Feb. 4, 2008 A comparison of use of the first two commercially available drug-releasing coronary stents (for the medications sirolimus and paclitaxel) among patients in "everyday clinical practice" indicates no significant differences for outcomes such as heart attack or cardiac death, according to a new study.
Drug-releasing (eluting) stents are used for percutaneous coronary interventions (PCI) to help reduce the rate of re-narrowing of a coronary artery, according to background information in the article. Approval of drug-eluting coronary stents was based on results of relatively small trials of selected patients; however, in routine practice, stents are used in a broader spectrum of patients.
Anders M. Galløe, M.D., of the University of Copenhagen, Denmark, and colleagues compared the efficacy and safety of sirolimus-eluting and paclitaxel-eluting stents in a study designed to reflect everyday clinical practice. The SORT OUT II trial included 2,098 men and women treated with PCI and randomized to receive either sirolimus-eluting (n = 1,065) or paclitaxel-eluting (n = 1,033) stents at five university hospitals in Denmark. The patients were initially treated for ST-segment elevation myocardial infarction (STEMI; a certain pattern on an electrocardiogram following a heart attack), non-STEMI or unstable angina pectoris, and stable angina.
The researchers found that the proportion of patients experiencing major adverse cardiac events, such as cardiac death, heart attack, target lesion revascularization, or target vessel revascularization, were 98 (9.3 percent) for the sirolimus-eluting stent group and 114 (11.2 percent) for the paclitaxel-eluting stent group. The stent thrombosis rates were 27 (2.5 percent) in the sirolimus-eluting stent group and 30 (2.9 percent) in the paclitaxel-eluting stent group.
"In conclusion, the SORT OUT II trial found no statistical significant differences in the primary or secondary end points between the sirolimus-eluting stent and paclitaxel-eluting stent in everyday clinical practice among patients undergoing PCI for ST-segment elevation myocardial infarction, non--ST-segment elevation myocardial infarction or unstable angina pectoris, and stable angina. The rates of serious adverse events, cardiac death, acute myocardial infarction, and stent thrombosis were low, suggesting that, at least when considering 18 months of follow-up, the use of drug-eluting stents in the general population may be safe," the authors write.
Journal reference: JAMA. 2008;299:409-416.
Editorial: Effectiveness of Drug-Eluting Stents in Real-World Patients
In an accompanying editorial, Debabrata Mukherjee, M.D., and David J. Moliterno, M.D., of the University of Kentucky, Lexington, comment on the findings of Galløe and colleagues regarding the comparison of stents.
"In 2008, clinicians will have additional choices of drug-eluting stents with the availability of second-generation devices--namely, the everolimus-eluting stent, which yielded similar or fewer major adverse cardiac events among patients as compared with the paclitaxel-eluting stent, and the zotarolimus-eluting stent, which was shown to be noninferior to the paclitaxel-eluting stent. The ongoing choice of a drug-eluting stent will likely depend on multiple factors that will include safety, effectiveness, deliverability, and--given recent cuts in reimbursement--cost of the device."
"The current literature for drug-eluting stents can be challenging to interpret because of differing criteria for study enrollment, definitions for acute stent thrombosis and other clinical end points, and varied intervals of dual antiplatelet therapy and follow-up after stent implantation. Similarly, current real-world registries are usually limited by lack of valid control groups and often use historical controls. A large longitudinal database for patients receiving these various drug-eluting stents with open entry to fully capture all procedures may help determine the safest and most effective revascularization practice possible and should help guide future recommendations," they write.
Reference for editorial: JAMA. 2008;299:454-455.
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