Paclitaxel-coated devices in femoropopliteal artery revascularization: Mortality risk fears unfounded?

Among patients undergoing femoropopliteal artery revascularization, mortality risk was not affected regardless of whether they were treated with drug-coated devices (DCDs) or non–drug-coated devices (NDCDs), according to updated results of the SAFE-PAD* study presented at SCAI 2022.

“In this report from SAFE-PAD, there remained no evidence of harm associated with DCDs,” noted study author Dr Eric Secemsky, Director of Vascular Intervention at the Beth Israel Deaconess Medical Center and Assistant Professor at Harvard Medical School, Boston, Massachusetts, US, and co-authors.

“DCDs were non-inferior to NDCDs in respect to mortality [and the] results [were] consistent in pre-specified subgroups, including those with lower mortality risks,” he said.

The real-world study cohort comprised 168,553 Medicare fee-for-service beneficiaries aged >66 years (mean age 77 years, 45 percent female, 82 percent White) who underwent femoropopliteal artery revascularization with a DCD or NDCD between April 2015 and December 2018. Of these, 41.9 percent (n=70,584) were treated with a DCD. The patients were followed up for a median 3.52 years, with the longest follow-up being 6.31 years (>32,000 patients had ≥5 years of follow-up data).

Forty-seven percent of patients had critical limb ischaemia and 8 percent had prior amputation. Comorbidities were frequent in this cohort, the most common being ischaemic heart disease (65 percent), diabetes mellitus (51 percent), and chronic kidney disease (50 percent).

At 6.3 years, the weighted cumulative mortality incidence was comparable between patients who underwent revascularization with DCDs and NDCDs (62.5 percent vs 63.6 percent; hazard ratio [HR], 0.98, 95 percent confidence interval [CI], 0.96–0.99; p_{noninferiority}<0.0001). [SCAI 2022, abstract A-54]

There was no difference in mortality risk between patients who received DCDs and NDCDs in the subpopulation of 4,212 patients deemed at lowest risk of mortality (age 66–70 years with ≤2 chronic major comorbidities and no critical limb ischaemia; HR, 0.98, 95 percent CI, 0.87–1.10).

The lack of difference in mortality between groups was also consistent in the multiple prespecified subgroups assessed including patients with the lowest quartile of total comorbidities (HR, 0.97), those with or without critical limb ischaemia (HRs, 0.96 and 0.98, respectively), those who had their index procedure done as inpatients or outpatients (HRs, 0.98 and 0.96, respectively), and those who underwent stent implantation (HR, 0.99) or balloon angioplasty only (HR, 0.97).

The SAFE-PAD study was created with the US Food and Drug Administration to assess the safety of paclitaxel-coated devices following publication of a meta-analysis that showed an increased risk of mortality with the use of these devices. [J Am Heart Assoc 2018;7:e011245]

“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 pointed out.

“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,” he continued.

“The findings presented today add to the growing body of evidence showing these devices are safe for use,” he concluded. “[It may be] time to revisit [the] current regulatory stance on paclitaxel-coated peripheral devices,” he said.