title: Thrombolysis outcomes in acute ischemic stroke patients with prior stroke and diabetes mellitus.
abstract: BACKGROUND
  Patients with concomitant diabetes mellitus (DM) and prior stroke (PS) were excluded from European approval of alteplase in stroke. We examined the influence of DM and PS on the outcomes of patients who received thrombolytic therapy (T; data from Safe Implementation of Thrombolysis in Stroke-International Stroke Thrombolysis Register) compared to nonthrombolyzed controls (C; data from Virtual International Stroke Trials Archive).
  
  
  METHODS
  We selected ischemic stroke patients on whom we held data on age, baseline NIH Stroke Scale score (NIHSS), and 90-day modified Rankin Scale score (mRS). We compared the distribution of mRS between T and C by Cochran-Mantel-Haenszel (CMH) test and proportional odds logistic regression, after adjustment for age and baseline NIHSS, in patients with and without DM, PS, or the combination. We report odds ratios (OR) for improved distribution of mRS with 95% confidence interval (CI) and CMH p value.
  
  
  RESULTS
  Data were available for 29,500 patients: 5,411 (18.5%) had DM, 5,019 had PS (17.1%), and 1,141 (5.5%) had both. Adjusted mRS outcomes were better for T vs C among patients with DM (OR 1.45 [1.30-1.62], n = 5,354), PS (OR 1.55 [1.40-1.72], n = 4,986), or concomitant DM and PS (OR 1.23 [0.996-1.52], p = 0.05, n = 1,136), all CMH p < 0.0001. These are comparable to outcomes between T and C among patients with neither DM nor PS: OR = 1.53 (1.42-1.63), p < 0.0001, n = 19,339. There was no interaction on outcome between DM and PS with alteplase treatment (tissue plasminogen activator × DM × PS, p = 0.5). Age ≤80 years or >80 years did not influence our findings.
  
  
  CONCLUSIONS
  Outcomes from thrombolysis are better than the controls among patients with DM, PS, or both. We find no statistical justification for the exclusion of these patients from receiving thrombolytic therapy.
authors.affiliation: Acute Stroke Unit, University Department of Medicine and Therapeutics, Gardiner Institute, Western Infirmary & Faculty of Medicine, University of Glasgow, Glasgow, UK.
authors.forename: N K
authors.initials: NK
authors.lastname: Mishra
authors.forename: N
authors.initials: N
authors.lastname: Ahmed
authors.forename: A
authors.initials: A
authors.lastname: Davalos
authors.forename: H K
authors.initials: HK
authors.lastname: Iversen
authors.forename: T
authors.initials: T
authors.lastname: Melo
authors.forename: L
authors.initials: L
authors.lastname: Soinne
authors.forename: N
authors.initials: N
authors.lastname: Wahlgren
authors.forename: K R
authors.initials: KR
authors.lastname: Lees
mesh_terms: D002545:Brain Ischemia / Q000150:complications*; D048909:Diabetes Complications / Q000503:physiopathology*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D016015:Logistic Models; D008297:Male; D012189:Retrospective Studies; D020521:Stroke / Q000150:complications / Q000188:drug therapy / Q000209:etiology; D015912:Thrombolytic Therapy / Q000379:methods*; D010959:Tissue Plasminogen Activator / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D010959:Tissue Plasminogen Activator