New Data Suggest Patients With Bifurcation Lesions Experienced Very Low Serious Event Rates With The CYPHER(R) Sirolimus-Eluting Coronary Stent

New Data Suggest Patients With Bifurcation Lesions Experienced Very Low Serious Event Rates With The CYPHER(R) Sirolimus-Eluting Coronary Stent

March 16, 2006

First Clinical Trial in This Difficult-to-Treat Patient Population Presented at ACC 2006

    ATLANTA, March 16 /Xinhua-PRNewswire/ -- Patients with
bifurcated lesions, which are lesions that are spread into
two parts at a common vessel juncture and are often
difficult to treat, experienced a low rate of serious
events at six-months with the CYPHER(R) Sirolimus-eluting
Coronary Stent regardless of the stenting strategy,
according to new multi-center, randomized clinical trial
data presented today at the 2006 American College of
Cardiology (ACC) Scientific Session.  The study compared
two stenting strategies:  stenting main branch only and
stenting both main vessel and side branch. 

    "Bifurcation lesions account for approximately 15
percent of the cases in daily interventional cardiology
practice, but until now the optimal stenting strategy for
these cases was unknown because of difficulties in
assessing the true complexity of the lesion," said
Leif Thuesen, M.D., Principal Investigator of the study and
cardiologist at the Skejby Hospital at the University of
Aarhus. "The results of our study show that the
CYPHER(R) Stent worked extremely well in patients with
bifurcation lesions."

    Bifurcation lesions involve blockage of both the main
coronary artery and an adjoining side-branch vessel,
resulting in a more difficult-to-treat lesion. 
Interventional treatments of these lesions with bare-metal
stents, balloon angioplasty or other techniques have
resulted in low angiographic success, high complications
and high restenosis rates. 

    The data from this study, "Main Vessel and Side
Branch Stenting versus Optional Side Branch Stenting Using
Sirolimus-eluting Stents in Bifurcation Lesions," were
presented today by Terje Steigen, M.D. from University
Hospital of North Norway in Tromso at ACC.

    About the Nordic Bifurcation Study 

    The bifurcation study is a multi-center, randomized
study that examined 413 patients with previously untreated
(de novo) bifurcation coronary artery lesions. The primary
end point of the study was major adverse cardiac events
(MACE), which was defined as cardiac death, heart attack
(myocardial infarction or MI), blood clots (thrombosis) and
re-treatment of the blocked vessel (target vessel
revascularization or TVR). 

    Individual endpoints (MACE) after six months were as
follows: 

                                     Main Vessel           
Main Vessel and
                                       Stenting          
Side Branch Stenting 
                                       (n=207)             
      (n=206)

    Total death                       1.0 percent          
  1.5 percent 
    Cardiac death                     1.0 percent          
  1.0 percent 
    MI                                1.4 percent          
  1.0 percent 
    Index lesion MI                   0.0 percent          
  1.0 percent 
    Total lesion revascularization    1.4 percent          
  2.0 percent 
    TVR                               1.4 percent          
  2.5 percent 
    Stent thrombosis                  1.0 percent          
  0.0 percent 

    P-value is not significant in this study. 

    The patients were divided into two treatment groups --
207 patients received stenting of the main vessel with the
CYPHER(R) Stent and 206 patients received stenting of the
main vessel and the side branch with the CYPHER(R) Stent. 
Participating centers included hospitals from Denmark,
Sweden, Norway, Finland and Latvia.

    "This bifurcation study further supports the use
of the CYPHER(R) Stent in treating difficult-to-treat,
real-world patients," said Dennis Donohoe, M.D., Vice
President, Worldwide Regulatory and Clinical Affairs,
Cordis Corporation.  "We are pleased to see positive
data on the CYPHER(R) Stent being presented at ACC, and the
outcomes of this study, in particular, add to the mounting
clinical evidence supporting the CYPHER(R) Stent." 

    Cordis Corporation sponsored this trial. 

    About the CYPHER(R) Stent

    The CYPHER(R) Stent has been chosen by cardiologists
worldwide to treat more than 1.7 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 40 studies, inclusive of independent
clinical trials, that examine the performance of the
CYPHER(R) Stent in a broad range of patients. Developed and
manufactured by Cordis Corporation, the CYPHER(R) Stent is
currently available in more than 80 countries and has the
longest-term clinical follow-up of any drug-eluting stent. 
The first next generation stent, the CYPHER SELECT(TM)
Sirolimus-eluting Coronary Stent, was launched in Europe,
Asia Pacific, Latin America and Canada in 2003.  More
information about the CYPHER(R) Stent can be found at
http://www.cypherusa.com . 

    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.

    For more information, please contact:

     Christopher Allman, Cordis Cardiology,
     Cordis Corporation
     Tel:   [phone]
     Email: [e-mail]

     Todd Ringler,
     Edelman 
     Tel:   [phone]
     Email: [e-mail]

SOURCE  Cordis Corporation