This study demonstrated the feasibility and efficacy of the DESolve BCS. Results showing low in-scaffold LLL, low % neointimal volume at 6 months, no chronic recoil, and maintenance of lumen patency at 12 months prompt further study. (DESolve First-in-Man; EudraCT number 2011-000027-32).

OBJECTIVE:The toxicity of anti-cancer chemotherapeutic agents can be reduced by associating these compounds, such as the anti-proliferative agent paclitaxel, with a cholesterol-rich nanoemulsion (LDE) that mimics the lipid composition of low-density lipoprotein (LDL). When injected into circulation, the LDE concentrates the carried drugs in neoplastic tissues and atherosclerotic lesions. In rabbits, atherosclerotic lesion size was reduced by 65% following LDE-paclitaxel treatment. The current study aimed to test the effectiveness of LDE-paclitaxel on inpatients with aortic atherosclerosis.METHODS:This study tested a 175 mg/m2 body surface area dose of LDE-paclitaxel (intravenous administration, 3/3 weeks for 6 cycles) in patients with aortic atherosclerosis who were aged between 69 and 86 yrs. A control group of 9 untreated patients with aortic atherosclerosis (72-83 yrs) was also observed.RESULTS:The LDE-paclitaxel treatment elicited no important clinical or laboratory toxicities. Images were acquired via multiple detector computer tomography angiography (64-slice scanner) before treatment and at 1-2 months after treatment. The images showed that the mean plaque volume in the aortic artery wall was reduced in 4 of the 8 patients, while in 3 patients it remained unchanged and in one patient it increased. In the control group, images were acquired twice with an interval of 6-8 months. None of the patients in this group exhibited a reduction in plaque volume; in contrast, the plaque volume increased in three patients and remained stable in four patients. During the study period, one death unrelated to the treatment occurred in the LDE-paclitaxel group and one death occurred in the control group.CONCLUSION:Treatment with LDE-paclitaxel was tolerated by patients with cardiovascular disease and showed the potential to reduce atherosclerotic lesion size.

A 60-year-old male patient with coronary disease was included in the "First-in Man" study 1 and received a single sirolimus-eluting stent (SES, fast release) in December 1999 to treat a 90% diameter stenosis lesion located in the proximal right coronary artery (RCA). The patient had mild to moderate (Ͻ50% diameter stenosis) obstructions in the left anterior descending and left circumflex arteries. Coronary angiography and intravascular ultrasound (IVUS) revealed minimal neointimal growth in the midstent region at 4 months, 1 year, and 2 years after implantation. The patient underwent aortic and mitral valve replacement without complication 3 years after SES implantation. Left ventricle ejection fraction was 22%. He had a cardiac arrest out of the hospital in January 2004 (4-year follow-up). The patient was resuscitated but suffered severe cerebral damage. Postarrest angiography showed a widely patent SES in the RCA with a % obstruction volume of 19% by IVUS with minimal intimal hyperplasia by IVUS (Figure 1). The patient developed brain death and died. At necropsy, there was a 60% cross-sectional area of luminal narrowing of the RCA proximal to the stent. The stented segment was widely patent and well healed. Scanning electron microscopy of the proximal stent showed Ͼ95% of stent surface endothelialized (Figure 2). Light microscopic sections of the distal portion of the stent demonstrated a thin neointima consisting of smooth muscle cells and macrophages (predominately KP1-positive cells) in collagen-rich matrix. Approximately 75% of stent struts were covered by a thin type I collagenrich neointima, and occasional calcific foci were present in neointima. The remaining 25% of struts were deeply embedded in the necrotic core of the plaque without associated inflammation. The RCA distal to stent was widely patent (Ͻ25% narrowing). The left anterior descending artery showed an acute plaque rupture and luminal thrombus in the proximal arterial segment. Atherosclerosis progression was noted in the left circumflex artery and posterior descending artery. The bioprosthetic aortic valve had a small fibrin thrombus deposition at the base of the right coronary cusp. Reference1. Sousa JE, Costa MA, Sousa AG, et al. Two-year angiographic and intravascular ultrasound follow-up after implantation of sirolimus-eluting stents in human coronary arteries.

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