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.

Local intravascular delivery of low-density-lipoprotein cholesterol corresponds with increased intimal thickening in a healthy porcine coronary model. A prelude to development of a model of atherosclerosis.

Introduction: Preclinical, vascular response studies are limited due to lack of underlying disease. The available cholesterol-diet-based and genetic atherosclerotic models are not satisfactory due to long breeding, unpredictable lesion formation, low plaque volume and degree of stenosis.

Aim: To evaluate the vascular response to local, intramural delivery of human, highly atherogenic lipids into healthy domestic swine (DS) coronary arteries.