(PC036) The uptake and impact of the VOYAGER PAD trial on utilization of direct oral anticoagulants after open revascularization for PAD in the Vascular Quality Initiative

Objectives: The VOYAGER PAD trial demonstrated that rivaroxaban plus aspirin was associated with lower incidence of adverse events after revascularization for PAD than aspirin alone. Since its publication, it remains unknown if there have been changes in clinic practice reflecting these data. Therefore, we aimed to assess the uptake of DOAC plus aspirin after open revascularization for PAD. We also examined differences in 1-year survival to evaluate for real-world clinical benefit using the Vascular Quality Initiative.

Methods: We identified all patients on pre-operative aspirin who underwent open surgical revascularization in the VQI from 2015–2024. We used interrupted time series and logistic regression analyses to evaluate the impact of the VOYAGER PAD trial on the utilization of post-operative DOAC plus aspirin. Our primary outcome was the level of change in DOAC plus aspirin use before and after study publication. We used Kaplan-Meier and Cox regression analyses to evaluate 1-year survival by DOAC plus aspirin vs aspirin only.

Results: Among 36,880 patients in the study, 4,452 (14%) received post-operative DOAC and aspirin (Table). Patients who received post-operative DOAC and aspirin were less likely to have CKD (2% vs 8%; p< 0.001) or prior PCI (22% vs 25%; p< 0.001), and were more likely to be on pre-operative anticoagulation (45% vs 16%; p< 0.001). They were also more likely to have undergone surgery for rest pain or tissue loss compared with patients on aspirin only. From 2015–2024, there has been a significant increase in the utilization of DOAC plus aspirin (β=0.02, p< 0.001). However, the publication of the VOYAGER PAD trial was not associated with a significant increase in the uptake of DOAC plus aspirin (β=0.0005, p=0.19) (Figure 1). Post-operative DOAC plus aspirin was associated with higher 1-year survival (93% vs 91%; hazard ratio (HR):1.3[95% confidence interval:1.1-1.4])(Figure 2). After adjusting for covariates (i.e. comorbidities, demographic characteristics, pre-operative anticoagulation), survival remained higher in the DOAC plus aspirin group although the difference was no longer significant (HR 1.1[0.83-1.4]).

Conclusions: Since the publication of the VOYAGER PAD study, there has not been a significant increase in the utilization of DOAC plus aspirin after open surgical revascularization for PAD. In the unadjusted analysis, DOAC plus aspirin was associated with higher 1-year survival compared with aspirin alone; however, the difference was no longer significant after adjusting for covariates. Further research is warranted to elucidate real-world clinical benefits, and promote utilization of DOAC plus aspirin in populations with the appropriate risk-benefit profile.