June 17, 2012European Heart Journal
Cox-2 inhibitors and cardiovascular disease: considerable heat, but not much light
Key result
Celecoxib 400 mg daily for 3 months slightly reduced lumen loss after stenting by 0.09 mm (P=0.02) compared to control, but was associated with a higher rate of MI and cardiovascular death.
Why the study?
Does celecoxib reduce lumen loss after stenting in patients undergoing coronary intervention?
Population
Patients undergoing coronary intervention
Comparison
Celecoxib 400 mg daily for 3 months vs Control group
Design
Editorial
Follow-up
3 months
Authors
Discussion
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Implication
The Mini-COREA trial suggests celecoxib slightly reduces lumen loss after stenting but may increase cardiovascular events, underscoring the need for definitive large-scale trials on the cardiovascular safety of COX-2 inhibitors.
Structured PICO
Does celecoxib reduce lumen loss after stenting in patients undergoing coronary intervention?
P
Population
Editorial discussing the Mini-COREA trial of celecoxib in patients undergoing coronary intervention.
I
Intervention
Celecoxib 400 mg daily for 3 months
C
Comparator
Control group
O
Outcome
Lumen loss after stentingsurrogate
Main Result
Mean Difference: 0.09
p-value: p=0.02
The Mini-COREA trial suggests celecoxib slightly reduces lumen loss after stenting but may increase cardiovascular events, underscoring the need for definitive large-scale trials on the cardiovascular safety of COX-2 inhibitors.
Limitations
- The primary endpoint was a surrogate measure (lumen loss) rather than clinical cardiovascular events.
- The 0.09 mm difference in lumen loss is likely not biologically significant.
- Secondary endpoints are hypothesis-generating and potentially unreliable.
- The number of adverse cardiovascular events was very small, making the findings fragile and potentially due to chance.
- Primary endpoint was a surrogate measure
- Difference in lumen loss was statistically but probably not biologically significant
- Small number of clinical events makes the safety findings fragile
- Multiple secondary endpoints showed no significant difference
Cite This Study
Steven E. Nissen (2012) conducted an editorial in coronary intervention. Celecoxib vs. control was evaluated on lumen loss after stenting (0.09 mm difference, p=0.02). Celecoxib 400 mg daily for 3 months slightly reduced lumen loss after stenting by 0.09 mm (P=0.02) compared to control, but was associated with a higher rate of MI and cardiovascular death.