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Treating menstruating women with thrombolytic therapy: insights from the global utilization of streptokinase and tissue plasminogen activator for occluded coronary arteries (GUSTO-I) trial.

Publication ,  Journal Article
Karnash, SL; Granger, CB; White, HD; Woodlief, LH; Topol, EJ; Califf, RM
Published in: J Am Coll Cardiol
December 1995

OBJECTIVES: The purpose of this study was to examine the clinical implications of administering thrombolytic therapy to menstruating women with acute myocardial infarction. BACKGROUND: Although anecdotal case reports have suggested that thrombolytic therapy is safe during menstruation, the risk of increased bleeding in menstruating women receiving such therapy is poorly defined. METHODS: We identified menstruating women who received thrombolytic therapy by soliciting information on all North American women enrolled in the GUSTO-I trial and then collected additional information about them with use of a one-page data form. We compared the characteristics and outcomes of these women with other GUSTO-I patient populations, including all North American women below the median age of menopause, all women and all patients. RESULTS: The median age of the 12 menstruating women was 46 years; 75% were cigarette smokers. The median hospital stay was 7 days, 2 fewer than the overall stay in GUSTO-I. None of these women died or had a stroke or severe bleeding. Three patients (25%) had moderate bleeding (vaginal in two patients [66%]) that required transfusion compared with 11% of all GUSTO-I patients and all North American premenopausal women (p = 0.13) and 17% of all female GUSTO-I patients (p = 0.47). Because of the small sample size of 12 women, the power was low (0.37) to detect the observed difference in moderate bleeding. The median nadir hematocrit was 33% in the menstruating women compared with 34% in the premenopausal women and all women. The median time from symptom onset to treatment for the 12 women was 3.7 h, which was 0.9 h longer than the overall median in the trial (p = 0.09). CONCLUSIONS: Although there was no statistically significant increase in bleeding risk during menstruation, this fact may be a result of low statistical power rather than a lack of effect. Thus, the results suggest that there may be a clinically significant increase in the risk of moderate bleeding. Nevertheless, the GUSTO-I experience is consistent with the concept that the lifesaving benefit of thrombolytic therapy for acute myocardial infarction should generally not be withheld because of active menstruation.

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Published In

J Am Coll Cardiol

DOI

ISSN

0735-1097

Publication Date

December 1995

Volume

26

Issue

7

Start / End Page

1651 / 1656

Location

United States

Related Subject Headings

  • Tissue Plasminogen Activator
  • Thrombolytic Therapy
  • Streptokinase
  • Plasminogen Activators
  • Middle Aged
  • Menstruation
  • Length of Stay
  • Humans
  • Hemorrhage
  • Female
 

Citation

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Karnash, S. L., Granger, C. B., White, H. D., Woodlief, L. H., Topol, E. J., & Califf, R. M. (1995). Treating menstruating women with thrombolytic therapy: insights from the global utilization of streptokinase and tissue plasminogen activator for occluded coronary arteries (GUSTO-I) trial. J Am Coll Cardiol, 26(7), 1651–1656. https://doi.org/10.1016/0735-1097(95)00386-x
Karnash, S. L., C. B. Granger, H. D. White, L. H. Woodlief, E. J. Topol, and R. M. Califf. “Treating menstruating women with thrombolytic therapy: insights from the global utilization of streptokinase and tissue plasminogen activator for occluded coronary arteries (GUSTO-I) trial.J Am Coll Cardiol 26, no. 7 (December 1995): 1651–56. https://doi.org/10.1016/0735-1097(95)00386-x.
Karnash, S. L., et al. “Treating menstruating women with thrombolytic therapy: insights from the global utilization of streptokinase and tissue plasminogen activator for occluded coronary arteries (GUSTO-I) trial.J Am Coll Cardiol, vol. 26, no. 7, Dec. 1995, pp. 1651–56. Pubmed, doi:10.1016/0735-1097(95)00386-x.
Journal cover image

Published In

J Am Coll Cardiol

DOI

ISSN

0735-1097

Publication Date

December 1995

Volume

26

Issue

7

Start / End Page

1651 / 1656

Location

United States

Related Subject Headings

  • Tissue Plasminogen Activator
  • Thrombolytic Therapy
  • Streptokinase
  • Plasminogen Activators
  • Middle Aged
  • Menstruation
  • Length of Stay
  • Humans
  • Hemorrhage
  • Female