Clinical
Stroke history or diabetes shouldn’t rule out thrombolysis: study
NEW YORK (Reuters Health) – Patients with prior stroke, diabetes, or both should not be excluded from thrombolysis for acute ischemic stroke, say researchers who analyzed data on nearly 30,000 patients.
”There are limited treatment options for stroke, and patients with diabetes are at risk of repeated strokes: it is desirable to keep their options open,” Dr. Kennedy R. Lees from Western Infirmary, Glasgow, UK told Reuters Health in an email.
Dr. Lees, the senior author on a report in the November 22 Neurology, noted that the European Medicines Evaluation Agency (EMEA) restricts the use of alteplase to patients without prior stroke or diabetes.
”The EMEA restriction was based on a paucity of evidence, with a tiny subgroup in whom they perceived a possible disadvantage,” Dr. Lees said. ”With accumulation of experience showing no interaction, this restriction should be relaxed.”
The new findings are drawn from data in the SITS registry (Safe Implementation of Thrombolysis in Stroke-International Stroke Thrombolysis) and VISTA (the Virtual International Stroke Trials Archive) on 23,334 stroke patients who received thrombolytic therapy and 6,166 patients who did not.
The cohort included 5,411 patients with diabetes mellitus, 5,019 with a previous stroke, and 1,141 with both.
Adjusted 90-day modified Rankin Scale scores were better with thrombolysis among patients with diabetes (odds ratio 1.45), previous stroke (OR 1.55), or both (OR 1.23), according to the authors (all p<0.0001).
The results were comparable to outcomes in thrombolysis and control patients without diabetes or a previous stroke, the authors note.
There was no interaction between diabetes or stroke and alteplase that had any effect on outcome, nor did age above or below 80 years have any effect.
Dr. Lees noted that ”there also is a European but not U.S. restriction” on using alteplase in patients older than 80. ”Again, we found equal benefit from treatment in the elderly. Treatment rates in the elderly have since improved,” Dr. Lees added.
”Observation studies cannot replace randomized controlled trials, but with careful analysis a well validated dataset such as VISTA can be used to supplement trials and guide therapy,” Dr. Lees said.
In an editorial, Dr. Bart M. Demaerschalk from the Mayo Clinic in Phoenix, Arizona said the study ”represents a concerted empirical effort to clarify the validity of withholding thrombolytic therapy in acute ischemic stroke in those with a history of prior stroke and concomitant diabetes, up to 15% of all acute ischemic stroke patients who present to emergency departments.”
”There appears to be no justification for the continued restriction of these patients from receiving thrombolytic therapy,” the editorial concludes.
Neurology 2011;77:1866-1872.
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