According to the results of research published in the journal ‘Neurology’, patients with prior stroke, diabetes, or both should not be excluded from thrombolysis for acute ischemic stroke.

The authors note that any history of prior stroke and concomitant diabetes is a contra-indication to the use of alteplase in the treatment of acute ischaemic stroke in the EU.  In their study, they sought to examine the influence of diabetes and prior stroke on the outcomes of patients receiving thrombolytic therapy (using data from the SITS registry [Safe Implementation of Thrombolysis in Stroke-International Stroke Thrombolysis]) compared to those who did not receive thrombolysis (data from VISTA [the Virtual International Stroke Trials Archive]). 

The analysis included 23,334 patients with ischaemic stroke who received thrombolytic therapy and 6,166 who did not.  The cohort included 5,411 patients with diabetes mellitus, 5,019 with a previous stroke, and 1,141 with both.
Only those with data available regarding their age, baseline NIH Stroke Scale score (NIHSS), and 90-day modified Rankin Scale score (mRS) were included.  The authors compared the distribution of mRS between those receiving thrombolysis and those not, in patients with and without diabetes, prior stroke, or the combination.  The analyses were adjusted according to age and baseline NIHSS.

The authors report that adjusted mRS outcomes were found to be better for those treated with thrombolysis compared to those receiving no thrombolysis among patients with diabetes (OR 1.45 [1.30–1.62]), prior stroke (OR 1.55 [1.40–1.72]), or with both (OR 1.23 [0.996–1.52]); all p<0.0001.  They note that the results were comparable to outcomes in thrombolysis and control patients without diabetes or a previous stroke (OR 1.53 [1.42–1.63], p<0.0001).

The authors conclude that they see no justification for the exclusion of patients with previous stroke and concomitant diabetes from receiving thrombolytic therapy.  They note that such observational studies cannot replace randomised controlled trials, but that analyses of a well validated dataset such as VISTA can be used to supplement trials and guide therapy.

The author of an accompanying editorial agrees with this conclusion, noting that these patients account for up to 15% of all acute ischaemic stroke patients presenting to the emergency department.