Abstract 95: Modeling Outcome After Intracerebral Hemorrhage Indicates No Benefit from Lowering Blood Pressure
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BACKGROUND: Outcome following ischemic stroke is strongly related to baseline severity. Differences in baseline balance between arms seen even in larger trials complicate analysis. We developed a method (pPREDICTS) that generates a pooled outcome model from baseline factors taken from randomized clinical trials (RCTs). It visualizes variability to assess whether an individual study treatment arm differs sufficiently from expected outcome to be considered positive if tested in a larger population, without need for any statistical corrections. Here we assessed whether intracerebral hemorrhage (ICH) could be similarly modeled and how blood pressure (BP) interventions fared considering between-trial variance. METHODS: pPREDICTS generates an outcomes and provides multi-dimensional p=.05 statistical surfaces to visualize the variance among these trials. ICH RCTs were selected that provided baseline NIHSS, age and 90 day outcomes. Individual results from 4 BP trials were tested against these models to determine whether outcomes surpassed the 95% prediction interval surfaces. Mortality and mRS0-2, the most frequently reported outcomes were modeled. RESULTS: Outcome functions derived from 12 ICH RCTs representing 2766 subjects were generated (middle surface p=.05 surfaces; Fig 1a: Mortality: r 2 =0.84; Fig 1b:mRS0-2:r 2 =0.79; p0.005). Control management (green) and treatment arm (red) outcomes of ATACH, ICH-ADAPT, INTERACT and INTERACT2 were plotted (see Figs). No mortality or functional outcome different from control was seen as outcomes are mostly distributed along the middle surface. However, tier 3 of ATACH, BP goal of SBP 110-140 showed increased mortality (>+95%) and decreased mRS 0-2 outcome (<-95%). CONCLUSION: Outcome models for mortality and mRS 0-2 were successfully developed. No benefit was seen from any BP intervention. We suspect small differences in outcomes reported as positive are more likely random variation.
