Abbott (NYSE:ABT) today released positive data from a Japanese study of its Absorb fully dissolving heart stent that pitted it against its own Xience permanent drug eluting stent. The results were announced at the European Society of Cardiology’s annual meeting in London.
The 400 patient multi-center, randomized Absorb study, published in the European Heart Journal, set out to compare the safety and effectiveness of the 2 stents in patients with coronary artery disease.
The study reported a rate of target lesion failure, the primary endpoint of the trial, of 4.2% for the Absorb stent and 3.8% for its Xience stent at 1 year. Target lesion failure includes heart disease-related deaths, heart attacks due to the treated vessel and repeat procedures.
Rates of angiographic late lumen loss, the trial’s secondary endpoint, were also similar between the 2 stents, according to the study, varying by 0.02 mm at maximum.
Stent thrombosis rates were similar between the cohorts at 1.5%, and the rate of repeat procedures was 2.6% for the Absorb group and 2.3% for the Xience group.
“The results of the Absorb Japan study continue to affirm that Absorb shows strong performance near-term and preserves the vessel for potential future procedures. Fully dissolving heart stents are the next evolution in percutaneous coronary intervention and are designed to leave nothing behind in the body, thus restoring the vessel more naturally over time, which cannot be achieved with a permanent drug eluting stent,” principal investigator Dr. Takeshi Kimura of Japan’s Kyoto University Hospital said in a press release.
“The Absorb Japan results contribute to the growing body of Absorb data, providing further clinical evidence that the fully dissolving stent initially functions like a permanent, metallic stent by opening up blocked heart vessels and restoring blood flow. However, unlike a metallic drug eluting stent, Absorb naturally dissolves over time, leaving nothing behind. The fact that Absorb completely dissolves means that the restored vessel has the potential to move as it needs to, based on lifestyle activities,” vascular medical affairs chief medical officer Dr. Charles Simonton said in a prepared statement.
In May, Abbott won CE Mark approval in the European Union for a next-generation delivery device for its Absorb stent. The GT1 upgrade consists of an updated delivery catheter, which Abbott said incorporates several improvements.
