SAFE-PAD: No Difference in Mortality with Paclitaxel-Coated Devices Up to 6 Years Out

Eric Secemsky, MD

New 6-year data from the SAFE-PAD study presented at the Society for Cardiovascular Angiography and Interventions (SCAI) 2022 Scientific Sessions outline the safety of paclitaxel drug-coated devices compared with non-drug coated devices, with results suggesting no difference in survival was observed between either group up to 6 years after the index procedure.

Created in collaboration with the US Food and Drug Administration to evaluate the long-term safety of paclitaxel-coated devices, results of the SAFE-PAD trial provide evidence of the devices’ safety for femoropopliteal artery revascularization among a real-world population of patients with peripheral artery disease (PAD).

“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 study presenter Eric Secemsky, MD, director of Vascular Intervention at Beth Israel Deaconess Medical Center, Section Head of Interventional Cardiology and Vascular Research at the Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, in a statement.

Although paclitaxel drug-coated devices have increased in popularity since the approval of the first paclitaxel-coated device in 2012, more recent data has cast doubt on the potential long-term safety and efficacy of these devices, with a 2018 meta-analysis suggesting use may increase mortality. An observational cohort study of Medicare fee-for-service beneficiaries who underwent femoropopliteal artery revascularization with either a drug-coated device or noncoated device, SAFE-PAD enrolled patients aged 66 years or older treated with drug-coated devices or non-drug coated devices beginning in April 2015.

With the intent of assessing whether drug-coated devices were noninferior to non-drug coated devices for all-cause mortality, SAFE-PAD was designed to evaluate risk of mortality with these devices using inverse probability of treatment weighting, with multiple subgroup analyses planned to estimate differences based on risk category, comorbidities, device type, PAD severity, and procedure location.

Overall, 168,553 patients were identified for inclusion in the investigators’ analyses. This cohort included 70,584 rated with a drug-coated device and 97,969 treated with a non-drug-coated device. The overall cohort had a mean age of 77±8 years, 45% were female, 82% were White, 48% were inpatients, 47% presented with critical limb ischemia, 51% had diabetes mellitus, and 65% had ischemic heart disease. Investigators pointed out the median follow-up time was 3.52 (IQR, 1.56-4.70) years, with the maximum follow-up being 6.31 years.

In their primary outcome analyses, which included data from more than 32,000 patients followed for at least 5 years, results indicated there was no significant difference in risk of mortality between those who received a paclitaxel-coated device and those receiving a non-drug-coated device, with weighted cumulative incidences of mortality of 63.6% with non-drug-coated devices and 62.5% with drug-coated devices (P <.0001). Investigators pointed out similar results were observed in subgroups analyses, with no significant increase in risk of mortality observed among those in the low-risk cohort (HR, 0.98 [95% CI, 0.87-1.10]), based on number of total comorbidities (HR, 0.97 [95% CI, 0.94-0.99]), in those with critical limb ischemia (HR, 0.96 [95% CI, 0.95-0.98]), in those without critical limb ischemic (HR, 0.98 [95% CI, 0.96-1.00]), and based on inpatient (HR, 0.98 [95% CI, 0.96-1.00]) or outpatient procedure index (HR, 0.96 [95% CI, 0.94-0.98]).

“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,” Secemsky added.

This study, “Update from the Safety Assessment of Femoropopliteal Endovascular treatment with PAclitaxel-coated Devices (SAFE-PAD) Study,” was presented at SCAI 2022.