No Evidence That Drug-Coated Devices Associate With Long-Term Harm

Surgeons performing open heart surgery in modern operation room
A study is being conducted to determine long-term outcomes in patients that have received drug-coated device for femoropopliteal artery revascularization.

An updated report found that drug-coated devices (DCDs) remained non-inferior to non-drug-coated devices (NDCDs) at up to 6.3 years. These findings were published in Circulation: Cardiovascular Interventions.

The Safety Assessment of Femoropopliteal Endovascular treatment with PAclitaxel-coated Devices (SAF-PAD) ( identifier: NCT04496544) study was designed to evaluate long-term, longitudinal DCD outcomes. All Medicare fee-for-service beneficiaries who underwent femoropopliteal artery revascularization between 2015 and 2018 with DCDs or NDCDs were evaluated for all-cause mortality through July 2021. An inverse probability of treatment weighting approach was used to balance cohort differences. Noninferiority of DCD was defined as 5% relative increase in mortality compared with NDCD.

The study cohort comprised 168,553 patients, among whom 41.9% received a DCD. The patients were aged mean 77.0±7.6 years, 44.9% were women, 81.9% were White, 80.3% had hypertension, 70.3% hyperlipidemia, 65.3% ischemic heart disease, and 51.0% diabetes. Prior to weighting, patients who received DCDs were more likely to receive atherectomy.

At a median follow-up of 3.52 (maximum, 6.31) years, the weighted mortality rate was 63.6% for NDCDs and 62.5% for DCDs (hazard ratio [HR], 0.98; 95% CI, 0.96-0.99; P <.0001).

In a subgroup analysis, no trends were observed among low-risk patients, patients with few comorbidities, inpatients, outpatients, or patients who received stents. DCD associated with decreased mortality risk among patients treated with balloon angioplasty alone (HR, 0.97; 95% CI, 0.95-0.99).

The major limitation of this updated analysis was the age of the study population due to sourcing data from Medicare claims. These findings may not be generalizable to a younger patient population.

The study authors concluded that these data indicated that DCDs remained non-inferior to NDCDs with respect to long-term survival. These data do not confirm that DCDs are potentially harmful and are in line with results of the SWEDEPAD and VOYAGER-PAD studies which did not find that DCDs were associated with harm.

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.


Secemsky EA, Song Y, Schermerhorn M, Yeh RW. Update from the Safety Assessment of Femoropopliteal Endovascular treatment with PAclitaxel-coated Devices (SAFE-PAD) study. Circ Cardiovasc Interv. Published online May 20, 2022. doi:10.1161/CIRCINTERVENTIONS.122.012074