Authors
Tsai TT, Ho PM, Xu S, et al.
Title
Increased risk of bleeding in patients on clopidogrel therapy after drug-eluting stents implantation: insights from the HMO Research Network-Stent Registry (HMORN-stent).
References
Circ Cardiovasc Interv 2010;3:230-5
Background
Studies suggest that extended clopidogrel use after drug-eluting stent (DES) implantation may decrease the risk of myocardial infarction (MI) and death. Little is known about the competing risk of bleeding from clopidogrel in "real world" clinical practice.
Purpose
To assess the risks (i.e., increased major bleeding events) and benefits (i.e., reduction in MI or death) of clopidogrel therapy in routine clinical practice after drug-eluting stent (DES) implantation
Design
Analysis of Registry data 7689 patients undergoing drug-eluting stent implantation enrolled in the HMO Research Network-Stent Registry between 2004 and 2007 The primary outcomes were hospitalization for major bleeding, MI, or death in 3 discrete time intervals (0 to 6 months, 7 to 12 months, and 13 to 18 months) after DES implantation
Exclusion Criteria
Clopidogrel use before the procedure.
Follow-Up
18 months
Treatment Regimen
Clopidogrel for DES implantation
Results
Primary Endpoints After Adjustment: Patients on clopidogrel therapy were associated with increased major bleeding in all time intervals (0 to 6 months: RR 2.70, 95% CI 1.41 to 5.19; 7 to 12 months: RR 1.71, 95% CI 1.05 to 2.79; 13 to 18 months: RR 2.34, 95% CI 1.26 to 4.34), compared with patients off clopidogrel. Clopidogrel use was also associated with decreased risk of MI for all time intervals (0 to 6 months: RR 0.52, 95% CI 0.36 to 0.77; 7 to 12 months: RR 0.46, 95% CI 0.30 to 0.70; 13 to 18 months: RR 0.53, 95% CI 0.29 to 0.99) and decreased death in the 7 to 12 month interval (RR 0.50, 95% CI 0.30 to 0.83)
Summary
Clopidogrel use was associated with increased major bleeding and decreased MI persisting to 18 months. Bleeding risks on clopidogrel therapy deserve consideration in the ongoing debate regarding optimal clopidogrel duration after PCI.
Implications
This registry analysis provided important insight into the bleeding risk with clopidogrel therapy, suggesting that the bleeding risk with clopidogrel is nearly three times elevated as compared to patients who did not take clopidogrel. The decrease in risk of stent thrombosis with clopidogrel has to be balanced against an increased risk of bleeding.
Related Figures
None.