Comparison of Outcomes Following Thrombolytic Therapy Among Patients With Prior Stroke and Diabetes in the Virtual International Stroke Trials Archive (VISTA)

OBJECTIVE - The use of alteplase in patients who have had a prior stroke and concomitant diabetes is not approved in Europe To examine the influence of diabetes and prior stroke on outcomes we compared data on thrombolysed patients with nonthrombolysed comparators RESEARCH DESIGN AND METHODS - We selected patients with ischemic stroke on whom we had data on age pretreatment baseline National Institutes of Health Stroke Scale (b-NIHSS) and 90-day outcome measures (functional modified Rankin score [mRS]) and neurological measures [NIHSS]) in the Virtual International Stroke Trials Archive We compared outcomes between thrombolysed patients and nonthrombolysed comparators in those with and without diabetes those who have had a prior stroke or both and report findings using the Cochran Mantel-Haenszel (CMH) test and proportional odds logistic regression analyses We report an age adjusted and b NIHSS adjusted CMH P value and odds ratio (OR) RESULTS - Rankin data were available for 5 817 patients 1 585 thrombolysed patients and 4 232 nonthrombolysed comparators A total 1 334 (24 1%) patients had diabetes 1 898 (33 7%) patients have had a prior stroke and 491 (8%) patients had both Diabetes and non-diabetes had equal b-NIHSS (median 13 P = 0 3) but patients who have had a prior stroke had higher b-NIHSS than patients who have not had a prior stroke (median 13 vs 12 P < 0 0001) Functional outcomes were better for thrombolysed patients versus nonthrombolysed comparators among both nondiabetic (P < 0 0001 OR 1 4 vertical bar 95% CI 1 3-1 6]) and diabetic (P = 0 1 1 3 [1 05-1 6 ]) subjects Similarly outcomes were better for thrombolysed patients versus nonthrombolysed comparators among who have not had a prior stroke (P < 0 0001 1 4 [1 2-1 6]) and those who have (P = 002 1 3 [1 04-1 6]) There was no interaction of diabetes and prior stroke with treatment (P = 0 8) Neurological outcomes were consistent with the mRS CONCLUSIONS - Outcomes from thrombolysis are better among patients with diabetes and/or those who have had a prior stroke than in control subjects Withholding thrombolytic treatment from otherwise eligible patients may not be justified