Department of Clinical, Internal Medicine, Anesthesiology and Cardiovascular Sciences, Sapienza University of Rome, Italy.
Department of Economics and Finance, University of Rome "Tor Vergata", Rome, Italy.
Thromb Haemost. 2020 May;120(5):866-875. doi: 10.1055/s-0040-1709711. Epub 2020 May 5.
Statins are guidelines recommended in patients with peripheral artery disease (PAD) for the prevention of cardiovascular (CV) events. Comprehensive meta-data on the impact of statins on major adverse limb events (MALE) in PAD patients are lacking. We examined the association of statin use with MALE in patients with PAD.
We performed a systematic review (registered at PROSPERO: number CRD42019137111) and metanalysis of studies retrieved from PubMed (via MEDLINE) and Cochrane (CENTRAL) databases addressing the impact of statin on MALE including amputation and graft occlusion/revascularization. Secondary endpoints were all-cause death, composite CV endpoints, CV death, and stroke.
We included 51 studies with 138,060 PAD patients, of whom 48,459 (35.1%) were treated with statins. The analysis included 2 randomized controlled trials, 20 prospective, and 29 retrospective studies. Overall, 11,396 MALE events, 21,624 deaths, 4,852 composite CV endpoints, 4,609 CV deaths, and 860 strokes were used for the analysis. Statins reduced MALE incidence by 30% (pooled hazard ratio [HR]: 0.702; 95% confidence interval [CI]: 0.605-0.815) and amputations by 35% (HR: 0.654; 95% CI: 0.522-0.819), all-cause mortality by 39% (pooled HR: 0.608, 95% CI: 0.543-0.680), CV death by 41% (HR: 0.594; 95% CI: 0.455-0.777), composite CV endpoints by 34% (pooled HR: 0.662; 95% CI: 0.591-0.741) and ischemic stroke by 28% (pooled HR: 0.718; 95% CI: 0.620-0.831).
Statins reduce the incidence of MALE, all-cause, and CV mortality in patients with PAD. In PAD, a high proportion of MALE events and deaths could be prevented by implementing a statin prescription in this patient population.
他汀类药物是外周动脉疾病（PAD）患者预防心血管（CV）事件的指南推荐药物。目前缺乏他汀类药物对 PAD 患者主要不良肢体事件（MALE）影响的综合元数据。我们研究了他汀类药物使用与 PAD 患者 MALE 的相关性。
我们进行了一项系统评价（在 PROSPERO 注册：编号 CRD42019137111）和荟萃分析，检索了来自 PubMed（通过 MEDLINE）和 Cochrane（CENTRAL）数据库的研究，这些研究涉及他汀类药物对包括截肢和移植物闭塞/再血管化在内的 MALE 的影响。次要终点是全因死亡、复合 CV 终点、CV 死亡和卒中。
我们纳入了 51 项研究，共纳入 138060 例 PAD 患者，其中 48459 例（35.1%）接受了他汀类药物治疗。分析包括 2 项随机对照试验、20 项前瞻性研究和 29 项回顾性研究。总体而言，分析中使用了 11396 例 MALE 事件、21624 例死亡、4852 例复合 CV 终点、4609 例 CV 死亡和 860 例卒中。他汀类药物可使 MALE 发生率降低 30%（合并风险比[HR]：0.702；95%置信区间[CI]：0.605-0.815），截肢发生率降低 35%（HR：0.654；95%CI：0.522-0.819），全因死亡率降低 39%（合并 HR：0.608，95%CI：0.543-0.680），CV 死亡率降低 41%（HR：0.594；95%CI：0.455-0.777），复合 CV 终点降低 34%（合并 HR：0.662；95%CI：0.591-0.741），缺血性卒中等 28%（合并 HR：0.718；95%CI：0.620-0.831）。
他汀类药物可降低 PAD 患者 MALE、全因和 CV 死亡率。在 PAD 患者中，通过在该患者人群中开具他汀类药物处方，可以预防很大比例的 MALE 事件和死亡。
