Microcrystalline paclitaxel-coated balloon for revascularization of femoropopliteal artery disease: Three-year outcomes of the randomized BIOPAC trial.

The aim of the BIOPAC trial was to determine long-term safety and efficacy of a novel microcrystalline paclitaxel-coated balloon (mcPCB) with a biocompatible polymer as an excipient in the treatment of occlusive femoropopliteal lesions. In this first-in-human prospective controlled randomized trial, 66 patients with femoropopliteal, symptomatic (Rutherford stages 2B to 5) occlusive arterial disease were randomized to either mcPCB (study group) or POBA (plain old balloon angioplasty) (control group) on a 1:1 basis. Late lumen loss (LLL) at 6 months was the primary endpoint of the study and serious adverse events (SAE: death, amputation, repeated revascularization) were considered a composite secondary endpoint.

Nanospheres encapsulated everolimus delivery into arterial wall-the tissue pharmacokinetics and vascular response experimental study.

Objective: This study aimed to evaluate the pharmacokinetic profile and tissue effects of everolimus delivered into arterial wall using biodegradable nanospheres.

Background: Delivery of everolimus into the arterial wall is challenging due to its low-lipophilic profile.

Methods: A pharmacokinetic study included 28 porcine coronary arterial segments initially injured with balloon angioplasty followed by the local delivery of everolimus encapsulated in nanospheres (EEN) via injection through a microporous delivery catheter.

Comparison of long-term outcomes after directional versus rotational atherectomy in peripheral artery disease.

Introduction: The rate of atherectomy utilization in peripheral artery diseases (PAD) is growing. The two atherectomy devices available on the market and used most frequently are the directional and rotational ones. Nonetheless, there is a lack of direct comparison between these two types of atherectomy in PAD.

Clinical significance of mirror lesions in lower extremity arterial disease.

Objective: The aim of this study was to investigate the clinical relevance of bilateral peripheral arterial disease (PAD) patterns.

Background: No prior study has evaluated the clinical significance of symmetrical lesion patterns, particularly the coexistence of same-level significant plaques in both lower extremities ("mirror lesions").

Methods: We conducted a single-facility, primary data analysis involving 225 patients with symptomatic PAD.