September 13, 2005JAMA
Effect of Clopidogrel Pretreatment Before Percutaneous Coronary Intervention in Patients With ST-Elevation Myocardial Infarction Treated With FibrinolyticsThe PCI-CLARITY Study
Key result
Clopidogrel pretreatment before PCI in STEMI patients reduced cardiovascular death, recurrent MI, or stroke compared to placebo (3.6% vs 6.2%; adjusted OR 0.54; 95% CI 0.35-0.85; P=0.008).
Why the study?
Does clopidogrel pretreatment reduce the composite of cardiovascular death, recurrent MI, or stroke in patients with STEMI receiving fibrinolytics and undergoing PCI?
Population
1,863 patients with recent ST-segment elevation myocardial infarction receiving fibrinolytics and undergoing…
Comparison
Clopidogrel pretreatment initiated with… vs Matching placebo initiated with fibrinolysis and…
Design
RCT, randomized, double-blind, placebo-controlled
Follow-up
30 days
Authors
Discussion
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Implication
Supports clopidogrel pretreatment before PCI in STEMI on fibrinolytics; confirms and extends CLARITY-TIMI 28 evidence for early loading.
Study Design
Type
RCT (n=1,863)
Blinding
Double-blind
Randomization
Randomized
Multicenter
Yes
Structured PICO
Does clopidogrel pretreatment reduce the composite of cardiovascular death, recurrent MI, or stroke in patients with STEMI receiving fibrinolytics and undergoing PCI?
P
Population
1,863 patients with recent ST-segment elevation myocardial infarction (STEMI) receiving fibrinolytics and undergoing percutaneous coronary intervention (PCI) after mandated angiography. Multinational (319 sites in 23 countries).
I
Intervention
Clopidogrel pretreatment (300 mg loading dose, then 75 mg once daily) initiated with fibrinolysis and given until coronary angiography (performed 2 to 8 days after initiation). All patients received aspirin.
C
Comparator
Matching placebo initiated with fibrinolysis and given until coronary angiography. All patients received aspirin. For patients undergoing coronary artery stenting in both groups, open-label clopidogrel (including a loading dose) was recommended after the diagnostic angiogram.
O
Outcome
Incidence of the composite of cardiovascular death, recurrent MI, or stroke from PCI to 30 days after randomization.composite
Main Result
Effect estimate: adjusted OR 0.54 (95% CI 0.35-0.85)
Absolute Event Rate: 3.6% vs 6.2%
p-value: p=.008
Clopidogrel pretreatment before PCI in STEMI patients receiving fibrinolytics significantly reduces cardiovascular death and ischemic complications without increasing bleeding risk.
Cite This Study
Marc S. Sabatine (2005) conducted an RCT in ST-segment elevation myocardial infarction (STEMI) (n=1,863). Clopidogrel vs. Placebo was evaluated on Composite of cardiovascular death, recurrent MI, or stroke from PCI to 30 days after randomization (adjusted OR 0.54, 95% CI 0.35-0.85, p=.008). Clopidogrel pretreatment before PCI in STEMI patients reduced cardiovascular death, recurrent MI, or stroke compared to placebo (3.6% vs 6.2%; adjusted OR 0.54; 95% CI 0.35-0.85; P=0.008).