Cardiovascular Business - March/April 2008 - (Page 33) “The negative results often grab the headlines, while the follow-up studies disproving the negative results don’t receive nearly enough attention.” —Stephen Ellis, MD, Interventional Cardiologist at the Cleveland Clinic latest findings, presented at the 2007 European Society of Cardiology Congress, show no difference between DES and BMS in terms of adverse side-effects when patients are followed out to four years, as opposed to three. The updated SCAAR study group analysis is based on a one- to four-year follow-up of more than 35,000 patients, who received nearly 62,000 stents: 21,480 patients with only BMS and 13,786 patients who received at least one DES. Head-to-head There is some debate regarding individual comparisons of Cypher (Cordis) and Taxus (Boston Scientific), or sirolimus-eluting stents and paclitaxel-eluting stents. Some studies suggest a slight edge for Cypher regarding in-stent restenosis and late stent thrombosis, but the difference seldom comes into play, said Ellis. The Settler et al meta-analysis, one of the most influential large registries in the last year, examined 38 randomized trials involving 18,023 patients. It compared sirolimus-eluting stents, paclitaxel-eluting stents and BMS to each other. Researchers found that the sirolimus-eluting stents were associated with lower risk of MI during follow-up than paclitaxel-eluting stents and bare metal stents, although mortality rates were similar. The paclitaxel-eluting stents at four years had a late stent thrombosis rate of 2.5 percent, whereas the sirolimus and BMS had nearly identical and slightly lower rates (Lancet 2007;370[9591]:937-948). Ellis said the Endeavor stent (Medtronic) is not nearly as efficacious as Cypher and Taxus to prevent restenosis and whether it’s safer is debatable. Safety and efficacy are important issues but these stents also need to prove cost-effective if their usage is to experience an uptick. To drill down to solid cost-effectiveness evidence, one needs to examine the comparator of either medical therapy or BMS, which will produce very different outcomes, according to William Weintraub, MD, chair of cardiology at Christiana Care Health System and director of the Christiana Center for Outcomes Research. When comparing DES with BMS, researchers should consider the differences in mortality and non-fatal events like MI, of which those differences are slight, Weintraub said. There are, however, DES Utilization 100 90 80 60 40 20 0 2003 2007 62 DES Utilization $300 Price Differential: DES vs. BMS DES BMS $2,000 despite the low cost of bare metal stents, cardiologists prefer to use drugeluting stents because of lower instent restenosis rates. At their height of popularity in 2003, drug-eluting stents were being deployed into 90 percent of patients receiving stents in United states. Today, it’s as low as 62 percent. CardiovascularBusiness.com Cardiovascular Business 33 http://CardiovascularBusiness.com
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