Introduction The Gaining Efficacy Long Term: HydroSoft, an Emerging, New, Embolic Coil (GEL THE NEC) randomized clinical trial was performed to investigate the safety and efficacy of HydroSoft coils in treating intracranial aneurysms. This study is a subgroup analysis evaluating the effect of tobacco smoking on immediate and long-term angiographic outcomes of patients in the GEL THE NEC trial.
Methods Patients from the GEL THE NEC trial were divided into 3 groups: 1) Current Smoker 2) Former Smoker, and 3) Never Smoker. The two primary outcomes studied were immediate and long-term angiographic outcomes after HydroSoft coil treatment of intracranial aneurysms. Kruskal-Wallis and chi-square tests were used to test statistical significance of differences in immediate and long-term angiographic outcomes amongst the 3 groups. A multivariate logistic regression analysis controlling for baseline variables that were significant on univariate analysis was also performed.
Results A total of 598 patients with 598 aneurysms were included in this study. Immediate (P = 0.48) and long-term (P = 0.29) angiographic outcomes were not significantly associated with smoking. On multivariate analysis, former smokers (OR 0.87, 95% CI 0.34–1.97; p = 0.73) and current smokers (OR 1.19, 95% CI 0.56–2.53; p = 0.66) had similar odds of recanalization compared with never smokers. Former smokers (OR 1.61, 95% CI 0.75–3.43; p = 0.22) and current smokers (OR 1.57, 95% CI 0.71–3.45; p = 0.27) had odds of complete/near complete occlusion similar to never smokers. The odds of retreatment for former smokers (OR 0.57, 95% CI 0.14–2.37; p = 0.44) and current smokers (OR 0.96, 95% CI 0.33–2.81; p = 0.94) were also similar to never smokers.
Conclusions This unplanned subgroup analysis found that tobacco smoking was not an independent factor in affecting immediate or long-term angiographic outcomes after HydroSoft coil treatment for intracranial aneurysms. Since this is a subgroup analysis, these results should not alter clinical practice. However, they do provide meaningful insight for the design of future randomized clinical trials. Patients with intracranial aneurysms should continue to be counseled about the risks of tobacco smoking.
Disclosures: A. Haider: None. W. Brinjikji: None. K. Layton: None. D. Kallmes: None.
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