Abstract 2483: No Increased Risk of sICH in tPA Treated Stroke Patients With ECASS Exclusion Criteria
Introduction: Only about 2% of ischemic stroke patients are currently treated with IV tPA, with the most common reason for exclusion from treatment being time. The positive results of ECASS III expanded the time window for treatment to 4.5 hours, however it used more stringent exclusion criteria than are in use for <3 hrs in the USA. For patients who present 3-4.5 hours from symptom onset, the scientific advisory from the AHA/ASA recommends use of the more narrow ECASS III criteria. We evaluated the outcomes of patients who had been treated with IV tPA to test the hypothesis that thrombolysis is not safe in patients with one of the additional exclusion criteria (age >80, NIHSS >25, combination of previous stroke and diabetes, aggressive measures required to control blood pressure (IV infusion), or oral anticoagulant treatment).
Methods: We performed a retrospective analysis of all acute ischemic stroke patients treated with IV tPA at our tertiary care academic medical center between June 2006 and June 2010. 191 patients were identified and stratified based on presence of each of the listed exclusion criteria. The primary outcomes are rate of symptomatic intracerebral hemorrhage (sICH) and in-hospital mortality. Additionally, patients with and without sICH were analyzed for differences in baseline characteristics.
Results: There were 31 patients older than 80 years, 5 with NIHSS >25, 14 with the combination of prior stroke and diabetes, 19 required continuous IV infusions to control blood pressure below 185/110 mmHg, and 11 were taking oral anticoagulants. No exclusion criterion was associated with increased risk of sICH. There was higher in hospital mortality in patients >80 years (5 of 31 (16%) vs. 6 of 160 (4%), p=0.0186, RR = 3.15, 95% CI: 1.50 to 6.59), and those with NIHSS >25 (2 of 5 (40%) vs. 7 of 159 (4.4%), Relative risk = 11.48, 95% CI: 2.19 to 60.30). sICH was associated with atrial fibrillation (5 of 9 (55%), vs. 35 of 182 (19.2%), p=0.021; RR = 4.72, 95% CI: 1.33 to 16.77), larger final infarct volume (mean 173 ml3 (SEM 43.3) vs. 42 ml3 (SEM 6.3),p=0.0002), and elevated glucose (mean 166 mg/dL (SEM 23.1) vs. 127 mg/dL (SEM 4.1), p=0.038).
Conclusions: In our cohort, none of the exclusion criteria from ECASS III, which were more stringent than those used in 0-3 hour US labeling, were associated with increased risk of sICH. tPA may be safe in these patients, who represent an important patient population of acute stroke patients. In agreement with prior studies, we have found that older patients and those with more severe deficits at presentation have higher mortality after acute ischemic stroke. Prospective studies are urgently needed to determine the safety and efficacy of tPA in this group of patients through all treatment time windows.
- © 2012 by American Heart Association, Inc.