The results from a three year clinical trial of Abbott‘s bioabsorbable drug eluting stent are in, and they look quite promising. The first 30 patients in the phase I of the ABSORB trial demonstrated “no blood clots (stent thrombosis) and no new major adverse cardiac events after six months (3.6 percent at three years),” according to a company representative. Furthermore, we are being told that “patient enrollment is complete for the Phase II of the ABSORB trial, which enrolled 101 additional patients. Initiation of a large-scale international trial called ABSORB EXTEND, which will enroll approximately 1,000 patients, is under way. The new study will enroll patients with more complex coronary artery disease from up to 100 centers internationally.”
From the press release:
Abbott is the only company with three-year clinical data evaluating the safety and performance of a fully bioabsorbable drug eluting coronary stent. Abbott’s bioabsorbable everolimus eluting coronary scaffold is made of polylactide, a proven biocompatible material that is commonly used in medical implants such as absorbable sutures. As with a metallic coronary stent, Abbott’s bioabsorbable technology is designed to restore blood flow by propping open a clogged vessel, and to provide support until the blood vessel heals. Unlike a metallic stent, however, a bioabsorbable scaffold is designed to be slowly metabolized by the body and is completely absorbed over time.
The ABSORB trial is a prospective, non-randomized (open label), two-phase study designed to enroll approximately 130 patients from Australia, Belgium, Denmark, France, the Netherlands, New Zealand, Poland and Switzerland. Key endpoints of the study include assessments of safety – MACE and stent thrombosis rates – at 30 days; six, nine, 12 and 18 months; and two years, with additional annual clinical follow-up for up to five years, as well as an assessment of the acute performance of the bioabsorbable drug eluting stent, including successful deployment of the system. Other key endpoints of the study include imaging assessments by angiography, intravascular ultrasound (IVUS), optical coherence tomography (OCT), and other state-of-the-art invasive and non-invasive imaging modalities at six months, one year and two years.
Press release: Abbott Announces Positive Three-Year Data on Its Fully Bioabsorbable Stent Technology, Initiates Large-Scale International Trial
Flashbacks: Abbott’s Bioabsorbable Stent Earns High Marks in Clinical Trial ; Bioabsorbable Stents: So Far So Good; Abbott Reports Positive Data from Study of Its Bioabsorbable Drug Eluting Stent; Dissolvable Heart Stents; Evaluation of Bioabsorbable Drug Eluting Coronary Stent Underway;