Dados do Trabalho

Título

Short-Term Efficacy Outcomes of Tenecteplase Versus Alteplase for Acute Ischemic Stroke: Meta-Analysis Of 5 Randomized Trials

Resumo

Background: Tenecteplase (TNK) has been shown to be non-inferior to Alteplase (ALT) for long-term efficacy and safety outcomes. Whether this also applies to short-term efficacy outcomes such as early clinical improvement and recanalization is unknown. Objective: Compare TNK and ALT regarding the short-term efficacy outcomes early neurological improvement and recanalization. Methods: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses PRISMA was used to conduct a meta-analysis, adapted to noninferiority analysis. The primary outcome was early (24-72 hours) neurological improvement, defined as either Nation Institutes of Health Stroke Scale (NIHSS) score 0 or reduction of at least 8 points compared to baseline. Recanalization was a secondary outcome. The noninferiority margin was set at 6.5%. Results: Search strategy yielded 5 randomized clinical trials (1585 patients: 828 TNK, 757 ALT). Across all trials, mean age was 70.8, 58.8% were men, mean baseline NIHSS was 7 and mean onset-to-treatment time was 148 minutes. Patients in intervention group received TNK at doses of 0.1mg/kg (6.8%), 0.25mg/kg (24.6%), and 0.4mg/kg (68.6%), while all ALT patients received 0.9mg/kg. In random-effects meta-analysis, TNK was non-inferior to ALT for the primary outcome early major neurological improvement (risk difference 8% in favor of TNK, 95% CI 1-15%). Recanalization was also non-inferior for the TNK compared to the ALT group (risk difference 9% in favor of TNK, 95% CI -6% to 23%). Fixed-effects models yielded similarly non-inferior results and signaled for a possible TNK superiority for both early neurological improvement and recanalization. Conclusions: TNK is non-inferior to ALT at the short-term efficacy outcomes early neurological improvement and recanalization.

Palavras Chave

Acute Ischemic Stroke, therapy, fibrinolytic agent, tenecteplase, tissue-type plasminogen activator

Área

Doença Cerebrovascular