8-LB: Risk Profile of Comorbid Diabetes and Benefit of Rivaroxaban in Patients with Critical Limb Ischemia: Insights from VOYAGER PAD

Individuals with diabetes mellitus (DM) have a high risk of peripheral artery disease (PAD), of which critical limb ischemia (CLI) is the most severe manifestation. The VOYAGER PAD trial demonstrated the efficacy of rivaroxaban 2.5mg twice daily plus aspirin for reducing risk of major adverse limb and cardiovascular events (acute limb ischemia, major amputation for vascular cause, myocardial infarction, ischemic stroke or cardiovascular death) in 6,564 PAD patients undergoing revascularization; 1,533 presented with CLI. The risk profile of CLI patients with comorbid DM and whether efficacy and safety of rivaroxaban is consistent in this population has not been described. Overall, 47% of CLI patients (n=716) had comorbid DM at baseline. The HR for the primary outcome at 3 years in CLI patients was 0.85 (CI 0.69-1.05); the risk was higher in DM (28.8%) versus those without (20.7%) although all were high risk; more than 1 in 5 had a first event at 3 years (Figure left). The benefit of rivaroxaban was consistent in CLI patients regardless of DM status as was the bleeding risk. However, due to higher baseline risk, the absolute benefit was greater in those with both CLI and DM vs. CLI alone. In conclusion, in patients with CLI, DM is associated with even greater risk of adverse limb and cardiovascular events. Rivaroxaban provides a robust benefit to reduce this risk in CLI patients having comorbid DM. Disclosure C. C. Low wang: None. M. R. Nehler: Other Relationship; Self; CPCResearch. L. Haskell: Employee; Self; Janssen Research & Development, LLC. S. D. Berkowitz: Employee; Self; Bayer U. S . R. M. Bauersachs: Advisory Panel; Self; Bayer AG, LEO Pharma Inc., Speaker’s Bureau; Self; Bristol-Myers Squibb Company, Pfizer Inc. M. P. Bonaca: Research Support; Self; Grant support to CPC from Amgen, Anthos, AstraZeneca, Bayer, Merck, NovoNordisk, Pfizer, Sanofi, Wraser.