It’s the European Society of Cardiology’s annual bash in London this week, hence the flurry of heart-related news items. One such comes from Abbott, which is touting one-year clinical results from its ABSORB Japan study.
Often covered on our pages, Abbott’s Absorb stent is made of a naturally dissolvable material that leaves behind a restored vessel free of a permanent implant. The aim is to implant a device that functions like a permanent, metallic stent by opening a blocked artery in the heart, restoring blood flow and providing relief from symptoms of CAD, but will ultimately disappear, leaving the vessel able to flex, pulse and dilate in response to various demands on the heart, based on people’s lifestyle and activities.
The question then, is whether a temporary stent will be as safe and effective as its metallic forebear, hence the ABSORB series of studies. Last year, Abbott announced positive one-year clinical results from ABSORB II, the world’s first prospective, randomized, controlled trial comparing the safety and effectiveness of its Absorb™ stent to XIENCE, the company’s market-leading, permanent drug eluting stent. At one year, overall clinical outcomes were comparable. The trial, conducted primarily in Europe, included 501 people with CAD.
The newly published data comes from the ABSORB Japan study, intended to support Abbott’s quest for approval of the device in that country. It is another multi-center, randomized trial compares the safety and effectiveness of Abbott’s fully dissolving Absorb stent to XIENCE ®. The trial was conducted in 38 sites in Japan and enrolled 400 people with coronary artery disease, the most common form of heart disease.
Abbott tells us the results will be featured at a late-breaking session at the ESC Congress 2015, published simultaneously in the European Heart Journal.
Results show 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).
“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,” said Takeshi Kimura, M.D., Ph.D., director, Department of Cardiovascular Medicine, Kyoto University Hospital, Japan, and principal investigator of the ABSORB Japan study.
“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.”
“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,” said Charles Simonton, M.D., FACC, FSCAI, chief medical officer and divisional vice president, Medical Affairs, vascular, Abbott. “The fact that Absorb completely dissolves means that the restored vessel has the potential to move as it needs to, based on lifestyle activities.”
Source: PR Newswire