New long-term data from the SAFE-PAD (Safety assessment of femoropopliteal endovascular treatment with paclitaxel-coated devices) study were presented today as late-breaking clinical research at the Society for Cardiovascular Angiography & Interventions (SCAI) 2022 Scientific Sessions (May 19–22) in Atlanta. The analysis found no meaningful difference in survival between patients treated with a paclitaxel drug-coated device and those treated with a non-drug-coated device for up to six years after the index procedure, regardless of the patient’s mortality risk and device type.
The SAFE-PAD study was created in collaboration with the Food & Drug Administration (FDA) to evaluate the long-term safety of paclitaxel-coated devices compared with non-paclitaxel-coated devices for femoropopliteal artery revascularization among a broad, real-world population of patients with peripheral arterial disease (PAD).
The study included Medicare beneficiaries ≥66 years treated with a drug-coated device or non-drug-coated device from April 1, 2015, to Dec. 31, 2018. Non-inferiority between devices was evaluated for mortality through 21 July 2021. A number of prespecified subgroups, including a cohort at the lowest risk of mortality defined as those aged 66–70 with no chronic limb-threatening ischemia (CLTI) and ≤2 comorbidities, were evaluated.
“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,” said Eric Secemsky, MD, from Beth Israel Deaconess Medical Center, Boston. “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 findings presented today add to the growing body of evidence showing these devices are safe for use.”
Of 168,553 patients, 70,584 (41.9%) were treated with a drug-coated device. Median follow-up was 3.52 years. The weighted cumulative incidence of mortality at 6.3 years was 63.6% with non-drug-coated devices and 62.5% with drug-coated devices (p<0.0001). Findings were consistent among all subgroups. In particular, there was no difference in risk among those at lowest risk of mortality (n=4,212; weighted hazard ratio [HR], 0.98; 95% confidence interval [CI], 0.87–1.10).
Researchers note there will in future be several reports from the SAFE-PAD study, with a final report published in the next two years.