Rivaroxaban regimen beneficial after revascularisation for claudication

A regimen of rivaroxaban plus low-dose aspirin showed consistent benefits for patients with claudication who underwent lower-extremity revascularisation (LER) and patients with critical limb-threatening ischaemia (CLTI) that were subjected to LER. Thus, rivaroxaban plus aspirin is a valid adjunctive therapy option for patients with claudication after LER [1].

The VOYAGER PAD trial (NCT02504216) showed a significant reduction of major cardiovascular events in patients with CLTI or claudication after LER who were treated with rivaroxaban compared with placebo (HR 0.86; P=0.0086) [2]. The current subanalysis analysed the consistency of these results across the different patient conditions (i.e. claudication or CLTI). Furthermore, the study described haemodynamic and patient-reported outcomes, and the risk profile of major adverse events in patients with claudication after LER. In total, 5,031 patients with claudication were assessed. The primary outcome was a composite score of major cardiovascular events, and the 3-year results were presented by Prof. Marc Bonaca (University of Colorado, CO, USA).

The primary endpoint was met: there was a significant risk reduction of major cardiovascular events in patients with claudication who were treated with rivaroxaban after LER (HR 0.86) compared with placebo. In addition, no interaction effect was observed between patients with claudication and patients with CLTI who underwent LER (P=0.94; see Figure).

Figure: Primary efficacy endpoint of rivaroxaban in claudication and CLTI



ARR, absolute risk reduction; CI, confidence interval; CLI, critical limb-threatening ischaemia; HR, hazard ratio; NNT number needed to treat.

Patients with claudication (both rivaroxaban and placebo pooled) showed an improved walking function 1 month after LER. Pre-LER, 38% of participants indicated in the Walking Impairment Questionnaire that they were able to walk 2 blocks compared with 82% of participants post-LER. This effect was durable over approximately 2–3 years regardless of surgical approach.

At 3 years after LER, the unplanned index limb revascularisation rate was 22%. In addition, major adverse limb events occurred with a rate of 8.5% per 3 years, and thus a high risk in patients with claudication following LER. Rivaroxaban consistently reduced these risks in those with claudication and CLI.

A risk-benefit analysis of rivaroxaban after LER for patients with claudication showed that a net value of 22 major cardiovascular events was prevented by the treatment at the expense of 5 major bleeding events. Moreover, a net value of 16 unplanned limb revascularisations was prevented by the treatment.

 

1. 
   
   1. Bonaca MP, et al. Efficacy and Safety of Rivaroxaban in Patients with PAD Undergoing Lower Extremity Revascularization for Claudication. FS06, AHA Scientific Sessions 2021, 13–15 November.
   2. Bonaca MP, et al. N Engl J Med 2020;382:1994–2004.

 

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Posted on 14 January, 20227 February, 2024