| Authors |
| Mehta SR, Yusuf S, Peters RJG, Bertrand ME, et al. |
| Title |
| Effects of pre-treatment with clopidogrel and aspirin followed by long-term therapy in patients undergoing percutaneous coronary intervention: the PCI-CURE study. |
| References |
| Lancet 2001;358:527-533. |
| Background |
| Antiplatelet therapy is important to reduce ischemic complications in patients undergoing percutaneous coronary intervention (PCI). Two things that remain unclear is the effect of pre-treatment with clopidogrel and whether long-term duration of dual antiplatelet therapy (up to one year) provides benefit. |
| Purpose |
| To determine whether in addition to aspirin, treatment with clopidogrel before PCI is superior to placebo in preventing major ischemic events. To determine whether long term therapy with clopidogrel for up to one year post-PCI is clinically beneficial. |
| Design |
- Randomized, double-blind, placebo controlled trial
- 2,658 patients with acute coronary syndrome (without ST-segment elevation), undergoing PCI. These patients had been previously randomised into the CURE study
|
| Exclusion Criteria |
| None. |
| Follow-Up |
| Mean 8 months |
| Treatment Regimen |
- Aspirin 75-325 mg pre-PCI and continued daily.
- Clopidogrel 300 mg loading dose or matching placebo. After PCI, open-label clopidogrel or ticlopidine in combination with aspirin for 2-4 weeks, then resumption of the randomly assigned study medication until the end of the scheduled follow-up (3-12 months after randomisation).
|
| Results |
| Primary Endpoint: Composite of cardiovascular death, MI or urgent target-vessel revascularisation. The composite of cardiovascular death or MI was significantly lower in the clopidogrel group compared with placebo, both at 30 days post PCI and to end of follow up. Patients on clopidogrel had significantly fewer myocardial infarctions (including Q wave MI) than patients on placebo. There was no significant difference in major bleeding (including life-threatening) between the groups at 30 days and at the end of follow-up. There was more minor bleeding in the clopidogrel group than the placebo group at the end of follow up (3.5% vs 2.1%; HR 1.68 (1.06-2.68, p=0.03)). |
| Summary |
| Clopidogrel pre-treatment, in addition to aspirin in patients with acute coronary syndrome undergoing PCI reduces major ischemic events. Long-term treatment for up to 12 months showed a reduction in major ischemic events. |
| Implications |
| None. |
| Related Figures |
| [1, 3, 4] |