Abbott announces results of its naturally dissolving stent
First Trial in Japan Meets Primary Endpoint
Abbott announced positive one-year clinical results from ABSORB Japan, a multi-center, randomized trial comparing the safety and effectiveness of Abbott's fully dissolving Absorb™ heart stent to XIENCE ®, Abbott's market-leading, permanent drug eluting stent. The trial was conducted in 38 sites in Japan and enrolled 400 people with coronary artery disease.
Absorb is a first-of-its-kind device that functions like a permanent, metallic stent by opening a blocked artery in the heart, restoring blood flow and providing relief from symptoms. However, unlike a metallic stent, which permanently restricts vessel movement and limits future treatment options, Absorb is made of a naturally dissolvable material that leaves behind a restored vessel free of a permanent implant, with the potential to flex, pulse and dilate in response to various demands on the heart.
Key findings of ABSORB Japan include:
- A primary endpoint of target lesion failure (TLF) of 4.2 percent for Absorb and 3.8 percent for XIENCE (non-inferiority p<0.0001, superiority p=0.85). TLF is a composite of heart disease-related deaths, heart attacks attributed to the treated vessel, and repeat procedures within the treated lesion caused by ischemia (lack of oxygen in the treated vessel), powered for non-inferiority at one year.
- The major secondary endpoint of angiographic in-segment late lumen loss (LLL), with 95 percent angiographic follow-up, at 0.13+0.30 mm for Absorb and 0.12+0.32 mm for XIENCE (non-inferiority p<0.0001, superiority p=0.74). LLL measures the difference in millimeters between the diameter of the treated vessel after a procedure compared to a follow-up angiogram, in this case at 13 months.
- The rates of stent thrombosis (ST) for Absorb and XIENCE were both 1.5 percent for definite and probable ST (p=1.0).
- Rate of repeat procedures was infrequent for both devices at 2.6 percent with Absorb and 2.3 percent with XIENCE (p=1.0).
Currently, Absorb is an investigational device in the United States and Japan, and it is not approved for commercial use in these countries.
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