Abstract 13663: Safety and Possible Effectiveness of Paclitaxel Associated to LDL-Like Nanoparticles (LDE) in the Treatment of Patients With Chronic Ischemic Heart Disease

Abstract

Introduction: Experimental studies have shown that anti-proliferative chemotherapeutic agents such as paclitaxel (PTX), associated to solid lipid nanoparticles (LDE), have marked anti-atherosclerotic effects. The combination with LDE nearly abolishes PTX toxicity. Hypothesis: Treatment with LDE-PTX in patients with chronic ischemic heart disease (CIHD) is tolerable and safe, and favorably changes plaque characteristics, as denoted by coronary computerized tomography angiography (CCTA). Methods: In this prospective, randomized, double-blind, placebo-controlled study, patients with multivessel CIHD received IV infusions of either LDE-PTX (n=20; PTX dose: 175 mg/m2 body surface) or LDE alone (n=20; placebo group). Infusions were administered every 3 weeks for 6 times. Analysis of cardiovascular risk and inflammatory biomarkers and CCTA data was performed at baseline and at the end of the study. Clinical and laboratorial safety evaluations were made before each infusion. Results: Overall, patients aged 65.6 ±8 yrs, 58% had diabetes, 50% had history of myocardial infarction and 91% were under statin and aspirin therapy. Baseline demographics, risk factors and laboratory data were similar between infusion groups. There was no statistical difference regarding the levels of hsCRP, IL-1β, IL-6, IL-8 and TNF-α from baseline to follow-up between groups, but there was a trend for decrease in IL-6 levels in the LDE-PTX group (-16%), not observed in the placebo group. Regarding the CCTA high-risk plaques, a tendency for reduction of the napking-ring signal after infusion was observed in the LDE-PTX group (figure 1) compared to placebo (p=0.098). No clinical or laboratorial toxicities were observed. Conclusions: This study shows that LDE-PTX was safe in CIHD patients and showed signs of benefits in reducing inflammatory biomarkers and modification of high-risk plaque characteristics.