Patient's age impacts stroke risk and aneurysm occlusion - SCENT Flow Diverter trial on large and giant aneurysms

ImportanceThe multicenter, prospective, single-arm, non-randomized SCENT trial on flow diverter (FD) treatment for intracranial aneurysms (IA) was analyzed for patients age and IA characteristics impacting stroke and occlusion rates over 5 years. DesignThe impact on major ipsilateral stroke and IA occlusion was studied by stratifying age as [&le;] 65 years versus >65 years. Product-limit (Kaplan-Meier) estimates of time to both endpoints, stratified by age group, were created. Univariate predictors of time to stroke were identified by including candidate variables in univariable proportional hazards regression models. Those variables found to be significant (p<0.10) at the univariate level were entered into a multivariable survival model to identify independent predictors. The stepwise selection produced a final reduced model with a significance level to both enter and stay set at 0.05. FindingsOf 180 patients with 180 large or giant IA enrolled in the modified intention-to-treat cohort, 119 subjects were [&le;] 65, while 61 patients were > 65 years old. When parent artery stenosis and IA size were entered into a multiple-stepwise survival model, only stenosis remained as an independently significant predictor of time to stroke. At 3-year follow-up, there were a total of 23 strokes (12.8%), with 11 occurring in subjects [&le;] 65 years; there was a greater risk for seniors (HR1.96, 95% CI 0.83-4.78). Four patients (4/180; 2.2%) experienced aneurysm rupture within the first week post-treatment, with 3 being [&le;] 65 and the fourth aged 66 years. No new strokes were reported between 3 and 5 years. Complete IA occlusion rates for seniors were 60.0% (33/55), 67.6% (25/37), and 85.7% (18/21) at 12, 36, and 60 months, respectively, as compared to 79.1% (87/110), 82.5% (66/80), and 91.8% (56/61) for younger subjects. The time to complete IA occlusion was shorter in younger patients (HR1.53, 95% CI 1.07-2.19). Five subjects (2.8%) underwent retreatment, 2 in 60-year-old patients, and one each aged 64, 70, and 75. Conclusions and RelevanceAge > 65 and parent artery stenosis are related to an increased risk of major ipsilateral stroke in patients with intracranial aneurysms treated with a flow diverter. Age > 65 is also predictive of increased time to and incomplete healing. With demographic shifts, future treatments need to focus on expedited and improved healing. Trial Registrationhttps://www.clinicaltrials.gov NCT01716117 KEY POINTSO_ST_ABSQuestionC_ST_ABSWhat key variables, including patients age and intracranial aneurysm (IA) characteristics, determine procedural stroke risks in subjects treated for large or giant IA with flow-diverting stents? FindingsAneurysm size and parent artery stenosis impacted occlusion rates and stroke risk, respectively. Over a 5-year observation period, the senior population had a significantly lower occlusion rate and higher risk for stroke, while the younger population was at higher risk for early aneurysm bleed following treatment. MeaningWith demographic shifts and a higher senior population being treated for IA, the stroke risk and incomplete occlusion rates need to be discussed with the patient before treatment.