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 <
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.
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