Results from one year study of Absorb dissolvable heart stent in coronary artery disease- Abbott

Abbott announced positive one-year clinical results from ABSORB Japan, a multi-center, randomised 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, the most common form of heart disease. 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). In addition, 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). Data also showed that the rates of stent thrombosis (ST) for Absorb and XIENCE were both 1.5 percent for definite and probable ST (p=1.0). Finally, rate of repeat procedures was infrequent for both devices at 2.6 percent with Absorb and 2.3 percent with XIENCE (p=1.0). The results were featured at a late-breaking session at ESC Congress 2015.

Comment: Absorb is currently available in more than 70 countries worldwide. The company recently received CE mark approval in the EU and completed its submission for regulatory approval of Absorb in Japan. It plans to submit reports, including data from pivotal trials, for regulatory approvals in the United States and China in the coming months.