PMID- 34989143 OWN - NLM STAT- MEDLINE DCOM- 20220726 LR - 20220822 IS - 2042-6984 (Electronic) IS - 2042-6976 (Linking) VI - 12 IP - 8 DP - 2022 Aug TI - Randomized, controlled, double-blinded clinical trial of effect of bevacizumab injection in management of epistaxis in hereditary hemorrhagic telangiectasia patients undergoing surgical cauterization. PG - 1034-1042 LID - 10.1002/alr.22961 [doi] AB - BACKGROUND: Given its role in the disease pathophysiology, inhibition of vascular endothelial growth factor (VEGF)-mediated angiogenesis has received attention as a potential strategy to reduce epistaxis associated with hereditary hemorrhagic telangiectasia (HHT). In this study we evaluated the efficacy of a submucosal injection of bevacizumab, a VEGF inhibitor, in reducing the severity of epistaxis and improving quality of life when given at the time of operative electrocautery. METHODS: This randomized, double-blinded, placebo-controlled trial was conducted at a single institution from 2014 to 2019. Patients scheduled to undergo operative bipolar electrocautery of nasal telangiectasias were randomized to receive a submucosal injection of saline or bevacizumab at time of surgery. Surveys to assess epistaxis severity and quality of life (QOL), including the Epistaxis Severity Score (ESS) and the 12-item Short Form (SF-12), were administered preoperatively and at 1, 2, 4, and 6 months postoperatively. The minimal clinically important difference (MCID) of the ESS instrument is reported to be 0.71. RESULTS: Of 39 patients enrolled, 37 (94.9%) completed the study. The saline group demonstrated a reduced ESS vs baseline at 1 (-1.2; p = 0.01) and 4 (-1.2; p = 0.05) months postprocedure. The bevacizumab group demonstrated a reduced ESS score vs baseline at 1 (-2.3; p < 0.001), 2 (-2.3; p < 0.001), 4 (-2.0; p = 0.003), and 6 (-1.3; p = 0.05) months postprocedure. The additive benefit of bevacizumab over saline exceeded the MCID at 1, 2, and 4 months, but the difference was not statistically significant. CONCLUSION: The addition of a single treatment of submucosal bevacizumab may be associated with additional clinically meaningful benefit for up to 4 months when compared with electrocautery alone. CI - (c) 2022 ARS-AAOA, LLC. FAU - Khanwalkar, Ashoke R AU - Khanwalkar AR AUID- ORCID: 0000-0001-9960-7758 AD - Department of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Palo Alto, CA. FAU - Rathor, Aakanksha AU - Rathor A AD - Department of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Palo Alto, CA. FAU - Read, Amelia K AU - Read AK AD - Department of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Palo Alto, CA. FAU - Paknezhad, Hassan AU - Paknezhad H AD - Geisinger Wyoming Valley Medical Center, Wilkes-Barre, PA. FAU - Ma, Yifei AU - Ma Y AD - Department of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Palo Alto, CA. FAU - Hwang, Peter H AU - Hwang PH AD - Department of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Palo Alto, CA. LA - eng PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20220119 PL - United States TA - Int Forum Allergy Rhinol JT - International forum of allergy & rhinology JID - 101550261 RN - 0 (Vascular Endothelial Growth Factor A) RN - 2S9ZZM9Q9V (Bevacizumab) SB - IM MH - Bevacizumab/therapeutic use MH - Cautery MH - Epistaxis/drug therapy/etiology/surgery MH - Humans MH - Quality of Life MH - *Telangiectasia, Hereditary Hemorrhagic/complications/drug therapy/surgery MH - Vascular Endothelial Growth Factor A/therapeutic use OTO - NOTNLM OT - ESS OT - Epistaxis Severity Score OT - HHT OT - bevacizumab OT - bipolar OT - electrocautery OT - epistaxis OT - hereditary hemorrhagic telangiectasis OT - quality of life OT - therapeutics EDAT- 2022/01/07 06:00 MHDA- 2022/07/27 06:00 CRDT- 2022/01/06 06:34 PHST- 2021/12/09 00:00 [revised] PHST- 2021/09/21 00:00 [received] PHST- 2021/12/27 00:00 [accepted] PHST- 2022/01/07 06:00 [pubmed] PHST- 2022/07/27 06:00 [medline] PHST- 2022/01/06 06:34 [entrez] AID - 10.1002/alr.22961 [doi] PST - ppublish SO - Int Forum Allergy Rhinol. 2022 Aug;12(8):1034-1042. doi: 10.1002/alr.22961. Epub 2022 Jan 19.