some discussion of market size...........
Monday September 3, 7:30 am Eastern Time
Press Release
SOURCE: McMaster University
Clopidogrel Beneficial in Patients Undergoing
Percutaneous Coronary Intervention
PCI-CURE Shows Early and Long-Term Benefits of Clopidogrel
STOCKHOLM, Sweden, Sept. 3 /PRNewswire/ -- Results of the PCI-CURE study, a
companion study of the landmark CURE (Clopidogrel in Unstable Angina to Prevent
Recurrent Events) trial, demonstrate the early and long-term benefits of clopidogrel on top of
standard therapy including ASA in patients with acute coronary syndrome (ACS) undergoing
percutaneous coronary intervention (PCI). These results were presented today at the Hotline
II session of the XXIII Congress of the European Society of Cardiology in Stockholm,
Sweden.
``The PCI-CURE study demonstrates that in patients with ACS who are pretreated with
clopidogrel and ASA prior to balloon angioplasty, there are significant reductions in major
ischemic events. Equally important, PCI-CURE also shows that continued treatment with
clopidogrel for up to one year after angioplasty reduces recurrent heart attacks and death
from cardiovascular causes,'' said Dr. Shamir Mehta, Assistant Professor of Medicine,
McMaster University, Director of the Coronary Care Unit, McMaster University Medical
Centre and principal investigator of PCI-CURE.
PCI-CURE shows that in patients with ACS (unstable angina and non-Q-wave myocardial
infarction [NQMI], also referred to as ``mild heart attack''), undergoing PCI (balloon
angioplasty with or without stent placement), there are large benefits with clopidogrel
treatment given prior to and continued up to one year after the procedure. Overall (including
events before and after PCI), there was a 31% reduction in cardiovascular death or heart
attack (p = 0.002). Between 30 days after the procedure and the end of follow-up, the rate
of cardiovascular death or MI was consistently lower in the clopidogrel group than in the
placebo group, as was the rate of cardiovascular death, MI, or rehospitalization. There was
no significant difference in major bleeding between the two groups.
These results were highly consistent with the CURE study, which was a multicenter,
randomized, double-blind, placebo-controlled trial in 12,562 patients, conducted in 482 sites
across 28 countries. The primary objective was to evaluate the early and long-term efficacy
and safety of clopidogrel on top of standard therapy (including ASA 75 - 325 mg/day)
versus standard therapy alone (including ASA 75-325 mg/day) in the prevention of heart
attack, stroke and cardiovascular death in patients with ACS. Overall, 2,658 of the 12,562 patients with ACS in CURE
underwent a PCI and were therefore assessed as part of PCI-CURE.
CURE demonstrated that initiating therapy with clopidogrel early, and continuing its use long-term, dramatically reduces the risk
of heart attack, stroke and cardiovascular death by 20% in patients with ACS (p<0.001). The early and long-term benefit was
incremental to, and independent of other therapies patients may have received (such as anticoagulants, GP IIb/IIIa antagonists,
ACE inhibitors, beta-blockers, and lipid-lowering agents) and consistent across all patient sub-types.
``We have now shown that when clopidogrel is added to standard therapy including ASA, there are significant, clinically
relevant reductions in major cardiac events,'' commented Dr. Salim Yusuf, Professor of Medicine and Director, Division of
Cardiology, McMaster University, Hamilton, Ontario, Canada and principal investigator of the CURE trial. ``As anticipated,
there was a small increase in both major and minor bleeding in the clopidogrel plus ASA group, as the patients were receiving
two antiplatelet therapies. Importantly, however, there was no increase in life-threatening bleeding. Major bleeding was readily
managed with transfusion or therapy interruption. ''In the CURE study, treating 1000 patients for 9 months prevents 27 major
vascular events, but there is a need for transfusions in 6 people with no long-term adverse sequelae. This is clearly a favorable
benefit to risk ratio,`` he concluded.
ACS is an example of atherothrombosis, the underlying process leading to heart attacks, ischemic strokes, peripheral arterial
disease and vascular death. Unstable angina is characterized by frequent and severe attacks of chest pain. The incidence of
unstable angina is similar to that of heart attack, with close to 1.5 million episodes per year in North America and several times
this figure worldwide(1).
The results of PCI-CURE were published in the Lancet(2) on 18th August 2001. The results of the CURE Study were
published in the New England Journal of Medicine(3) on 16th August 2001. Key study slides are currently available on the
website ``http://www.thecurestudy.com''. PCI-CURE slides will be available from September 4, 2001.
Clopidogrel is marketed worldwide as Plavix® and Iscover®. The CURE study was supported by a grant from
Sanofi-Synthelabo and Bristol-Myers Squibb Company.
The Canadian Cardiovascular Collaboration Project Office, located at McMaster University, is the coordinating centre for the
CURE study and one of Canada's leading research institutions and is located in Hamilton, Ontario. McMaster's Faculty of
Health Sciences is recognized internationally for its leading edge research, innovation and excellence in education.
References:
1 Cairns J et al Unstable Angina: Report from a Canadian Expert Roundtable
Can J Cardiol 1996; 12(12): 1279-1292
2 Mehta SR, Yusuf S, Peters RJG, Bertrand ME, Lewis BS, Natarajan MK,
Malmberg K, Rupprecht H-J, Zhao F, Chrolavicius S, Copland I. for the CURE
trial investigators. Effects of pretreatment with clopidogrel and aspirin
followed by long-term therapy in patients undergoing percutaneous coronary
intervention: the PCI-CURE study. Lancet 2001; 358:527 - 533
3 The CURE Trial Investigators. Effects of clopidogrel in addition to
aspirin in patients with acute coronary syndromes without ST-segment
elevation. N Engl J Med 2001; 345:494 - 502
SOURCE: McMaster University |
