Novel sirolimus eluting stents (SES) have shown non-inferior clinical outcomes when compared to everolimus eluting stents (EES), however only limited preclinical data have been published. Therefore, we evaluate vascular response of a new generation biodegradable polymer SES (BP-SES: Alex Plus, Balton) and fluoropolymer EES (EES: Xience Pro, Abbott) in the porcine coronary restenosis model.
We aimed to comprehensively evaluate poly-lactide polymer degradation and sirolimus release kinetics from a drug-eluting stent matrix in the in vivo setting using a nuclear magnetic resonance (NMR) method. The utilization of NMR method for BP absorption kinetics evaluation is a useful tool, which may be widely adopted to test other biodegradable implants. Further, it may substantially improve their safety and efficacy by facilitating programmed polymer and drugs elution.
There is limited comparative clinical data regarding the safety and efficacy profile of paclitaxel delivery via balloon versus stent-polymer matrix. In this study, we aimed to compare the clinical and angiographic results of two different methods of paclitaxel delivery among patients undergoing percutaneous coronary intervention (PCI) for single de novo coronary lesions. Paclitaxel delivery via drug coated balloon or polymer-stent matrix achieved comparable angiographic and clinical results among patients with de novo coronary lesions. BMS + PCB revascularization was associated with a higher rate of stent thrombosis when compared to newer generation drug eluting stents, therefore, should be recommended as a bail-out for PCB alone angioplasty.
Fast releasing, rapamycin-eluting stents, although safe, showed inferior results with regard to inhibition of restenosis. Therefore, we report vascular effects of a novel, biodegradable polymer stent matrix with elevated sirolimus dose and fast release kinetics (ed-frSES, Alex, Balton) in the porcine coronary in-stent restenosis model. Sirolimus dose-dependent vascular response was reported. The elevated dose, fast releasing SES shows satisfactory vascular healing, similar to regular dose, fast release SES, with improved efficacy in restenosis inhibition.
This randomized prospective clinical trial aimed to evaluate safety and efficacy of preoperative use of eptifibatide in high risk patients with non--ST--segment elevation acute coronary syndrome (NSTE--ACS), requiring urgent coronary artery bypass graft surgery (CABG). Preoperative use of eptifibatide vs. placebo is linked to significantly reduced 12--month MACCE rate in patients with NSTE--ACS requiring urgent CABG, while it simultaneously seems not to confer a greater risk of postoperative bleeding.
The optimal revascularization strategy in patients with complex coronary artery disease and non-ST-segment elevation acute coronary syndromes is undetermined. In conclusion, in patients presenting with non-ST-segment elevation acute coronary syndromes and complex coronary artery disease, immediate stenting was associated with lower mortality risk in the long term compared with surgical revascularization, especially in subgroups at high clinical risk.
We aimed to compare the vascular effects exclusive to antiproliferative agents by using identical stent and biodegradable polymeric matrices eluting everolimus (BP-EES) (Carlo; Balton) and paclitaxel (BP-PES) (Luc-Chopin2; Balton) in the porcine model of coronary injury. Temporal differences in vascular response were seen by the delivery of different antiproliferative agents. In contrast to everolimus, paclitaxel seems to induce a slightly higher degree of inflammation in the short term, potentially leading to further neointimal hyperplasia in the long term.
Women typically present with coronary artery disease later than men with more unfavorable clinical and anatomic characteristics. It is unknown whether differences exist in women undergoing treatment for unprotected left main coronary artery (ULMCA) disease. Our aim was to evaluate long-term clinical outcomes in women treated with percutaneous coronary intervention (PCI) with drug-eluting stents versus coronary artery bypass grafting (CABG). In women with significant ULMCA disease, no difference was observed after PCI or CABG in death, MI, and CVA at long-term follow-up.
To quantify differences in vascular injury and healing between second-generation SES and balloon-expandable stents (BES) and the effects of balloon post-dilatation in a porcine. The mechanism of stent expansion influences the degree of vascular injury and healing. The synergistic use of balloon post dilatation changes the dynamics of healing and may impact the potential beneficial effects inherent to SES technologies.
The aim of this study was to compare, in a large all-comer registry, the long-term clinical outcomes after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) for ostial/mid-shaft lesions versus distal bifurcation lesions in unprotected left main coronary artery (ULMCA) stenosis. This study demonstrates that PCI for ostial/mid-shaft lesions is associated with better clinical outcomes than are distal bifurcation lesions in ULMCA, largely because there is a lower need for repeat revascularization in ostial/mid-shaft lesions.
Aim of the study was to evaluate the association between circulating endothelial progenitor cells (EPCs) and angiographic outcomes after implantation of GenousTM stent in patients with non-ST-segment elevation acute coronary syndromes (ACS) (NSTE-ACS) undergoing urgent percutaneous coronary intervention (PCI). Use of GenousTM stents in NSTE-ACS is associated with lower restenosis rate than BMS at 6 months. There was no ST through 1 year. The number of circulating EPCs is inversely correlated with in-stent late loss (LL).
New paclitaxel coated balloons (PCB) developments have been proposed to maintain therapeutic levels of drug in the tissue while decreasing particle release. In this series of studies, we evaluated the pharmacokinetic profile and biological effects after paclitaxel delivery via novel microcrystalline PCB coating (mcPCB, Pax®, Balton) in porcine iliofemoral arteries. Delivery of paclitaxel via a novel mcPCB resulted in low long-term tissue retention of paclitaxel. However, this technological approach displayed reduced neointimal proliferation and favorable healing profile.
In United States alone there are more than 12 million people with peripheral artery disease (PAD). Long-term outcomes of plaque excision in high-risk population (patients with diabetes and patients with end stage renal disease on dialysis) are scarce. SilverHawk Plaque Excision combined with aggressive pharmacotherapy in this presented high-risk population is associated with promising long-term outcomes that compare favourably with accepted standards of care.
The biodegradable polymer drug-eluting stents have been proposed as an alternative to durable polymer DES, theoretically improving vessel healing and reducing the need for prolonged double anti platelet therapy (DAPT), however clinical significance of this technology is under debate. Therefore, we sought to compare the clinical outcomes of two Paclitaxel eluting stents (PES) containing different polymer-based eluting matrices. In this observational analysis, BP-PES were comparable to DP-PES, with regard to incidence of repeated revascularizations, stent thromboses and MACCE despite earlier DAPT discontinuation.
Although durable polymer coated drug-eluting stents (DES) are standard care in percutaneous coronary interventions, new stent platforms employing biodegradable polymer based drug delivery are increasingly being used in clinical practice. The PROLIM - a biodegradable polymer coated sirolimus-eluting stent - demonstrates very good short-term and medium-term angiographic and histological results. The lack of 'catch-up phenomenon', fast endothelialisation process, and minimal inflammatory reaction may contribute to favourable clinical outcomes using PROLIM stents.
Heme oxygenase-1 (HO-1) decreases apoptosis, inflammation and oxidative stress. The aim of the study was to investigate the effects of intracoronary infusion of allogenic bone marrow cells (BMC) overexpressing HO-1 in the porcine model of myocardial infarction (MI). In conclusion, intracoronary delivery of allogeneic BMC immediately prior to reperfusion improved the LVEF and reduced the infarct size. HO-1 BMC were not superior to control cells after 14 days, however, produced faster recovery of LVEF. Transplanted cells survived in the peri-infarct zone.
The reperfusion injury (RI) remains a significant limitation of primary PCI, therefore we evaluated the role of intracoronary abciximab and bivalirudin for anticoagulation on myocardial salvage and RI in the porcine model of ischemia/reperfusion. Despite lowered concentrations of adhesion molecules, intracoronary abciximab with peripheral bivalirudin is not superior to bivalirudin unaided in terms of myocardial salvage caused by RI in the porcine ischemia/reperfusion model. This might be due to local hemorrhage caused by abciximab.
To assess the effects of local paclitaxel delivery using the Remedy catheter on neointimal hyperplasia in a porcine model and compare these results to commercially available BMS and biodegradable polymer-coated paclitaxel-eluting stents (BP-PES). Our study demonstrates that local paclitaxel delivery using the Remedy transport catheter in the two studied doses (250 and 500 μg) is not effective at neointimal hyperplasia inhibition.
Carotid artery stenting (CAS) has become an alternative to carotid endarterectomy. Moreover, percutaneous transluminal angioplasty (PTA) allows other cephalad arteries revascularization. The aim of this study was to evaluate late outcomes of cephalad arteries PTA. CAS is safe and successful procedure with low early and long-term adverse events. Special attention should be put on patients with bilateral and left ICA stenoses. If possible, longer stents should be applied.
The optimal treatment strategy for coronary bifurcation lesions is still unknown. The BiOSS Lim stents (Bifurcation Optimisation Stent System) is a novel dedicated bifurcation stent introduced over a single wire in to the main vessel, covered with biodegradable polymer and sirolimus. It has wider proximal and narrower distal parts. The aim of the study was to assess applicability of the the BiOSS Lim stent in a porcine coronary model. The novel BiOSS Lim stent demonstrates good short- and mid-term vascular effects in a porcine coronary bifurcation model.
Reperfusion injury (RI) remains an important limitation of myocardial revascularization. The aim of the present study was to evaluate the influence of the intracoronary injection of adiponectin on RI and cardiomyocyte death in a porcine myocardial infarction model. The administration of adiponectin into the infarct- related artery is safe and feasible. The treatment significantly reduced the infarct size.
To present a prospective, single-center trial of the Cardiva Catalyst II, a vascular closure device that provides temporary hemostasis after the procedure and is removed under manual compression, leaving no material behind. Cardiva Catalyst is safe and effective device in achieving local hemostasis after percutaneous diagnostic procedures and interventions performed under bivalirudin anticoagulation. The use of this device with an appropriate protocol facilitates same-day discharge.
Biodegradable polymer-coated stents may have positive effects on arterial healing, and reduce the need for prolonged antiplatelet therapy. To assess the vascular effects of the biodegradable polymer proposed as a stent coating, as well as to evaluate inhibition of intimal hyperplasia by Biodegradable Polymer-Coated Paclitaxel-Eluting Stents (BP-PES, LUC-Chopin, Balton) in porcine coronary arteries. It seems that the biodegradable polymer-coated, paclitaxel-eluting stent examined in the present study is both safe and feasible. This supports the first such study in humans being conducted.
The high radial force and durability of cobalt-chromium alloy enable the construction of low-profile stents with thin struts, which improves their elasticity and may play a key role in reducing the incidence of neointimal hyperplasia as well as allow faster endothelialization. The aim of this study was to compare cobalt-chromium (CoCr) and stainless steel (SS) coronary stents in a pig model of neointimal hyperplasia. Despite thinner struts, CoCr stents have no advantage over stainless steel stents in terms of neointimal hyperplasia inhibition. However, their positive safety results together with their high radial strength, low profile, and excellent elasticity can ensure their usage, especially in lesions of complex morphology.
The aim of the study was to evaluate early and late outcomes after percutaneous coronary intervention (PCI) of unprotected left main coronary artery disease (ULMCA) and to compare bare-metal stent (BMS) and drug-eluting stent (DES) subgroups. Stenting of ULMCA is feasible and offers good long-term outcome. Implantation of DES for ULMCA decreased the risk of long-term MACCE, and particularly improved survival in patients with distal ULMCA disease.
In-stent restenosis (ISR) is one of the major limitations of percutaneous coronary intervention (PCI). To evaluate the relationship between the levels of hs-CRP, IL-6, IL-10 and intimal hyperplasia six months after coronary bare metal stent (BMS) implantation. We demonstrated that elevated inflammatory markers 6 months after PCI are associated with late angiographic in-stent restenosis.
Restenosis occurs invariably within 1 year following balloon valvulopasty in aortic valve stenosis. The mechanism of restenosis seems to involve a dynamic cellular component that could be a target for drug inhibition. We investigated the feasibility of local drug delivery at the aortic valve tissues of healthy pigs with a paclitaxel-eluting balloon. Local drug delivery at the aortic valve leaflets of healthy pigs with a paclitaxel-eluting balloon is feasible and concentrations within the therapeutic window are detected 30 minutes after the procedure. The antirestenotic potential of this treatment should be studied
The purpose of this study was to compare the early and late results of percutaneous and surgical revascularization of left main coronary artery stenosis. Unprotected left main coronary artery (ULMCA) stenting is being investigated as an alternative to bypass surgery. Patients with ULMCA disease treated with PCI had favorable early outcomes in comparison with the CABG group. At 1 year, LVEF had improved significantly only in the PCI group. After more than 2 years, MACCE-free survival was similar in both groups with a trend toward improved survival after PCI.
The purpose of the present study was to evaluate the efficacy and safety of a biodegradable polymer coated, paclitaxel eluting stent (Luc-Chopin(2)) based on 9-months angiographic and 12-months clinical follow-up results. First-generation drug-eluting stents utilize nonbioabsorbable polymeric coatings, whose persistent presence in the arterial wall may negatively affect long-term outcomes. Bioabsorbable coatings with a degradation period matched to that of the drug elution may be a better alternative, clinically and economically. This first-in-man experience obtained in a multicenter registry of real-world de novo lesions (almost half of lesions were class B2 or C by AHA classification) showed a favorable safety profile and acceptable efficacy through 12 months. Randomized comparison with a benchmark nonbioabsorbable polymer coated paclitaxel eluting stent should be undertaken to validate this initial positive experience.
Cobalt-chromium (Co-Cr) stents are a new type of endovascular prostheses characterised by better mechanical properties than traditional stainless steel stents. To assess the safety and efficacy of percutaneous coronary interventions (PCI) using the new Co-Cr Kos stent (Balton, Poland). Implantation of the new Co-Cr Kos stent during PCI is safe and effective.
In-stent restenosis still remains a serious clinical problem. Local intramural drug delivery (LDD -- Local Drug Delivery) seems to be an interesting alternative to drug-eluting stents (DES). The aim of the study was to assess the safety and effectiveness of local intramural paclitaxel administration in the treatment of recurrent in-stent restenosis (ISR). Local intramural paclitaxel delivery is a safe and effective method of ISR treatment. The optimal paclitaxel dose should be established in further studies.
The aim of the present study was to assess the safety and efficacy of percutaneous coronary interventions (PCI) using the new Polish stent "Chopin" (Balton, Poland). Implantation of the new Polish stent "Chopin" during PCI is safe and effective.