July 03, 2012
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Blood-clot drug appears safe in warfarin-treated patients after stroke

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The use of intravenous tissue plasminogen activator among warfarin-treated ischemic stroke patients was not associated with increased symptomatic intracranial hemorrhage compared with non-warfarin treated patients, according to researchers.

The study results should alleviate concerns that using the blood thinner warfarin increases the risk for symptomatic intracranial hemorrhage in post-stroke patients treated with tissue plasminogen activator (tPA), a blood clot-dissolving drug, they said.

For the observational study, researchers gathered data from the American Heart Association’s stroke registry.

Ying Xian, MD, PhD, assistant professor of medicine at Duke Clinical Research Institute, and colleagues analyzed data from 23,437 patients with ischemic stroke and an international normalized ratio of 1.7 or lower who were treated with intravenous tPA in 1,203 registry hospitals from 2009 to 2011.

Current AHA guidelines suggest administering intravenous tPA to warfarin-treated patients if their INR is 1.7 or lower.

“To date, we have no randomized trials or large cohort studies to guide us,” Xian said in a press release. “Our large national study found no statistically significant increase in risk, which supports using intravenous tPA in warfarin-treated patients following stoke if their INR is less than or equal to 1.7.”

Overall, 1,802 (7.7%) stroke patients treated with tPA were receiving warfarin.

The unadjusted symptomatic intracranial hemorrhage rate in warfarin-treated patients was higher than non-warfarin patients (5.7% vs. 4.6%, P<.001). However, the rate differences were not significant after adjusting for baseline clinical factors such as age, stroke severity and comorbid conditions (adjusted OR=1.01; 95% CI, 0.82-1.25), according to the study results.

Xian and researchers also found the potential for under-treatment among warfarin-treated patients. Up to 50% of patients who qualified for tPA after stroke did not receive the drug.

“More studies are needed to look at tPA use in patients with an INR greater than 1.7, as well as in those who are taking one of the newer warfarin alternative anticoagulants (dabigatran and rivaroxiban),” Xian said in a press release.

Disclosure: Dr. Xian reports no relevant financial disclosures.