MedWire News: Outcomes after stroke thrombolysis are no worse if patients have contraindications, based on current licensing restrictions, than if they have none, suggests a large Finnish study.
The one exception was age over 80 years, which was associated with poor outcome if thrombolysis was used, but not with symptomatic intracerebral hemorrhage (ICH).
But Atte Meretoja (University of Helsinki) and co-workers note: “The same association between age and outcome probably is true also without thrombolytic therapy.”
The researchers therefore believe that the European label contraindications for tissue plasminogen activator in stroke patients are too restrictive.
“Violating official license is not legally possible in many parts of the world, and thus the license indications and contraindications, although not necessarily evidence-based, do matter,” they write in the journal Stroke.
They say that many of the current license contraindications are based on exclusion criteria of randomized controlled trials, even though these were not supported by scientific evidence.
The team treated 985 stroke patients, 449 (51%) of whom had at least one license contraindication to thrombolysis. These were age over 80 years in 159 patients; mild stroke in 129, based on a National Institutes of Health Stroke Scale score lower than 5; use of intravenous antihypertensives in 112; onset-to-needle time exceeding 3 hours in 95; blood pressure exceeding 185/110 mmHg in 47; and use of oral anticoagulation in 39 patients.
However, the only contraindication that was independently associated with outcome was age over 80 years, which was associated with a 2.18-fold increased risk for a poor functional outcome (modified Rankin Scale >2) relative to on-label treatment.
No contraindication was associated with symptomatic ICH.
Higher baseline blood glucose and dense artery sign or occluded artery on imaging were associated with increased risk for both ICH and poor outcome. Greater initial neurologic deficit and previous disability were also associated with poor outcome, and early infarct signs were associated with ICH risk.
“Half of our patients would not have been treated if all European label contraindications would have been followed,” conclude Meretoja and team.
But they caution that, until more data become available, “the safest way for inexperienced centers to give thrombolysis is to follow official license indications and contraindications.”
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