Endoscopic clips useful in patients on coumadin anticoagulation therapy undergoing colonoscopy
By Boston Scientific
May 25, 2006, 12:46

Boston Scientific Corporation announced the results of a study to determine the efficacy of using the Resolution® Clip, an endoscopic mechanical clip, to treat gastrointestinal (GI) bleeding instead of traditional electrocautery and injection therapy.

Endoscopists traditionally achieve endoscopic hemostasis with a combination of injection therapy and electrocautery. However, electrocautery is often associated with risks and complications, such as recurrent bleeding and delayed ulcer healing. Alternatively, endoscopic hemostasis can be achieved with mechanical clips - a method that is less widely known or employed compared to electrocautery.
The hemostasis study, led by Sri Komanduri, M.D., of Rush University Medical Center in Chicago, analyzed the use of the Resolution Clip as an alternative to electrocautery as the primary mechanism of hemostasis after epinephrine injection. The results of the 10-patient study demonstrated that adequate endoscopic hemostasis was achieved with the use of Resolution Clip instead of electrocautery in combination with injection therapy in all patients. None of the cases in the study required electrocautery and none of the patients had clinical or laboratory evidence of rebleeding.

“This study, which is more of a foundation for a large prospective study, supports the effectiveness of the Resolution Clip to achieve endoscopic hemostasis without the risks and complications often associated with electrocautery,” said Dr. Komanduri. “These results should be instrumental in advancing the use of mechanical clips to treat GI bleeding.”

In a separate but related study presented at DDW, researchers investigated the use of hemostatic clips in patients on coumadin anticoagulation therapy (CAC) who undergo a colonoscopy. Although the American Society for Gastrointestinal Endoscopy (ASGE) has published guidelines suggesting management options, no consensus exists regarding the resumption of CAC which increases the risk of post-polypectomy hemorrhage by fivefold. This study examined whether definitive hemostasis at the time of polypectomy would permit minimal or no interruption of CAC.

The study led by Douglas A. Howell, M.D., of the Portland Endoscopy Center (Maine), found that patients receiving CAC can safely undergo a colonoscopy, with or without polypectomy, after brief interruption of coumadin therapy and completion of definitive mechanical hemostasis using clips. Immediate resumption of anticoagulation therapy can generally be advised without a significant risk of delayed post-polypectomy bleeding.

“These studies and others presented at DDW® underscore the effectiveness of the Resolution® Clip to treat GI bleeding,” said Michael P. Phalen, President, Boston Scientific Endoscopy. “We are pleased with the results of these studies and are hopeful that Endoscopists will consider the use of Resolution Clip technology to assist them in improving the outcome of these high-risk and critical medical conditions.”

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