Real World Applicability Of Voyager-Pad According To Oac3pad Score

Abstract

Introduction: Lower extremity peripheral artery disease (PAD) is associated with a high risk of cardiovascular and limb adverse events. Optimal post intervention antithrombotic strategy may significantly impact medium to long-term outcomes. The VOYAGER PAD trial showed a clinical benefit of combining low dose rivaroxaban plus aspirin by reducing cardiovascular and limb major adverse events. However, safety of this dual pathway inhibition (DPI) may be questionable. Current European Society for Vascular Surgery guidelines on this subject suggest DPI for symptomatic PAD patients undergoing invasive treatment, in the absence of high bleeding risk. However, real-world patients differ from those enrolled in the VOYAGER PAD trial, especially chronic limb threatening ischemia (CLTI) patients. The OAC3PAD score is a novel risk stratification tool to assess bleeding risk in PAD patients that may help balance the benefits and risks of antithrombotic therapy.
Methods: Single center retrospective study analyzing data all patients admitted for lower limb revascularization procedures between 2020 and 2023. The primary objective was to evaluate the proportion of patients, as categorized into the different categories of the OAC3PAD score, eligible for DPI, according to the VOYAGER PAD trial criteria.
Results: A total of 652 patients were included in this study. Mean age of the patients was 69,6 ±10,3 years, and 76,8% were male. Out of the 652 patients, 12% were classified as high bleeding risk, 23% as intermediate to high bleeding risk, 46% as low to moderate bleeding risk, and 19% as low bleeding risk. Based on the VOYAGER PAD trial criteria, 441 patients (67,6%) were identified as potential candidates for low-dose rivaroxaban therapy. Eligibility for DPI varied significantly (p<0.001) across OAC3PAD scores, with the highest proportion of patients observed in the low to intermediate bleeding risk patients, while the lowest was in the high bleeding risk patients.
Conclusion: Current evidence points to a higher bleeding risk of PAD patients than previous stated, especially when CLTI patients are being considered. Despite showing promising results, DPI with low dose rivaroxaban plus aspirin may require special caution in almost 50% of CLTI patients due to bleeding risk. This is a more frail and older population were adverse cardiovascular and limb events are more common and would benefit the most from strategies to reduce such events.