Written by Peter Liu
Spoon Feed
Low-dose rivaroxaban added to aspirin improved vascular outcomes in medically fragile patients with peripheral artery disease (PAD) who had lower extremity revascularization, independent of frailty.
Synopsis
The VOYAGER PAD trial examined the safety and efficacy of low-dose rivaroxaban (2.5 mg twice daily) combined with aspirin in fragile patients undergoing lower extremity revascularization for PAD. Fragile patients, defined by age >75 years, weight ≤50 kg, or impaired renal function (eGFR <50 mL/min/1.73 m²), had significantly higher risks of ischemic events and bleeding. Rivaroxaban reduced major adverse limb events (6.2% vs. 10.4%; HR 0.58; P = 0.002) and total vascular events (82.1 vs. 99.3 events/100 patients; HR 0.81; P = 0.026). Although it increased bleeding risk (4.6% vs. 4.3%; HR 1.54; P = 0.65), the overall benefit-risk profile favored its use, particularly for limb protection in this high-risk population. (AI-generated)
Will it break the fragile PAD patient?
The COMPASS trial and VOYAGER PAD trial put low-dose rivaroxaban (2.5mg twice daily) on the map as an effective addition to aspirin for improving coronary artery disease (CAD) and PAD outcomes, respectively. The addition of rivaroxaban increases bleeding risk, but the expected increase in the number of serious bleeding events is generally significantly smaller than the expected number of prevented serious vascular events for most patients. In this subgroup analysis of VOYAGER PAD, it appears that these findings continue to hold true for most patients with high frailty, without a clear interaction between frailty and this benefit/risk balance. Other notable findings include the high prevalence of fragility in the patient population undergoing lower extremity revascularization. Management of anticoagulation in this older, frailer population tends to be complex, with discontinuation occurring more frequently in frail patients even in the absence of side effects. In general, these results would make me favor starting low-dose rivaroxaban in more of my patients with severe PAD with high age and frailty. However, I frequently find myself in a deprescribing, simplifying mindset when I approach many of these high-frailty patients, especially those admitted to the hospital due to falls.
Source
Low-Dose Rivaroxaban Plus Aspirin in Fragile Patients After Lower Extremity Revascularization. J Am Coll Cardiol. 2024 Aug 27;84(9):801-811. doi: 10.1016/j.jacc.2024.05.060. PMID: 39168566
