Eligibility for dual pathway inhibition in patients with peripheral artery disease undergoing revascularization.
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.
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.
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.
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.
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.
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.
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.
Authors
Greco Greco, Laudani Laudani, Spagnolo Spagnolo, Cavallo Cavallo, Bulla Bulla, Giaquinta Giaquinta, Isola Isola, PedullĂ PedullĂ , De Pasquale De Pasquale, Uva Uva, Di Cataldo Di Cataldo, Capranzano Capranzano, Calvi Calvi, Veroux Veroux, Tamburino Tamburino, Capodanno Capodanno
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