Highlights from

ACC 2020

Together with World Congress of Cardiology

Virtual 28 - 30 March 2020

Subgroup analysis VOYAGER PAD

A subgroup analysis of VOYAGER PAD demonstrated that adding clopidogrel to rivaroxaban and aspirin in patients with symptomatic peripheral artery disease (PAD) with lower extremity peripheral revascularisation increases their risk of major bleeding and does not add clinical benefit. Thus, clopidogrel exposure along with aspirin and rivaroxaban should be minimised or avoided to reduce this risk in this population [1].

This subgroup analysis of VOYAGER PAD, presented by Prof. William Hiatt (University of Colorado, USA), aimed to evaluate whether efficacy and safety of rivaroxaban were consistent regardless of background clopidogrel use in symptomatic PAD patients undergoing lower extremity revascularisation who were randomised to either rivaroxaban 2.5 mg twice daily and aspirin or aspirin alone. The secondary objective was to explore temporal patterns of bleeding in relationship to exposure and duration of clopidogrel.

Results of the subgroup analysis suggested that the benefit of rivaroxaban + aspirin versus aspirin alone in patients with symptomatic PAD undergoing revascularisation is consistent, regardless of background clopidogrel. The primary efficacy endpoint had a hazard ratio ~0.85 with rivaroxaban, regardless of clopidogrel with number needed to treat (NNT) <50 with or without clopidogrel. The safety of rivaroxaban + aspirin versus aspirin alone was also consistent regardless of background clopidogrel. The principal safety outcome of Thrombolysis in Myocardial Infarction (TIMI) major bleeding had a hazard ratio of ~1.3 to 1.5 regardless of clopidogrel, with number needed to harm (NNH) >90 with or without clopidogrel. Exposure to clopidogrel was associated with higher rates of bleeding overall, particularly with longer durations (e.g. > 30 days).

  1. Hiatt WR, et al. The Benefit And Risk Of Rivaroxaban Plus Aspirin In Patients With Peripheral Artery Disease After Lower Extremity Revascularization (ler) With And Without Concomitant Clopidogrel: A Key Subgroup Analysis From VOYAGER-PAD. Abstract 406-13. ACC/WCC 28-30 March 2020.

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