Despite being at low risk for bleeding, nearly all patients on an antiplatelet therapy regimen developed gastrointestinal mucosal injury, according to findings from the OPT-PEACE trial presented Nov. 6 during TCT 2021 and simultaneously published in the Journal of the American College of Cardiology. However, researchers noted that dual antiplatelet therapy (DAPT) for six months followed by six to 12 months of single antiplatelet therapy (SAPT) with aspirin or clopidogrel resulted in less gastrointestinal injury and clinical bleeding compared with a 12-month DAPT regimen.

The study out of China, authored by Yaling Han, MD, PhD, FACC, and colleagues, used a novel magnetically-controlled capsule endoscopy system to identify a total of 505 patients undergoing PCI who demonstrated no ulcerations or bleeding after six months of DAPT. The patients were then randomly assigned to aspirin plus placebo (n=168), clopidogrel plus placebo (n=169) or aspirin plus clopidogrel (n=168) for an additional six months. The primary endpoint was the incidence of gastrointestinal mucosal injury (erosions, ulceration, or bleeding) at six-month or 12-month capsule endoscopy.

Results found less gastrointestinal mucosal injury through 12 months with SAPT compared with DAPT (94.3% vs. 99.2%, respectively). Similar results were observed with aspirin and clopidogrel monotherapy had similar effects. Researchers did note that while overt bleeding was infrequent, some element of gastrointestinal injury was observed in roughly all patients receiving antiplatelet therapy, regardless of regimen.

In other findings, lower rates of gastrointestinal bleeding were observed between six and 12 months with SAPT compared with DAPT (0.6% vs. 5.4%). This trend was even more pronounced in patients who were event-free and without gastrointestinal ulceration or bleeding at six months. Han and colleagues suggest that further studies are warranted “to determine whether prophylactic administration of an H2-blocker or proton-pump inhibitor medication or more frequent Heliobacter pylori eradication therapy is beneficial for patients at low bleeding risk when prolonged antiplatelet therapy is needed.”

In a related editorial comment, John A. Bittl, MD, FACC, and Loren Laine, MD, write that the study findings “should compel cardiologists to start thinking like gastroenterologists” and “should continue to motivate the collaboration between cardiologists and gastroenterologists in the search for safer agents and regimens in patients who have [gastrointestinal] bleeding and require antiplatelet agents after undergoing PCI.”

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Interventions and Imaging, Angiography, Nuclear Imaging

Keywords: Transcatheter Cardiovascular Therapeutics, TCT21, Angiography, ACC International

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