Restrictive access to clopidogrel and mortality following coronary stent implantation
Key result
Absence of outpatient clopidogrel therapy (HR 1.70) or delayed therapy (HR 1.34) significantly increased the risk of all-cause mortality at 1 year following percutaneous coronary intervention with stenting.
Why the study?
Does delayed or absent clopidogrel therapy increase all-cause mortality in patients following coronary stent implantation?
Population
13,663 patients who underwent coronary stent implantation between January 2000 and September 2004 and filled…
Comparison
Delayed or absent outpatient clopidogrel therapy vs Timely filling of clopidogrel prescription
Design
Cohort
Follow-up
1 year
Authors
Discussion
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Implication
Restrictive clopidogrel policies were associated with higher post-stent mortality; leaves open whether removing barriers improves outcomes.
Study Design
Type
Cohort (n=13,663)
Structured PICO
Does delayed or absent clopidogrel therapy increase all-cause mortality in patients following coronary stent implantation?
P
Population
13,663 patients (median age 70, 37% female) who underwent percutaneous coronary intervention with stenting, followed for 1 year to evaluate the association between restricted access to clopidogrel and all-cause mortality.
E
Exposure
Delayed (at least 1 day, median 5 days) or absent outpatient clopidogrel therapy
C
Comparator
Timely filling of clopidogrel prescription
O
Outcome
All-cause mortality in the year following percutaneous coronary interventionhard clinical
Main Result
Hazard Ratio: 1.7 (95% CI 1.35–2.15)
Absolute Event Rate: 6.9% vs 2.9%
p-value: p=<0.001
Restrictive drug insurance policies that delay or prevent clopidogrel therapy after coronary stenting are associated with significantly increased all-cause mortality.
Limitations
- Administrative database lacks information on many important risk factors, leading to potential residual confounding.
- Potential for immortal time bias since groups were defined by prescription filling behavior.
- Suboptimal use of clopidogrel could be due to patient- or physician-related factors rather than the authorization process.
- Type of stent used (bare-metal vs drug-eluting) was unavailable from the database.
- Inability to know if and when the authorization was sent to the pharmacy.
Cite This Study
Sheehy et al. (2008) conducted a cohort in Coronary stent implantation (n=13,663). Absent clopidogrel therapy vs. Clopidogrel therapy without delay was evaluated on All-cause mortality (HR 1.70, 95% CI 1.35-2.15, p=<0.001). Absence of outpatient clopidogrel therapy (HR 1.70) or delayed therapy (HR 1.34) significantly increased the risk of all-cause mortality at 1 year following percutaneous coronary intervention with stenting.