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Safety of IV tPA in Pregnancy-Related Stroke: Findings from a Large US Stroke Registry
Abstract Number: S-55
Abstract Type: Original Research
Background: Tissue plasminogen activator (tPA) is an efficacious therapy for acute ischemic stroke. Pregnancy and recent delivery are thought to pose unacceptable risks of bleeding complications after IV tPA. Pregnant or recently postpartum women with ischemic stroke have been excluded from trials of IV tPA and therefore are rarely treated. We sought to determine the frequency of IV tPA use and short term outcomes among pregnant/recently postpartum vs. non-pregnant women with ischemic stroke entered in Get with the Guidelines® (GWTG) stroke, the largest contemporary U.S. stroke registry.
Methods: GWTG stroke is a national, voluntary quality improvement program sponsored by the American Heart Association with more than 1,700 participating hospitals and over 3 million patients. There were 1928 women aged 18-44 with ischemic stroke who were treated from 2008-2013 with IV tPA (without intra-arterial therapy) who were pregnant or recently postpartum (<6 weeks) (n=15) vs. non-pregnant (n=1913), identified based on medical history or ICD-9 codes. Patient and hospital categorical variables were compared by Chi-square; continuous variables by Wilcoxon Rank-Sum.
Results: Pregnant patients were less likely to receive IV tPA in the 0-3 hr treatment window vs. non-pregnant patients (4.4% vs. 7.9%, p = 0.03) due to pregnancy itself (58% vs. 0%), recent surgery (47% vs. 12%), mild stroke symptoms (16% vs. 31%) or rapidly improving of symptoms (13% vs. 32%). There were no significant differences in major bleeding complications and discharge outcomes were comparable. Overall rates of in-hospital mortality were low (0-2%) and rates of home discharge were high (60-72%). Length of stay was greater among pregnant patients (Table).
Conclusions: Although ischemic stroke in women of childbearing age is uncommon, it can be devastating. Pregnant women with ischemic stroke rarely receive IV tPA, due to the FDA labelled warnings regarding pregnancy. However, in this the largest contemporary series of tPA in pregnancy, the short term outcomes and complication rates compare favorably with non-pregnant women of similar ages. As the data are underpowered to show true differences between the groups, larger prospective studies are warranted to assess the efficacy and safety of thrombolysis during or immediately after pregnancy.