.7% for patients given Watchman. Ischemic stroke and systemic embolism rates were also higher for Amulet at 5% than Watchman at 4.6%.
The results of the three-year trial, which consisted of over 1,800 patients, is a follow-up to 18-month results released in August 2021.
In the first 18 months of the trial, there were 63 deaths among patients given Amulet compared to 85 with Watchman. Between 18 months to three years, the numbers were more comparable, with 70 deaths among patients given Amulet and 69 for Watchman.
The latest results add to the growing rivalry between Boston Scientific and Abbott in the left atrial appendage closure (LAAC) market.
LAAC is a procedure to prevent blood from building up in a small pouch, or appendage, located in the left atrium of the heart, where the blood can then clot and cause a stroke if those clots are pumped through the body and reach the brain.
Devices like Watchman and Amulet close up the left atrial appendage, preventing blood from pooling and clotting in the appendage.
Boston Scientific had a monopoly in the space with its Watchman device until last year when Abbott’s Amulet was approved by the Food and Drug Administration. Electrophysiologists predicted that Amulet would quickly take market share from Watchman, but Wall Street analysts said that a second device could help boost the entire market.
While Abbott is comparing Amulet to Watchmen in its three-year study, it is not going head-to-head with the latest version of the device, Watchman FLX. The trial compares Amulet with Watchman 2.5.
In November 2021, the first head-to-head clinical trial for Amulet and Watchman FLX also showed mixed results.
Boston Scientific released data in May that showed Watchman FLX performed better than previous versions of the device, which could boost the product as Amulet adoption grows.
Abbott also presented data at TCT 2022 showing improved procedural efficacy and safety outcomes for Amulet when high-resolution scans of patients' hearts were used, which were generated by FEops HEARTguide, according to a Saturday press release.