Is thrombolytic therapy associated with increased mortality? Meta-analysis of randomized controlled trials.
BACKGROUND
Although thrombolytic therapy has shown substantial benefits in neural outcomes, concerns remain regarding the association between thrombolytic therapy and possible increased mortality.


OBJECTIVE
To determine the mortality risk of certain thrombolytic agents that are a treatment option for acute ischemic stroke.


METHODS
Studies were identified using MEDLINE, the Cochrane Central Register of Controlled Trials, and the reference lists of the articles selected. Randomized placebo-controlled trials of thrombolytic agents for the treatment of acute ischemic stroke patients were eligible. Study quality was evaluated using a previously validated scale. Data were extracted in duplicate by two independent investigators. All-cause mortality during follow-up was the main outcome. Random effects models were used to pool the individual effects of trials. Several preplanned sensitivity and subgroup analyses were completed to explain the heterogeneity among trials. Odds ratios, absolute risk differences, and numbers needed to harm were calculated.


RESULTS
Eleven placebo-controlled randomized trials of thrombolytic agents involving 3709 participants were included in the analysis. Thrombolytic therapy was associated with an insignificant increase in mortality (odds ratio, 1.07; 95% confidence interval, 0.8-1.39; P = .3). The treatment was associated with an absolute increased risk of mortality of 11 per 1000 persons (95% confidence interval, -24 to 48; P = .3), and the number needed to harm was 84 (the 95% confidence interval included 0).


CONCLUSIONS
These findings suggest that thrombolytic therapy does not significantly increase all-cause mortality.
Ergin
Ahmet
A
Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, La, USA. aergin@pamukkale.edu.tr
Ergin
Nesrin
N
D002545:Brain Ischemia / Q000188:drug therapy / Q000401:mortality; D016001:Confidence Intervals; D006801:Humans; D016017:Odds Ratio; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data; D020521:Stroke / Q000188:drug therapy / Q000401:mortality; D015912:Thrombolytic Therapy / Q000009:adverse effects / Q000401:mortality* / Q000706:statistics & numerical data