Key result
Rivaroxaban plus aspirin cuts major adverse limb events ~43% vs. aspirin alone in PAD.
Why the study?
There is limited information on the prognosis of patients with lower extremity PAD who experience major adverse limb events (MALE) and the impact of treatment with low-dose rivaroxaban and aspirin on these outcomes.
Does the combination of low-dose rivaroxaban and aspirin reduce the incidence of major adverse limb events compared with aspirin alone in patients with lower extremity peripheral artery disease?
RCT (n=6,391)
double-blind
randomized
Does the combination of low-dose rivaroxaban and aspirin reduce the incidence of major adverse limb events compared with aspirin alone in patients with lower extremity peripheral artery disease?
Effect estimate: 43% reduction
p-value: p=0.01
In patients with lower extremity peripheral artery disease, the addition of low-dose rivaroxaban to aspirin significantly reduces the risk of major adverse limb events and amputations.
BACKGROUND: Patients with lower extremity peripheral artery disease (PAD) are at increased risk of major adverse cardiovascular events (MACE) and major adverse limb events (MALE). There is limited information on the prognosis of patients who experience MALE. OBJECTIVES: Among participants with lower extremity PAD, this study investigated: 1) if hospitalizations, MACE, amputations, and deaths are higher after the first episode of MALE compared with patients with PAD who do not experience MALE; and 2) the impact of treatment with low-dose rivaroxaban and aspirin compared with aspirin alone on the incidence of MALE, peripheral vascular interventions, and all peripheral vascular outcomes over a median follow-up of 21 months. METHODS: We analyzed outcomes in 6,391 patients with lower extremity PAD who were enrolled in the COMPASS (Cardiovascular Outcomes for People Using Anticoagulation Strategies) trial. COMPASS was a randomized, double-blind placebo-controlled study of low-dose rivaroxaban and aspirin combination or rivaroxaban alone compared with aspirin alone. MALE was defined as severe limb ischemia leading to an intervention or major vascular amputation. RESULTS: A total of 128 patients experienced an incident of MALE. After MALE, the 1-year cumulative risk of a subsequent hospitalization was 61.5%; for vascular amputations, it was 20.5%; for death, it was 8.3%; and for MACE, it was 3.7%. The MALE index event significantly increased the risk of experiencing subsequent hospitalizations (hazard ratio [HR]: 7.21; p < 0.0001), subsequent amputations (HR: 197.5; p < 0.0001), and death (HR: 3.23; p < 0.001). Compared with aspirin alone, the combination of rivaroxaban 2.5 mg twice daily and aspirin lowered the incidence of MALE by 43% (p = 0.01), total vascular amputations by 58% (p = 0.01), peripheral vascular interventions by 24% (p = 0.03), and all peripheral vascular outcomes by 24% (p = 0.02). CONCLUSIONS: Among individuals with lower extremity PAD, the development of MALE is associated with a poor prognosis, making prevention of this condition of utmost importance. The combination of rivaroxaban 2.5 mg twice daily and aspirin significantly lowered the incidence of MALE and the related complications, and this combination should be considered as an important therapy for patients with PAD. (Cardiovascular Outcomes for People Using Anticoagulation Strategies [COMPASS]; NCT01776424).
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Anand et al. (2018) conducted an RCT in lower extremity peripheral artery disease (PAD) (n=6,391). low-dose rivaroxaban and aspirin vs. aspirin alone was evaluated on incidence of major adverse limb events (MALE) (43% reduction, p=0.01). Compared with aspirin alone, rivaroxaban 2.5 mg twice daily plus aspirin lowered the incidence of major adverse limb events by 43% (p=0.01) in patients with peripheral artery disease.
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