title: Thienopyridine derivatives as risk factors for bleeding following high risk endoscopic treatments: Safe Treatment on Antiplatelets (STRAP) study.
abstract: OBJECTIVE
  The optimal method of perioperative management of antiplatelet agents during endoscopic procedures that carry a high risk of bleeding is still controversial. The aim of this study was to evaluate the safety of continuing aspirin treatment during these procedures in an Asian population.
  
  
  METHODS
  A multicenter, prospective, observational cohort study was conducted at six high volume endoscopy centers in Japan. The study included patients at high risk of thromboembolism who were regularly taking antiplatelet agents (e. g. thienopyridine derivatives and aspirin). Enrolled patients continued their aspirin therapy, and underwent endoscopic procedures that had a high risk of bleeding for treatment of lesions in the upper and lower gastrointestinal tracts. The primary end point was the rate of major bleeding complications after endoscopic procedures.
  
  
  RESULTS
  The study was terminated in accordance with predetermined safety criteria because 7 of 28 consecutive patients experienced major bleeding complications (25.0 %; 95 % confidence interval 10.7 % - 44.9 %). All major bleeding complications occurred following endoscopic submucosal dissection (ESD; 6 stomach, 1 colon). Univariate analysis showed that postoperative administration of thienopyridine derivatives was the only significant factor associated with postoperative bleeding (P = 0.01). Subanalysis of gastric ESD (23 lesions in 19 patients) confirmed that the administration of thienopyridine derivatives (P = 0.01) and that of multiple agents (P = 0.02) were the significant factors. All bleeding complications (postoperative day 11.2 ± 3.5) occurred after resuming thienopyridine derivative therapy postoperatively (postoperative day 2.3 ± 2.4).
  
  
  CONCLUSIONS
  In Asian patients taking thienopyridine derivatives with aspirin, cautious postoperative care is necessary for those undergoing endoscopic procedures that are associated with a high risk of bleeding, especially gastric ESD. Continuation of aspirin alone during these endoscopic procedures may be acceptable.
  
  
  BACKGROUND
  UMIN000009176.
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, University of Tokyo, Tokyo, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Ono
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, University of Tokyo, Tokyo, Japan.
authors.forename: Mitsuhiro
authors.initials: M
authors.lastname: Fujishiro
authors.affiliation: Department of Gastroenterology, Ishikawa Prefectural Central Hospital, Kanazawa, Japan.
authors.forename: Naohiro
authors.initials: N
authors.lastname: Yoshida
authors.affiliation: Department of Gastroenterology, Ishikawa Prefectural Central Hospital, Kanazawa, Japan.
authors.forename: Hisashi
authors.initials: H
authors.lastname: Doyama
authors.affiliation: Department of Internal Medicine, Hitachi General Hospital, Hitachi, Japan.
authors.forename: Toshiro
authors.initials: T
authors.lastname: Kamoshida
authors.affiliation: Department of Internal Medicine, Hitachi General Hospital, Hitachi, Japan.
authors.forename: Shinji
authors.initials: S
authors.lastname: Hirai
authors.affiliation: Gastroenterology Center, Cancer Institute Hospital of JFCR, Tokyo, Japan.
authors.forename: Teruhito
authors.initials: T
authors.lastname: Kishihara
authors.affiliation: Gastroenterology Center, Cancer Institute Hospital of JFCR, Tokyo, Japan.
authors.forename: Yorimasa
authors.initials: Y
authors.lastname: Yamamoto
authors.affiliation: Department of Gastroenterology, Mitoyo General Hospital, Kanonji, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Sakae
authors.affiliation: Department of Gastroenterology, Mitoyo General Hospital, Kanonji, Japan.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Imagawa
authors.affiliation: Department of Gastroenterology, Niigata Prefectural Central Hospital, Niigata, Japan.
authors.forename: Masaaki
authors.initials: M
authors.lastname: Hirano
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, University of Tokyo, Tokyo, Japan.
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Koike
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001241:Aspirin / Q000009:adverse effects* / Q000627:therapeutic use; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D016099:Endoscopy, Gastrointestinal; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D011182:Postoperative Care / Q000009:adverse effects; D019106:Postoperative Hemorrhage / Q000139:chemically induced* / Q000453:epidemiology; D011446:Prospective Studies; D012307:Risk Factors; D058924:Thienopyridines / Q000009:adverse effects* / Q000627:therapeutic use; D013923:Thromboembolism / Q000517:prevention & control
chemical_list: D010975:Platelet Aggregation Inhibitors; D058924:Thienopyridines; D001241:Aspirin