1.
Hemostatic spray (TC-325) vs. standard endoscopic therapy for non-variceal gastrointestinal bleeding: A meta-analysis of randomized controlled trials
Deliwala SS, Chandan S, Mohan BP, Khan S, Reddy N, Ramai D, Bapaye JA, Dahiya DS, Kassab LL, Facciorusso A, et al
Endoscopy international open. 2023;11(3):E288-e295
Abstract
Background and study aims Hemospray (TC-325) is a mineral powder with adsorptive properties designed for use in various gastrointestinal bleeding (GIB) scenarios. We conducted a systematic review & meta-analysis of randomized controlled trials (RCTs) comparing TC-325 to standard endoscopic therapy (SET) for non-variceal GIB (NVGIB). Methods Multiple databases were searched through October 2022. Meta-analysis was performed using a random-effects model to determine pooled relative risk (RR) and proportions with 95 % confidence intervals (CI) for primary hemostasis, hemostasis failure, 30-day rebleeding, length of stay (LOS), and need for rescue interventions. Heterogeneity was assessed using I (2) %. Results Five RCTs with 362 patients (TC-325 178, SET 184) - 123 females and 239 males with a mean age 65 ± 16 years). The most common etiologies were peptic ulcer disease (48 %), malignancies (35 %), and others (17 %). Bleeding was characterized as Forrest IA (7 %), IB (73 %), IIA (3 %), and IIB (1 %). SET included epinephrine injection, electrocautery, hemoclips, or a combination. No statistical difference in primary hemostasis between TC-325 compared to SET, RR 1.09 (CI 0.95-1.25; I (2) 43), P = 0.2, including patients with oozing/spurting hemorrhage, RR 1.13 (CI 0.98-1.3; I (2) 35), P = 0.08. Failure to achieve hemostasis was higher in SET compared to TC-325, RR 0.30 (CI 0.12-0.77, I (2) 0), P = 0.01, including patients with oozing/spurting hemorrhage, RR 0.24 (CI 0.09 - 0.63, I (2) 0), P = 0.004. We found no difference between the two interventions in terms of rebleeding, RR 1.13 (CI 0.62-2.07, I (2) 26), P = 0.8 and LOS, standardized mean difference (SMD) 0.27 (CI, -0.20-0.74; I (2) 62), P = 0.3. Finally, pooled rate of rescue interventions (angiography) was statistically higher in SET compared to TC-325, RR 0.68 (CI 0.5-0.94; I (2) 0), P = 0.02. Conclusions Our analysis shows that for acute NV GIB, including oozing/spurting hemorrhage, TC-325 does not result in higher rates of primary hemostasis compared to SET. However, lower rates of failures were seen with TC-325 than SET. In addition, there was no difference in the two modalities when comparing rates of rebleeding and LOS.
2.
The Efficacy and Safety of Hemospray for the Management of Gastrointestinal Bleeding: A Systematic Review and Meta-Analysis
Ofosu A, Ramai D, John F, Mohan BP, Dhindsa B, Antoine G, Hajiyeva G, Alatevi EM, Ofori E, Dhaliwal AS, et al
Journal of clinical gastroenterology. 2020
Abstract
GOALS/BACKGROUND Hemospray is a new hemostatic powder recently approved for endoscopic hemostasis in gastrointestinal (GI) bleeding. Data are limited in terms of its clinical outcomes, and its role in the treatment algorithm of GI bleeds. We conducted a systematic review and meta-analysis to study the clinical performance of Hemospray in the management of GI bleeding. STUDY We searched multiple databases from inception through March 2019 to identify studies that reported on the clinical outcomes of Hemospray in GI bleeding. The primary outcome was pooled rates of clinical success after the application of Hemospray in GI bleeding. The secondary outcomes were pooled rebleeding rates and adverse events after use of Hemospray. RESULTS A total of 19 studies, 814 patients, of which 212 patients were treated with Hemospray as monotherapy, and 602 patients were treated with Hemospray with conventional hemostatic techniques. Overall pooled clinical success after the application of Hemospray was 92% [95% confidence interval (95% CI), 87%-96%; I=70.4%]. Overall pooled early rebleeding rates after application of Hemospray was 20% (95% CI, 16%-26%; I=54%). Overall pooled delayed rebleeding rates after the application of Hemospray was 23% (95% CI, 16%-31%; I=34.9%). There was no statistical difference in clinical success (RR, 1.02; 95% CI, 0.96-1.08; P=0.34) and early rebleeding (RR, 0.89; 95% CI, 0.75-1.07; P=0.214) in studies that compared the use of Hemospray as monotherapy versus combination therapy with conventional therapy. CONCLUSIONS Hemospray is highly effective in achieving immediate hemostasis in gastrointestinal bleeding. However, due to significantly high rebleeding rates, Hemospray is not suited for definitive long-term therapy.