Choice of intravenous thrombolysis therapy in patients with mild stroke complaining of acute dizziness

Introduction: Ischemic stroke patients with mild deficits were largely excluded from pivotal trials of IV rt-PA. The balance of benefit versus risk of intravenous thrombolysis for this large, understudied patient cohort is uncertain. The PRISMS trial is underway to test the benefit of IV rt-PA for treatment of mild stroke. Objective: To characterize baseline features of the first 100 patients enrolled in this prospective cohort of exclusively mild stroke. Methods: The PRISMS trial is a Phase 3b, double-blind, 75-center, 948-subject study evaluating IV rt-PA administered within three hours of mild stroke onset to improve 90-day functional outcome (modified Rankin Scale 0 or 1). Mild stroke is defined as NIHSS ≤5 and not “clearly disabling” (i.e., inability to return to work or perform basic activities of daily living based on current deficits). Patients are randomized 1:1 to IV rt-PA 0.9 mg/kg with aspirin placebo or IV rt-PA placebo with aspirin 325 mg. Here we describe baseline characteristics, including clinical presentations by NIHSS item, of the first 100 enrolled patients. The study team remains fully blinded to patient treatment assignment and outcomes. Results: The 100th subject was enrolled on June 15, 2015. Baseline characteristics are presented in the Table. Median NIHSS was 2 (IQR 1-3). Clinical presentations of each patient by abnormal NIHSS items are shown in the Figure. Dysarthria, facial palsy, and sensory loss were the most common deficits. Conclusions: This initial 100-patient PRISMS cohort is consistent with expectations. Upon completion, the PRISMS trial will determine the benefit of IV rt-PA for mild stroke.

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Direct access to a hospital offering intravenous thrombolysis therapy improves functional outcome of acute ischemic stroke patients

Journal of Clinical Neuroscience ◽

10.1016/j.jocn.2014.03.014 ◽

2014 ◽

Vol 21 (8) ◽

pp. 1428-1432 ◽

Cited By ~ 7

Author(s):

Dae-Hyun Kim ◽

Jae-Kwan Cha ◽

Hyun-Seok Park ◽

Jae-Hyung Choi ◽

Myung-Jin Kang ◽

...

Keyword(s):

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Functional Outcome ◽

Intravenous Thrombolysis ◽

Direct Access ◽

Stroke Patients ◽

Thrombolysis Therapy

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Sex Differences in Long-Term Survival after a First Stroke with Intravenous Thrombolysis: Ebrictus Study

Cerebrovascular Diseases Extra ◽

10.1159/000440734 ◽

2015 ◽

Vol 5 (3) ◽

pp. 95-102 ◽

Cited By ~ 8

Author(s):

José Luis Clua-Espuny ◽

Rosa Ripolles-Vicente ◽

Teresa Forcadell-Arenas ◽

Vicente Francisco Gil-Guillen ◽

Maria Lluïsa Queralt-Tomas ◽

...

Keyword(s):

Therapy Group ◽

Intravenous Thrombolysis ◽

Term Survival ◽

Death Rates ◽

Barthel Score ◽

The Relationship ◽

Cardiovascular Secondary Prevention ◽

Stroke Death ◽

Thrombolysis Therapy

Background: A number of large trials have confirmed the benefits of thrombolysis in acute stroke, but there are gender differences. We sought to examine the relationship between sex and outcome after thrombolysis. Methods: This was a prospective cohort study including 1,272 incident ischemic strokes (597 in women) from April 1, 2006 to December 31, 2014. Statistical approaches were used for analyzing survival outcomes and their relationship with thrombolysis therapy. Results: The death rates were lower (p = 0.003) in the thrombolysis therapy group with an incidence ratio of 0.57 (95% CI 0.39-0.83). 113 (8.8%) patients (53 women) received thrombolysis. They were significantly younger (69.2 ± 12.7 vs. 73.9 ± 12.5 years; p < 0.001), had higher NIHSS score (12.7 ± 6.3 vs. 7.3 ± 7.0; p < 0.001), spent more days in hospital (10.4 ± 8.3 vs. 8.3 ± 7.9; p < 0.001), and had a higher average Barthel score at discharge (85.5 ± 24.4 vs. 79.2 ± 28.6; p = 0.023). The male/female incidence ratio showed a significant decrease (p = 0.01) in the incidence of mortality in women and a better Barthel score. The thrombolysis improved the survival in the overall group with thrombolysis versus without thrombolysis (p = 0.028), in women versus in men with thrombolysis (p = 0.023), and in women with thrombolysis versus in those without thrombolysis (p < 0.001) but not in men with thrombolysis versus in those without thrombolysis (p = 0.743). The protective factors as regards mortality were thrombolysis therapy (95% CI 0.37-0.80; p = 0.002), Barthel score ≥60 (95% CI 0.81-0.94; p = 0.002), and cardiovascular secondary prevention 1 year after stroke (0.13, 95% CI 0.06-0.28). Conclusions: The stroke death rates were lower in women after thrombolysis treatment and suggest significant benefit for women in this setting. The overall benefit on survival of the patients treated with thrombolysis might be explained by the beneficial effect of the thrombolysis on the women.

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