J Cardiovasc Med (Hagerstown). 2026 Apr 1;27(4):306-317. doi: 10.2459/JCM.0000000000001862. Epub 2026 Mar 27.
ABSTRACT
BACKGROUND: Dual pathway inhibition (DPI) with low-dose rivaroxaban and aspirin offers superior ischemic protection compared with single-agent therapy in patients with peripheral artery disease (PAD). However, its real-world adoption remains limited. We aimed to determine the proportion of revascularized PAD patients eligible for DPI, and to explore reasons for ineligibility and associated clinical outcomes.
METHODS: Consecutive patients undergoing lower limb revascularization for PAD between May 2021 and May 2023 were prospectively enrolled in the RAPID (RivAroxaban for PerIpheral artery Disease) registry and followed up for a median time of 283 (interquartile range 142-445) days. VOYAGER PAD eligibility criteria were applied. The primary outcome was eligibility for DPI. Exploratory clinical outcomes included major adverse limb events (MALE) - defined as the composite of cardiovascular death, acute limb ischemia, or repeat limb revascularization - and major bleeding.
RESULTS: A total of 196 patients were enrolled during the study period. Among them, 98 (50.0%) met DPI eligibility criteria; however, DPI was administered only to 4.1% of eligible patients. The most frequent exclusion factors were high bleeding risk (99.0%), low hemoglobin (48.8%), and age at least 75 years (36.7%). MALE occurred in 35 patients (28%), driven by recurrent revascularization (20%), while major bleeding occurred in nine patients (5%). DPI eligibility was associated with a lower risk of MALE (hazard ratio 0.42; 95% confidence interval 0.20-0.85), but this association faded out after statistical adjustment. Major bleeding did not differ between eligible and noneligible patients.
CONCLUSION: In a contemporary population of PAD patients undergoing revascularization, only half met the VOYAGER PAD eligibility criteria. Bleeding-related exclusions prevailed, highlighting the need for systematic anemia correction and bleeding avoidance strategies to broaden eligibility for DPI and improve clinical outcomes.
PMID:42065945 | DOI:10.2459/JCM.0000000000001862