BACKGROUND There is limited data availability regarding safety and feasibility of outpatient percutaneous coronary interventions (PCI). AIM To evaluate the short- and long-term outcomes of patients undergoing outpatient PCI with special regard to patients with left main and proximal left anterior descending artery disease. METHODS The retrospective, single-center study was conducted in a hemodynamics laboratory dedicated to one-day procedures. We have analyzed short-, medium- and long-term outcomes of the patients undergoing PCI mostly from radial or ulnar access being discharged few hours after procedure. RESULTS During the follow-up period, 787 procedures were performed on 444 patients, including 25 procedures in the left main and 115 procedures in the proximal left anterior descending artery. The median time to discharge was 150 minutes. The median time of follow-up in the general group was 587 days. There was no myocardial infarction (MI), death, stroke or emergent bypass within 24 hours after surgery. During the 30 days of major adverse cardiac and cerebrovascular events follow-up, there were 1 MI (0.17%), 7 cases (0.88%) of target vessel revascularization (TVR) and 4 unplanned hospitalizations (0.7%); there were no deaths or strokes. During 720 days of major adverse cardiac and cerebrovascular events follow-up, there were 11 deaths (1.93%), 5 MIs (0.88%), 60 cases of TVR (7.62%), and 1 stroke (0.17%). Cases of repeat revascularization were observed more often in combined group of patients with diabetes or pre-diabetes than in patients without these conditions (P = 0.046). Patients who underwent PCI with femoral access were statistically more likely to undergo repeat revascularization within 2 years after the procedure [19 (21.84%) vs 41 (5.85%) P < 0.001]. There was a statistically significant higher prevalence of TVR within 2 years after the procedure in patients who had more than one lesion treated compared to single lesion procedures [22 (11.70%) vs 38 (6.34%); P = 0.015]. CONCLUSION The results of this study suggest that PCIs performed on an outpatient basis with very short discharge times may be safe and feasible. However, as this is a hypothesis- generating study, the present findings should be interpreted with caution and confirmed in future large- scale randomized controlled trials.
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. The animals were sacrificed at 1 hour, 1,7,28, and 90-day follow-up. In the tissue effects study 16 coronary bare metal stent (BMS) were implanted following EEN delivery, 15 BMS following nanospheres delivery without the drug (reference group) and 16 implanted BMS served as a control. Angiographic and histology follow-up was scheduled at 28 and 90-day. Results The study showed high-everolimus concentrations in arterial tissue early after nanoparticles delivery followed by its gradual decrease to 1.15 +/- 0.40 ng/mg at 90 days. Histology analysis showed favorable biocompatibility and healing profile with comparable area stenosis between groups at both time-points. Conclusions The present study demonstrates for the first time the safety, biocompatibility, and long-term retention of everolimus in arterial tissue after single local delivery of biodegradable nanospheres.
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. AIM:To compare the long-term outcomes after PAD endovascular revascularization with two types of atherectomies: rotational (AR) (Phoenix Philips) and directional (AD) (SilverHawk Medtronic). MATERIAL AND METHODS:This was a single-center, retrospective study of obstructive and symptomatic PAD patients who underwent revascularization with atherectomy. The endpoints were considered as target lesion revascularization (TLR), death, amputations and bailout stenting (BS). RESULTS:The AR group consisted of 97 patients, while the AD group consisted of 85 individuals. There were no significant differences between the groups in terms of baseline characteristics except for an increased critical limb ischemia (CLI) prevalence in the AR group. The mean follow-up for AD and AR was 282.6 ±147.4 and 255.7 ±186.1 days, respectively (p = 0.44). There were no significant differences in the death rate (AD: 1 (1.7%) vs. AR: 5 (5.7%); p = 0.54), amputations (AD: 2 (2.3%) vs. AR: 5 (5.7%); p = 0.45) or bailout stenting (AD: 2 (2.3%) vs. AR: 3 (3.2%); p = 0.74), whereas TLR was more frequent in the AD group (AD: 25 (29%) vs. AR: 15 (15.9%; p = 0.03). The Kaplan-Meier analysis showed no significant differences between the groups in time to TLR, amputation or death. CONCLUSIONS:In this hypothesis-generating study the AR had a lower rate of TLR when compared to the AD. Nevertheless, this should be confirmed in further controlled randomized trials.