Anticoagulation after peripheral revascularization – results from the VOYAGER study

There was limited data available about antithrombotic treatment after peripheral revascularization. Current guideline recommendation is mostly based on small studies and expert consensus opinion [1]. Especially following peripheral angioplasty data from large randomized studies is rare. According to experience from coronary intervention usually dual antiplatelet therapy is used for 1 to 3 months. After bypass surgery single anti-platelet therapy is recommended in most patients. According to the results from the Dutch Bypass Oral anticoagulants or Aspirin (BOA) study anticoagulation with Vitamin K antagonists can be used after bypass surgery and in some patients dual antiplatelet therapy can be considered according to the results of the Clopidogrel and Acetyl Salicylic Acid in Bypass Surgery for Peripheral ARterial Disease (CASPAR) study [2, 3].

The Vascular Outcomes Study of ASA Along With Rivaroxaban in Endovascular or Surgical Limb Revascularization for Peripheral Artery Disease (VOYAGER PAD) study is a randomized trial including 6564 patients after successful surgical or endovascular lower-extremity revascularization [4].  All patients received Aspirin 100 mg and were randomized to Rivaroxaban 2.5 mg twice daily or placebo comparable with the previously published COMPASS (Cardiovascular Outcomes for People Using Anticoagulation Strategies) study [5]. Treatment with Clopiodgrel 75 mg was allowed for up to 6 months. After a follow-up period of 3 years, the primary efficacy endpoint (acute limb ischemia, major amputation, myocardial infarction, stroke, cardiovascular death) was significantly decreased using low dose Rivaroxaban compared with placebo. Absolute risk reduction was 2.6% mostly triggered by reduction of acute limb ischemia. There was no significant difference in the primary safety outcome (TIMI major bleeding) which occurred in 2.7% Rivaroxaban group and in 1.9% in the Placebo group (p=0.07). There was no significant difference between treatment groups in the subgroup of patients using Clopiodgrel 75mg.

In conclusion, the VOYAGER PAD trial is the largest randomized trial concerning antithrombotic therapy after peripheral revascularization.  In line with the results from the COMPASS trial cardiovascular events were significantly reduced by combination of Aspirin and low-dose Rivaroxaban. In particular acute limb ischemia after peripheral revascularization could be decreased using the dual pathway inhibition with low dose Rivaroxaban and Aspirin 100 mg. Bleeding risk must be kept in mind especially in the first months of treatment, but for the long time beneficial effects overweigh the initial risk in most patients.