COMPARISON OF A NEW FIBRIN SEALANT TO CURRENT HEMOSTASIS METHODS IN PERIPHERAL VASCULAR SURGERY- A SYSTEMATIC REVIEW AND NETWORK META-ANALYSIS
Author(s)
Danker III W1, Ferko N2, Garcia D3, Hogan A2
1Ethicon, Inc., Somerville, NJ, USA, 2Cornerstone Research Group Inc., Burlington, ON, Canada, 3Cornerstone Research Group Inc., Sydney, NS, Canada
OBJECTIVES: Network meta-analyses (NMA) comparing fibrin sealants in surgery are not available. This study evaluated efficacy and safety of a new fibrin sealant (Vistaseal®, Veraseal® outside the US, manufactured by Grifols) compared with other fibrin sealants, as well as manual compression, in peripheral vascular surgery. METHODS: A comprehensive systematic review of randomized trials for fibrin sealants was conducted in Medline, Embase, and Cochrane databases within the last 15 years across surgery types. Data were available to conduct an NMA in peripheral vascular surgery. The primary outcome was the proportion of patients achieving hemostasis by four minutes (T4) using Bayesian mixed-treatment comparisons. Fibrin sealant treatment arms were further broken-down and assessed by clotting time (i.e., 2-minute (2C) or 1-minute (1C)). Treatment-related (i.e. definitely, probably, or possibly) serious and non-serious adverse events (AEs) were qualitatively assessed. RESULTS: Five studies, totaling 693 patients, were included in the NMA, while 7 studies were included in the qualitative systematic review. Results predicted the treatment with the highest probability of achieving T4 to be Vistaseal® 2C. Compared with manual compression, significant improvements in T4 were found with Vistaseal® 2C (relative risk [RR]=2.66, 95%CI: 2.12-3.34), Evicel 1C (RR=2.58, 95%CI: 2.04-3.23), Vistaseal® 1C (RR=2.01, 95%CI: 1.45-2.65), and Tisseel 2C (RR=1.98, 95%CI: 1.48-2.61). Tisseel 1C was not significantly different than manual compression (RR=1.41, 95%CI: 0.70-2.33). Among fibrin sealants, Vistaseal® 2C was associated with a significantly higher probability of achieving T4 compared with Vistaseal® 1C (RR=1.33, 95%CI: 1.02-1.82), Tisseel 2C (RR=1.34, 95%CI: 1.04-1.77), and Tisseel 1C (RR=1.89, 95%CI: 1.18-3.72). Treatment-related serious and non-serious AE rates were typically <2%, with a comparable proportion across fibrin sealants. CONCLUSIONS: In peripheral vascular surgeries, Vistaseal® showed the best balance of efficacy relative to safety, with the highest probability for achieving rapid hemostasis. Future studies should expand networks across surgery types as data become available.
Conference/Value in Health Info
2019-11, ISPOR Europe 2019, Copenhagen, Denmark
Code
PBI2
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
Biologics and Biosimilars, Surgery