Magnetically Controlled Capsule Endoscopy for Assessment of Antiplatelet Therapy-Induced Gastrointestinal Injury
Yaling Han, Zhuan Liao, Yi Li, Xianxian Zhao, Shuren Ma, Dan Bao, Miaohan Qiu, Jie Deng, Jinhai Wang, Peng Qu, Chunmeng Jiang, Shaobin Jia, Shaoqi Yang, Leisheng Ru, Jia Feng, Wei Gao, Yonghui Huang, Ling Tao, Ying Han, Kan Yang, Xiaoyan Wang, Wenjuan Zhang, Bangmao Wang, Yue Li, Youlin Yang, Junxia Li, Jiangqiu Sheng, Yitong Ma, Min Cui, Sicong Ma, Xiaozeng Wang, Zhaoshen Li, Gregg W Stone, Yaling Han, Zhuan Liao, Yi Li, Xianxian Zhao, Shuren Ma, Dan Bao, Miaohan Qiu, Jie Deng, Jinhai Wang, Peng Qu, Chunmeng Jiang, Shaobin Jia, Shaoqi Yang, Leisheng Ru, Jia Feng, Wei Gao, Yonghui Huang, Ling Tao, Ying Han, Kan Yang, Xiaoyan Wang, Wenjuan Zhang, Bangmao Wang, Yue Li, Youlin Yang, Junxia Li, Jiangqiu Sheng, Yitong Ma, Min Cui, Sicong Ma, Xiaozeng Wang, Zhaoshen Li, Gregg W Stone
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).
Keywords: antiplatelet therapy; endoscopy; gastrointestinal injury; percutaneous coronary intervention.
Conflict of interest statement
Funding Support and Author Disclosures The trial was supported by the China National Key R&D Project (contract nos. 2016YFC1301300 and 2016YFC1301303) and an investigator-initiated grant from Ankon Medical Technologies, Shanghai, China. Dr Stone has received speaker honoraria from Cook and Infraredx; has served as a consultant for Valfix, TherOx, Robocath, HeartFlow, Ablative Solutions, Vectorious, Miracor, Neovasc, Abiomed, Ancora, Elucid Bio, Occlutech, CorFlow, Apollo Therapeutics, Impulse Dynamics, Reva, Vascular Dynamics, Shockwave, V-Wave, Cardiomech, and Gore; and has equity/options from Ancora, Cagent, Applied Therapeutics, Biostar funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, and MedFocus funds. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
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Source: PubMed