Diabetic Patients Among Broad Patient Group Found to Benefit From Treatment With the CYPHER(reg) Sirolimus-eluting Coronary Stent

Main Category: Cholesterol
Also Included In: Cardiovascular / Cardiology
Article Date: 28 May 2004 - 11:00 PDT

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Data presented at the EuroPCR Congress provide further clinical evidence that the CYPHER(reg) Sirolimus- eluting Coronary Stent is a formidable treatment option for a broad range of patients, including diabetics who are some of the most difficult to treat patients.

The six-month data from e-CYPHER(SM) Registry, the world's largest Internet-based post market surveillance study, highlights key areas of improvement including a large number of diabetic patients that did not have to be retreated for coronary blockages.

The diabetic patient subset is the single-largest high risk group of patients enrolled in this study.

While still enrolling, the registry currently is comprised of 12,180 patients who received the CYPHER(reg) Stent in 275 medical centers outside of the United States. Physicians conducted clinical follow-up and adjudication on more than 80 percent of the patient population in the study, providing further validity of the data.



"The results are encouraging and provide a much needed broader view of the efficacy of the CYPHER(reg) Stent in a range of lesion subsets and high-risk patient populations," said Dr. Philip Urban, director of Invasive Cardiology, La Tour Hospital in Geneva, Switzerland.

In the overall patient population, Dr. Urban reported a 2.5 percent Major Cardiac Adverse Event (MACE) rate, one percent Target Lesion Revascularization (TLR) rate that included angioplasty and by-pass surgery and a 0.3 percent Sub-acute Thrombosis (SAT) rate.

Diabetic Patients

Diabetic patients, especially insulin-dependent diabetics, are considered one of the highest-risk patient subsets to treat for cardiovascular disease because they tend to have a more diffuse and aggressive vascular disease than non diabetic patients. Nearly 30 percent of the patients enrolled in e-CYPHER(SM) Registry are diabetic (n=2,716), of which more than one-third are insulin-dependent.

Dr. Urban highlighted the excellent results achieved in the overall diabetic subset in whom the six month MACE rate is 4.2 percent, TLR rate is 1.4 percent and the SAT (clotting) rate is 0.5 percent.

The results of the insulin-dependent diabetic patient population were similar to those of the overall diabetic patient population, with a six month MACE rate of 5.9 percent, TLR of 1.5 percent and SAT rate of 0.4 percent.

"These results are particularly impressive given the significant difference in the pre-existing medical history of diabetic patients versus the non-diabetic population," said Dr. Urban. These include a greater percent of patients with hypertension (70.9 versus 58.1), multivessel disease (59.7 versus 54.8), narrower vessels (2.8 mm versus 2.9 mm) and serious obesity (17.7 versus 11.1).

"The results from the diabetic sub-set are very encouraging given that they are from the largest real-world diabetic patient population," stated Dr. Dennis Donohoe, vice president, Clinical and Regulatory Affairs, Cordis Corporation. "We continue to be encouraged by the strong performance of the CYPHER(reg) Stent in everyday clinical practice."

About the e-CYPHER(SM) Registry

The largest Internet-based post marketing surveillance registry of its kind, the e-CYPHER(SM) Registry is designed to determine the safety, efficacy and reliability of the CYPHER(reg) Stent in daily clinical practice. In addition, e-CYPHER(SM) will also help in the identification of MACE predictors and validate the reproducibility of results obtained in randomized, controlled clinical trials.

To date, a total of 14,300 patients from 275 sites in Latin America, Europe, Middle East and Asia Pacific, out of the target patient population of 15,000, have been enrolled into the e-CYPHER(SM) database. Of these, 83 percent have completed six-month follow-up. The registry is monitored by an independent advisory board with adverse events/endpoints adjudicated by an independent endpoints review committee.

About Cordis Corporation

For more than 40 years, Cordis Corporation, a Johnson & Johnson company, has pioneered less-invasive treatments for vascular disease. Technological innovation and a deep understanding of the medical marketplace and the needs of patients have made Cordis Corporation the world's leading developer and manufacturer of breakthrough products in the interventional cardio-vascular field. Today, more than 7,000 Cordis Corporation employees worldwide share a strong commitment to continue the company's groundbreaking work in the fight against vascular disease.

Johnson & Johnson

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