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THE JOURNAL OF CARDIOVASCULAR SURGERY
Rivista di Chirurgia Cardiaca, Vascolare e Toracica
Indexed/Abstracted in: BIOSIS Previews, Current Contents/Clinical Medicine, EMBASE, PubMed/MEDLINE, Science Citation Index Expanded (SciSearch), Scopus
Impact Factor 1,632
The Journal of Cardiovascular Surgery 2017 Mar 06
Copyright © 2017 EDIZIONI MINERVA MEDICA
Seizures associated with tranexamic acid for cardiac surgery: a meta-analysis of randomized and non-randomized studies
Hisato TAKAGI 1 ✉, Tomo ANDO 2, Takuya UMEMOTO 1, For the ALICE (All-Literature Investigation of Cardiovascular Evidence) Group
1 Department of Cardiovascular Surgery, Shizuoka Medical Center, Shizuoka, Japan; 2 Department of Cardiology, Detroit Medical Center, Detroit, MI, USA
BACKGROUND: We focused whether tranexamic acid (TXA) therapy for adult cardiac surgery is associated with an increase in the risk of seizures and performed a meta-analysis of randomized controlled trials (RCTs) and non-randomized observational studies.
METHODS: MEDLINE and EMBASE were searched through December 2016 using PubMed and OVID. Eligible studies were RCTs and non-randomized observational studies of TXA versus control (no TXA, placebo, or active control such as low-dose TXA, aprotinin, and epsilon aminocaproic acid) enrolling adult patients undergoing cardiac surgery and reporting the postoperative incidence of seizures as an outcome. Study-specific estimates were combined using inverse variance-weighted averages of logarithmic odds ratios in the random-effects model.
RESULTS: Of 90 potentially relevant articles screened initially, 16 reports of eligible studies were identified and included. A pooled analysis of all 16 studies (enrolling 45,235 patients) demonstrated that TXA therapy was associated with a statistically significant increase in the seizures incidence (odds ratio, 4.13; 95% confidence interval, 2.59 to 6.57; P < 0.00001). A subgroup analysis indicated a statistically significant increase in the seizures incidence with TXA therapy in all subgroups of 5 RCTs, 5 adjusted observational studies, and 6 unadjusted observational studies with no statistically significant subgroup differences (P = 0.36; I2 = 1.5%).
CONCLUSIONS: The results of the present meta-analysis of 16 studies enrolling 45,235 patients confirmed that TXA therapy for adult cardiac surgery is associated with a 4.1-fold increase in the risk of seizure.
KEY WORDS: Cardiac surgical procedures – Meta-analysis – Seizures – Tranexamic acid