Ten-Year Follow-Up Results Presented for the Cordis Cypher SES

August 31, 2010—At the European Society of Cardiology meeting in Stockholm, Cordis Corporation (Bridgewater, NJ) announced the results of 10-year follow-up tests on the first patient treated with a Cypher sirolimus-eluting coronary stent that have demonstrated the device's long-term efficacy and safety. The results were published earlier this year in Journal of the American College of Cardiology: Cardiovascular Interventions (2010;3:556-558). The patient, now 85 years old, was the first-ever patient to be treated with a Cypher stent and the first person enrolled in the nonrandomized, in-human trial of the device. Professor Eduardo Sousa, MD, 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, discussed the 10-year results during a Cordis tutorial session.

According to Cordis, the patient was treated in 1999 with the Cypher stent at the age of 75 years after coronary angiography showed a significant, single, de novo lesion in the proximal left anterior descending (LAD) artery. The patient underwent further invasive follow-up revealing a sustained antiproliferative effect of the Cypher stent by both angiography and IVUS examination in 2009. The patient also underwent optical coherence tomography (OCT) assessment, which revealed complete coverage of more than 90% of the analyzed struts. The 10-year follow-up procedure was broadcast live during the 2009 meeting of the Latin America Society of Interventional Cardiology (SOLACI) in Rio de Janeiro, Brazil.

Professor Sousa commented, “We are very pleased with these results. This historic follow-up has revealed a sustained antiproliferative effect of the Cypher stent by both angiography (in-stent late lumen loss of 0.1 mm at 9 months as compared to 0.11 at 48 months) and IVUS examination (in stent obstruction of 1% at 4 months and 1, 2, 4, and 9 years). In addition, the 10-year OCT assessment revealed complete coverage of more than 90% of the analyzed struts. This is an impressive outcome and a testament to the efficacy of the Cypher stent."

Marie Claude Morice, MD, who led the initial RAVEL trial presented to the European Society of Cardiology in 2001, explained, "The Cypher 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 the 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. It is also the longest-studied drug-eluting stent, with more than 200 medical trials having been carried out and 155,000 patients observed. These trials, from the initial RAVEL trial in 2001 to this latest 10-year follow-up, have proven the Cypher stent's safety and effectiveness."

The multicenter, randomized, double-blind RAVEL trial commenced enrollment in 2000. The primary objective of RAVEL was the safety and effectiveness of the Cypher sirolimus-eluting stent in reducing angiographic in-stent late loss (at 6-month follow-up) in de novo native coronary artery lesions as compared to the uncoated BX Velocity balloon-expandable stent. The trial was conducted in 15 centers in Europe and in four centers in Latin America. Marie Claude Morice, MD, presented the results at the 2001 Congress of the European Society of Cardiology in Stockholm. The results from this trial surpassed expectations, demonstrating virtual elimination of neointimal in-stent proliferation with no measurable late loss (-0.01 mm), a binary angiographic restenosis rate of 0%, and no acute or late stent thrombosis, the company stated.