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ORLANDO, Fla., March 6, 2005 /PRNewswire via COMTEX/ -- Clinical investigators at today's session of the American College of Cardiology Conference Annual Scientific Session reported 12-month data suggesting the CYPHER(R) Sirolimus-eluting Coronary Stent may be a safe, effective and less invasive alternative to coronary artery bypass grafting in patients with multi-vessel coronary artery disease.
The Arterial Revascularization Therapy Study II (ARTS II) study, sponsored by Cordis Corporation, a Johnson & Johnson company, is an extension of ARTS I, which compared results of bare metal stents to those obtained with bypass surgery.
"For years, physicians have debated the merits of stent procedures versus coronary artery bypass grafting in challenging patients with lesions in two or more vessels," said principal investigator Professor Patrick Serruys, The Thoraxcenter, Erasmus Medical Center, Rotterdam, Netherlands. "These data suggest that percutaneous procedures using the CYPHER(R) Stent may be as effective as surgery in these patients and much less invasive."
He noted that ARTS II represents one of the most complex patient populations studied to date with any drug-eluting stent. An average of 3.7 CYPHER(R) Stents were implanted per patient.
The primary endpoint of the study was major adverse cardiac and cerebrovascular events or MACCE, comprising the safety end-points of death, stroke, and heart attack, as well as the efficacy end-point of the need for re-treatment (any re-vascularization) at one year. Despite the fact that the patients enrolled in ARTS II were considerably more complex than those enrolled in ARTS I, the MACCE rate in patients who received the CYPHER(R) Stent in the ARTS II trial was not inferior to the outcome in the CABG arm of ARTS I (10.2% ARTS II versus 11.6 % ARTS-I CABG) and superior to the bare metal stent arm at one-year post treatment.
ARTS II ARTS I - CABG ARTS I - PCI
# 607 # 602 # 600
Death * 1.0 % 2.7 % 2.7 %
Stroke * 0.8 % 1.8 % 1.8 %
MI * 1.0 % 3.5 % 5.0 %
(Repeat) surgery 2.0 % 0.7 % 4.7 %
(Repeat) percutaneous
intervention 5.4 % 3.0 % 12.3 %
All MACCE 10.2 % 11.6 % 26.5 %
*Death, Stroke and MI ARTS II vs ARTS I - CABG p<0.001
Importantly, the composite rate for death, stroke, and heart attack (myocardial infarction) were significantly lower in ARTS II compared with both the surgical and PCI arms in ARTS I.* Conversely, the rate of revascularization was slightly higher for the ARTS II patients than for those in the surgical arm of ARTS I , but significantly lower than for the bare stent arm of ARTS I. Professor Serruys further noted that acute and subacute thrombosis (blood clot) rate-one of the chief variables impacting the overall safety of a stent procedure-was lower for ARTS II CYPHER(R) Stent patients (0.8 percent) than for ARTS I patients who had received a bare metal stent (2.8 percent) at 30 days.
"The findings for ARTS II are particularly impressive when you consider the characteristics of the patients who received a CYPHER stent. Compared to the ARTS I population, the ARTS II CYPHER stent patients included substantially more patients with triple vessel disease (54 percent versus 30 percent in the CABG and 27 percent in the PCI arm of ARTS I), as well a higher number of patients with significant risk factors such as diabetes, hypertension, and hyperlipidemia," said Professor Serruys.
ARTS II includes 607 patients from 45 European centers treated with a CYPHER(R) Stent. Investigators compared the findings for these patients to those from the ARTS I trial, which included 602 patients treated with coronary bypass grafting and 600 treated with a bare metal stent.
About the CYPHER(R) Stent
The CYPHER(R) Stent continues to break new ground in fighting one of the most formidable challenges in the treatment of heart disease: restenosis (reblockage). Developed and manufactured by Cordis Corporation, the CYPHER(R) Stent is currently available in 80 countries and has been used by doctors to treat more than 1,000,000 patients worldwide.
About Cordis Corporation
Cordis Corporation, a Johnson & Johnson company, is a worldwide leader in developing and manufacturing interventional vascular technology. Through the company's innovation, research and development, physicians worldwide are better able to treat the millions of patients who suffer from vascular disease.
* 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.
Terri Mueller, +1-786-313-8687, or cell, +1-305-903-9980, tmueller@crdus.jnj.com, or Chris Allman, cell, +1-267-261-6396, callman@crdus.jnj.com, both of Cordis Corporation; or Todd Ringler of Edelman, +1-212-704-4572, or cell, +1-617-872-1235, todd.ringler@edelman.com, for Cordis Corporation
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SOURCE Cordis Corporation
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