Department of Medicine, Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Ontario, Canada.
Department of Medicine, Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Ontario, Canada; CISSS du Bas-St-Laurent, Quebec, Canada.
J Am Coll Cardiol. 2018 May 22;71(20):2306-2315. doi: 10.1016/j.jacc.2018.03.008. Epub 2018 Mar 11.
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.
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.
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.
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).
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).
下肢外周动脉疾病（PAD）患者发生主要不良心血管事件（MACE）和主要不良肢体事件（MALE）的风险增加。关于经历 MALE 后患者预后的信息有限。
在下肢 PAD 患者中，本研究调查：1）与无 MALE 经历的 PAD 患者相比，首次发生 MALE 后住院、MACE、截肢和死亡是否更高；2）与单独使用阿司匹林相比，使用低剂量利伐沙班和阿司匹林治疗对 MALE、外周血管介入和所有外周血管结局的影响，中位随访时间为 21 个月。
我们分析了 6391 例下肢 PAD 患者在 COMPASS（抗凝策略在人群中的心血管结局）试验中的结局。COMPASS 是一项比较低剂量利伐沙班和阿司匹林联合治疗与单独使用阿司匹林的随机、双盲、安慰剂对照研究。MALE 定义为严重肢体缺血导致干预或大血管截肢。
共有 128 例患者发生 MALE 事件。发生 MALE 后，1 年内再次住院的累积风险为 61.5%；血管截肢为 20.5%；死亡为 8.3%；MACE 为 3.7%。MALE 指数事件显著增加了随后发生住院治疗（风险比[HR]：7.21；p<0.0001）、随后发生截肢（HR：197.5；p<0.0001）和死亡（HR：3.23；p<0.001）的风险。与单独使用阿司匹林相比，每日两次口服 2.5mg 利伐沙班联合阿司匹林治疗降低了 43%的 MALE 发生率（p=0.01）、总血管截肢率 58%（p=0.01）、外周血管介入率 24%（p=0.03）和所有外周血管结局 24%（p=0.02）。
在下肢 PAD 患者中，MALE 的发生与不良预后相关，因此预防这种情况至关重要。每日两次口服 2.5mg 利伐沙班联合阿司匹林治疗显著降低了 MALE 及相关并发症的发生率，这种联合治疗应被视为 PAD 患者的重要治疗选择。（抗凝策略在人群中的心血管结局[COMPASS]；NCT01776424）。
