But even in low-bleeding-risk patients, DAPT or SAPT still leads to GI injury post-PCI, study finds
In patients at low bleeding risk, antiplatelet therapy resulted in gastrointestinal (GI) mucosal injury after percutaneous coronary intervention (PCI) during 12-month follow-up regardless of antiplatelet regimen used, although clinically evident bleeding was infrequent, according to new study results.
The OPT-PEACE study also found that dual antiplatelet therapy (DAPT) with clopidogrel and aspirin for 6 months followed by 6 months of single antiplatelet therapy (SAPT) with either clopidogrel or aspirin resulted in less GI mucosal injury than DAPT for 12 months.
The trial results were first reported in November at Transcatheter Cardiovascular Therapeutics (TCT) 2021. The paper reporting the results, written by Yaling Han, MD, from the General Hospital of Northern Theater Command, Shenyang, China, and colleagues, was published in the Jan. 18 issue of the Journal of American College of Cardiology.
The study was performed using a novel magnetically controlled capsule endoscopy diagnostic tool. The trial was a multicenter, randomized, double blind, placebo-controlled study that was conducted at 28 Chinese centers.
The initial study population included patients (n=1,028) with chronic coronary syndrome or acute coronary syndrome who underwent PCI with contemporary drug-eluting stents, while high-bleeding-risk patients with age >80 years, baseline anemia, previous GI bleeding or ulcers within 24 months, severe chronic kidney disease and on chronic oral anticoagulation were excluded.
These patients underwent screening capsule endoscopy examinations 30 to 120 hours after successful PCI, and 783 patients were enrolled. Of these, 629 were event-free (no GI ulceration or bleeding [erosions were permitted]) at 6 months and were randomized (n=505) in a 1:1:1 fashion to receive 100 mg of aspirin per day plus a matching clopidogrel placebo (n=168), 75 mg of clopidogrel per day plus a matching aspirin placebo (n=169), or aspirin plus clopidogrel (n=168) for an additional 6 months. Finally, a third capsule endoscopy was performed at 12 months in these patients.
At baseline, the patients were well-matched in three groups, with the majority being male (74.2%) and mean baseline hemoglobin around 14.2 ± 1.3 g/dL.
The primary endpoint was the incidence of any gastric or small intestinal mucosal injury (erosions, ulceration or bleeding), detected by either capsule endoscopy at 6 or 12 months or any clinically driven standard endoscopy were less with single antiplatelet therapy (SAPT) than with dual antiplatelet therapy (DAPT; 94.3% vs. 99.2%; p=0.02). SAPT also caused less GI injury (68.1% vs. 95.2%; p=0.006), including fewer new ulcers (8.5% vs. 38.1%, p=0.009) in 68 patients who had no GI injury at the time of randomization. Furthermore, the secondary endpoint of incidence of clinical GI bleeding was less with SAPT than with DAPT (0.6% vs. 5.4%, p=0.001) from 6 to 12 months without an increase in ischemic events (0% vs. 0%).
A key limitation of the study is that the enrollment of only low-bleeding-risk and East Asian patients limits the extrapolation of results to high-bleeding-risk and Caucasian populations. Moreover, an endoscopic examination was not performed to assess severity and site of GI mucosal injury in patients who had clinical GI bleed.
In an accompanying editorial, John Bittl, MD, of the AdventHealth Ocala, Florida, and Loren Laine, MD, of the Yale School of Medicine and Veterans Affairs Connecticut Healthcare System, commended the authors for performing this randomized trial, which challenges the conventional wisdom that aspirin is the culprit in DAPT responsible for GI injury and raises the possibility that inhibition of a P2Y12 receptor may be ulcerogenic or impair mucosal injury healing.
Furthermore, the editorialists pointed that the ubiquitous presence of erosions supports the clinical impression that physicians should be more concerned with symptomatic ulceration or overt bleeding than with incidentally detected endoscopic erosions.
Han Y, Liao Z, Li Y, et al. Magnetically Controlled Capsule Endoscopy for Assessment of Antiplatelet Therapy-Induced Gastrointestinal Injury. J Am Coll Cardiol 2022;79:116–128.
Bittl JA, Laine L. Gastrointestinal Injury Caused by Aspirin or Clopidogrel Monotherapy Versus Dual Antiplatelet Therapy. J Am Coll Cardiol 2022;79:129–131.
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