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Abstract
Objective: To quantify the risk for bleeding complications after thrombolysis for ischemic stroke in patients on warfarin (international normalized ratio [INR] ≤1.7) and to put these data into perspective with previous studies.
Methods: A total of 548 consecutive stroke patients receiving IV recombinant tissue plasminogen activator (rtPA) were prospectively evaluated and details about warfarin pretreatment were carefully recorded. Prothrombin time–based INR values were measured before thrombolysis and 6 and 24 hours thereafter. Intracranial hemorrhage occurring within 72 hours was assessed by CT examinations and defined according to National Institute of Neurological Disorders and Stroke criteria. Main outcome variables were symptomatic intracranial and major systemic bleedings.
Results: Of the 548 patients, 33 (6.0%) and 14 (2.6%) experienced symptomatic intracranial and major systemic bleedings, respectively. Patients taking warfarin until the day of or day before admission (n = 15, mean ± SD INR 1.21 ± 0.32 vs 1.01 ± 1.12, p = 0.030) faced an approximately 4-fold risk for intracranial hemorrhage (20.0% vs 5.6%, unadjusted odds ratio [OR] [95% confidence interval (CI)] 4.2 [1.1–15.7], p = 0.033). Findings were similar after adjustment for age, NIH Stroke Scale score, and diabetes (adjusted OR [95% CI] 4.1 [1.0–16.1], p = 0.044) and when focusing on any major bleeding (intracranial or systemic) (unadjusted OR [95% CI] 4.1 [1.3–13.6], p = 0.019). Half of the patients with bleedings showed an INR rise above 1.7 6 hours after thrombolysis. A meta-analysis yielded confirmatory yet heterogeneous results (unadjusted OR [95% CI] derived from a random effects model, 2.31 [1.15–4.62], p = 0.018, I2 = 58% [11%–80%]).
Conclusions: Our data suggest a statistically significant and clinically meaningful increase in the risk for symptomatic intracranial and major systemic bleedings among patients with stroke thrombolysis receiving warfarin up to the day of or day before stroke. Neurology® 2012;79:31–38
GLOSSARY
- CI=
- confidence interval;
- CRP=
- C-reactive protein;
- ECASS=
- European Cooperative Acute Stroke Study;
- INR=
- international normalized ratio;
- mRS=
- modified Rankin Scale;
- NIHSS=
- NIH Stroke Scale;
- NINDS=
- National Institute of Neurological Disorders and Stroke;
- OR=
- odds ratio;
- PACS=
- picture archiving and communication system;
- PT=
- prothrombin time;
- PTT=
- partial thromboplastin time;
- rtPA=
- recombinant tissue plasminogen activator;
- SITS-MOST=
- Safe Implementation of Thrombolysis in Stroke–Monitoring Study
Footnotes
Study funding: The prospective stroke registry and standardized 3-month follow-up are part of a governmental quality assessment program for stroke care in Austria financed by the Federal Ministry of Health, administered by Gesundheit Österreich GmbH (GÖG), and based on the federal law promoting quality in health (“Gesundheitsqualitätsgesetz”).
Editorial, page 17
Supplemental data at www.neurology.org
- Received August 23, 2011.
- Accepted November 17, 2011.
- Copyright © 2012 by AAN Enterprises, Inc.
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