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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 study search, selection and inclusion process.
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f1: The study search, selection and inclusion process.

Mentions: A total of 764 titles and abstracts were screened (Fig. 1). After removing the duplicates and irrelevant records, 26 full-text articles were assessed for eligibility. An additional 21 articles were excluded due to the limitation of publication types: 1 protocol study, 2 post-hoc analyses, 3 meta-analyses, 7 comments, and 8 reviews. Ultimately, we identified 5 articles that met the eligibility criteria for this meta-analysis7891011. Of the 5 articles included in the analysis, all except one7 were international multicenter trials. DIAS-2 and DIAS-3 were phase III clinical trials and were published in Lancet Neurology. The remaining three phase II clinical trials were published in Stroke. The detailed characteristics of the included studies are listed in Table 1.


Desmoteplase for Acute Ischemic Stroke within 3 to 9   Hours after Symptom Onset: Evidence from Randomized Controlled Trials
The study search, selection and inclusion process.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

f1: The study search, selection and inclusion process.
Mentions: A total of 764 titles and abstracts were screened (Fig. 1). After removing the duplicates and irrelevant records, 26 full-text articles were assessed for eligibility. An additional 21 articles were excluded due to the limitation of publication types: 1 protocol study, 2 post-hoc analyses, 3 meta-analyses, 7 comments, and 8 reviews. Ultimately, we identified 5 articles that met the eligibility criteria for this meta-analysis7891011. Of the 5 articles included in the analysis, all except one7 were international multicenter trials. DIAS-2 and DIAS-3 were phase III clinical trials and were published in Lancet Neurology. The remaining three phase II clinical trials were published in Stroke. The detailed characteristics of the included studies are listed in Table 1.

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.