Continuous DAPT raises GI bleeding risk even in low risk patients after PCI: JAMA

In the secondary analysis of the OPT-PEACE randomized clinical trial (RCT) with 394 participants, clopidogrel, aspirin, or their combination was tied to progressive small-intestinal and gastric injury in a substantial proportion of patients after percutaneous coronary intervention, specifically during dual antiplatelet therapy (DAPT) compared with monotherapy.

Antiplatelet regimens are used widely for secondary prevention of cardiovascular disease (CVD) to lower the risk of recurrent ischemic events following PCI. Practice guidelines recommend using clopidogrel plus aspirin for patients without high bleeding risk for at least 12 months after PCI for those with acute coronary syndromes (ACS) and for at least six months for those with stable coronary artery disease (CAD) to avoid subsequent cardiac events. However, antiplatelet agents raise the risk of GIB with about 1% of patients experiencing overt GIB within the first 30 days of therapy.

Long-term antiplatelet therapy leads to both upper and lower GIB. There is a lack of information about gastrointestinal injury progression induced by antiplatelet therapy in patients after PCI. To fill this knowledge gap, Chen He, Changhai Hospital, Naval Medical University, Shanghai, China, and colleagues aimed to assess the association of clopidogrel, aspirin, and their combination with gastrointestinal injury progression among patients without high bleeding risk after PCI.

The trial based in China took place from 2017 to 2019 and included patients with stable CAD or ACS without ST-segment elevation after PCI. Patients underwent magnetically controlled capsule endoscopy (MCE) at baseline and following 6 months of DAPT with aspirin (100 mg/d) plus clopidogrel (75 mg/d).

Those with no evidence of gastrointestinal ulcers or bleeding were randomized in the ratio of 1:1:1 to aspirin (100 mg/d) plus a matching placebo (aspirin alone; n=132), clopidogrel (75 mg/d) plus matching placebo (clopidogrel alone; n=132), or DAPT for an additional 6 months (n=130). A third MCE was performed 12 months after PCI.

The study led to the following findings:

• Gastric injury progression occurred in 37.1% of aspirin users, 48.5% of clopidogrel users, and 53.1% of DAPT users, reflecting a lower rate of gastric injury progression among aspirin users vs DAPT users (risk ratio [RR], 0.70).
• No significant difference was observed between clopidogrel alone and DAPT (48.5% versus 53.1%) or between aspirin alone and clopidogrel alone (37.1% versus 48.5%).
• A total of 38.6% of aspirin users, 49.2% of clopidogrel users, and 54.6% of DAPT users developed progressive small-intestinal injury, reflecting a lower rate of small-intestinal injury among aspirin users vs DAPT users (RR, 0.71).
• No difference was observed between patients treated with clopidogrel vs DAPT (49.2% versus 54.6%) or aspirin vs clopidogrel (38.6% versus 49.2%).

"Further studies are warranted to determine whether incorporating the findings from routine MCEs into clinical decision-making for the duration and selection of antiplatelet therapy may improve outcomes for patients with ischemic heart disease," they concluded.

Reference:

He C, Li Y, Jiang X, et al. Progression of Gastrointestinal Injury During Antiplatelet Therapy After Percutaneous Coronary Intervention: A Secondary Analysis of the OPT-PEACE Randomized Clinical Trial. JAMA Netw Open. 2023;6(11):e2343219. doi:10.1001/jamanetworkopen.2023.43219