RESUMO
Introduction: Complex, coronary stenosis remains a technical challenge that may be responsible for in-stent restenosis and vessel thrombosis. Here we investigated the efficacy and safety of excimer laser coronary atherectomy (ELCA) with contrast mix injection for improving vessel wall stent apposition in undilatable, mostly calcified lesions. Aim: To assess ELCA with contrast mix injection in complex, stented, calcified coronary lesions. Material and methods: This prospective single-center observational study enrolled 52 consecutive patients (73 lesions), with suboptimal stents implanted in de novo lesions and lesions requiring in-stent restenosis (ISR) due to stent underexpansion using all available means to achieve an optimal result. Patients presenting with ST-segment elevation myocardial infarction were excluded. All patients underwent coronary angiography 6 months after ELCA with intravascular ultrasound or optical coherence tomography study. We used contrast media mixed with saline (25-75%) to supply maximum laser energy output when a standard approach was unsuccessful. Procedural success was defined as relative stent expansion of > 80% minimal stent area (MSA) divided by average reference lumen area. Results: Procedural success was achieved in all cases. The cross-sectional area measured in treated segment improved significantly from 2.9 (0.72) mm2 to 7.3 (0.79) mm2 after ELCA. The in-hospital device-oriented major adverse cardiac event (DOCE) rate was 9.6%. No vessel perforation occurred during ELCA. After 6 months, the DOCE rate was 13.4%, while the rate of target lesion revascularization (TLR) was 8.2%. Conclusions: This registry confirms the efficacy and safety of ELCA with contrast mix injection as a possible approach for stent expansion/ISR in failed PCI.
RESUMO
Atherosclerosis involves an ongoing inflammatory response of the vascular endothelium and vessel wall of the aorta and vein. The pleiotropic effects of statins have been well described in many in vitro and in vivo studies, but these effects are difficult to achieve in clinical practice due to the low bioavailability of statins and their first-pass metabolism in the liver. The aim of this study was to test a vessel wall local drug delivery system (DDS) using PLA microstructures loaded with simvastatin. Wistar rats were fed high cholesterol chow as a model. The rat vessels were chemically injured by repeated injections of perivascular paclitaxel and 5-fluorouracil. The vessels were then cultured and treated by the injection of several concentrations of poly(L,L-lactide) microparticles loaded with the high local HMG-CoA inhibitor simvastatin (0.58 mg/kg) concentration (SVPLA). Histopathological examinations of the harvested vessels and vital organs after 24 h, 7 days and 4 weeks were performed. Microcirculation in mice as an additional test was performed to demonstrate the safety of this approach. A single dose of SVPLA microspheres with an average diameter of 6.4 µm and a drug concentration equal to 8.1% of particles limited the inflammatory reaction of the endothelium and vessel wall and had no influence on microcirculation in vivo or in vitro. A potent pleiotropic (anti-inflammatory) effect of simvastatin after local SVPLA administration was observed. Moreover, significant concentrations of free simvastatin were observed in the vessel wall (compared to the maximum serum level). In addition, it appeared that simvastatin, once locally administered as SVPLA particles, exerted potent pleiotropic effects on chemically injured vessels and presented anti-inflammatory action. Presumably, this effect was due to the high local concentrations of simvastatin. No local or systemic side effects were observed. This approach could be useful for local simvastatin DDSs when high, local drug concentrations are difficult to obtain, or systemic side effects are present.
