Hemorrhage after thrombolytic therapy for stroke - The clinically relevant number needed to harm

被引:100
作者
Saver, Jeffrey L.
机构
[1] Univ Calif Los Angeles, Stroke Ctr, David Geffen Sch Med, Los Angeles, CA 90095 USA
[2] Univ Calif Los Angeles, Dept Neurol, David Geffen Sch Med, Los Angeles, CA 90095 USA
关键词
intracerebral hemorrhage; ischemic stroke; number needed to treat; stroke; thrombolysis;
D O I
10.1161/STROKEAHA.107.487009
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
Background and Purpose - A clinically relevant number needed to harm for tissue plasminogen activator (tPA)-related symptomatic intracerebral hemorrhage (SICH) would greatly assist therapeutic decision-making. Methods - A 15-variable prognostic model was derived from a placebo group enrolled in National Institute of Neurological Disorders and Stroke tPA Trials 1 and 2 and used to predict final global disability outcome for patients with tPA-related SICH had they been treated with placebo, rather than tPA, and not experienced SICH. Results - Among 312 tPA-treated patients, 20 experienced SICH. Compared with placebo patients, patients treated with tPA who experienced SICH were older, had more severe stroke deficits, had higher serum glucose levels, and more often displayed mass effect on pretreatment imaging. Observed 3-month modified Rankin Scale outcomes among the patients experiencing SICH after tPA were: 0-5%, 1-5%, 4-10%, 5-5%, and 6-75%. Predicted outcomes had they been treated with placebo were: 0-2%, 1-5%, 2-7%, 3-14%, 4-28%, 5-12%, and 6-32%. The number needed to harm for one more patient to have a final disabled or dead outcome (modified Rankin Scale >= 3) attributable to tPA- related SICH was 707. Number needed to harm for severely disabled or dead outcome (modified Rankin Scale >= 4) was 126; for fatal outcome 36.5, and for worsened outcome by any degree (>= 1 modified Rankin Scale grade) between 29.7 and 40.1. Conclusions - Most patients who experience SICH have severe baseline infarcts and already are destined for poor outcomes. For every 100 patients treated with tPA, approximately 1 will experience a severely disabled or fatal final outcome as a result of tPA- related SICH.
引用
收藏
页码:2279 / 2283
页数:5
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