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Major Adverse Limb Events and Mortality in Patients With Peripheral Artery Disease: The COMPASS Trial
Sonia S Anand1, Francois Caron2, John W Eikelboom1
1Department of Medicine, Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Ontario, Canada.
Insights
Major adverse limb events (MALE) in peripheral artery disease (PAD) patients indicate a poor prognosis. Combining low-dose rivaroxaban with aspirin significantly reduces MALE incidence and related complications in PAD patients.
Area of Science:
- Vascular Medicine
- Cardiovascular Research
- Clinical Trials
Background:
- Patients with lower extremity peripheral artery disease (PAD) face elevated risks of major adverse cardiovascular events (MACE) and major adverse limb events (MALE).
- Prognostic data for patients experiencing MALE is notably limited, highlighting a critical knowledge gap.
Purpose of the Study:
- To investigate the prognosis of PAD patients following a MALE, comparing outcomes like hospitalizations, MACE, amputations, and deaths to those without MALE.
- To evaluate the efficacy of low-dose rivaroxaban plus aspirin versus aspirin alone in preventing MALE, peripheral vascular interventions, and other vascular outcomes.
Main Methods:
- Analysis of 6,391 patients with lower extremity PAD from the randomized, double-blind COMPASS trial.
- MALE was defined as severe limb ischemia necessitating intervention or major vascular amputation.
Main Results:
- The index MALE event significantly increased risks for subsequent hospitalizations (HR: 7.21), amputations (HR: 197.5), and death (HR: 3.23).
- The combination of rivaroxaban 2.5 mg twice daily and aspirin reduced MALE incidence by 43% (p=0.01), amputations by 58% (p=0.01), and peripheral vascular interventions by 24% (p=0.03) compared to aspirin alone.
Conclusions:
- MALE development in PAD patients is linked to a poor prognosis, underscoring the critical importance of preventative strategies.
- The combination of rivaroxaban and aspirin demonstrates significant efficacy in lowering MALE and related complications, warranting consideration as a key therapy for PAD patients.
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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