A stent that dissolves leaving 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, has received a positive response following a trial in Japan.
The one-year clinical results from ABSORB Japan, a multi-center, randomized trial, were presented at ESC Congress and published simultaneously in the European Heart Journal. The study considered the safety and effectiveness of Abbott's fully dissolving Absorb heart stent when compared to XIENCE, Abbott's permanent drug eluting stent.
The trial was conducted in 38 sites in Japan and involved 400 people with coronary artery disease, the most common form of heart 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 of CAD. However, unlike a more traditional metallic stent, which permanently restricts vessel movement and limits future treatment options, Absorb naturally dissolves, meaning there’s no restrictions once it has repaired the vessel.
The results follow on from last year’s clinical results from ABSORB II, the world's first prospective, randomized, controlled trial comparing the safety and effectiveness of Absorb to XIENCE. At one year, overall clinical outcomes for Absorb were comparable to XIENCE. The trial, conducted primarily in Europe, included 501 people with CAD.
Other key findings of ABSORB Japan include:
- A primary endpoint of target lesion failure (TLF) of 4.2% for Absorb and 3.8% for XIENCE
- The major secondary endpoint of angiographic in-segment late lumen loss (LLL), with 95% angiographic follow-up, at 0.13±0.30 mm for Absorb and 0.12±0.32 mm for XIENCE
- The rates of stent thrombosis (ST) for Absorb and XIENCE were both 1.5% for definite and probable ST (p=1.0)
- Rate of repeat procedures was infrequent for both devices at 2.6% with Absorb and 2.3% 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."
Abbott will present one-year pivotal data from ABSORB III and ABSORB China at late-breaking sessions, as well as two-year data from ABSORB II.