SOLACI | Latin American Society of Interventional Cardiology

This work was conducted alongside the US Food and Drug Administration (FDA) to investigate the association between all-cause mortality and paclitaxel-eluting devices in peripheral vascular disease.

SAFE-PAD: Dispositivos liberadores de paclitaxel en enfermedad periférica

According to data from SAFE-PAD, presented at the American College of Cardiology (ACC) 2021 Congress and simultaneously published in JAMA, there is no increase in mortality compared with conventional devices.

Mortality at a mean 2.7 years was 53.8% for patients with peripheral vascular disease treated with paclitaxel-eluting devices vs. 55.1% for those treated with non-eluting devices (pnon-inferiority < 0.001).

The first data on the possible association between these devices and mortality emerged in 2018, following the publication of a meta-analysis of several randomized studies.

According to that first research, mortality would increase between follow-up years two and three in patients with paclitaxel-eluting stents or balloons vs. conventional devices.

This prompted the FDA to convene an expert panel, which ultimately limited the use of these devices to patients at increased risk of restenosis or new interventions in femoropopliteal disease.

The SAFE-PAD study included 168,553 patients with peripheral vascular disease who underwent angioplasty between 2015 and 2018. After multiple analysis, no association with mortality could be established in the general population or the multiple pre-specified subgroups.

In fact, some subgroups showed an advantage in favor of paclitaxel eluting devices.

Results from SAFE-PAD follow those from the recently published SWEDEPAD study.

One fact that emerges from this analysis is the high mortality rate of patients with peripheral vascular disease in daily clinical practice: over 50% in mortality at three years in both treatment arms, which highlights the pending effort in secondary prevention.

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Original Title: Longitudinal assessment of safety of femoropopliteal endovascular treatment with paclitaxel-coated devices among Medicare beneficiaries: the SAFE-PAD study.

Reference: Secemsky EA et al. Presentado en el congreso de la ACC 2021 y publicado simultáneamente en JAMA Intern Med. 2021. Epub ahead of print. doi:10.1001/jamainternmed.2021.2738.