Rivaroxaban reduces total ischaemic events after peripheral artery revascularisation

An analysis of the VOYAGER PAD trial showed that rivaroxaban (2.5 mg twice daily) reduced both first and subsequent adverse limb and cardiovascular events in patients with peripheral artery disease (PAD) and should therefore be considered as adjunctive therapy following lower extremity revascularisation (LER) [1,2].

Patients with PAD are known to have an elevated risk (1 in 5) of major adverse limb events (MALE) (i.e. acute limb ischaemia or major limb amputation due to a vascular cause) and major adverse cardiovascular events (MACE) following LER despite antiplatelet therapy. The previously published VOYAGER PAD (NCT02504216) results demonstrated that the direct oral anticoagulant rivaroxaban combined with usual care lowered the risk of first events [3].

VOYAGER PAD randomised 6,564 participants with PAD who had recently undergone LER to receive either 2.5 mg rivaroxaban twice daily (n=3,286) or a matching placebo (n=3,278) in addition to usual care. The primary outcome measure of the main study was time to first MALE or MACE. Rivaroxaban reduced the incidence of first events by 15%. A pre-specified analysis aimed to investigate the number of both first and total MALE and MACE in patients with PAD who had undergone LER [1].

Dr Rupert Bauersachs (Klinikum Darmstadt, Germany) presented the results of this pre-specified analysis. The primary endpoint included MALE and MACE as well as additional vascular events (including venous thromboembolism and peripheral revascularisations). A total of 4,714 first and subsequent events occurred among the entire study population in VOYAGER PAD. Of the 1,614 first events, 745 occurred in the rivaroxaban group and 869 in the placebo group. Of the 3,100 remaining subsequent events, 1,659 occurred in the placebo group compared with 1,441 in the rivaroxaban group. Rivaroxaban reduced both total primary endpoint events (HR 0.86; 95% CI 0.75–0.98; P=0.02) and total vascular events (HR 0.86; 95% CI 0.79–0.95; P=0.003), equating to an estimated avoidance of 4.4 primary and 12.5 vascular events per 100 participants over 3 years (see Figure).

Figure: Accrual of total primary and total vascular events per 100 patients [1]



Figure kindly provided by Prof. Bonaca.

Dr Bauersachs concluded that aspirin plus 2.5 mg rivaroxaban given twice daily versus aspirin alone to patients with PAD who have undergone LER reduced both first and subsequent MALE and MACE; this benefit is even greater when considered in the context of recurrent events. In light of these favourable data, the researchers recommended that rivaroxaban given with aspirin should be considered adjunctive therapy in this patient population to prevent first and subsequent MALE and MACE.

1. 
   
   1. Bauersachs RM. Reductions in Total Ischaemic Events with Rivaroxaban in Patients with Symptomatic Pad after Revascularization: The VOYAGER PAD Trial. Abstract 406-13, ACC 2021 Scientific Session, 15–17 May.
   2. Bauersachs RM, et al. J. Am. Coll. Cardiol. 2021;May 16.
   3. Bonaca MP, et al. N Engl J Med 2020;382:1994–2004.

 

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Posted on 9 July, 202129 July, 2021