Optimal antiplatelet therapy for prevention of gastrointestinal injury evaluated by ANKON magnetically controlled capsule endoscopy: Rationale and design of the OPT-PEACE trial

Yi Li, Xiaozeng Wang, Dan Bao, Zhuan Liao, Jing Li, Xiao Han, Heyang Wang, Kai Xu, Zhaoshen Li, Gregg W Stone, Yaling Han, Yi Li, Xiaozeng Wang, Dan Bao, Zhuan Liao, Jing Li, Xiao Han, Heyang Wang, Kai Xu, Zhaoshen Li, Gregg W Stone, Yaling Han

Abstract

Background: Gastrointestinal injury is a common complication in patients treated with antiplatelet agents after percutaneous coronary intervention (PCI). However, the effects of different antiplatelet regimens on the incidence and severity of gastrointestinal injury have not been well studied, principally due to the lack of a low-risk sensitive and accurate detection system.

Trial design: OPT-PEACE is a multicenter, randomized, double-blind, placebo-controlled trial. Gastrointestinal injury will be evaluated with the ANKON magnetically controlled capsule endoscopy system (AMCE), a minimally invasive approach for detecting mucosal lesions in the stomach, duodenum and small intestine. Patients without AMCE-detected gastrointestinal erosions, ulceration or bleeding after drug-eluting stent implantation are enrolled and treated with open-label aspirin (100 mg/d) plus clopidogrel (75 mg/d) for 6 months. Thereafter, 480 event-free patients will undergo repeat AMCE and are randomly assigned in a 1:1:1 ratio to receive aspirin plus clopidogrel, aspirin plus placebo or clopidogrel plus placebo for an additional 6 months. A final AMCE is performed at 12 months. The primary endpoint is the incidence of gastric or intestinal mucosal lesions (erosions, ulceration, or bleeding) within 12 months after enrollment.

Conclusions: OPT-PEACE is the first study to investigate the incidence and severity of gastrointestinal injury in patients receiving different antiplatelet therapy regimens after stent implantation. This trial will inform clinical decision-making for personalized antiplatelet therapy post-PCI.

Conflict of interest statement

Declaration of competing interest Drs. Yi Li, Xiaozeng Wang, Dan Bao, Zhuan Liao, Jing Li, Xiao Han, Heyang Wang, Kai Xu, Zhaoshen Li and Yaling Han have no competing interests to declare. Dr. Gregg W. Stone has received speaker or other honoraria from Cook, Terumo, QOOL Therapeutics and Orchestra Biomed; has served as a consultant to Valfix, TherOx, Vascular Dynamics, Robocath, HeartFlow, Gore, Ablative Solutions, Miracor, Neovasc, V-Wave, Abiomed, Ancora, MAIA Pharmaceuticals, Vectorious, Reva, Matrizyme, Cardiomech; and has equity/options from Ancora, Qool Therapeutics, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, MedFocus family of funds, Valfix.

Copyright © 2020 Elsevier Inc. All rights reserved.

Figures

Figure 1
Figure 1
ANKON magnetically controlled capsule endoscopy system. a) capsule endoscope; b) portable data recorder; c) magnetic navigation control system.
Figure 2
Figure 2
Representative examples of gastrointestinal mucosal images captured by ANKON magnetically controlled capsule endoscopy. a) normal; b) erosions (blue arrows); c) ulcers with fibrin coating; d) bleeding.
Figure 3
Figure 3
Study flowchart. PCI: percutaneous coronary intervention; DES, drug-eluting stent; GI: gastrointestinal; AMCE: ANKON magnetically controlled capsule endoscopy.

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Source: PubMed

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