Cordis' Cypher Sirolimus-eluting coronary stent has demonstrated long-term efficacy and safety in the follow-up tests undertaken 10 years after the first patient was treated with the stent in the non-randomised, in-human trial.
In the trial, a 75 year old patient was treated in 1999 with the Cypher stent after her coronary angiography showed a single, de novo lesion in the proximal left anterior descending (LAD) artery, under-went further invasive follow-up revealing a sustained anti-proliferative effect of the Cypher stent by both angiography and IVUS examination in 2009.
Additionally, the patient has undergone an optical coherence tomography (OCT) assessment which revealed a complete coverage of over 90% of the analysed struts.
Eduardo Sousa, 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 that they were pleased with those results.
“This follow-up has revealed a sustained anti-proliferative effect of the Cypher 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),” Sousa said.
“In addition, the ten-year OCT assessment revealed a complete coverage of over 90% of the analysed struts.”
Morice said that the Cypher Sirolimus-eluting coronary stent was the first of its kind and was an advance over bare-metal stents.
“A key trial showing the efficacy of Cypher stent found that up to 5 years after receiving the stent, the risk of restenosis of the artery is reduced by 60 to 70% compared to an uncoated stent,” Morice said.
“These trials, from the initial Ravel trial in 2001 to this latest ten-year follow-up, have proven the Cypher stent’s safety and effectiveness.”
Cordis R&D global head and chief scientific officer Campbell Rogers said that they continue to be gratified by the performance of Cypher compared with other drug-eluting stents.