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Comparison of outcomes following thrombolytic therapy among patients with prior stroke and diabetes in the Virtual International Stroke Trials Archive (VISTA).

Mishra NK, Davis SM, Kaste M, Lees KR, VISTA Collaborati - Diabetes Care (2010)

Bottom Line: Functional outcomes were better for thrombolysed patients versus nonthrombolysed comparators among both nondiabetic (P < 0.0001; OR 1.4 [95% CI 1.3-1.6]) and diabetic (P = 0.1; 1.3 [1.05-1.6 ]) subjects.Neurological outcomes were consistent with the mRS.Withholding thrombolytic treatment from otherwise-eligible patients may not be justified.

View Article: PubMed Central - PubMed

Affiliation: Acute Stroke Unit, University Department of Medicine and Therapeutics, Gardiner Institute, Western Infirmary and Faculty of Medicine, University of Glasgow, Glasgow, UK.

ABSTRACT

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 nondiabetes 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 [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 = 0.02; 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.

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Related in: MedlinePlus

Forest plots (A and B) and bar diagrams (C) showing outcomes in the approved population (absence of diabetes or prior strokes) and the affected population (presence of diabetes or prior stroke). All outcomes are outcomes on day 90 after the stroke. Excellent outcomes refer to m-RS 0-1 and favorable outcomes to m-RS 0-2. Neurological outcomes refer to the NIHSS scores on day 90. Analyses for neurological outcomes were undertaken using proportional odds logistic regression analyses. NIHSS by day 90 were combined into categories as 0–4, 5–8, 9–12, 13–16, 17–20, 21–24, and ≥25, and distributions were compared in a manner similar to Rankin scores.
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Figure 2: Forest plots (A and B) and bar diagrams (C) showing outcomes in the approved population (absence of diabetes or prior strokes) and the affected population (presence of diabetes or prior stroke). All outcomes are outcomes on day 90 after the stroke. Excellent outcomes refer to m-RS 0-1 and favorable outcomes to m-RS 0-2. Neurological outcomes refer to the NIHSS scores on day 90. Analyses for neurological outcomes were undertaken using proportional odds logistic regression analyses. NIHSS by day 90 were combined into categories as 0–4, 5–8, 9–12, 13–16, 17–20, 21–24, and ≥25, and distributions were compared in a manner similar to Rankin scores.

Mentions: We examined the outcomes in patients with diabetes, those who have had prior strokes, and their combinations. Findings are shown in Fig. 2.


Comparison of outcomes following thrombolytic therapy among patients with prior stroke and diabetes in the Virtual International Stroke Trials Archive (VISTA).

Mishra NK, Davis SM, Kaste M, Lees KR, VISTA Collaborati - Diabetes Care (2010)

Forest plots (A and B) and bar diagrams (C) showing outcomes in the approved population (absence of diabetes or prior strokes) and the affected population (presence of diabetes or prior stroke). All outcomes are outcomes on day 90 after the stroke. Excellent outcomes refer to m-RS 0-1 and favorable outcomes to m-RS 0-2. Neurological outcomes refer to the NIHSS scores on day 90. Analyses for neurological outcomes were undertaken using proportional odds logistic regression analyses. NIHSS by day 90 were combined into categories as 0–4, 5–8, 9–12, 13–16, 17–20, 21–24, and ≥25, and distributions were compared in a manner similar to Rankin scores.
© Copyright Policy - creative-commons
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2992183&req=5

Figure 2: Forest plots (A and B) and bar diagrams (C) showing outcomes in the approved population (absence of diabetes or prior strokes) and the affected population (presence of diabetes or prior stroke). All outcomes are outcomes on day 90 after the stroke. Excellent outcomes refer to m-RS 0-1 and favorable outcomes to m-RS 0-2. Neurological outcomes refer to the NIHSS scores on day 90. Analyses for neurological outcomes were undertaken using proportional odds logistic regression analyses. NIHSS by day 90 were combined into categories as 0–4, 5–8, 9–12, 13–16, 17–20, 21–24, and ≥25, and distributions were compared in a manner similar to Rankin scores.
Mentions: We examined the outcomes in patients with diabetes, those who have had prior strokes, and their combinations. Findings are shown in Fig. 2.

Bottom Line: Functional outcomes were better for thrombolysed patients versus nonthrombolysed comparators among both nondiabetic (P < 0.0001; OR 1.4 [95% CI 1.3-1.6]) and diabetic (P = 0.1; 1.3 [1.05-1.6 ]) subjects.Neurological outcomes were consistent with the mRS.Withholding thrombolytic treatment from otherwise-eligible patients may not be justified.

View Article: PubMed Central - PubMed

Affiliation: Acute Stroke Unit, University Department of Medicine and Therapeutics, Gardiner Institute, Western Infirmary and Faculty of Medicine, University of Glasgow, Glasgow, UK.

ABSTRACT

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 nondiabetes 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 [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 = 0.02; 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.

Show MeSH
Related in: MedlinePlus