Major adverse limb events in patients with femoro-popliteal and below-the-knee peripheral arterial disease treated with either sirolimus-coated balloon or standard uncoated balloon angioplasty: a structured protocol summary of the “sirpad” randomized controlled trial

HIGHLIGHTS

SUMMARY

    A minority of symptomatic PAD patients would present with infra-popliteal (distal or below-the-knee) lesions: in these patients, the endovascular treatment remains challenging. Although the short-term effects appeared promising based on imaging outcomes and patency rates, the results of a recent meta-analysis of 28 trials showed an increased 2-year mortality in the group of patients treated with paclitaxel-coated balloons with a consequent warning and safety concern from the Food and Drug Administration (FDA) concerning paclitaxel-based devices. The presence of any one of the following exclusion criteria will . . .

     

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