Abbott’s Bioabsorbable Stent Earns High Marks in Clinical Trial

The Lancet just published results from a two year clinical trial of Abbott‘s bioabsorbable drug eluting stent. The study has shown that the implant is completely absorbed by the body after two years, as documented by CT scanning, and none of the enrolled patients had an episode of stent stenosis in the 2 year period.
From the study abstract:

Methods
In this prospective, open-label study we enrolled 30 patients who had either stable, unstable, or silent ischaemia and a single de-novo lesion that was suitable for treatment with a single 3·0×12 mm or 3·0×18 mm stent. Patients were enrolled from four academic hospitals in Auckland, Rotterdam, Krakow, and Skejby. The composite endpoint was cardiac death, myocardial infarction, and ischaemia-driven target lesion revascularisation. Angiographic endpoints were available for 26 patients and intravascular-ultrasound endpoints for 24 patients. Clinical endpoints were assessed in all 30 patients at 6 and 12 months. In a subset of 13 patients, optical coherence tomography was undertaken at baseline and follow-up. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00300131.
Findings
Procedural success was 100% (30/30 patients), and device success 94% (29/31 attempts at implantation of the stent). At 1 year, the rate of major adverse cardiac events was 3·3%, with only one patient having a non-Q wave myocardial infarction and no target lesion revascularisations. No late stent thromboses were recorded. At 6-month follow-up, the angiographic in-stent late loss was 0·44 (0·35) mm and was mainly due to a mild reduction of the stent area (−11·8%) as measured by intravascular ultrasound. The neointimal area was small (0·30 [SD 0·44] mm2), with a minimal area obstruction of 5·5%.
Interpretation
This study shows the feasibility of implantation of the bioabsorbable everolimus-eluting stent, with an acceptable in-stent late loss, minimal intrastent neointimal hyperplasia, and a low stent area obstruction.

Press release: The Lancet Publishes Two-Year Results of Abbott’s Fully Bioabsorbable Drug Eluting Stent
Abstract in The Lancet…
Flashback: FDA Approves Abbott’s Everolimus Eluting Stent
UPDATE (3/17/09): Please note that the device used in the study is not XIENCE V drug eluting stent, as we have previously reported. XIENCE is Abbott’s drug eluting stent, and it is not the bioabsorbable stent. We appologize for the confusion. The image of the device has been updated.