Key result
Low-dose rivaroxaban plus clopidogrel matches aspirin plus clopidogrel for bleeding in PCI patients with GI disease.
Why the study?
DAPT is the cornerstone for CHD patients undergoing PCI but increases bleeding risk, especially with gastrointestinal disease, prompting evaluation of low-dose rivaroxaban plus clopidogrel.
Does low-dose rivaroxaban plus clopidogrel reduce bleeding compared to aspirin plus clopidogrel in patients with coronary atherosclerotic heart disease and gastrointestinal disease undergoing PCI?
RCT (n=1,042)
Open-label
1:1
No
Does low-dose rivaroxaban plus clopidogrel reduce bleeding compared to aspirin plus clopidogrel in patients with coronary atherosclerotic heart disease and gastrointestinal disease undergoing PCI?
Effect estimate: ARD 0.38% (95% CI -1.02-1.78)
Absolute Event Rate: 1.5% vs 1.2%
p-value: p=<0.0001 for non-inferiority
In patients with coronary heart disease and gastrointestinal disease undergoing PCI, low-dose rivaroxaban plus clopidogrel was non-inferior to standard DAPT for bleeding outcomes.
Supports low-dose rivaroxaban-clopidogrel as non-inferior bleeding alternative to DAPT; extends antithrombotic options for GI-comorbid PCI patients.
Purpose Dual antiplatelet therapy (DAPT) is the cornerstone for patients with coronary atherosclerotic heart disease (CHD) undergoing percutaneous coronary intervention (PCI) while increasing the risk of bleeding, particularly when combined with gastrointestinal disease (GID). Rivaroxaban 10 mg once daily is widely used in Asia. This study compared the effects of low-dose rivaroxaban (10 mg daily) plus clopidogrel vs. DAPT in CHD patients with GID undergoing PCI. Methods In this prospective, single-center, randomized controlled trial, eligible CHD patients with GID undergoing PCI were randomized (1:1) to either the dual pathway inhibition (DPI) group (rivaroxaban 10 mg plus clopidogrel 75 mg daily) or the DAPT group (aspirin 100 mg plus clopidogrel 75 mg daily). The primary outcome was Bleeding Academic Research Consortium (BARC) type 2–5 bleeding. The secondary outcome was major adverse cardiovascular or cerebrovascular events (MACCE), which included cardiac death, nonfatal myocardial infarction, ischemia-driven target vessel revascularization, all-cause death, stent thrombosis, and stroke during the 6-month follow-up. Results A total of 1042 patients were enrolled and analyzed (DPI, 522; DAPT, 520). Low-dose rivaroxaban (10 mg daily) plus clopidogrel was non-inferior to DAPT in BARC type 2–5 bleeding [8 (1.5%) vs. 6 (1.2%), absolute risk difference 0.38%, 95% confidence interval (CI) (− 1.02–1.78), p < 0.0001 for non-inferiority]. Abdominal pain was significantly lower in the DPI group ( p = 0.009). Other abdominal discomforts, gastrointestinal bleeding, or MACCE were similar. Conclusions In CHD patients with GID undergoing PCI, low-dose rivaroxaban (10 mg daily) plus clopidogrel was non-inferior to DAPT. Trial registration Chinese Clinical Trial Registry ChiCTR2100044319. Registered on March 16, 2021.
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Li et al. (2025) conducted an RCT in Coronary atherosclerotic heart disease with gastrointestinal disease undergoing percutaneous coronary intervention (n=1,042). Rivaroxaban plus clopidogrel vs. Aspirin 100 mg once daily plus clopidogrel 75 mg once daily was evaluated on Bleeding Academic Research Consortium (BARC) type 2-5 bleeding (ARD 0.38%, 95% CI -1.02-1.78, p=<0.0001 for non-inferiority). Low-dose rivaroxaban plus clopidogrel was non-inferior to aspirin plus clopidogrel for BARC type 2-5 bleeding in CHD patients with gastrointestinal disease undergoing PCI (ARD 0.38%, p<0.0001 for non-inferiority).
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