HEMOSTASIS EFFICACY OF EVARRESTTM COMPARED TO TACHOSIL® IN LIVER AND OTHER SURGICAL BLEEDING- AN INDIRECT COMPARISON
Author(s)
Corral M1, Jamous N2, Ferko N3, Bourque M3
1Ethicon Biosurgery, Somerville, NJ, USA, 2Ethicon Biosurgery, Berkshire, UK, 3Cornerstone Research Group Inc., Burlington, ON, Canada
OBJECTIVES: Surgical bleeding remains prevalent and associated with substantial burden. Such bleeding can be more difficult to manage in certain surgeries (e.g., liver). Hemostats with a fibrinogen, thrombin and patch component may be especially beneficial for problematic bleeding types; however, direct comparative data are limited. This study indirectly compared the hemostats EVARREST and TachoSil. METHODS: A structured literature search identified studies of fibrin sealants combined with use of a pad, patch, fleece or sponge, for surgical bleeding. The search was restricted to RCTs, 2000 onward, studies including standard of care (SoC) and time to hemostasis (TTH). EVARREST (4 trials) and TachoSil (6 trials) were identified as the comparators. Pair-wise meta-analyses were completed using a random-effects model for hemostat vs. SoC. An adjusted indirect comparison was conducted using Bucher methodology and ITC software (Wells, 2009) for calculating the mean difference (MD) in TTH between EVARREST and TachoSil with 95% confidence intervals (CI). Mean TTH was analysed as it is a well-accepted, recommended measure. Typically, TTH measurements began at either 3 or 4 minutes. SoC was used as the ‘anchor’ to perform the indirect comparison and consisted of either conventional methods or topical hemostats. Indirect comparisons were completed for all surgery types and a liver surgery subgroup. RESULTS: A total of 894 patients were assessed. Across surgery types, the adjusted indirect comparison demonstrated EVARREST reduced mean TTH by 1.15 minutes compared to TachoSil (MD: -1.15; 95%CI: -3.29, 0.99), however, this difference was not statistically significant. In the subgroup of liver surgical bleeding, EVARREST significantly reduced mean TTH by 2.73 minutes (MD: -2.73; 95%CI: -4.48, -0.981). CONCLUSIONS: This analysis suggests EVARREST may provide better hemostasis than TachoSil, particularly in liver surgical bleeding. Caution must be taken in interpreting results given some patient differences. A head-to-head trial comparison may be necessary to confirm differences between products.
Conference/Value in Health Info
2015-05, ISPOR 2015, Philadelphia, PA, USA
Value in Health, Vol. 18, No. 3 (May 2015)
Code
PMD79
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
Multiple Diseases