Thrombolysis outcomes in acute ischemic stroke patients with prior stroke and diabetes mellitus

TY - JOUR

T1 - Thrombolysis outcomes in acute ischemic stroke patients with prior stroke and diabetes mellitus

AU - Mishra, N K

AU - Ahmed, N

AU - Davalos, A

AU - Iversen, Helle Klingenberg

AU - Melo, T

AU - Soinne, L

AU - Wahlgren, N

AU - Lees, K R

AU - SITS and VISTA collaborators

PY - 2011/11/22

Y1 - 2011/11/22

N2 - 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.

AB - 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.

KW - Brain Ischemia

KW - Diabetes Complications

KW - Female

KW - Follow-Up Studies

KW - Humans

KW - Logistic Models

KW - Male

KW - Retrospective Studies

KW - Stroke

KW - Thrombolytic Therapy

KW - Tissue Plasminogen Activator

KW - Treatment Outcome

U2 - 10.1212/wnl.0b013e318238ee42

DO - 10.1212/wnl.0b013e318238ee42

M3 - Journal article

C2 - 22094479

SN - 0028-3878

VL - 77

SP - 1866

EP - 1872

JO - Neurology

JF - Neurology

IS - 21

ER -