Abstract TMP78: Do Hospital Complications Justify Excluding Elderly Patients from Stroke Clinical Trials?

Background and Objectives: There is a paucity of data from recent trials analyzing outcomes and hospital complications in octogenarians after acute ischemic stroke (AIS). Stroke trials often set an arbitrary upper age limit (usually age 80) as an inclusion criterion. We hypothesized that based on hospital complication rates and outcome, age ≥80 does not justify exclusion from clinical trials testing new AIS therapies. Methods: From our prospectively compiled stroke registry, we identified AIS patients older than 50 from January 1, 2007 to March 30, 2012. Patients were excluded if they 1) had a baseline mRS >2, 2) received intra-arterial therapy, or 3) were enrolled in a trial. Demographic and clinical data were analyzed in patients ≥80 and 50-79 to determine if age ≥80 raises the odds for hospital complications and worse outcomes. Results: We identified 526 patients ≥80 and 1572 aged 50-79. Compared with their younger counterparts, patients ≥80 had a higher incidence of vascular risk factors, higher NIHSS scores, higher IV tPA rates, and a 1.3 times higher odds (95% confidence interval 1.01 - 1.7) of developing in-hospital complications, after controlling for all co-variates (including NIHSS, t-PA, vascular risk factors). However, higher complication rates appeared to be driven by UTIs. A stratified analysis of age cutoffs at 5 year intervals for all complications other than UTI did not show that ages 85 and above have significantly higher odds of complications as compared to those aged 50-74. Older patients had higher odds (OR 2.11 95% CI 1.34 - 3.31) of a poor outcome at 90 days (mRS >2) compared with younger patients, after adjusting for co-variates. Conclusion: Age ≥80 is a predictor of in-hospital complications but only the rates of UTI were significantly higher. These findings support re-considering age >80 as an exclusion from participating in clinical trials testing new AIS therapies. The higher odds for poor outcome also raise the need to design therapies for patients ≥80.