November 22, 2013Journal of Cardiovascular Pharmacology and Therapeutics
Clustering of Acute and Subacute Stent Thrombosis Related to the Introduction of Generic Clopidogrel
Key result
Generic clopidogrel use was associated with a 2.7-fold increase in definite 30-day stent thrombosis compared to historic controls (0.38% vs 0.14%; P=0.076).
Why the study?
Does generic clopidogrel increase the risk of acute and subacute stent thrombosis within 30 days of PCI compared to historic controls?
Population
Patients undergoing successful percutaneous coronary intervention at a single center in the United States…
Comparison
Generic clopidogrel administered post-PCI vs Historic controls prior to generic clopidogrel…
Design
Cohort
Follow-up
30 days
Authors
Discussion
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Implication
May warrant post-PCI vigilance with generic clopidogrel; hypothesis-generating and requires randomized confirmation.
Study Design
Type
Observational (n=15,486)
Multicenter
No
Structured PICO
Does generic clopidogrel increase the risk of acute and subacute stent thrombosis within 30 days of PCI compared to historic controls?
P
Population
15,486 percutaneous coronary interventions performed at a single center, comparing an 80-day period of generic clopidogrel use to a 3-year historic control period.
E
Exposure
Generic clopidogrel administered post-PCI
C
Comparator
Historic controls prior to generic clopidogrel availability (80 days prior and 3 years prior)
O
Outcome
Incidence of definite acute and subacute stent thrombosis (ST) within 30 days of successful PCIhard clinical
Main Result
Relative Risk: 2.7
Absolute Event Rate: 0.38% vs 0.14%
p-value: p=.076
The introduction of generic clopidogrel was associated with a >2-fold increase in 30-day stent thrombosis compared to historic controls, warranting increased vigilance.
Limitations
- Cannot ascribe causality
- Cannot ascribe causality due to observational design
- Single center study
Cite This Study
Kovacic et al. (2013) conducted an observational in Percutaneous coronary intervention (PCI) (n=15,486). Generic clopidogrel vs. Historic controls (prior to generic clopidogrel use) was evaluated on Definite 30-day stent thrombosis (2.7-fold increase, p=.076). Generic clopidogrel use was associated with a 2.7-fold increase in definite 30-day stent thrombosis compared to historic controls (0.38% vs 0.14%; P=0.076).