Abbott Laboratories, a global, broad-based health care company, announced the recent launch of its Dexamet (dexamethasone-eluting) stent in Europe following CE-mark approval, which was received in December 2002. This introduction represents a significant milestone for Abbott Vascular Devices, Abbott's cardiovascular device franchise, and its evolving drug-eluting stent program.
Abbott Vascular Devices' CE-marked Dexamet coronary stent is the first and only approved stent to couple the anti-inflammatory compound, dexamethasone, with PC Technology, an innovative biologically inert coating designed to mimic the body's own chemistry and minimize its response to implanted devices.
The Dexamet stent, available in a wide range of lengths and sizes on Abbott Vascular Devices' rapid exchange coronary stent platform, was studied in the STRIDE trial. This prospective, non-randomized European clinical trial successfully demonstrated that dexamethasone on a PC-coated coronary stent has a positive impact on late lumen loss (0.45mm) (the amount of tissue obstruction within the vessel that occurs during the healing period) and the occurrence of major adverse cardiac events (MACE) (3.3 per cent) at six-month follow up when compared to the results of the earlier DISTINCT trial, which evaluated PC-coated stents without a drug coating. With percentage improvements from the STRIDE over DISTINCT of 52.1 per cent and 80.6 per cent respectively for late loss and six-month MACE, the Dexamet stent may offer a new option for improving clinical outcomes.
"The Dexamet stent demonstrates that the clinical benefits of proven compounds, such as dexamethasone, can be further expanded through new applications," said Ivan DeScheerder, professor at the Catholic University, Leuven, Belgium, and principal investigator of the STRIDE trial. "As we understand more about the role of inflammation in heart disease, it seems likely that using the Dexamet stent, which delivers the anti-inflammatory compound directly to the vessel wall, could have a positive therapeutic effect."
Stent implantation may cause localized injury to the endothelium, triggering the body's healing response. In 30 to 50 per cent of patients, the response to the injury is exaggerated and results in restenosis, or a re-narrowing, of the artery. The restenosis process is marked by four phases — inflammation, proliferation, migration and healing. Upon implantation, the Dexamet stent elutes dexamethasone into the tissue at the time inflammation begins — thereby helping to decrease the number and activity of inflammatory cells. This may minimize the impact of an inflammatory response as a precursor to restenosis.
"There is no single solution in the drug-eluting stent arena. Our goal is to develop diversified offerings that provide the physician and patient with highly targeted options for treating coronary artery disease," said Chip Hance, vice president, vascular devices, Abbott Laboratories. "The Dexamet stent illustrates Abbott's ongoing commitment to providing options that improve the care of people with cardiovascular disease."
PC Technology is a polymer copy of the outside surface of a red blood cell. Clinical studies suggest that PC Technology acts as a versatile drug-eluting platform, providing a foundation for release of a variety of compounds that address the complex origin of restenosis. Additionally, the stents are designed with symmetrical cell configuration and consistent strut spacing to ensure even distribution of the drug around the artery and along the length of the lesion.