April 25, 2008 - An everolimus-eluting stent compared with a paclitaxel-eluting stent resulted in reduced angiographic late loss, noninferior rates of target vessel failure, and fewer major adverse cardiac events during one-year of follow-up in a recent study published in JAMA.
Gregg W. Stone, M.D. (Columbia University Medical Center and the Cardiovascular Research Foundation, New York) and colleagues aimed to evaluate the safety and efficacy of an everolimus-eluting stent compared with a widely used paclitaxel-eluting stent.
To compare everolimus-releasing stents with paclitaxel-releasing stent, Stone and colleagues conducted the SPIRIT III trial using a sample of 1,002 patients with coronary artery disease. During randomization, 669 patients received the everolimus-releasing stent and 333 received the paclitaxel-releasing stent. After 8 months, 436 of 564 patients who were scheduled for an angiographic follow-up completed it, and clinical follow-ups occurred after 1, 6, 9, and 12 months.
Results showed that restenosis as measured by angiography was significantly lowered in the group receiving the everolimus-releasing stent compared to the paclitaxel group. After 9 months, 7.2 percent of patients receiving everolimus stents compared to 9.0 percent receiving paclitaxel stents demonstrated target vessel failure. The risk of major adverse cardiac events (cardiac death, heart attack, or target vessel revascularization) at nine months was reduced by 44 percent in patients receiving the everolimus stent compared with the paclitaxel stent. After one year, this reduction in risk was 42 percent, and it can be explained by fewer heart attacks and target lesion revascularization procedures for patients receiving everolimus.
"This large-scale, prospective, randomized, single-blind, controlled study demonstrates that an everolimus-eluting stent compared with a widely used paclitaxel-eluting stent results in a significant reduction in angiographic in-segment late loss at eight months, with noninferior nine-month rates of ischemia-driven target vessel failure," said the researchers.
Manesh R. Patel, M.D. (Duke University, Durham, N.C.) and David R. Holmes, Jr., M.D. (Mayo Clinic, Rochester, Minn.), in an accompanying editorial, believe that the results found by Stone and colleagues are optimistic.
"These data are encouraging and would qualify as demonstrating biological plausibility and mechanistic effect at the level of a phase 2 study," they said. "What happens next with the everolimus-eluting stent is critical. The current data from the SPIRIT III trial are analogous to the initial comparisons of drug-eluting versus bare-metal stents. Restenosis is reduced with the everolimus stent, potentially with a clinical reduction in target lesion revascularization and myocardial infarction [heart attack]. The clinical effect in a broad population of patients who may be clinically exposed following device approval is unknown. Furthermore, clinical efficacy without any mandated angiographic analysis and long-term safety remain important unanswered clinical issues. Postmarketing approval registries, although complex and expensive to perform optimally, may not address both these concerns."
Comparison of an Everolimus-Eluting Stent and a Paclitaxel-Eluting Stent in Patients With Coronary Artery Disease: A Randomized Trial
Gregg W. Stone; Mark Midei; William Newman; Mark Sanz; James B. Hermiller; Jerome Williams; Naim Farhat; Kenneth W. Mahaffey; Donald E. Cutlip; Peter J. Fitzgerald; Poornima Sood; Xiaolu Su; Alexandra J. Lansky; for the SPIRIT III Investigators
JAMA (2008). 299: 1903-1913.
For more information: http://jama.ama-assn.org/cgi/content/short/299/16/1903