Data for New Drug-Coated Stent Published
The Journal of the American Medical Association (JAMA) included a new report to evaluate the efficacy of a new drug-coated stent, the Xience stent, from Abbott Laboratories. The newest stent is coated with everolimus. In the trial, the study was compared to the Taxus stent.
Findings indicate that the Xience stent is superior to the Taxus with respect to both effectiveness and overall safety with one year of follow-up data. Xience, however, had a more dramatic decrease in the reduction of major cardiovascular events, including heart attack. The researchers have yet to collect sufficient data to compare mortality rates between patients treated with the two types of stents.
The study reported in JAMA was funded by Abbott, the stent manufacturers, and completed at over 65 different facilities across the country. Over 1,00 patients were recruited to participate in the trial; 669 had a Xience stent implanted and 333 had a Taxus stent. The majority of the patients had relatively simple artery blockages.
After nine months of follow-up, 9 percent of patients with the Taxus stent implanted had re-closure of the arteries compared to 7.2 percent of patients with the Xience stent. The intent of drug coated stents is to reduce the reclosure of arteries after implantation. The adverse event rate was lower in the Xience group, 6 percent, than that in the Taxus, 10.3 percent after 12 months of follow-up.
The new Xience stent has been recommended for approval by an advisory panel at the Food and Drug Administration. A final decision by the federal agency is expected late this year. The FDA has already requested for a longer follow-up period. Information about the Xience was presented last year at the annual American College of Cardiology meeting, as described on HospitalBuyer.
Some of the supposed advantages of the Xience include the fact that the stent and the drug coating are thinner than the three other drug coated stents available in the U.S. market. One of the study authors noted that the Xience is pliable, in addition to being easy to use during placement.
April 25, 2008 Related topics: New Technology & Innovation, Quality, Safety, Errors, Cardiology