Longwinded article, but I bolded the interesting part ,...that there are other drugs that can be used in these self eluting stents other than taxol and derivatives, and if that interests you, you may find reading the rest interesting because this stent's drug may be a better choice than the taxol ones for patients with difficult to treat lesions .....................
Final Results of Large-Scale U.S. Study Confirm Positive Performance Of Cordis CYPHER(TM) Sirolimus-eluting Stent
U.S. SIRIUS Study: 1,058 Patients
WASHINGTON, Sept. 24 /CNW/ -- Clinical investigators at today's
session of the 14th annual Transcatheter Cardiovascular Therapeutics (TCT)
symposium reported final results for SIRIUS, a landmark U.S. study of the
CYPHER(TM) Sirolimus-eluting Stent. These findings support the stent's
continued excellent performance in significantly reducing re-blockage of de
novo coronary artery lesions in patients with coronary artery disease.
Sponsored by Cordis Corporation, a Johnson & Johnson company, SIRIUS is a
randomized, double-blind, controlled clinical trial involving 53 U.S.
treatment centers and 1,058 patients.
Co-Principal Investigators, Jeffrey W. Moses, M.D., and Martin B. Leon,
M.D., Lenox Hill Hospital and the Cardiovascular Research Foundation,
New York, NY, presented eight-month angiographic and nine-month clinical data,
as well as eight-month intravascular ultrasound (IVUS) data.
"The remarkable results of the CYPHER(TM) Sirolimus-eluting Stent are
holding," said Dr. Moses. "Findings of the SIRIUS trial are very positive and
consistent with results of earlier studies. There are no significant
differences between our preliminary findings and our final data set. The
results continue to support the excellent performance of the product."
SIRIUS: Second Large-Scale Trial to Support Efficacy and Safety
Dr. Moses noted the CYPHER(TM) Stent is the only drug-eluting coronary
stent whose performance is supported by two large-scale, randomized,
double-blind, controlled clinical studies, SIRIUS and RAVEL*.
The 1,058 SIRIUS patients were randomized to two treatment arms:
533 patients received a CYPHER(TM) Stent and 525 received a bare metal
Bx VELOCITY(TM) Coronary Stent.
Eight-month angiographic follow-up showed minimal in-stent late lumen loss
(0.17 mm) in patients treated with the CYPHER(TM) Stent. The 3.2% rate of
angiographic in-stent restenosis represents a 91% reduction vs. the control
arm (bare metal stent), and the 8.9% angiographic in-lesion restenosis
(including a 5-mm area at each end of the stent) represents a 75% reduction
vs. the control arm. These results support the excellent findings of earlier
studies, including the 12-month RAVEL study in Europe and Latin America, and
the two-year First-in-Man feasibility study.
"We are extremely impressed by the consistency in findings pertaining to
the major reductions of in-stent restenosis and late lumen loss-renarrowing of
the artery wall-associated with the CYPHER(TM) Stent," said Dr. Moses.
"Reduction in late lumen loss is perhaps the most reliable and
discriminating indicator cardiologists have to gauge long-term efficacy of
this device," he continued. "There was also significantly less late loss on
both the proximal and distal CYPHER(TM) Stent margins than with the control
stent."
SIRIUS: Positive Results
Dr. Leon described the SIRIUS study as one that has set a standard for
drug-eluting stents. "Not only is SIRIUS the largest study of its kind," he
said, "but it is also the most comprehensive study of its kind. Our SIRIUS
study reached new levels in terms of high-risk patients and difficult-to-treat
lesions."
* The 12-month RAVEL study (RAndomized Study with the Sirolimus-eluting
VELocity Balloon-Expandable Stent), which ended in Spring 2002, involved
238 patients at 19 centers in Europe and Latin America.
The SIRIUS study was designed with a high degree of difficulty to more
closely approximate everyday practice and clearly demonstrate the clinical
economic value of treatment with the CYPHER(TM) Stent versus treatment with a
conventional bare metal stent. The SIRIUS patient population included
substantial numbers of patients at significant risk for restenosis, including
patients with diabetes mellitus (26.4 %), longer lesions (average 14.4 mm),
hyperlipidemia, (73.6 %), hypertension (67.7 %), and multivessel disease
(41.6 %), as well as patients who had previously undergone percutaneous
coronary interventions or coronary artery bypass surgery (34.2 %). Within the
treatment arm, a substantial number of patients (27.7%) had lesions requiring
placement of overlapping stents.
92.7% Event-free Survival in CYPHER(TM) Stent Arm
SIRIUS investigators reported excellent safety findings for the CYPHER(TM)
Stent. At nine-month follow-up, the event-free survival rate was 92.7% in the
sirolimus-treated cohort versus 80.7% in the bare metal stent cohort
(p less than 0.001).
"We were particularly impressed by the low incidence of thrombosis in the
CYPHER(TM) Stent group (0.4%) in spite of only three months of anti-platelet
therapy administered post-procedure," said Dr. Leon.
At nine-month clinical follow-up, there was a 75% reduction in the target
lesion revascularization (TLR) rate in the CYPHER(TM) Stent group vs. the bare
metal stent group.
About the CYPHER(TM) Sirolimus-eluting Stent
An investigational device in the U.S., the CYPHER(TM) Sirolimus-eluting
Stent received European CE Mark approval in April and is now available in
approximately 50 countries worldwide. Pre-clinical research has shown that
sirolimus uniquely provides for normal re-endothelialization (does not inhibit
endothelial cell coverage of the stent) while inhibiting smooth muscle cell
proliferation. Cordis chose sirolimus for its cytostatic properties. Unlike
a cytotoxic drug, which kills cells, a cytostatic agent prevents cells from
dividing without destroying them, leaving them in a quiescent, or resting,
state.
Sirolimus, the active drug released from the stent, is a naturally
occurring substance marketed by Wyeth Pharmaceuticals, a division of Wyeth
(NYSE: WYE), under the name Rapamune* and used for the prophylaxis of organ
rejection in patients receiving renal transplants. Cordis has entered into an
exclusive worldwide license agreement with Wyeth for delivery of sirolimus via
a stent.
About Treating Coronary Artery Disease
Each year, more than five million Americans are treated for coronary
artery disease. Approximately four million are treated medically, with the
remainder requiring more invasive therapy. Coronary artery bypass grafting
(CABG), once considered the standard treatment for life-threatening coronary
artery blockages, can now be avoided in many patients. Minimally invasive
procedures, including balloon angioplasty, introduced in 1977, and coronary
artery stenting, pioneered by Johnson & Johnson Interventional Systems
(now Cordis Corporation) in 1994, enable more than a million patients each
year to avoid the trauma and prolonged recovery associated with CABG. Among
those who receive coronary artery stents each year, approximately
15-20% require repeat treatment for restenosis, or reblockage. The CYPHER(TM)
Sirolimus-eluting Stent is currently being studied for its potential to reduce
the incidence of restenosis.
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 the world's leading developer and manufacturer of
breakthrough products for interventional medicine, minimally invasive
computer-based imaging, and electrophysiology. Today, 5,300 Cordis employees
worldwide share a strong commitment to continue the Company's groundbreaking
work in the fight against vascular disease.
Note: The CYPHER(TM) Sirolimus-eluting Stent is an investigational device
limited by federal (U.S.) law to investigational use in the United States.
*Rapamune is a trademark of Wyeth Pharmaceuticals. 9192002
/Company News On-Call: prnewswire.com
/Web site: jnj.com /
-30-
For further information: Public Relations - Martin E. Schildhouse,
+1-786-313-2545, or Cell, +1-305-606-3577, or Terri Mueller, +1-786-313-8687,
or +1-305-903-9980, or David Swearingen, +1-732-562-3132, or Cell,
+1-908-803-6811, or Jeffrey Leebaw, +1-732-524-3350, or Cell,
+1-908-227-7231, or Investor Relations - Helen Short, +1-732-524-6491, or
Andrea Ferris, +1-732-524-6486, or Lesley Fishman, +1-732-524-3922, all for
Cordis Corporation |
