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Desmoteplase for Acute Ischemic Stroke within 3 to 9   Hours after Symptom Onset: Evidence from Randomized Controlled Trials

View Article: PubMed Central - PubMed

ABSTRACT

Recent studies have shown inconsistent results regarding the value of desmoteplase for treating acute ischemic stroke (AIS) when administered within an extended time window. We performed a meta-analysis to explore the value of desmoteplase in AIS treatment. The MEDLINE, EMBASE, and Cochrane Library databases were searched for randomized controlled trials (RCTs) that had evaluated desmoteplase versus placebo for AIS. The primary outcomes were intracranial hemorrhage (ICH) within 72 hours and favorable outcome at Day 90. We pooled 819 patients from 5 RCTs. Desmoteplase treatment showed a neutral effect on favorable outcome (P = 0.42) but a favorable safety profile in terms of ICH (P = 0.64) compared with the placebo group. In the subgroup analysis, 90 μg/kg desmoteplase, a late time to treatment (6–9 hours), and serious stroke symptoms at baseline (NIHSS > 12) subgroups showed high risks of ICH (P ≤ 0.02). A high dose of desmoteplase (125 μg/kg) showed a tendency to improve recanalization (P = 0.05), but was also associated with an increased risk of death (P = 0.04). In conclusion, desmoteplase administered over an extended time window had no significant effect on functional recovery but exhibited a favorable safety profile in patients with AIS.

No MeSH data available.


The pooled relative risk of the efficacy outcomes.The diamond indicates the estimated relative risk (95% confidence interval) for all patients.
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f2: The pooled relative risk of the efficacy outcomes.The diamond indicates the estimated relative risk (95% confidence interval) for all patients.

Mentions: All 5 RCTs enrolling 819 patients were available for the analysis of primary efficacy and safety outcomes. Desmoteplase showed a neutral effect on favorable outcome (RR 1.07, 95% CI 0.91 to 1.24, P = 0.42; Fig. 2A), a favorable safety profile in sICH (RR 1.22, 95% CI 0.51 to 2.90, P = 0.66; Fig. 3A), but an increased risk of aICH (RR 1.28, 95% CI 1.05 to 1.57, P = 0.02; Fig. 3B) compared with the placebo group. No significant differences were observed in any of the secondary efficacy or safety outcomes, including mRS response at Day 90 (P = 0.78; Fig. 2B), NIHSS response at Day 90 (P = 0.36; Fig. 2C), recanalization within 24 hours (P = 0.11; Fig. 2D), major hemorrhage within 72 hours (P = 0.46; Fig. 3C), or death rate at Day 90 (P = 0.45; Fig. 3D), between the desmoteplase and placebo groups.


Desmoteplase for Acute Ischemic Stroke within 3 to 9   Hours after Symptom Onset: Evidence from Randomized Controlled Trials
The pooled relative risk of the efficacy outcomes.The diamond indicates the estimated relative risk (95% confidence interval) for all patients.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC5037417&req=5

f2: The pooled relative risk of the efficacy outcomes.The diamond indicates the estimated relative risk (95% confidence interval) for all patients.
Mentions: All 5 RCTs enrolling 819 patients were available for the analysis of primary efficacy and safety outcomes. Desmoteplase showed a neutral effect on favorable outcome (RR 1.07, 95% CI 0.91 to 1.24, P = 0.42; Fig. 2A), a favorable safety profile in sICH (RR 1.22, 95% CI 0.51 to 2.90, P = 0.66; Fig. 3A), but an increased risk of aICH (RR 1.28, 95% CI 1.05 to 1.57, P = 0.02; Fig. 3B) compared with the placebo group. No significant differences were observed in any of the secondary efficacy or safety outcomes, including mRS response at Day 90 (P = 0.78; Fig. 2B), NIHSS response at Day 90 (P = 0.36; Fig. 2C), recanalization within 24 hours (P = 0.11; Fig. 2D), major hemorrhage within 72 hours (P = 0.46; Fig. 3C), or death rate at Day 90 (P = 0.45; Fig. 3D), between the desmoteplase and placebo groups.

View Article: PubMed Central - PubMed

ABSTRACT

Recent studies have shown inconsistent results regarding the value of desmoteplase for treating acute ischemic stroke (AIS) when administered within an extended time window. We performed a meta-analysis to explore the value of desmoteplase in AIS treatment. The MEDLINE, EMBASE, and Cochrane Library databases were searched for randomized controlled trials (RCTs) that had evaluated desmoteplase versus placebo for AIS. The primary outcomes were intracranial hemorrhage (ICH) within 72 hours and favorable outcome at Day 90. We pooled 819 patients from 5 RCTs. Desmoteplase treatment showed a neutral effect on favorable outcome (P = 0.42) but a favorable safety profile in terms of ICH (P = 0.64) compared with the placebo group. In the subgroup analysis, 90 μg/kg desmoteplase, a late time to treatment (6–9 hours), and serious stroke symptoms at baseline (NIHSS > 12) subgroups showed high risks of ICH (P ≤ 0.02). A high dose of desmoteplase (125 μg/kg) showed a tendency to improve recanalization (P = 0.05), but was also associated with an increased risk of death (P = 0.04). In conclusion, desmoteplase administered over an extended time window had no significant effect on functional recovery but exhibited a favorable safety profile in patients with AIS.

No MeSH data available.