One-Year Data Presented for Abbott Vascular's ABSORB Japan Trial

September 1, 2015—Abbott Vascular announced positive 1-year clinical results from ABSORB Japan, a multicenter, randomized trial comparing the safety and effectiveness of the company’s fully dissolving Absorb coronary stent to the company’s Xience permanent drug-eluting stent. The trial was conducted in 38 sites in Japan and enrolled 400 patients with coronary artery disease.

The results were presented at a late-breaking session at the European Society of Cardiology’s ESC Congress 2015, being held August 29 to September 2 in London, United Kingdom. The data were published simultaneously online in the European Heart Journal.

Abbott Vascular reported that for ABSORB Japan’s primary endpoint, the rate of target lesion failure was 4.2% for Absorb versus 3.8% for Xience (noninferiority P < .0001, superiority P = .85). The major secondary endpoint of angiographic in-segment late lumen loss, with 95% angiographic follow-up at 13 months, was 0.13 ± 0.30 mm for Absorb versus 0.12 ± 0.32 mm for Xience (noninferiority P < .0001, superiority P = .74).

Additionally, the rate of stent thrombosis for both Absorb and Xience was 1.5% for definite and probable stent thrombosis (P = 1.0), and the repeat procedures rates were 2.6% with Absorb and 2.3% with Xience (P = 1.0).

ABSORB Japan is designed to support regulatory approval of the Absorb device in Japan. Abbott Vascular completed its submissions for regulatory approval of Absorb in Japan, as well as in the United States. Abbott Vascular has advised that Absorb is an investigational device and is not approved for commercial use in either country.

Takeshi Kimura, MD, principal investigator of the ABSORB Japan study, commented in Abbott Vascular’s press release, “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.” Dr. Kimura is director, Department of Cardiovascular Medicine, at Kyoto University Hospital in Kyoto, Japan.

Abbott Vascular also announced that 1-year pivotal data from the ABSORB III and ABSORB China trial will be presented during late-breaking sessions at TCT 2015, the 27th annual Transcatheter Cardiovascular Therapeutics scientific symposium being held October 11–15 in San Francisco, California.

Also at TCT 2015, Abbott will present 2-year data from ABSORB II. Last year, positive 1-year clinical results from ABSORB II, comparing the safety and effectiveness of Absorb to Xience, showed that overall clinical outcomes for Absorb were comparable to XIENCE. The trial, conducted primarily in Europe, included 501 people with coronary artery disease. The Absorb device, which received European CE Mark approval in January 2011, is available in more than 90 countries worldwide.