SAFE-PAD Long-Term Data Shows No Increased Mortality With Paclitaxel Devices Versus Non–Drug-Coated Devices

May 20, 2022—New long-term data were presented from the Safety Assessment of Femoropopliteal Endovascular Treatment With Paclitaxel-coated Devices (SAFE-PAD) study.

The analysis found no meaningful difference in survival between patients treated with a paclitaxel drug-coated device (DCD) and those treated with a non–drug-coated device (NDCD) for up to 6 years after the index procedure, regardless of the patient’s mortality risk and device type.

The SAFE-PAD data were presented as late-breaking clinical research at the Society for Cardiovascular Angiography & Interventions (SCAI) 2022 scientific sessions held May 19-22 in Atlanta, Georgia.

As noted in the SCAI press release, the SAFE-PAD study was created in collaboration with the 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 artery disease (PAD). The Principal Investigators of SAFE-PAD are Eric A. Secemsky, MD, and Robert W. Weh, MD, of Beth Israel Deaconess Medical Center in Boston, Massachusetts.

The study was initiated in the wake of the meta-analysis by Konstantinos Katsanos, MD, et al published online in December 2018 in Journal of the American Heart Association that found that paclitaxel-coated peripheral devices were associated with increased mortality. The meta-analysis raised questions about the safety of these devices.

The SAFE-PAD study data presented at SCAI 2022 included Medicare beneficiaries ≥ 66 years treated with a DCD or an NDCD from April 1, 2015, to December 31, 2018. Noninferiority between devices was evaluated for mortality through July 21, 2021. The investigators evaluated a number of prespecified subgroups, including a cohort at the lowest risk of mortality, defined as patients aged 66 to 70 years with no critical limb ischemia and two or fewer comorbidities.

Of 168,553 patients, 70,584 (41.9%) were treated with a DCD. Median follow-up was 3.52 years.

As summarized in the SCAI press release, the SAFE-PAD study found:

• The weighted cumulative incidence of mortality at 6.3 years was 63.6% with NDCDs versus 62.5% with DCDs (P < .0001). Findings were consistent among all subgroups.
• There was no difference in risk among those patients at lowest risk of mortality (n = 4,212; weighted hazard ratio, 0.98; 95% CI, 0.87-1.10).

There will be several reports from the SAFE-PAD study in the future and a final report published in the next 2 years, noted the investigators in the SCAI press release.

Dr. Secemsky stated in the SCAI press release, “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. 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.”

Dr. Secemsky is Director of Vascular Intervention at Beth Israel Deaconess Medical Center and Section Head of Interventional Cardiology and Vascular Research at the Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology and Assistant Professor of Medicine at Harvard Medical School in Boston, Massachusetts.