CORDIS reports positive results from 10-year follow-up of CYPHER Sirolimus-eluting coronary stent study

May 26, 2017

Professor Eduardo Sousa, M.D., who led the team carrying out the first-in-human trial in 1999 and the 10-year follow-up tests in 2009 in Sao Paolo, Brazil, said, "We are very pleased with these results. This historic follow-up has revealed a sustained anti-proliferative effect of the CYPHER(R) stent by both angiography (in-stent late lumen loss of 0.10mm at 9 months as compared to 0.11 at 48 months) and IVUS examination (in stent % of obstruction of 1% at 4 months and 1,2,4, and 9 years). In addition, the ten-year OCT assessment revealed a complete coverage of over 90% of the analyzed struts. This is an impressive outcome and a testament to the efficacy of the CYPHER(R) stent."

Marie Claude Morice, M.D., who led the initial RAVEL trial presented to the European Society of Cardiology in 2001, explained, "The CYPHER(R) Sirolimus-eluting coronary stent was the first of its kind and was a major advance over bare-metal stents. A key trial showing the efficacy of CYPHER(R) stent found that up to 5 years after receiving the stent, the risk of restenosis of the artery is reduced by 60 - 70% compared to an uncoated stent. It is also the longest-studied drug-eluting stent, with over 200 medical trials having been carried out and 155,000 patients observed. These trials, from the initial RAVEL trial in 2001 to this latest ten-year follow-up, have proven the CYPHER(R) stent's safety and effectiveness."

Campbell Rogers, M.D., Chief Scientific Officer and Global Head R&D at Cordis, said, "We continue to be gratified by the outstanding performance of CYPHER(R) compared with other drug-eluting stents. The breadth of clinical safety and efficacy data and the long-term follow-up data on patient outcomes associated with the CYPHER(R) stent are unmatched by the competition. These historic long term results with the CYPHER(R) stent join ever-growing datasets demonstrating superiority of the CYPHER(R) stent over other newer DES competitors in diverse patient and lesion subsets and establish CYPHER(R) stent as the gold standard treatment for patients with coronary disease undergoing PCI."

SOURCE Cordis Corporation