Johnson & Johnson's Cordis unit is eagerly pointing to study data it says demonstartes that its older Cypher stent is as safe and effective as the Xience V made by Abbott.
The Cypher stent has been used successfully in the U.S. for more than five years, the company says. Last year, sales in the Cordis franchise were $2.7 billion, a decline of 10.3 percent versus the prior year. The decline reflects lower sales of the Cypher stent due to increased global competition, according to J&J's 2009 annual report.
The SORT OUT IV study included more than 2,600 patients and was designed to test whether the Xience V stent is non-inferior to the Cypher stent. Both drug-eluting stents performed better than planned for the composite endpoint of major acute coronary events (4.9 percent for Xience versus 5.2 percent for Cypher). Investigators discussed the data at the 2010 Transcatheter Cardiovascular Therapeutics conference in Washington, D.C.
"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," says Campbell Rogers, M.D., chief scientific officer and head, global R&D, Cordis. According to the company, Cypher has been chosen by cardiologists to treat approximately 3 million patients with coronary artery disease. The safety and efficacy of the device is supported by a clinical trial program that includes more than 70 studies.
Abbott also had some comments about the results of the trial: "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," the company tells MassDevice in an emailed 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."
Indeed, during the conference, the results of another study, ISAR-TEST 4 , showed that the newer Xience V had comparable clinical outcomes out to two years versus the Cypher, as Heartwire points out. "A lot of the times, the SORT-OUT investigators come up with the same questions and present similar data, perhaps using similar methodology," says Robert Byrne, the lead investigator of the ISAR-TEST 4 study. "Most of the time, we come to the same conclusion. Here, in these two studies, we both fail to detect any significant clinical difference between the two stents, Cypher and Xience."
ALSO: Johnson & Johnson has completed the acquisition of Micrus Endovascular, a global developer and manufacturer of minimally invasive devices for hemorrhagic and ischemic stroke. Johnson & Johnson announced its agreement to acquire Micrus on July 12, 2010. J&J release