SAFETY AND EFFICACY OF TRANEXAMIC ACID IN ADULT SPINAL DEFORMITY SURGERY- A META-ANALYSIS
Author(s)
Hariharan D1, Mammi M2, Daniels K3, Petrucci K4, Lamba N2, Cerecedo-Lopez CD2, Doucette J4, Papatheodorou S5, Hulsbergen A2, Aglio LS2, Smith TR2, Mekary DR4, Zaidi H2
1Brandeis University, Waltham, MA, USA, 2Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA, 3Precision Xtract, Boston, MA, USA, 4MCPHS University, Boston, MA, USA, 5Harvard T.H. Chan School of Public Health, Boston, MA, USA
Presentation Documents
OBJECTIVES: Spinal corrective surgeries are associated with large amount of blood loss and increased associated risks among elderly. The objective of this systematic review and meta-analysis was to assess the safety and efficacy of Tranexamic Acid (TXA) as an antifibrinolytic agent in Adult Spinal Deformity (ASD) surgery. METHODS: Search strategy included TXA, spinal surgery and other keywords pertaining to spinal deformity. Articles from PubMed, Embase, Cochrane, and clinicaltrials.gov were screened using PRISMA guidelines through December 2018. Blood loss, transfusion levels, and thromboembolic events were primary outcomes of interest. Randomized controlled trials (RCTs) and observational studies (OBS) with adult patients (≥ 18 years) were included. Continuous variables were analyzed using standardized mean difference (SMD) and categorical variables were analyzed using Peto odds ratio (OR), using random effects models. RESULTS: Of the 604 articles screened, 5 studies (1 RCT and 4 cohort studies) were included. The pooled SMD was statistically significantly lower in the TXA group compared to the control group for intraoperative blood loss (OBS: -0.78, 95%CI: -1.09, -0.48; P-heterogeneity= 0.70; 198 patients; 3 studies) and total transfusion volume (OBS: -0.92, 95%CI: -1.60, -0.25; P-heterogeneity= 0.13; 93 patients; 2 studies). These 2 outcomes were not reported in any RCT. Incidence of thromboembolic events was not significantly different between TXA (1 event/19) and placebo (0 event/13) in the RCT: Peto OR= 1.36, 95%CI: 0.05, 36.3; 32 patients; 1 study) and in the OBS: TXA (2 events/115) vs. control (0 event/62); Peto OR= 1.35, 95%CI: 0.15, 12.3; P-heterogeneity= 0.72; 177 patients; 2 studies). CONCLUSIONS: This meta-analysis showed that TXA was not only associated with lower intraoperative blood loss and total transfusion volume in ASD surgery, but also appeared to not significantly increase thromboembolic events. Nevertheless, the need for larger clinical trials evaluating hemostatic factors and its use in elderly population is necessary.
Conference/Value in Health Info
2019-05, ISPOR 2019, New Orleans, LA, USA
Value in Health, Volume 22, Issue S1 (2019 May)
Code
PDG78
Topic
Clinical Outcomes
Topic Subcategory
Clinical Outcomes Assessment, Comparative Effectiveness or Efficacy
Disease
Drugs, Geriatrics, Surgery