EFFICACY AND SAFETY OF PURASTAT® FOR HEMOSTASIS IN GASTROINTESTINAL BLEEDING: A SYSTEMATIC REVIEW AND META-ANALYSIS

Background & Aim:
Non-variceal upper gastrointestinal bleeding (NVUGIB) accounts for a significant number of patient visits to emergency rooms and remains a major cause of mortality and morbidity worldwide. The re-bleeding rates of NVUGIB after endoscopic treatment within 72 hours have been reported to be up to 25%. re-UI-EWD is a newly developed novel endoscopic hemostatic powder UI-EWD(UI-EWD) that forms an adhesive hydropolymer when sprayed on the surface of the gastrointestinal tract. The aim of this study was to evaluate efficacy of UI-EWD on decreasing the re-bleeding rate after standard endoscopic treatment (SET) of acute NVUGIB.
Methods:
This prospective, multicenter, randomized controlled trial was conducted from December 2018 to November 2021. Consecutive patients with acute NVUGIB from high-risk lesions (Forrest classification Ia, Ib, and IIa) who achieved immediate hemostasis through SET were randomized in a 1:1 ratio to UI-EWD powder (P) with SET group (SET+P, test) vs SET only group (SET, control). Primary outcomes were defined as re-bleeding rate within 72 hours following treatment and secondary outcomes were re-bleeding rate within 30 days following treatment, as well as safety of UI-EWD.
Results:
A total of 348 patients were randomized into the test (n=175) vs control (n=173) groups. Baseline characteristics were not statistically different between groups. The classification of lesion type (test vs control: Forrest Ia and Ib, 115(66.8%) vs 113(67.3%), p=0.831), Glasgow-Blatchford bleeding score (test vs control: 10.7 vs 10.4, p=0.589) was not statistically different between groups. Re-bleeding rate within 3 days was statistically significantly lower in the test group than in the control group (2.9% (n=5) vs 11.3% (n=19), p=0.005). The 30-day cumulative re-bleeding rate was also lower in the test group than in the control group [7.0% (n=12) vs 18.5% (n=31), p=0.003] There was no reported UI-EWD related adverse events such as perforation, bowel obstruction, or gas embolization during the study period.
Conclusion:
This study demonstrates that UI-EWD application following SET significantly reduced 3-day and 30-day re-bleeding rates in patients treated for NVUGIB without any adverse reactions.

Introduction

The utilization of PuraStat® (3D Matrix Europe SAS, Caluire-et-Cuire, France), a viscous transparent gel which utilizes self-assembling peptide (SAP) technology, as a hemostatic agent has been reported in cardiac and sinus surgery. Recently, several studies have evaluated its use in acute gastrointestinal bleeding (GIB). To appraise the published literature further, we conducted a systematic review & meta-analysis of the efficacy and safety of PuraStat® in upper and lower GIB.

Methods

A systematic search of several databases was performed through November 2022 to identify studies assessing the utilization of endoscopically delivered PuraStat® as a primary or salvage hemostatic agent for upper and lower GIB. Endpoints assessed included technical success, defined as complete coverage of the lesion by the gel, initial hemostasis, defined as visual confirmation of bleeding cessation following application, and cumulative 7-day and 30-day rebleeding rates. Pooled proportions of outcomes assessed were calculated using the random-effects model. Heterogeneity was assessed using I² statistics. All p-values <0.05 were considered statistically significant.

Results

A total of 7 studies with 404 patients (256 males and 148 females) were included in the final analysis. The mean/median age ranged from 66.9 to 76 years. A variety of lesions and etiologies of high-risk (oozing/spurting) GIB including peptic ulcer disease (PUD), vascular lesions e.g., angiectasias, mucosal lesions e.g., Mallory-Weiss, refractory radiation proctitis as well as post-resection bleeding [endoscopic mucosal resection (EMR)/endoscopic submucosal dissection (ESD)], among others, were included. The overall pooled rate of technical success was 100% [95% Confidence Interval (CI) 0-100; I² 0%]. The pooled rate of initial hemostasis as primary and salvage therapy was 92.98% (95% CI 87.5-96.17; I² 32%) and 86.12% (95% CI 70.55-94.15; I² 81%), respectively. The quantity of PuraStat® needed to achieve hemostasis ranged from 1-6 mL and the average application time was 2 minutes (from 2 studies).

The pooled proportions of cumulative, 7-day, and 30-day rebleeding rates were 11.39% (95%CI 4.78-24.79; I² 84%), 10.56% (95%CI 1.53-47.29; I² 88%), 10.46% (95%CI 5.97-17.67; I² 54%), respectively. No adverse events were noted after PuraStat® application.

Conclusion

Our study demonstrates that application of PuraStat® to bleeding culprit gastrointestinal lesions is safe, technically feasible and is highly effective in achieving hemostasis as primary as well as salvage therapy. Furthermore, it can be applied quickly and significantly reduces the risk of delayed bleeding. Further studies are warranted to validate our findings.