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The gender effect in stroke thrombolysis

Of CASES, controls, and treatment-effect modification

From the Center for Cardiovascular Health Services Research (D.M.K.), Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Tufts University School of Medicine, Boston, MA; Oxford University (A.M.B.), UK; and Calgary Stroke Program (M.D.H.), Department of Clinical Neurosciences, University of Calgary, Foothills Hospital, Alberta, Canada.

Address correspondence and reprint requests to Dr. David M. Kent, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, 800 Washington St, #63, Boston, MA 02111 Dkent1{at}tuftsmedicalcenter.org

Background: Large studies of patients with acute stroke not receiving thrombolytic therapy have repeatedly demonstrated poorer outcomes for women compared to men. An analysis of five pooled randomized controlled trials testing IV recombinant tissue plasminogen activator (rtPA) demonstrated that rtPA benefits women more than men; the usual gender difference, apparent among controls, was totally nullified in the rtPA group. This nullification of the usual gender effect among rtPA-treated patients has not been confirmed.

Methods: We analyzed baseline characteristics and functional outcomes in men vs women in the Canadian Alteplase for Stroke Effectiveness Study (CASES), a multicenter study that collected outcomes data for patients treated with rtPA in Canada to assess the safety and effectiveness of alteplase for stroke in the context of routine care.

Results: Among 1,110 patients, including 615 men and 505 women, a normal or near normal outcome at 90 days was found in 37.1% of men vs 36.0% of women (p = 0.71). This was essentially unchanged after adjusting for differences in baseline characteristics, including age >70, glucose, hypertension, atrial fibrillation, hypercholesterolemia, baseline National Institute of Health Stroke Severity, and baseline Alberta Stroke Program Early CT score (35.2% in men vs 38.2% in women, p = 0.332). Ninety-day mortality was similar between the sexes in both the adjusted and unadjusted analysis.

Conclusions: There was no difference in 90-day outcomes in recombinant tissue plasminogen activator (rtPA)-treated men and rtPA-treated women. This is consistent with the pooled analysis of randomized controlled trials, showing greater benefit for thrombolysis in women and nullification of the usual gender difference in outcome.

GLOSSARY: ASPECT = Alberta Stroke Program Early CT; CASES = Canadian Alteplase for Stroke Effectiveness Study; LACS = lacunar stroke; MAP = mean arterial pressure; mRS = modified Rankin Score; NIHSS = National Institute of Health Stroke Severity; OCSP = Oxfordshire Community Stroke Project; PACS = partial anterior circulation stroke; POCS = posterior circulation stroke; rtPA = recombinant tissue plasminogen activator; sICH = symptomatic intracerebral hemorrhage; TACS = total anterior circulation stroke.

Editorial, page 1048

e-Pub ahead of print on May 21, 2008, at www.neurology.org.

Dr. David Kent is supported by a Career Development Award from NINDS (K23 NS044929). Dr. Buchan was funded in part by the Alberta Heritage Foundation for Medical Research and the Heart & Stroke Foundation of Alberta/NWT/NU. Dr. Hill was funded in part by the Heart & Stroke Foundation of Alberta/NWT/NU, the Canadian Institutes for Health Research, and the Alberta Heritage Foundation for Medical Research.

Disclosure: The CASES study was funded cooperatively by the Canadian Stroke Consortium, the Canadian Stroke Network, and Hoffmann-La Roche Canada Ltd.

Received September 4, 2007. Accepted in final form February 15, 2008.

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