Key result
Off-label drug-eluting stent implantation had a higher unadjusted incidence of MACE than on-label use (17.9% vs 8.6%), but the adjusted risk was not significantly different (HR 1.7; 95% CI 0.8-3.6).
Why the study?
Does off-label indication for drug-eluting stents increase the risk of major cardiovascular events compared to on-label indication in patients undergoing coronary intervention?
Population
Patients who underwent coronary intervention with one or more drug-eluting stent implantation in 2006 at the…
Comparison
Off-label indication for drug-eluting stent… vs On-label indication for drug-eluting stent…
Design
Cohort
Follow-up
until mid 2008
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Off-label DES use warrants no practice change; leaves open residual confounding behind the nonsignificant adjusted MACE trend in this cohort.
Cohort (n=332)
No
Does off-label indication for drug-eluting stents increase the risk of major cardiovascular events compared to on-label indication in patients undergoing coronary intervention?
Hazard Ratio: 1.7 (95% CI 0.8–3.6)
Absolute Event Rate: 17.9% vs 8.6%
p-value: p=0.16
Off-label use of drug-eluting stents is frequent and associated with higher unadjusted MACE rates, though this difference is attenuated after adjusting for baseline clinical confounders.
A 2013 study conducted a cohort in Coronary artery disease requiring percutaneous coronary intervention (n=332). Off-label indication for drug-eluting stent implantation vs. On-label indication for drug-eluting stent implantation was evaluated on Major cardiovascular events (MACE) (HR 1.7, 95% CI 0.8-3.6, p=0.16). Off-label drug-eluting stent implantation had a higher unadjusted incidence of MACE than on-label use (17.9% vs 8.6%), but the adjusted risk was not significantly different (HR 1.7; 95% CI 0.8-3.6).
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