Continuous Anticoagulation and Cold Snare Polypectomy Versus Heparin Bridging and Hot Snare Polypectomy in Patients on Anticoagulants With Subcentimeter Polyps: A Randomized Controlled Trial.

Adult Aged Aged, 80 and over Anticoagulants / administration & dosage Colonic Polyps / surgery Colonoscopy Electrocoagulation / methods Female Hemostasis, Surgical Heparin / administration & dosage Humans Incidence Japan / epidemiology Length of Stay / statistics & numerical data Male Middle Aged Operative Time Postoperative Hemorrhage / epidemiology

Journal

Annals of internal medicine

ISSN: 1539-3704

Titre abrégé: Ann Intern Med

Pays: United States

ID NLM: 0372351

Informations de publication

Date de publication:
20 08 2019

Historique:

pubmed: 16 7 2019

medline: 17 6 2020

entrez: 16 7 2019

Statut: ppublish

Résumé

Management of anticoagulants for patients undergoing polypectomy is still controversial. Cold snare polypectomy (CSP) is reported to cause less bleeding than hot snare polypectomy (HSP). To compare outcomes between continuous administration of anticoagulants (CA) with CSP (CA+CSP) and periprocedural heparin bridging (HB) with HSP (HB+HSP) for subcentimeter colorectal polyps. Multicenter, parallel, noninferiority randomized controlled trial. (University Hospital Medical Information Network Clinical Trials Registry: UMIN000019355). 30 Japanese institutions. Patients receiving anticoagulant therapy (warfarin or direct oral anticoagulants) who had at least 1 nonpedunculated subcentimeter colorectal polyp. Patients were randomly assigned to undergo HB+HSP or CA+CSP and followed up 28 days after polypectomy. The primary end point was incidence of polypectomy-related major bleeding (based on the incidence of poorly controlled intraprocedural bleeding or postpolypectomy bleeding requiring endoscopic hemostasis). The prespecified inferiority margin was -5% (CA+CSP vs. HB+HSP). A total of 184 patients were enrolled: 90 in the HB+HSP group, 92 in the CA+CSP group, and 2 who declined to participate after enrollment. The incidence of polypectomy-related major bleeding in the HB+HSP and CA+CSP groups was 12.0% (95% CI, 5.0% to 19.1%) and 4.7% (CI, 0.2% to 9.2%), respectively. The intergroup difference for the primary end point was +7.3% (CI, -1.0% to 15.7%), with a 0.4% lower limit of 2-sided 90% CI, demonstrating the noninferiority of CA+CSP. The mean procedure time for each polyp and the hospitalization period were longer in the HB+HSP than in the CA+CSP group. An open-label trial assessing 2 factors (anticoagulation approach and polypectomy procedure type) simultaneously. Patients having CA+CSP for subcentimeter colorectal polyps who were receiving oral anticoagulants did not have an increased incidence of polypectomy-related major bleeding, and procedure time and hospitalization were shorter than in those having HB+HSP. Japanese Gastroenterological Association.

Sections du résumé

Background

Management of anticoagulants for patients undergoing polypectomy is still controversial. Cold snare polypectomy (CSP) is reported to cause less bleeding than hot snare polypectomy (HSP).

Objective

To compare outcomes between continuous administration of anticoagulants (CA) with CSP (CA+CSP) and periprocedural heparin bridging (HB) with HSP (HB+HSP) for subcentimeter colorectal polyps.

Design

Multicenter, parallel, noninferiority randomized controlled trial. (University Hospital Medical Information Network Clinical Trials Registry: UMIN000019355).

Setting

30 Japanese institutions.

Patients

Patients receiving anticoagulant therapy (warfarin or direct oral anticoagulants) who had at least 1 nonpedunculated subcentimeter colorectal polyp.

Intervention

Patients were randomly assigned to undergo HB+HSP or CA+CSP and followed up 28 days after polypectomy.

Measurements

The primary end point was incidence of polypectomy-related major bleeding (based on the incidence of poorly controlled intraprocedural bleeding or postpolypectomy bleeding requiring endoscopic hemostasis). The prespecified inferiority margin was -5% (CA+CSP vs. HB+HSP).

Results

A total of 184 patients were enrolled: 90 in the HB+HSP group, 92 in the CA+CSP group, and 2 who declined to participate after enrollment. The incidence of polypectomy-related major bleeding in the HB+HSP and CA+CSP groups was 12.0% (95% CI, 5.0% to 19.1%) and 4.7% (CI, 0.2% to 9.2%), respectively. The intergroup difference for the primary end point was +7.3% (CI, -1.0% to 15.7%), with a 0.4% lower limit of 2-sided 90% CI, demonstrating the noninferiority of CA+CSP. The mean procedure time for each polyp and the hospitalization period were longer in the HB+HSP than in the CA+CSP group.

Limitation

An open-label trial assessing 2 factors (anticoagulation approach and polypectomy procedure type) simultaneously.

Conclusion

Patients having CA+CSP for subcentimeter colorectal polyps who were receiving oral anticoagulants did not have an increased incidence of polypectomy-related major bleeding, and procedure time and hospitalization were shorter than in those having HB+HSP.

Primary Funding Source

Japanese Gastroenterological Association.

Identifiants

DOI: 10.7326/M19-0026 PMID: 31307055

pubmed: 31307055

pii: 2738160

doi: 10.7326/M19-0026

doi:

Substances chimiques

Anticoagulants 0

Heparin 9005-49-6

Banques de données

UMIN-CTR

['UMIN000019355']

Types de publication

Comparative Study Journal Article Multicenter Study Randomized Controlled Trial Video-Audio Media

Langues

eng

Sous-ensembles de citation

Pagination

229-237

Investigateurs

Kenta Hamada (K)

Satoki Shichijo (S)

Yasushi Yamasaki (Y)

Minoru Kato (M)

Yusuke Tonai (Y)

Hiroyoshi Iwagami (H)

Masamichi Arao (M)

Hiroko Nakahira (H)

Taro Iwatsubo (T)

Shunntaro Inoue (S)

Kenji Matsuno (K)

Kentaro Nakagawa (K)

Masayasu Ohmori (M)

Noriko Matsuura (N)

Akira Maekawa (A)

Takashi Kanesaka (T)

Koji Higashino (K)

Noriya Uedo (N)

Ryu Ishihara (R)

Motowo Mizuno (M)

Mio Matsumoto (M)

Daisuke Miyamoto (D)

Shigetsugu Tsuji (S)

Yasushi Sano (Y)

Sachiyo Komai (S)

Kenichiro Imai (K)

Masafumi Naito (M)

Yuichi Yoshida (Y)

Kiyonori Yuguchi (K)

Hirokazu Sasakawa (H)

Naoki Dan (N)

Ayako Sakai (A)

Yuichi Satomoto (Y)

Maria Taniguchi (M)

Masao Hanafusa (M)

Sasaki Kazunari (S)

Bensuleiman Yahaya (B)

Myojo Satoshi (M)

Takuo Kado (T)

Hiroko Nebiki (H)

Yuhei Sakata (Y)

Yu Yasui (Y)

Akie Kimura (A)

Hiroshi Kashida (H)

Toshiharu Sakurai (T)

Tomoyuki Nagai (T)

Mitsunari Yamada (M)

Masashi Kono (M)

Kazuki Okamoto (K)

Eisuke Akamine (E)

Naoki Fujimoto (N)

Takumi Ichinona (T)

Eisuke Nakao (E)

Kotaro Takeshita (K)

Yuki Kano (Y)

Kenji Matsuo (K)

Taro Nakamichi (T)

Haruaki Naneta (H)

Hayato Hirashima (H)

Yasuki Nakatani (Y)

Yoshiyuki Harada (Y)

Maiko Ikenouchi (M)

Keijirou Okada (K)

Takuya Yamada (T)

Ayaka Shoji (A)

Seiya Kato (S)

Sho Suzuki (S)

Shinjiro Yamaguchi (S)

Kohei Fukumoto (K)

Takaaki Kishino (T)

Hideto Shimokobe (H)

Tomoko Kitaichi (T)

Daiki Maeda (D)

Yoshitaka Kadowaki (Y)

Jun Konishi (J)

Maki Konno (M)

Hirofumi Naito (H)

Motohiko Kato (M)

Hideki Mori (H)

Commentaires et corrections

Type : CommentIn