The efficacy and safety of intravenous thrombolysis with tenecteplase versus alteplase for acute ischemic stroke: a systematic review and meta-analysis.

OBJECTIVES

We aimed to evaluate the available evidence on the efficacy and safety outcomes of intravenous tenecteplase (TNK) compared with intravenous alteplase(ALT) for patients with acute ischemic stroke (AIS) in randomized controlled trials (RCTs).

METHODS

The MEDLINE/PubMed, Embase, Springer, Web of Science, Cochrane Collaboration database, China National Knowledge Infrastructure (CNKI) database, and Wanfang database were comprehensively searched for RCTs regarding the effects of TNK versus ALT among AIS patients in these English and Chinese electronic databases from inception dates to August 1, 2022. This meta-analysis followed PRISMA guidelines. Two reviewers independently retrieved RCTs and extracted relevant information. The methodological quality of the included trials was estimated using the Cochrane risk of bias tool. The pooled analyses were performed using RevMan 5.3 software. The primary outcome was functional outcome on the modified Rankin Scale (mRS) (range 0 to 5) and mortality at 90 days. The secondary outcomes included successful recanalization, early neurologic improvement < 48 h, any intracranial hemorrhage (ICH), and symptomatic ICH. The follow-up time of all studies was at least 3 months.

RESULTS

A total of nine RCTs involving 1958 patients in TNK group and 1731 patients in ALT group were finally included. For the efficacy outcomes, there were no significant differences between the two groups in terms of mRS score 0 ~ 2 (RR 1.00; 95% CI 0.88-1.13; P = 0.96), mRS score 0 ~ 1 (RR 1.03; 95% CI 0.96-1.10; P = 0.36), successful recanalization (RR 1.25; 95% CI 0.88-1.76; P = 0.21), and early neurologic improvement < 48 h (RR 1.08; 95% CI 0.92-1.26; P = 0.37). Similar results were seen for the safety outcomes, which have no statistical differences in terms of any ICH (RR 1.01; 95% CI 0.72-1.41; P = 0.96), symptomatic ICH (RR 1.19; 95% CI 0.81-1.76; P = 0.37), and mortality at 90 days (RR 0.99; 95% CI 0.83-1.19; P = 0.94).

CONCLUSION

Overall, the efficacy and safety outcomes of intravenous thrombolysis with TNK versus ALT for AIS were not statistically different. However, TNK at a dose of 0.25 mg/kg may be a reasonable alternative to ALT for thrombolysis.