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
Aim:
- Determine whether pretreatment followed by long term clopidogrel therapy is superior to aspirin alone in patient with ACS undergoing PCI.
Design:
- Prospective, multi-centered, double blinded, randomized clinical trial
Treatment:
- Clopidogrel (300 mg oral loading, then 75 mg per day) and aspirin (75 mg to 325 mg daily) continued for 3-12 months.
Control:
- Aspirin plus placebo (dose noted above; clopidogrel or ticlopidine without pretreatment was given for 2-4 weeks after PCI), for 3-12 months.
Cohort:
- 2,658 patients
Inclusion criteria:
- 60 years and older with history of CAD
- Presenting within 24 hours of symptom onset
- Elevated cardiac enzymes or EKG changes
Exclusion criteria:
- ST elevation
- Contraindications to anticoagulation
- High risk for bleeding or severe heart failure
- Prior use of anticoagulation
- Coronary revascularization in previous three months
Follow up:
- 30 days and 8 months
Primary endpoint:
- Composite of cardiovascular death, myocardial infarction, or urgent target-vessel revascularisation within 30 days of PCI. Cardiovascular death or MI assessed at 12 months.
Safety endpoint:
- 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).
Secondary endpoint:
- Reinfarction, ventricular fibrillation, other cardiac arrest, cardiogenic shock, and related conditions.
Main results:
- 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.
