PERIPHERAL vascular intervention is used to treat symptomatic peripheral artery disease (PAD), a condition that has a prevalence of 6.5 million people in the USA. Paclitaxel-coated peripheral devices were previously considered the gold standard when treating these patients. However, these devices have recently been associated with increased mortality, leading to concerns about their safety. The SAFE-PAD trial was conducted to assess the long-term safety of paclitaxel-coated peripheral devices compared with non-paclitaxel-coated devices for femoropopliteal endovascular treatment. Results were presented at the Society for Cardiovascular Angiography and Interventions (SCAI) 2022 Scientific Sessions, 19th–22nd May 2022.
Eric Secemsky, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA, highlighted the objective of the study: “Our goal is to give patients the most durable treatment possible that will keep them out of the hospital and living their lives. Patients with PAD tend to be of lower socioeconomic status, more likely to be underserved minority populations, and often need to travel long distances or take time off work to seek treatment.” Secemsky added: “Not having access to important treatment options known to reduce the risk of repeat intervention can have a substantial influence on our PAD patients, ultimately impacting their outcomes and quality of life.”
The study enrolled Medicare beneficiaries aged 66 years or older, treated with either a drug-coated device or non-drug-coated device between 1st April 2015 and 31st December 2018. The researchers also analysed a number of prespecified subgroups, including low-risk cohorts. The primary outcome was all-cause mortality.
Of 168,553 patients, approximately 42% were treated with a drug-coated device. After weighting, the cumulative incidence of mortality at 6.3 years was 63.6% and 62.5% with non-drug-coated and drug-coated devices, respectively. This difference was shown to be statistically significant (p<0.0001). Similar results were observed among all the subgroups. Commenting on the relevance of the research results, Secemsky said: “The findings presented today add to the growing body of evidence showing these devices are safe for use.”