Bioabsorbable Drug Eluting Coronary Stent Shows Promise

Positive results from a follow-up clinical trial of a novel bioabsorbable everolimus-eluting stent (BVS) show that it could provide a breakthrough treatment for heart disease with the potential to improve patients' lives.

Researchers at the ThoraxCentre at Erasmus University Hospital (Rotterdam, The Netherlands), Auckland City Hospital (New Zealand), and other institutions have published the one year results of the ABSORB trial; a prospective, nonrandomized (open-label) study to asses the performance of a fully bioabsorbable drug eluting stent for the treatment of coronary artery disease, with projected annual follow-up for up to five years. The study has so far enrolled 30 patients who had stable, unstable, or silent ischemia and a single de-novo lesion that was suitable for treatment with a single 3·0×12 mm or 3·0×18 mm stent. The data demonstrated no stent thrombosis, no clinically driven target lesion revascularizations, and a low 3.3% rate of major adverse cardiac events (MACE) in the 30 patients at one year. Late loss, a measure of reduction in vessel lumen diameter after stenting, was 0.44 mm. At one year, the overall MACE rate in the ABSORB trial was consistent with results at 6 months. The BVS, under development by Abbott (Abbott Park, IL, USA; www.abbott.com), has so far demonstrated 100% procedural success and 94% device success in the trial. The follow-up data study was published in the March 15, 2008, issue of The Lancet.

"Patients and physicians like the idea of a stent that does its job and is then absorbed away,” said co- principal investigator in the ABSORB trial John A. Ormiston, M.B., Ch.B., a cardiologist at Auckland City Hospital. "Abbott's bioabsorbable stent has the potential to hold an artery open long enough for healing to occur, and we would expect an artery that is healed to function as it did before it became diseased.”

"Abbott's bioabsorbable everolimus eluting stent has demonstrated excellent clinical safety out to one year in patients with coronary artery disease,” added co-principal investigator Patrick W. Serruys, M.D., Ph.D., a professor of interventional cardiology at the Thoraxcentre. "The positive results from this clinical trial form a strong basis for the development of additional bioabsorbable stent platforms with the potential to eliminate some of the restrictions posed by metallic stents in areas such as vessel imaging and vessel remodeling.”

The Abbott BVS has a backbone of poly-L-lactic acid that provides the support and a coating of poly-D,L-lactic acid that contains and controls the release of the antiproliferative agent everolimus. Polylactic acid is a proven biocompatible material that is commonly used in medical implants such as dissolvable sutures.


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Erasmus University Hospital
Auckland City Hospital