Effects of pretreatment with clopidogrel and aspirin followed by long-term therapy in patients undergoing percutaneous coronary intervention: the PCI-CURE study
Topic: Antiplatelets in acute coronary syndrome
- Determine whether pretreatment followed by long term clopidogrel therapy is superior to aspirin alone in patient with ACS undergoing PCI.
- Prospective, multi-centered, double blinded, randomized clinical trial
- Clopidogrel (300 mg oral loading, then 75 mg per day) and aspirin (75 mg to 325 mg daily) continued for 3-12 months.
- Aspirin plus placebo (dose noted above; clopidogrel or ticlopidine without pretreatment was given for 2-4 weeks after PCI), for 3-12 months.
- 2,658 patients
- 60 years and older with history of CAD
- Presenting within 24 hours of symptom onset
- Elevated cardiac enzymes or EKG changes
- ST elevation
- Contraindications to anticoagulation
- High risk for bleeding or severe heart failure
- Prior use of anticoagulation
- Coronary revascularization in previous three months
- 30 days and 8 months
- Composite of cardiovascular death, myocardial infarction, or urgent target-vessel revascularisation within 30 days of PCI. Cardiovascular death or MI assessed at 12 months.
- Life-threatening bleed (5 gram drop in hemoglobin, hemodynamic compromise), major bleed (2 or more units of blood, CNS bleed), or minor bleed (bleeding that led to interruption of study medication).
- Reinfarction, ventricular fibrillation, other cardiac arrest, cardiogenic shock, and related conditions.
- Mean age 61, 30% were women.
- Unfractionated heparin was used during PCI in 2313 (87%) of patients, and low-molecular-weight heparin in 309 (12%).
- Prior to PCI, significantly fewer patient on clopidogrel than on placebo had a MI or refractory ischemia (206 (15.3%) vs 159 (12.1%); RR 0.76, p = 0.008).
- Significantly fewer patients in the clopidogrel group than the placebo group had a primary outcome of cardiovascular death, myocardial infarction, or urgent revascularisation by 30 days after PCI.
- All deaths within the first 30 days after PCI were CV deaths and were similar between groups (13 vs 14).
- Composite of CV death, MI, or any revasculartization was significantly lower in clopidogrel group vs placebo at the end of follow up (292 (21.7%) vs 240 (18.3%); OR 0.83, p = 0.03).
- There was no significant difference in life threatening or major bleeding between groups, with a significant increase of minor bleeding (from PCI to end of follow up) in the clopidogrel group compared to placebo (28 (2.1%) vs 46 (3.5%); RR 1.68, p = 0.03).
TAKE AWAY: Clopidogrel pretreatment and long term therapy when added to aspirin is superior to aspirin alone in patients with NSTEMI treated with PCI.
Reference: Mehta SR, Yusuf S, Peters RJ, 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(9281):527-33.