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.
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