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(Stroke. 2009;40:3067.)
© 2009 American Heart Association, Inc.

Original Contributions

Factors Associated With Intracerebral Hemorrhage After Thrombolytic Therapy for Ischemic Stroke

Pooled Analysis of Placebo Data From the Stroke-Acute Ischemic NXY Treatment (SAINT) I and SAINT II Trials

Brett Cucchiara, MD; Scott E. Kasner, MD; David Tanne, MD; Steven R. Levine, MD; Andrew Demchuk, MD; Steven R. Messe, MD; Lauren Sansing, MD; Kennedy R. Lees, MD; Patrick Lyden, MD for the SAINT Investigators

From the Department of Neurology (B.C., S.E.K., S.R.M., L.S.), University of Pennsylvania, Philadelphia, Pa; the Department of Neurology (D.T.), Chaim Sheba Medical Center and Tel Aviv University, Tel-Hashomer, Israel; the Department of Clinical Neurosciences (A.D.), University of Calgary, Alberta, Canada; the Stroke Center (S.R.L.), The Mount Sinai School of Medicine, New York, NY; the Division of Cardiovascular and Medical Sciences (K.R.L.), Faculty of Medicine, University of Glasgow, Glasgow, UK; and the Department of Neurology (P.L.), University of California–San Diego, San Diego, Calif.

Correspondence to Brett Cucchiara, MD, Department of Neurology, University of Pennsylvania Medical Center, 3400 Spruce Street, Philadelphia, PA 19104. E-mail cucchiar{at}mail.med.upenn.edu

Background and Purpose— A number of factors have been associated with postthrombolysis intracerebral hemorrhage, but these have varied across studies.

Methods— We examined patients with acute ischemic stroke treated with intravenous tissue plasminogen activator within 3 hours of symptom onset who were enrolled in the placebo arms of 2 trials (Stroke-Acute Ischemic NXY Treatment [SAINT] I and II Trials) of a putative neuroprotectant. Early CT changes were graded using the Alberta Stroke Program Early CT Score (ASPECTS). Post–tissue plasminogen activator symptomatic intracerebral hemorrhage was defined as a worsening in National Institutes of Health Stroke Scale of 4 points within 36 hours with evidence of hemorrhage on follow-up neuroimaging. Good clinical outcome was defined as a modified Rankin scale of 0 to 2 at 90 days.

Results— Symptomatic intracerebral hemorrhage occurred in 5.6% of 965 patients treated with tissue plasminogen activator. In multivariable analysis, symptomatic intracerebral hemorrhage was increased with baseline antiplatelet use (single antiplatelet: OR, 2.04, 95% CI, 1.07 to 3.87, P=0.03; double antiplatelet: OR, 9.29, 3.28 to 26.32, P<0.001), higher National Institutes of Health Stroke Scale score (OR, 1.09 per point, 1.03 to 1.15, P=0.002), and CT changes defined by ASPECTS (ASPECTS 8 to 9: OR, 2.26, 0.63 to 8.10, P=0.21; ASPECTS 7: OR, 5.63, 1.66 to 19.10, P=0.006). Higher National Institutes of Health Stroke Scale was associated with decreased odds of good clinical outcome (OR, 0.82 per point, 0.79 to 0.85, P<0.001). There was no relationship between baseline antiplatelet use or CT changes and clinical outcome.

Conclusions— Along with higher National Institutes of Health Stroke Scale and extensive early CT changes, baseline antiplatelet use (particularly double antiplatelet therapy) was associated with an increased risk of post–tissue plasminogen activator symptomatic intracerebral hemorrhage. Of these factors, only National Institutes of Health Stroke Scale was associated with clinical outcome.

Key Words: acute ischemic stroke • intracerebral hemorrhage • prognosis • thrombolysis