Abstract T P67: Similar Outcomes With tPA Protocol Violations as with Protocol Adherence
Background: Nearly twenty years after demonstrating the efficacy of IV tPA in clinical trials, it continues to be widely underused. Fibrinolytic therapy is heavily restricted by a long list of laboratory, radiographic, and clinical inclusion/exclusion criteria. We sought to evaluate whether patients who received IV-tPA in violation of these criteria had different outcomes.
Methods: We included all ischemic stroke patients who received IV tPA (no intra-arterial therapy) and were followed to 90 -days. Group A: IV-tPA use despite contraindication (protocol violation), Group B: IV-tPA protocol-adherent. We compared baseline variables and demographics (age, sex, race, ethnicity, diabetes, hypertension, atrial fibrillation, cerebrovascular disease, baseline NIHSS, and smoking). We analyzed the frequency of symptomatic intracranial hemorrhage (sICH) and gastrointestinal bleeding (GIB). Measures of good clinical outcome included modified Rankin Scale (mRS) 0-1 and discharge home.
Results: A total of 660 tPA-treated patients were included from October 2003 to August 2014, Group A included 22 patients; group B included 638. Group A had 2 patients under 18 years of age, 4 with bleeding risks (low platelets, elevated PTT, or known bleeding diathesis), 4 with recent surgery, trauma, or clinical bleeding, 2 with recent stroke or past ICH, one patient with abnormal glucose accounting for the deficit, and 11 patients outside the time window, rapidly improving, or no disabling deficit.
Baseline demographics and stroke severity were similar, except for diabetes, which was more common in Group A (45.5% vs. 24.3%, p=0.04). There was no difference in sICH (4.55 vs. 3.46%, p=0.55) or GIB (0 vs. 0.6%, p>0.99). Good clinical outcomes were similar (mRS 0-1 38.5% vs. 33.2%, p=0.77; discharge home 65.0 vs 61.8%, p=0.82).
Conclusions: Clinical outcomes and bleeding risks were similar between patients who received IV tPA despite contraindications. Our analysis is limited by small numbers in Group A. Larger patient samples are needed to better understand the role of individual contraindications.
Author Disclosures: K.H. Schlick: None. D. Le: None. S.S. Song: None. R. Raman: None. K. Ernstrom: None. M. Ali: None. H. Ramani: None. D. Meyer: None. R. Modir: None. B.C. Meyer: Research Grant; Modest; SPOTRIAS P50N5044148. Speakers' Bureau; Modest; Genentech. T. Hemmen: Consultant/Advisory Board; Modest; Merck.
- © 2015 by American Heart Association, Inc.