A Meta-Analysis Proves PuraStat Efficacy in Reducing Post-Procedural Delayed Bleeding after Endoscopic Resections of Gastrointestinal Lesions

Despite the high technical success rates of endoscopic resections (ER), post-procedural delayed bleeding is still a major complication with rates of 2% to 15%, especially in high-risk situations.

The main risks for delayed bleeding include: the location of the resection site, the resected lesion's size, and the use of antiplatelet, anticoagulant, or non-steroidal anti-inflammatory drugs (NSAIDs). The success of the employed techniques to reduce delayed bleeding, such as prophylactic clipping and coagulation, has been suboptimal and has shown varied results.

A new meta-analysis from Dr Neil Sharma et al. (United States), evaluated the available data addressing the use of PuraStat to reduce delayed bleeding in patients undergoing advanced endoscopic resection of gastrointestinal lesions (esophageal, gastric, duodenal, colorectal). Electronic databases (PubMed, Embase, and Cochrane Library) from January 2010 through October 2022 were searched. Pooled proportions were calculated using fixed (inverse variance) and random effects (DerSimonian-Laird) models.

The primary outcome evaluated was PuraStat's efficacy in preventing post-procedural delayed bleeding after advanced endoscopic resection of gastrointestinal luminal lesions.
Secondary outcomes were: rate of delayed bleeding, adverse event rate, and PuraStat ease of use (as reported by the endoscopist).

The final analysis included data from 6 studies comprising 307 patients. Among these, 36% were on antithrombotic medications. Endoscopic submucosal dissection (ESD) was used in 72.69%, while endoscopic mucosal resection (EMR) was used in 26.42% of the procedures. 

The weighted mean size of resected lesions treated with prophylactic PuraStat was 36.2 mm. The pooled rate of delayed bleeding was 5.73%.

No adverse events were attributable to PuraStat use.

The authors stated that “these results are comparable and better than other modalities used previously to prevent delayed bleeding after advanced endoscopic resections (ER) [...]. [PuraStat] appears promising in reducing post-procedural delayed bleeding after advanced endoscopic resection of high-risk gastrointestinal lesions, with no reported adverse events”. 

Click here to read the full study.

For application within GI, PuraStat is indicated for⁽¹⁾:
- Bleeding from small blood vessels and oozing from capillaries of the GI tract following surgical procedures and the surrounding tissues.
- PuraStat is also indicated for the reduction of delayed bleeding following gastrointestinal endoscopic submucosal dissection (ESD) procedures in the colon. 
(1) - PuraStat IFU-007 Rev-2