In acute stroke patients, receiving IV thrombolysis, is there an increased risk of intracerebral bleeding if pretreated with statins?

Study metrics

Prospectively collected data from the Safe Implementation of Treatments in Stroke-East registry (SITS-EAST) on consecutive 1660 AIS patients (373 – 23% on statins) treated with IV Thrombolysis between October 2013 and December 2011 (8 years).


Patients using statins had had higher baseline stroke severity. No correlation was observed with statin uses and increased risk for intracranial hemorrhage. There was no impact on 3-month all-cause mortality (odds ratio, 0.92; 95% confidence interval, 0.57–1.49; P=0.741) or 3-month favorable functional outcome (odds ratio, 0.81; 95% confidence interval, 0.52–1.27; P=0.364). But there was a favorable effect on early clinical recovery (odds ratio, 1.91; 95% confidence interval, 1.25–2.92; P=0.003).


In patient with acute ischemic stroke who had IV thrombolysis, statin pretreatment was not associated with adverse outcomes. The effect of statin pretreatment on early functional outcomes deserves further investigation.

Strengths – Weakness

Adequate sample size from an international, multi-center registry with standardized protocol. The multivariate analyses, were adjusted for numerous potential confounders.

Information on statin dosage was lacking as well as neuroimaging parameters (e.g., brain micro bleeds). Autopsy data, recurrent stroke rate, and ethnicity data were not collected. Patients who died ≤ 24 hours (n=15) may have had undetected sICH. Lack of Improved functional outcome at 3 months may be attributed to unavailable follow-up data in 53% of the study population.

Selected Quote

“Our findings underline the safety of statin pretreatment (in terms of sICH or death) in AIS patients treated with systemic thrombolysis.”


The impact of statins in preventing Atherothrombotic complications has been well established. In the SPARCL study an increased risk of hemorrhagic complications was associated with statin treatment. Potentially some of the pleiotropic, anti-thrombotic effects of statins could theoretically explain these results. Since then several observational studies, including this one, seem to refute this potential increased bleeding risk and even show some benefits in terms better functional recovery even in ICH patients. There is a clear need for a RCT to solve this problem. Ideally using a lipophilic and hydrophilic statin to address this potential confounder as well.

Safety of Statin Pretreatment in Intravenous Thrombolysis for Acute Ischemic Stroke. Tsivgoulis G, Kadlecova P, Kobayashi A et al. Stroke 2015; PMID: 26173726.

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