Yaling Han1, Zhuan Liao2, Yi Li3, Xianxian Zhao2, Shuren Ma3, Dan Bao3, Miaohan Qiu3, Jie Deng4, Jinhai Wang4, Peng Qu5, Chunmeng Jiang5, Shaobin Jia6, Shaoqi Yang6, Leisheng Ru7, Jia Feng7, Wei Gao8, Yonghui Huang8, Ling Tao9, Ying Han9, Kan Yang10, Xiaoyan Wang10, Wenjuan Zhang11, Bangmao Wang11, Yue Li12, Youlin Yang12, Junxia Li13, Jiangqiu Sheng13, Yitong Ma14, Min Cui14, Sicong Ma3, Xiaozeng Wang3, Zhaoshen Li15, Gregg W Stone16. 1. General Hospital of Northern Theater Command, Shenyang, China. Electronic address: hanyaling@263.net. 2. Changhai Hospital of Navy Military Medical University, Shanghai, China. 3. General Hospital of Northern Theater Command, Shenyang, China. 4. Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. 5. Second Affiliated Hospital of Dalian Medical University, Dalian, China. 6. General Hospital of Ningxia Medical University, Yinchuan, China. 7. No. 980 Hospital of Joint Logistical Support Force, Shijiazhuang, China. 8. Peking University Third Hospital, Beijing, China. 9. Xijing Hospital of Air Force Medical University, Xi'an, China. 10. Third Xiangya Hospital of Central South University, Changsha, China. 11. General Hospital of Tianjin Medical University, Tianjin, China. 12. First Affiliated Hospital of Harbin Medical University, Harbin, China. 13. Seventh Medical Center of the General Hospital of the People's Liberation Army, Beijing, China. 14. The First Affiliated Hospital of Xinjiang Medical University, Urumqi, China. 15. Changhai Hospital of Navy Military Medical University, Shanghai, China. Electronic address: zhsl@vip.163.com. 16. Icahn School of Medicine at Mount Sinai, Mount Sinai Heart and the Cardiovascular Research Foundation, New York, New York, USA.
Abstract
BACKGROUND: Gastrointestinal bleeding is the most frequent major complication of antiplatelet therapy. In patients at low bleeding risk, however, clinically overt gastrointestinal bleeding is relatively uncommon. OBJECTIVES: The authors sought to assess the effects of different antiplatelet regimens on gastrointestinal mucosal injury by means of a novel magnetically controlled capsule endoscopy system in patients at low bleeding risk. METHODS: Patients (n = 505) undergoing percutaneous coronary intervention in whom capsule endoscopy demonstrated no ulcerations or bleeding (although erosions were permitted) after 6 months of dual antiplatelet therapy (DAPT) were randomly assigned to aspirin plus placebo (n = 168), clopidogrel plus placebo (n = 169), or aspirin plus clopidogrel (n = 168) for an additional 6 months. The primary endpoint was the incidence of gastrointestinal mucosal injury (erosions, ulceration, or bleeding) at 6-month or 12-month capsule endoscopy. RESULTS: Gastrointestinal mucosal injury through 12 months was less with single antiplatelet therapy (SAPT) than with DAPT (94.3% vs 99.2%; P = 0.02). Aspirin and clopidogrel monotherapy had similar effects. Among 68 patients without any gastrointestinal injury at randomization (including no erosions), SAPT compared with DAPT caused less gastrointestinal injury (68.1% vs 95.2%; P = 0.006), including fewer new ulcers (8.5% vs 38.1%; P = 0.009). Clinical gastrointestinal bleeding from 6 to 12 months was less with SAPT than with DAPT (0.6% vs 5.4%; P = 0.001). CONCLUSIONS: Despite being at low risk of bleeding, nearly all patients receiving antiplatelet therapy developed gastrointestinal injury, although overt bleeding was infrequent. DAPT for 6 months followed by SAPT with aspirin or clopidogrel from 6 to 12 months resulted in less gastrointestinal mucosal injury and clinical bleeding compared with DAPT through 12 months. (OPT-PEACE [Optimal Antiplatelet Therapy for Prevention of Gastrointestinal Injury Evaluated by Ankon Magnetically Controlled Capsule Endoscopy]; NCT03198741).
BACKGROUND: Gastrointestinal bleeding is the most frequent major complication of antiplatelet therapy. In patients at low bleeding risk, however, clinically overt gastrointestinal bleeding is relatively uncommon. OBJECTIVES: The authors sought to assess the effects of different antiplatelet regimens on gastrointestinal mucosal injury by means of a novel magnetically controlled capsule endoscopy system in patients at low bleeding risk. METHODS: Patients (n = 505) undergoing percutaneous coronary intervention in whom capsule endoscopy demonstrated no ulcerations or bleeding (although erosions were permitted) after 6 months of dual antiplatelet therapy (DAPT) were randomly assigned to aspirin plus placebo (n = 168), clopidogrel plus placebo (n = 169), or aspirin plus clopidogrel (n = 168) for an additional 6 months. The primary endpoint was the incidence of gastrointestinal mucosal injury (erosions, ulceration, or bleeding) at 6-month or 12-month capsule endoscopy. RESULTS: Gastrointestinal mucosal injury through 12 months was less with single antiplatelet therapy (SAPT) than with DAPT (94.3% vs 99.2%; P = 0.02). Aspirin and clopidogrel monotherapy had similar effects. Among 68 patients without any gastrointestinal injury at randomization (including no erosions), SAPT compared with DAPT caused less gastrointestinal injury (68.1% vs 95.2%; P = 0.006), including fewer new ulcers (8.5% vs 38.1%; P = 0.009). Clinical gastrointestinal bleeding from 6 to 12 months was less with SAPT than with DAPT (0.6% vs 5.4%; P = 0.001). CONCLUSIONS: Despite being at low risk of bleeding, nearly all patients receiving antiplatelet therapy developed gastrointestinal injury, although overt bleeding was infrequent. DAPT for 6 months followed by SAPT with aspirin or clopidogrel from 6 to 12 months resulted in less gastrointestinal mucosal injury and clinical bleeding compared with DAPT through 12 months. (OPT-PEACE [Optimal Antiplatelet Therapy for Prevention of Gastrointestinal Injury Evaluated by Ankon Magnetically Controlled Capsule Endoscopy]; NCT03198741).
Authors: Davide Capodanno; Usman Baber; Deepak L Bhatt; Jean-Philippe Collet; George Dangas; Francesco Franchi; C Michael Gibson; Hyeon-Cheol Gwon; Adnan Kastrati; Takeshi Kimura; Pedro A Lemos; Renato D Lopes; Roxana Mehran; Michelle L O'Donoghue; Sunil V Rao; Fabiana Rollini; Patrick W Serruys; Philippe G Steg; Robert F Storey; Marco Valgimigli; Pascal Vranckx; Hirotoshi Watanabe; Stephan Windecker; Dominick J Angiolillo Journal: Nat Rev Cardiol Date: 2022-06-13 Impact factor: 32.419