Clinical Data Indicate that Percutaneous Coronary Intervention with the Cypher Sirolimus-eluting Coronary Stent Is Comparable to Bypass Surgery
MUNICH--(BUSINESS WIRE)--Sep 4, 2008 - Data from the largest randomized trial of its kind performed to date indicate that the use of percutaneous coronary intervention (PCI) with the CYPHER(R) Sirolimus-eluting Coronary Stent was comparable to bypass surgery (coronary artery bypass grafting or CABG) in key safety endpoints in patients with multi-vessel disease and diabetes. These data were presented here recently at the European Society of Cardiology meeting.
The CYPHER(R) Stent is the only drug-eluting stent with such randomized clinical data indicating that it is comparable to bypass surgery in these key safety areas in patients with diabetes and multi-vessel disease, whose coronary artery disease presents unique challenges.
Data from CARDia (Coronary Artery Revascularization in Diabetes Trial) showed that after one year, there was no significant difference between PCI with the CYPHER(R) Stent and bypass surgery in terms of death, heart attacks or stroke, the primary endpoints for this study (10.1 percent for the CYPHER(R) Stent compared to 10.2 percent for bypass surgery; p=0.98).
"The results of CARDia provide important new information to our understanding of the treatment of patients with multi-vessel disease and diabetes who present with coronary artery conditions," said Akhil Kapur, M.D., London Chest Hospital, Barts and London National Health Service Trust, London, UK, and one of the principal investigators.
"This is the largest randomized data set comparing angioplasty and surgery in diabetic patients. The results of this study indicate that PCI with the CYPHER(R) Stent was comparable to CABG in key safety outcomes in these high risk patients." Aside from providing limited support for the CARDia trial, Cordis Corporation has no financial relationship with Dr. Kapur and the other principal investigators.
Key secondary endpoints, including revascularization (need for another procedure), were remarkably low in both arms. As expected, patients who received the CYPHER(R) Stent were somewhat more likely to undergo revascularization (7.3 percent versus 2.0 percent; p=0.013). This contributed to low but not statistically different rates of the composite outcome of death, heart attack, stroke and repeat revascularization (15.1 percent for the CYPHER(R) Stent compared to 11 percent for bypass surgery; p=0.217).
All patients in the study had diabetes and multi-vessel disease and were amenable to either surgery or PCI.
The trial, conducted at 24 medical centers throughout the United Kingdom and Ireland, was designed as a non-inferiority trial. In the discussion of the trial in the hotline session, the CARDia investigators were congratulated on the trial, but it was pointed out that due to enrollment of only 510 of the originally planned 600 patients that there was insufficient power to answer the specific question whether stenting was non-inferior to surgery in this population.
Overall Results Favorable for PCI (the CYPHER(R) Stent or a Bare Metal Stent)
The CYPHER(R) Stent portion of this study was part of an overall comparison of PCI versus surgery. The CARDia trial included 510 patients randomized to receive bypass surgery (254 patients) or PCI with either the CYPHER(R) Stent or a bare metal stent (256 patients). Of those patients who received PCI, 180 patients (71%) were randomized to receive the CYPHER(R) Stent and 72 were randomized to receive a bare metal stent. The CYPHER(R) Stent cohort was uniformly numerically lower for all outcomes compared to the overall PCI population.
The composite rate of death, heart attack and stroke at one year was similar between the two groups (11.6 percent for PCI and 10.2 percent for surgery; p=0.63). Specifically, the rates of death for total PCI was 3.2 percent compared to 3.3 percent for bypass surgery (p=0.83) and clinically reported non-fatal heart attacks was 8.4 percent for PCI compared to 5.7 percent for bypass surgery (p=0.25). The rate of stroke showed a trend toward being lower with PCI (0.4 percent) compared to bypass surgery (2.5 percent, p=0.09).
Trial Results Show Benefits of PCI to Bypass Surgery for Patients
For many years, patients with multi-vessel disease and diabetes were treated with coronary bypass surgery, considered to be the gold standard for these difficult-to-treat conditions. However, surgery is associated with higher health care costs as well as a lengthy recovery period. Patients receiving PCI are treated with minimally invasive techniques that greatly reduce both health care costs, as well as the amount of time it takes a patient to recover and resume activities of daily living.
"Prior to this trial, there were limited randomized clinical data directly comparing the CYPHER(R) Stent to bypass surgery in diabetics so these results are critical to our understanding of how to optimally treat coronary artery disease in patients with diabetes," said Campbell Rogers, M.D., Chief Technology Officer, Cordis Corporation. "These results are also important because the CYPHER(R) Stent is now the only drug-eluting stent with randomized clinical data compared to bypass surgery specifically in this difficult-to-treat patient population."
The study was supported by major grants from the Hammersmith Hospitals special trustees, Eli Lilly Corporation, Sanofi Aventis and Cordis Corporation. Further support was provided by Boston Scientific, Medtronic, Guidant and Jomed.
Data Consistent with other Trials of the CYPHER(R) Stent in Patients with Diabetes
The use of drug-eluting stents in patients with diabetes has been the focus of debate and discussion within the medical community for some time. The data from CARDia are consistent with other clinical trial data on the use of the CYPHER(R) Stent in patients with diabetes.
According to data appearing recently in the Journal of the American College of Cardiology, in patients with diabetes, the CYPHER(R) Stent outperformed the Taxus(R) Stent with significantly lower rates of in-segment restenosis (a reblockage within the stented area), target lesion revascularization (TLR; the need for another interventional procedure) and major adverse events (MACE, a composite of death, heart attack and TLR) at nine months.
In this multi-center randomized clinical trial, the six month rate of in-segment restenosis was more than five times lower for the CYPHER(R) Stent compared to the Taxus(R) Stent (4.0 percent vs. 20.8 percent respectively (p less than 0.001). Most important for patients and physicians, key clinical outcomes measures were about four times lower for the CYPHER(R) Stent -- at nine-months, clinically driven TLR for the CYPHER(R) Stent was 1.5 percent compared to 6.0 percent for the Taxus(R) Stent (p=0.032) while the composite clinical endpoint of MACE was 2.0 percent for the CYPHER(R) Stent compared to 8.0 percent for the Taxus(R) Stent (p=0.010).
The CYPHER(R) Stent does not have an approved indication for use in patients with diabetes or multi-vessel disease in the United States.
About the CYPHER(R) Stent
The CYPHER(R) Stent has been chosen by cardiologists worldwide to treat approximately three million patients with coronary artery disease. The safety and efficacy of the device is supported by a robust clinical trial program that includes more than 70 studies that examine the performance of the CYPHER(R) Stent in a broad range of patients.
For more complete information on indications, contraindications, warnings and precautions, see the Instructions for Use available at www.cypherstent.com.
About Cordis Corporation
Cordis Corporation, a Johnson & Johnson company, is a worldwide leader in the development and manufacture of interventional vascular technology. Through the company's innovation, research and development, Cordis partners with interventional cardiologists worldwide to treat millions of patients who suffer from vascular disease. More information about Cordis Corporation can be found at www.cordis.com.
(a)Cordis Corporation has entered into an exclusive worldwide license with Wyeth for the localized delivery of sirolimus in certain fields of use, including delivery via vascular stenting. Sirolimus, the active drug released for the stent, is marketed by Wyeth Pharmaceuticals, a division of Wyeth, under the name Rapamune(R). Rapamune is a trademark of Wyeth Pharmaceuticals.
(b)The third party trademarks used herein are trademarks of their respective owners.
Christopher Allman, 305-586-6024
Edelman Public Relations
Todd Ringler, 617-872-1235
Posted: September 2008