Cath Lab Digest

The Publication of 10-Year Follow-Up Test Results on the First CYPHER® Sirolimus-Eluting Coronary Stent Patient Reveal the Stent's Outstanding Efficacy and Safety

STOCKHOLM, August 31, 2010. Cordis Corporation announced at European Society of Cardiology in Stockholm that the results of follow-up tests undertaken 10 years after the first patient was treated with a CYPHER® sirolimus-eluting coronary stent have proven outstanding long-term efficacy and safety and were published earlier this year in "JACC: Cardiovascular Interventions". The 85-year-old patient was the first-ever patient to be treated with a CYPHER stent and made history by undergoing the longest term follow-up, ten years later. The patient was the first person to be treated with a CYPHER stent in the nonrandomized, in-human trial.

The patient, who was treated in 1999 with the CYPHER(R) stent at the age of 75 after her coronary angiography showed a significant, 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. The patient also underwent an optical coherence tomography (OCT) assessment which revealed a complete coverage of over 90% of the analyzed struts. This 10-Year follow-up of the first-ever patient to be treated with CYPHER took place continuing a tradition of comprehensive testing for the most studied drug-eluting stent in the world and reinforcing the CYPHER Sirolimus-eluting coronary stent's reputation for efficacy and safety. The follow-up procedure was broadcast live during the 2009 meeting of the Latin America Society of Interventional Cardiology (SOLACI, Rio de Janeiro - Brazil).

In a history of impressive CYPHER stent data announcements at ESC in Stockholm, Marie-Claude Morice, MD, Institut Cardiovasculaire Paris Sud, had presented the initial results of the highly successful RAVEL trial, the first CYPHER stent randomized trial, at the Annual Congress of the European Society of Cardiology in 2001. And this year at ESC in 2010, the results of the 10-year follow-up of the first-ever patient to be treated with CYPHER drug-eluting stent are discussed during Cordis Hands-On Tutorials sessions.

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, said, "We are very pleased with these results. This historic 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). 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 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 CYPHER 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 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."

About CYPHER stent studies:
The CYPHER stent is the most studied drug-eluting stent in the world, it has a proven safety profile out to 10 years and has been used in nearly 4 million patients worldwide. Today, with more than 9.000 citations on PubMed, CYPHER Sirolimus-eluting coronary stent is recognized as having the most in depth clinical data, which marked it out as the most effective drug-eluting stent available today with a safety profile presenting minimal risks. CYPHER's body of clinical evidence is completely unmatched by any other drug-eluting stent. The CYPHER stent has consistently proven to control late loss across all vessel sizes and across a broad patient population, even in the most complex types of patients such as patients with diabetes and acute myocardial infarction. In fact, the CYPHER stent has shown more than 70% risk reduction in target lesion revascularization (TLR) when compared with bare metal stents.

About the RAVEL trial:
In 2000, patients were enrolled in the RAVEL Trial, the first multi-center, randomized, double-blind, trial in history for drug-eluting stents. The primary objective of RAVEL was the safety and effectiveness of the CYPHER(R) 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(TM) balloon-expandable stent. The trial was conducted in 15 centers in Europe and 4 in Latin American and presented by Dr Marie Claude Morice at the Annual Congress of the European Society of Cardiology in Stockholm on 4th September 2001. The results from this trial surpassed expectations, demonstrating virtual elimination of neointimal in-stent proliferation with no measurable late loss (-0.01mm), a binary angiographic restenosis rate of 0%, and no acute or late stent thrombosis.

Cypher Timeline at a Glance:

* 1999: Cordis initiates the first clinical investigation of a drug-eluting stent. The First-In-Human trial, a safety and feasibility study is conducted in Sao Paolo/Brazil with Dr. Eduardo Sousa, and Rotterdam/The Netherlands with Dr. Patrick Serruys
* 2000: Cordis embarks on the first multicenter, double-blind, randomized, drug-eluting stent trial in history - RAVEL
* 2001: Dr. Marie-Claude Morice presents the initial results of the highly successful RAVEL trial, the first CYPHER(R) stent randomized trial, at the Annual Congress of the European Society of Cardiology in 2001
* 2009: Dr. Eduardo Sousa, who led the team carrying out the first-in-human trial in 1999 initiated the 10-year follow-up tests in 2009 in Sao Paolo, Brazil with the first patient ever treated with CYPHER®
* 2010: Results of the ten-year CYPHER(R) Sirolimus-eluting coronary stent follow-up are published

Source: Cordis Corporation