Peripheral artery disease (PAD) is a common condition with increasing prevalence domestically and worldwide. Patients with PAD have a poor prognosis, as PAD is associated with high rates of myocardial infarction, ischemic stroke, and cardiovascular disease death. The primary symptom of PAD, claudication, significantly reduces quality of life and functional status and is associated with depression.

In addition to several advances in medications for PAD over the last decade, endovascular device therapy has seen a significant breakthrough in the form of paclitaxel-coated devices (PCDs), which significantly reduce rates of restenosis relative to non-PCDs, a finding which has been demonstrated in numerous randomized clinical trials. After their introduction to the market in 2012 (paclitaxel-eluting stents) and 2014 (paclitaxel-coated balloons) their use surged as they replaced non-PCDs and were designated the first-line endovascular therapy by society guidelines.

This trend was abruptly reversed, however, after a meta-analysis of summary-level data was published in December of 2018 that reported an elevated mortality associated with PCDs compared with non-PCDs 2–5 years after treatment. This meta-analysis has been criticized for considerable methodological flaws. The Food and Drug Administration conducted a review and concluded that insufficient data existed to make a definitive statement regarding the safety of PCDs. They called for restriction of the use of PCDs to the highest-risk patient populations. At the same time, the FDA deemed pursuing new RCTs to better evaluate PCDs unfeasible due to the high numbers of patients and long follow-up time that would be required.

In this setting, real-world data emerged as a powerful source of information for the evaluation of PCDs. Real-world data offers advantages over randomized-controlled trials including expeditious access to and analysis of data and the availability of large numbers of patients. Several retrospective observational studies demonstrate no difference in long-term all-cause mortality in patients treated with PCDs relative to those treated with non-PCDs. This paclitaxel controversy has illustrated the critical role that real-world data is assuming in long-term safety monitoring of medical devices.

外周动脉疾病（PAD）是一种常见疾病，在国内外的患病率不断增加。 PAD 患者预后较差，因为 PAD 与心肌梗塞、缺血性中风和心血管疾病死亡率高相关。 PAD 的主要症状是跛行，它会显着降低生活质量和功能状态，并与抑郁症相关。

除了过去十年中 PAD 药物治疗取得的几项进展外，血管内装置治疗在紫杉醇涂层装置 (PCD) 方面也取得了重大突破，与非 PCD 相比，它显着降低了再狭窄率，这一发现已已在众多随机临床试验中得到证实。 2012 年（紫杉醇洗脱支架）和 2014 年（紫杉醇涂层球囊）引入市场后，其使用量激增，取代了非 PCD，并被协会指南指定为一线血管内治疗。

然而，2018 年 12 月发布的汇总数据荟萃分析显示，与非 PCD 相比，治疗后 2-5 年 PCD 相关死亡率升高，这一趋势突然逆转。这种荟萃分析因存在相当大的方法论缺陷而受到批评。美国食品和药物管理局进行了审查，得出的结论是，没有足够的数据来对 PCD 的安全性做出明确的声明。他们呼吁限制高危患者群体使用 PCD。与此同时，FDA 认为寻求新的随机对照试验来更好地评估 PCD 是不可行的，因为这需要大量的患者和较长的随访时间。

在这种背景下，真实世界数据成为评估 PCD 的强大信息来源。真实世界数据比随机对照试验具有优势，包括快速获取和分析数据以及大量患者的可用性。几项回顾性观察研究表明，与接受非 PCD 治疗的患者相比，接受 PCD 治疗的患者的长期全因死亡率没有差异。紫杉醇的这场争议说明了现实世界数据在医疗器械的长期安全监测中所发挥的关键作用。