Cordis Corp., the stent-making subsidiary of Johnson & Johnson (NYSE:JNJ), put a cap on the 2010 Transcatheter Cardiovascular Therapeutics conference in Washington, D.C., with a final volley in the stent wars: A study indicating that its venerable Cypher stent is just as safe and effective as the market-leading Xience V made by rival Abbott (NYSE:ABT).
Citing results from the Sort Out IV trial, a head-to-head comparison of the two drug-eluting stents, Cordis chief scientific officer Dr. Campbell Rogers said the study confirms “the excellent sustained clinical outcomes consistently seen over the last 10 years.”
“The Sort Out consortium has used Cypher stent as the comparator in a number of studies and, to date, no newer stent has proven a benefit over Cypher stent in terms of safety or efficacy,” Rogers said in prepared remarks.
The 2,600-patient Sort Out IV study, designed to examine whether the Xience V is “non-inferior” to the Cypher, showed that the rate of major adverse cardiac events was comparable for each stent. The Abbott device produced a MACE rate of 4.9 percent, versus a rate of 5.2 percent for the Cordis stent. The incidence of cardiac death was 1.9 percent for the Xience V and 1.4 percent for the Cypher and rates of myocardial infarction (heart attack) were also on par, at 1.1 percent for the Xience V and 1.4 percent for the Cypher. Rates of stent thrombosis were a dead heat at 0.9 percent for each stent.
“The Sort Out IV trial demonstrates that both drug eluting stents perform extremely well,” Rogers said. “The unique design characteristics of the Cypher stent continue to make it an essential treatment option for today’s interventional cardiologists.”
In an emailed statement, Abbott said the trial reinforces the superiority of the Xience V.
“The Sort Out trial findings add to the strong body of clinical evidence that has made Xience V the market-leading drug-eluting stent around the world,” according to the statement. “Xience was shown to have numerically better outcomes in several key measurements than the first-generation Cypher stent. With thinner struts than Cypher, Xience V combines an outstanding safety and efficacy profile with the excellent deliverability of a newer-generation stent.”