Abstract 10889: Unplanned Limb Revascularization With Rivaroxaban versus Placebo in Patients With Critical Limb Ischemia After Endovascular and Surgical Treatment: Insights From Voyager Pad
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Overview
abstract
Introduction:
Patients with critical limb ischemia (CLI) have a class I indication for lower extremity revascularization (LER) by either endovascular or surgical approach. A common complication is recurrent arterial occlusion requiring unplanned index limb revascularization (UILR). VOYAGER PAD established the efficacy of rivaroxaban in patients with symptomatic peripheral artery disease (PAD) after successful LER, including a reduction in UILR. Whether this benefit differs by LER approach for CLI is unknown.
Hypothesis:
Rivaroxaban reduces UILR regardless of LER approach for CLI.
Methods:
LER indication (CLI or claudication) and approach were captured at baseline. The primary composite endpoint was acute limb ischemia, major vascular amputation, MI, ischemic stroke or CV death. TIMI major bleeding was the primary safety outcome. UILR was a prespecified secondary outcome. A Cox proportional-hazards model was used to calculate hazard rations and 95% confidence intervals.
Results:
Among 6,564 participants randomized
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1,533 (23%) had CLI, of whom 696 (45%) and 837 (55%) underwent surgical and endovascular LER, respectively. CLI patients on rivaroxaban had fewer events at three years compared to those on placebo (HR 0.85). Efficacy of rivaroxaban for the primary endpoint (p-interaction 0.40) and safety (p-interaction 0.18) in CLI were consistent regardless of approach. On background therapy (aspirin in all, statins ~80%, DAPT ~50%), at a median of 28 months, UILR occurred in 26.2% and 14.3% after endovascular and surgical LER, respectively. Rivaroxaban significantly reduced UILR by 22% in patients with CLI (HR 0.78, p=0.019, Figure), with consistent benefits in those treated with endovascular and surgical LER (p-interaction 0.70).
Conclusions:
CLI patients have high rates of UILR after LER. Rivaroxaban reduced the rate of UILR in this population, regardless of endovascular or surgical approach.
