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.
Efficacy of pharmacologic treatment for treating gastrointestinal angiodysplasias-related bleeding: a systematic review and meta-analysis
Gkolfakis P, Fostier R, Tziatzios G, Lazaridis N, Fernandez Y Viesca M, Facciorusso A, Despott E, Triantafyllou K, Devière J, Arvanitakis M
European journal of gastroenterology & hepatology. 2022
Abstract
INTRODUCTION We evaluated the efficacy of pharmacologic treatments for patients with overt or occult bleeding due to gastrointestinal angiodysplasias (GIADs). METHODS A systematic computer-aided literature search across Medline, Cochrane, Scopus and Embase databases was performed. Studies evaluating pharmacologic treatments for patients presenting with GIADs-related overt or occult bleeding were included. Post-treatment rebleeding was the primary outcome. Need for red blood cells (RBC) transfusion, post-treatment hemoglobin levels and adverse events rate comprised secondary outcomes. Results are presented as odds ratio (OR), mean difference (MD) or pooled rates (%) with 95% confidence intervals (95%CI). RESULTS Four types of pharmacologic treatment were identified (25 studies): somatostatin analogs, hormonal therapy, thalidomide and angiogenesis inhibitors. Pharmacologic treatment of any kind led to significantly reduced bleeding episodes [OR (95% CI), 0.08 (0.04-0.18)]. No pharmacologic treatment was superior to others (P = 0.46). Overall, pooled rebleeding rate post-treatment was 34% (26-43%). Similarly, significantly fewer patients required RBC transfusion during the post-treatment period [0.03 (0.03-0.07)], with no differences among various treatments (P = 0.83), yielding an overall pooled transfusion rate of 33% (19-46%). Administration of pharmacological treatment led to significant improvement in terms of hemoglobin levels [MD (95% CI), 3.21 g/dL (2.42-3.99)]. The pooled rate of adverse events was 32% (22-42%). CONCLUSION In patients with GIADs administration of any pharmacologic treatment significantly decreases rebleeding episodes and transfusions leading to higher hemoglobin values. One-third of them experience at least one adverse event related to the treatment.
3.
Effectiveness of hemostatic powders in lower gastrointestinal bleeding: a systematic review and meta-analysis
Facciorusso A, Bertini M, Bertoni M, Tartaglia N, Pacilli M, Ramai D, Mohan BP, Chandan S, Ambrosi A, Sacco R
Endoscopy international open. 2021;9(8):E1283-e1290
Abstract
Background and study aims There is limited evidence on the effectiveness of hemostatic powders in the management of lower gastrointestinal bleeding (LGIB). We aimed to provide a pooled estimate of their effectiveness and safety based on the current literature. Patients and methods Literature review was based on computerized bibliographic search of the main databases through to December 2020. Immediate hemostasis, rebleeding rate, adverse events, and mortality were the outcomes of the analysis. Pooled effects were calculated using a random-effects model. Results A total of 9 studies with 194 patients were included in the meta-analysis. Immediate hemostasis was achieved in 95 % of patients (95 % confidence interval [CI] 91.6 %-98.5 %), with no difference based on treatment strategy or bleeding etiology. Pooled 7- and 30-day rebleeding rates were 10.9 % (95 %CI 4.2 %-17.6 %) and 14.3 % (95 %CI 7.3 %-21.2 %), respectively. Need for embolization and surgery were 1.7 % (95 %CI 0 %-3.5 %) and 2.4 % (95 %CI 0.3 %-4.6 %), respectively. Overall, two patients (1.9 %, 95 %CI 0 %-3.8 %) experienced mild abdominal pain after powder application, and three bleeding-related deaths (2.3 %, 95 %CI 0.2 %-4.3 %) were registered in the included studies. Conclusion Novel hemostatic powders represent a user-friendly and effective tool in the management of lower gastrointestinal bleeding.
4.
Efficacy of hemostatic powders in upper gastrointestinal bleeding: A systematic review and meta-analysis
Facciorusso A, Straus Takahashi M, Eyileten Postula C, Buccino VR, Muscatiello N
Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver. 2019
Abstract
BACKGROUND There is limited evidence on the efficacy of hemostatic powders in the management of upper gastrointestinal bleeding. AIMS Provide a pooled estimate of the efficacy and safety profile of hemostatic powders in digestive endoscopy. METHODS A computerized bibliographic search on the main databases was performed through December 2018. Pooled effects were calculated using a random-effects model. The primary outcome was immediate hemostasis rate. Secondary outcomes were rebleeding rate (either at 7 and 30 days), bleeding-related mortality, and all-cause mortality rate. RESULTS A total of 24 studies, of which three were randomized-controlled trials, with 1063 patients were included in the meta-analysis. Immediate hemostasis was achieved in 95.3% (93.3%-97.3%) of patients, with no difference based on treatment strategy, hemostatic agent used, bleeding etiology. Success rate was slightly lower in spurting bleeding (91.9%). Hemostatic powders showed similar efficacy as compared to conventional endoscopic therapy (odds ratio: 0.84, 0.06-11.47; p=0.9). Thirty-day rebleeding rate was 16.9% (9.8%-24%) with no difference in comparison to other endoscopic treatments (odds ratio 1.59, 0.35-7.21; p=0.55). All-cause and bleeding-related mortality rates were 7.6% (4%-10.8%) and 1.4% (0.5%-2.4%), respectively. CONCLUSION Novel hemostatic powders represent a user-friendly and effective tool in the management of upper gastrointestinal bleeding.