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- the Clopidogrel in Unstable Angina to Prevent Recurrent Events (CURE) has
examined whether the addition of clopidogrel improves outcomes in this setting
- prospective, placebo-controlled, randomised
- more than 12,500 patients presenting with non-ST elevation acute coronary
syndrome - almost all patients manifested some ECG abnormallity or raised
concentrations of serum markers for myocardial injury
- exclusion criteria included contraindications to antithrombotic or antiplatelet
therapy, a high risk of bleeding, or severe heart failure
- study continued for a mean duration of 9 months
- patients not already on aspirin were given this drug after randomisation;
in addition patients were randomised to receive either clopidogrel (300mg
loading dose followed by a maintenance dose of 75 mg daily) or matching
placebo for 3-12 months (mean 9 months)
- clopidogrel was associated with a lower rate of a composite endpoint
of cardiovascular death, myocardial infarction or stroke - 9.3% instead
of 11.3% (relative risk 0.80, 95% CI 0.72-0.89) - this finding seemed
consistent across conventional subgroups, across clinical status at presentation,
irrespective of whether or not a patient underwent a revascularisation
- the addition of clopidogrel "significantly increased the rate
of major bleeding (i.e. substantially disabling bleeding, intraocular
bleeding leading to loss of vision, or bleeding necessitating transfusion
of at least 2 units of blood) by 1% (from 2.7% to 3.7%), with the rate
being higher both during the 30 days after randomisation (2% vs. 1.5%)
and from 30 days after randomisation until the end of the trial (1.7%
vs. 1.1%). Such treatment also increased the absolute rate of minor bleeding
complications from 2.4% to 5.1% (1)"
- for ever 100 patients in this higher-risk subgroup treated with conventional
therapy, the addition of clopidogrel for around 9 months prevents 2 additional
cardiovasclar deaths, or non-fatal MIs or strokes, but also causes 1 addtional
patient to have a major bleed (1)
- clopidogrel and percutaneous coronary intervention (PCI) - patients
who underwent PCI and had been randomised to receive clopidogrel plus
aspirin (compared with those on placebo plus aspirin) had an absolute
reduction in the rate of cardiovascular death, MI or urgent revascularisation
of 1.9% (4.5% vs. 6.4%, relative risk 0.70, 95% CI 0.50-0.97) in the 30-day
period following PCI. Note however that more than 80% in each group undergoing
PCI received open label treatment wth either ticlodipine or clopidogrel
for a median of 30 days after PCI and therefore the results suggest the
benefit observed in the 30-day perioda after PCI required treatment with
clopidogrel prior to the procedure. It is unclear how clopidogrel compares
with glycoprotein IIb/IIIa inhibitors
The Drugs and Therapeutics Bulletin (1) concludes that the results of the CURE
study do not provide evidence that routine use of clopidogrel in addition to
conventional therapy including aspirin is warranted in patients with acute coronary
syndrome without ST elevation.
- Drugs and Therapeutics Bulletin (2002), 40 (6), 41-42.
Clopidogrel in Unstable Angina to Prevent Recurrent Events Trial Investigators.
Effects of clopidogrel in addition to aspirin in patients with acute coronary
syndromes without ST-elevation. NEJM 2001; 345;494-502.
SR et al. 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: 527-33.
Last reviewed 01/2018