Among patients who completed 6 months of dual antiplatelet therapy (DAPT) after successful percutaneous coronary intervention (PCI), gastrointestinal injury was lower in those who replaced DAPT with single antiplatelet therapy (SAPT) for the next 6 months, the OPT-PEACE randomized trial showed.
Gastrointestinal mucosal injury including ulcerations, bleeding, and erosions, on 12-month capsule endoscopy was less with SAPT than with DAPT (94.3% vs 99.2% respectively, P=0.02), driven by erosions, reported Yaling Han, MD, of General Hospital of Northern Theater Command in Shenyang, China, and co-authors.
Mucosal injury for aspirin alone was similar to mucosal injury for clopidogrel alone, and no increase in ischemic events was seen.
“In patients without gastrointestinal ulcers or bleeding after 6 months of DAPT, SAPT with aspirin or clopidogrel for an additional 6 months resulted in a lower risk of gastrointestinal mucosal injury compared with DAPT through 12 months, an effect that was especially pronounced in patients without gastrointestinal injury of any type (including erosions) at 6 months,” Han and colleagues wrote in the Journal of the American College of Cardiology.
“Despite being at low risk of bleeding, nearly all patients receiving antiplatelet therapy developed gastrointestinal injury, although overt bleeding was infrequent,” they added.
The researchers recruited patients who had successful PCI for cardiac conditions excluding ST-segment elevation between July 2017 and July 2019. A screening capsule endoscopy capturing two frames per second of the stomach and small intestine was done 30-120 hours after PCI. This identified 783 candidates who all received DAPT.
Six months later, a second capsule endoscopy excluded those with ulcers or bleeding (erosions were allowed), leaving 505 participants who were randomized for the next 6 months to SAPT (aspirin plus placebo, n=168; or clopidogrel plus placebo, n=169) or to ongoing DAPT (aspirin plus clopidogrel, n=168). Of these, 95.2% initially presented with non-ST-segment acute coronary syndromes and the mean age was 57. Males made up 74.5% of the SAPT group and 73.8% of the DAPT group.
A third capsule endoscopy 12 months after PCI was completed in 394 patients. The primary endpoint was the incidence of any gastric or small intestinal mucosal injury—ulcerations, bleeding, or erosions—detected by capsule endoscopy (or standard endoscopy if clinically indicated) at 6 or 12 months.
More than 95% of erosions were newly developed or worsened lesions. Endoscopic bleeding was not found in any patient.
For ulcer, a non-significant difference between SAPT (14.4%) versus DAPT (18.5%) over 12 months was seen (P=0.30). In the subgroup of 68 patients without any mucosal injury at 6-month endoscopy, though, SAPT caused less gastrointestinal injury compared with DAPT (68.1% vs 95.2%, P=0.006), including fewer new ulcers (8.5% vs 38.1%, P=0.009).
Overall clinical bleeding from any source was uncommon, seen in 11/505 patients (2.2%), and was mild, with no major bleeds in any patient. Minor bleeding from any source was less common in the SAPT group versus DAPT (5.9% versus 11.9%, RR 0.50, 95% CI 0.23-0.90, P=0.002).
Any gastrointestinal bleeding from 6 to 12 months was less with SAPT than with DAPT (0.6% vs 5.4%, P=0.001) with no increase in ischemic events (0% for both SAPT and DAPT).
“The study affirms that using aspirin or clopidogrel monotherapy after a 6-month course of DAPT in patients undergoing PCI predominantly for acute coronary syndrome has a better safety record than using a 12-month course of DAPT,” observed John Bittl, MD, of Advent Health Ocala in Florida, and Loren Laine, MD, of the Yale School of Medicine, in an accompanying editorial.
Study results “should compel cardiologists to start thinking like gastroenterologists,” they stated, suggesting that patients at high bleeding risk undergoing PCI “should thus be considered for SAPT after 1-3 months of DAPT after PCI, as long as they remain at low risk of ischemic events. They should also receive proton pump inhibitors.”
The near ubiquity of erosions—”almost every patient had erosions in the stomach or small intestine on every capsule endoscopy study”—along with non-specificity and a tendency to being over-read, “suggests that erosions as a marker of GI injury are not really useful as a clinical endpoint or a discriminator of safety,” the editorialists noted. “This supports the clinical impression that patients and doctors should be more concerned with symptomatic ulceration or overt bleeding than with incidental endoscopic erosions.”
“Mounting evidence suggests that a short course of DAPT followed by SAPT reduces bleeding without increasing ischemic events in patients with either stable ischemic heart disease or acute coronary syndromes, but it is uncertain whether using either aspirin or a P2Y12 antagonist alone reduces gastrointestinal injury,” Bittl and Laine added.
Limitations of the study included an East Asian population at low risk for bleeding due to multiple exclusion criteria, limiting generalizability to other groups, the researchers acknowledged.
“Current guidelines recommend lifelong antiplatelet therapy with at least one agent for secondary prevention in nearly all patients with ischemic heart disease, a practice that dictated the present trial design,” Han and co-authors wrote. “We therefore did not evaluate the extent to which gastrointestinal injury at 12 months might have been reduced with no antiplatelet drug use after 6 months.”
Among patients who completed 6 months of dual antiplatelet therapy (DAPT) after successful percutaneous coronary intervention, gastrointestinal mucosal injury was lower in those who replaced DAPT with single antiplatelet therapy (SAPT) for the next 6 months, a randomized trial showed.
The effect was especially pronounced in patients without gastrointestinal injury of any type, including erosions, at 6 months.
Paul Smyth, MD, Contributing Writer, BreakingMED™
The trial was supported by the China National Key R&D Project and an investigator-initiated grant from Ankon Medical Technologies, Shanghai, China.
Han had no disclosures.
Bittl and Lane had no disclosures.
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