Department of Vascular Medicine Research Group GermanVasc University Medical Center Hamburg-Eppendorf Hamburg Germany.
BARMER Wuppertal Germany.
J Am Heart Assoc. 2020 Nov 17;9(22):e018338. doi: 10.1161/JAHA.120.018338. Epub 2020 Nov 13.
Background An increasing number of patients with a peripheral arterial occlusive disease were put on statins during the past years. This study assessed whether statin therapy was effective and safe for these new users. Methods and Results Using health insurance claims data from Germany's second-largest insurance fund, BARMER, we identified patients with peripheral arterial occlusive disease who had index revascularization between 2008 and 2018 without prior statin therapy. We compared patients with and without statin therapy in addition to antithrombotics during the first quarter after discharge (new users versus nonusers). Outcomes were all-cause mortality, cardiovascular events, and incident major amputation for effectiveness and incident diabetes mellitus and incident myopathy for safety. Propensity score matching was used to balance the study groups. All analyses were stratified into patients with chronic limb-threatening ischemia and intermittent claudication. A total of 22 208 patients (mean age 71.1 years and 50.3% women) were included in the study. In 10 922 matched patients, statin initiation was associated with lower all-cause mortality (chronic limb-threatening ischemia: hazard ratio [HR], 0.75 [95% CI, 0.68-0.84]; intermittent claudication: HR, 0.80 [95% CI, 0.70-0.92]), lower risk of major amputation in patients with chronic limb-threatening ischemia (HR, 0.73; 95% CI, 0.58-0.93) and lower risk of cardiovascular events (hazard ratio, 0.80; 95% CI, 0.70-0.92) in patients with intermittent claudication during 5 years of follow-up. Safety outcomes did not differ among the study groups. Conclusions Initiating statin therapy in patients with peripheral arterial occlusive disease after index revascularization is efficient and safe with an effect size comparable to earlier studies. Awareness campaigns for evidence-based optimal pharmacological treatment among patients are recommended.
在过去几年中，越来越多的外周动脉阻塞性疾病患者开始接受他汀类药物治疗。本研究评估了他汀类药物治疗对外周动脉阻塞性疾病新使用者的有效性和安全性。
我们使用德国第二大保险公司 BARMER 的健康保险索赔数据，确定了 2008 年至 2018 年间接受外周动脉再血管化治疗但此前未接受他汀类药物治疗的外周动脉阻塞性疾病患者。我们比较了出院后第一个季度（新使用者与非使用者）加用抗血栓药物时加用和不加用他汀类药物的患者。有效性的结局指标为全因死亡率、心血管事件和主要截肢的发生，安全性的结局指标为新发糖尿病和新发肌病。采用倾向评分匹配来平衡研究组。所有分析均按慢性肢体威胁性缺血和间歇性跛行患者进行分层。共纳入 22208 例患者（平均年龄 71.1 岁，女性占 50.3%）。在 10922 例匹配患者中，他汀类药物的起始治疗与全因死亡率降低相关（慢性肢体威胁性缺血：风险比 [HR]，0.75 [95%置信区间，0.68-0.84]；间歇性跛行：HR，0.80 [95%置信区间，0.70-0.92]），慢性肢体威胁性缺血患者的主要截肢风险降低（HR，0.73；95%置信区间，0.58-0.93），间歇性跛行患者的心血管事件风险降低（HR，0.80；95%置信区间，0.70-0.92），随访 5 年。两组安全性结局无差异。
在外周动脉阻塞性疾病患者索引血管重建后开始他汀类药物治疗是有效且安全的，其疗效与早期研究相当。建议针对患者开展基于证据的最佳药物治疗的宣传活动。
