Reduction Of Restenosis Research Articles

Carotid artery revascularization using second generation stents versus surgery: a meta-analysis of clinical outcomes.

Meta-analyses and emerging randomized data indicate that second-generation ('mesh') carotid stents (SGS) may improve outcomes versus conventional (single-layer) stents but clinically-relevant differences in individual SGS-type performance have been identified. No comparisons exist for SGS versus carotid endarterectomy (CEA). Thirty-day death (D), stroke (S), myocardial infarction (M), and 12-month ipsilateral stroke and restenosis in SGS studies were meta-analyzed (random effect model) against CEA outcomes. Eligible studies were identified through PubMed/EMBASE/COCHRANE. Forest plots were formed for absolute adverse evet risk in individual studies and for relative outcomes with each SGS deign versus contemporary CEA outcomes as reference. Meta-regression was performed to identify potential modifiers of treatment modality effect. Data were extracted from 103,642 patients in 25 studies (14 SGS-treated, 41% symptomatic; nine randomized controlled trial (RCT)-CEA-treated, 37% symptomatic; and two Vascular Quality Initiative (VQI)-CEA-treated, 23% symptomatic). Casper/Roadsaver and CGuard significantly reduced DSM versus RCT-CEA (-2.70% and -2.95%, P<0.001 for both) and versus VQI-CEA (-1.11% and -1.36%, P<0.001 for both). Gore stent 30-day DSM was similar to RCT-CEA (P=0.581) but increased against VQI-CEA (+2.38%, P=0.033). At 12 months, Casper/Roadsaver ipsilateral stroke rate was lower than RCT-CEA (-0.75%, P=0.026) and similar to VQI-CEA (P=0.584). Restenosis with Casper/Roadsaver was +4.18% vs. RCT-CEA and +4.83% vs. VQI-CEA (P=0.005, P<0.001). CGuard 12-month ipsilateral stroke rate was similar to VQI-CEA (P=0.850) and reduced versus RCT-CEA (-0.63%, P=0.030); restenosis was reduced respectively by -0.26% and -0.63% (P=0.033, P<0.001). Twelve-month Gore stent outcomes were overall inferior to surgery. Meta-analytic integration of available clinical data indicates: 1) reduction in stroke but increased restenosis rate with Casper/Roadsaver, and 2) reduction in both stroke and restenosis with CGuard MicroNET-covered stent against contemporary CEA outcomes at 30 days and 12 months used as a reference. This may inform clinical practice in anticipation of large-scale randomized trials powered for low clinical event rates (PROSPERO-CRD42022339789).

Stem Cell Therapy Post-Angioplasty: A Novel Approach to Counteract Restenosis in Coronary Artery Disease Patients

Introduction: Cardiovascular diseases (CVDs) continue to be a primary global health challenge, responsible for significant morbidity and mortality. Despite the advancements in therapeutic modalities, challenges persist. Angioplasty stands out as a key intervention for coronary artery disease (CAD), but post-procedural complications, particularly restenosis, remain a concern. Stem cells, given their regenerative properties, have garnered attention as a potential therapeutic avenue following angioplasty, but clinical understanding is still emerging. Objective: This study aimed to investigate the therapeutic potential of stem cell administration following angioplasty in reducing restenosis rates and improving vascular repair. Methods: A randomized controlled trial was conducted with 500 CAD patients (aged 45-75) undergoing angioplasty. Participants were randomly allocated to control (standard post-angioplasty care) and experimental groups (standard care + stem cell therapy). Primary outcome was the rate of restenosis at 12 months, with secondary outcomes like intimal hyperplasia and quality of life assessed using EQ-5D. Results: At 12-month follow-up, the restenosis rate was significantly lower in the experimental group (12%) than in the control group (27%) [p&lt;0.001]. Additionally, the experimental group demonstrated a 40% reduction in intimal hyperplasia and reported higher quality of life scores compared to controls. Discussion: Our results signify the potential benefits of stem cell therapy post-angioplasty. The marked reduction in restenosis aligns with prior pre-clinical evidence highlighting stem cells' reparative capacities. Limitations include the study's 12-month duration and the specific age bracket of participants. Conclusions: Stem cell therapy after angioplasty shows promise in reducing restenosis and improving patient outcomes. More long-term studies are essential to solidify these findings and guide clinical applications.

Intraprocedural endothelial cell seeding of arterial stents via biotin/avidin targeting mitigates in-stent restenosis

Impaired endothelialization of endovascular stents has been established as a major cause of in-stent restenosis and late stent thrombosis. Attempts to enhance endothelialization of inner stent surfaces by pre-seeding the stents with endothelial cells in vitro prior to implantation are compromised by cell destruction during high-pressure stent deployment. Herein, we report on the novel stent endothelialization strategy of post-deployment seeding of biotin-modified endothelial cells to avidin-functionalized stents. Acquisition of an avidin monolayer on the stent surface was achieved by consecutive treatments of bare metal stents (BMS) with polyallylamine bisphosphonate, an amine-reactive biotinylation reagent and avidin. Biotin-modified endothelial cells retain growth characteristics of normal endothelium and can express reporter transgenes. Under physiological shear conditions, a 50-fold higher number of recirculating biotinylated cells attached to the avidin-modified metal surfaces compared to bare metal counterparts. Delivery of biotinylated endothelial cells to the carotid arterial segment containing the implanted avidin-modified stent in rats results in immediate cell binding to the stent struts and is associated with a 30% reduction of in-stent restenosis in comparison with BMS.

Vascular restenosis reduction with platelet membrane coated nanoparticle directed M2 macrophage polarization

SummaryVascular restenosis is the main factor affecting the prognosis of angioplasty in cardiovascular diseases, and inflammation is a central link in the progression of restenosis. Previous research that applies interleukin 10 (IL10) nanoparticles can effectively regulate local inflammation, but their targeted delivery efficacy remains to be improved. In this study, IL10 nanoparticles were successfully prepared and then coated by a preactive platelet membrane. The ability to target and regulate macrophage polarization has been demonstrated, thereby regulating smooth muscle cell and endothelial cell functions. In vivo experiments were carried out in a carotid artery injury model and verified the above functions and the effect on inhibiting vascular restenosis. Immune regulation-based platelet membrane coated nanoparticle loaded with IL10 proved to be an excellent candidate for targeting vascular injury and holds promise as an innovative drug delivery system for suppressing vascular restenosis.

Paclitaxel-Coated versus Uncoated Balloon for Femoropopliteal In-Stent Restenosis: A Systematic Review and Meta-Analysis.

Several prospective controlled trials to date have assessed the safety and efficacy of paclitaxel-coated balloon angioplasty (PCBA) versus uncoated balloon angioplasty (UCBA) for femoropopliteal (FP) in-stent restenosis (ISR). Therefore, this meta-analysis of prospective controlled trials aimed to summarize the results of these trials and present reliable conclusions. We systematically searched the PubMed, Embase, Cochrane Library, Web of Science, ClinicalTrials.gov, and CNKI databases for prospective randomized controlled trials (published between January 1, 2008, and July 31, 2021; no language restrictions) comparing PCBA with UCBA in the management of FP ISR. The main endpoints were recurrent restenosis, primary patency, freedom from target lesion revascularization (TLR), clinical improvement, ankle-brachial index (ABI), and major adverse events (MAEs). We assessed the pooled data using a fixed effects model. Of the 206 identified studies, seven were eligible and included in our analysis (N = 593 participants). Compared with UCBA, PCBA yielded a reduction in recurrent restenosis (odds ratio [OR], 0.22; 95% confidence interval [CI], 0.13-0.38), a better primary patency (OR, 3.59; 95% CI, 1.72-7.47), an improved likelihood of freedom from TLR (OR, 2.70; 95% CI, 1.36-5.35), greater clinical improvement (OR, 2.38; 95% CI, 1.50-3.79), and a similar mean difference in ABI (0.02; 95% CI, -0.11-0.14) and OR in MAEs (0.71; 95% CI, 0.24-2.14). PCBA as a treatment strategy can achieve better short-term outcomes of FP ISR management, including potent recurrent restenosis-lowering and symptom-improving capacity without increased MAEs. Therefore, it is a promising therapeutic strategy for patients with FP ISR. This work was registered in PROSPERO, the international prospective register of systematic reviews (number: CRD42021261574).

Hematoporphyrin- mediated focused ultrasound sonodynamic therapy combined with catheter- based rhenium-186 brachytherapy after B- mode ultrasound- guided balloon angioplasty of occluded artery

Background and Aims : Three mechanisms are responsible for the development of restenosis: elastic recoil, intimal hyperplasia and late vascular constriction, all grouped under the catch phrase “negative remodeling”. Neointimal hyperplasia is usually defined in an artery as thickening of the intimal layer after an injury such as balloon angioplasty methods. The aim of this study was to evaluate the effect of combined ultrasound sonodynamic therapy and catheter- based 186Re-mediated beta radiation (β-) brachytherapy on restenosis reduction after balloon angioplasty.

Outcomes of supraflex sirolimus eluting coronary stents

Background: The introduction of Sirolimus Eluting Coronary Stents (SES) was a major breakthrough in interventional cardiology. The large, randomized, clinical trials using SES have shown a remarkable reduction in angiographic restenosis and target vessel revascularization (TVR) compared with bare-metal stents as well as other drug-eluting stents (DESs). However, there is only limited data on the outcome of Indian patients treated by DES of Indian origin. The purpose of the study was to evaluate the outcomes of the supraflex sirolimus-eluting coronary stents for the treatment of coronary artery disease and to determine major adverse cardiovascular and cerebrovascular events (MACCE). Materials and Methods: This was a single-centre, observational, nonrandomized study that enrolled unselected real-world patients at a tertiary care center who had undergone implantation with supraflex sirolimus-eluting stents. The primary end-point of the study was MACCE, which is a conglomeration of cardiac death, target lesion revascularization (TLR), TVR, cerebrovascular accident (CVA), and heart failure at 1-year follow-up. Results: A total of 100 patients were intervened successfully with sirolimus-eluting stents. Out of total patients, diabetes and hypertension were observed in 38% and 35% of patients. According to ACC/AHA classification, there were 68% Type B lesions and 32% Type C lesions. At 1-year follow-up, MACE was found to be 11%, which is a composite of 4% TLR, 3% TVR, 1% CVA, and 5% heart failure. Diabetes (P = 0.02), hypertension (P = 0.01), kidney dysfunction (P = 0.002), and LV function (P = 0.01) strongly correlate with outcome (MACCE). Conclusion: There was an acceptable rate of adverse events after implantation of the supraflex sirolimus-eluting stents, although it was slightly higher compared to other studies. Diabetes, hypertension, kidney dysfunction, and LV function strongly correlate with outcome (MACCE).

B- mode ultrasound- guided balloon angioplasty of occluded artery accompanied by combined focused ultrasound sonodynamic therapy and catheter- based 192Ir- mediated brachytherapy

Abstract Background and aims Three mechanisms are responsible for the development of restenosis: elastic recoil, intimal hyperplasia and late vascular constriction, all grouped under the catch phrase “negative remodeling”. Neointimal hyperplasia is usually defined in an artery as thickening of the intimal layer after an injury such as balloon angioplasty methods. The aim of this study was to evaluate the effect of combined ultrasound sonodynamic therapy and catheter- based 192Ir-mediated β-brachytherapy on restenosis reduction after balloon angioplasty. Methods Briefly, golden Syrian hamsters were submitted to common carotid artery advanced atherosclerotic occlusion by primary perivascular Co2 laser-mediated far-infrared injury followed by a 2% cholesterol-rich diet for six weeks. Histopathology results showed the formation of a thick-cap fibroatheromatic plaque, resulted to occlusion in all of the hamsters' arteries. Then treatment group (n=10) underwent B-mode ultrasound-guided balloon angioplasty followed by combined pulsed low level focused ultrasound (F=750 KHz, I=1.5 W/cm2, PD=120 ms)-mediated sonosensitizer protoporphyrin-IX-loaded PESDA (Perfluorocarbon Exposed Sonicated Dextrose Albumin) microbubbles (100ml/kg, 2–5×105 bubbles/ml) sonodynamic therapy and catheter- based β-brachytherapy (125I−, 18 Gy). Results Results from ultrasonography and histopathology showed a significant reduction in the mean value for macrophages and smooth muscle hyperplasia cells density after balloon angioplasty in the treated group compared with the other groups (p&amp;lt;0.05). Conclusions Enhanced anti-inflammatory effect of sonodynamic therapy, induced by collapsed microbubbles accompanied by apoptotic effect of β-brachytherapy, can cause to reduce the inflammation and smooth muscle hyperplasia cells in the intimal layer. Funding Acknowledgement Type of funding sources: Public Institution(s). Main funding source(s): Mehrad Research Lab

ACUTE MYOCARDIAL INFARCTION: AN UNUSUAL INITIAL PRESENTATION OF POLYCYTHEMIA VERA

TOPIC: Critical Care TYPE: Medical Student/Resident Case Reports INTRODUCTION: Polycythemia Vera (PV) is a chronic myeloproliferative disorder that affects the hematopoietic progenitor cells and increases the production of red cells, platelets and granulocytes1. The incidence of PV is around 2.3 per 100,000 persons/year2. Major cause of morbidity and mortality in PV patients is thrombosis that is either microcirculatory or arterial4. Hyperviscosity and thrombocytosis lead to coronary thrombosis resulting in acute myocardial infarction (AMI)4. However, the initial presentation of PV as AMI is extremely rare, with less than 10 cases reported in literature4. This is a unique case of a young healthy male with no cardiovascular risk factors, who presented with an AMI with the ultimate diagnosis of PV. CASE PRESENTATION: A 42-year-old French male presented with severe substernal chest pain radiating to the left arm, nausea, diaphoresis and left arm numbness ongoing for an hour. He had no significant medical, social or family history. He had a HR of 101 BPM and a BP of 137/92 mmHg. Labs included: high sensitivity troponin 701 pg/mL, LDL 111mg/dL, WBC 11.7K, platelets 357K, Hgb 22.5 g/dL and Hct 67.6%. An EKG was suggestive of an antero-septal STEMI. A cardiac catheterization with a drug eluting stent was deployed in the left anterior descending artery that was 99% occluded. The findings of an elevated hemoglobin and hematocrit triggered a cascade of investigations. Erythropoietin level was unremarkable, while bone marrow biopsy displayed panmyelosis. Imaging demonstrated hepatosplenomegaly. Ultimately, the diagnosis of PV was established when genetic testing revealed a JAK2 V617F mutation. Post-MI and PV treatment with hydroxyurea and therapeutic phlebotomies to maintain a hematocrit goal of less than 45% was initiated. DISCUSSION: Coronary events in PV patients occur at a rate of 11.4% in 10-year follow-up4. The two most important risk factors for thrombosis are advanced age and prior history of thrombosis1. Although not clearly established, overproduction of thromboxane A2, endothelial dysfunction, platelet and leukocyte activation are believed to contribute to vascular events4. The mainstay of treatment of PV is antiplatelet medications, therapeutic phlebotomies and cytoreductive drugs4. There are no current guidelines for risk reduction of stent restenosis or the treatment of AMI in PV1. CONCLUSIONS: This case emphasizes the need to consider PV in the differential diagnosis of acute coronary syndrome in young patients without any cardiovascular risk factors. Furthermore, it re-affirms the need for an annual examination to identify abnormal studies and the benefit of timely intervention. REFERENCE #1: Adel G. Polycythemia Vera and Acute Coronary Syndromes: Pathogenesis, Risk Factors and Treatment. J Hematol Thromboembolic Dis. 2013;01(01). doi:10.4172/2329-8790.1000107 REFERENCE #2: Bahbahani H, Aljenaee K, Bella A. Polycythemia vera presenting as acute myocardial infarction: An unusual presentation. J Saudi Hear Assoc. 2015;27(1):57-60. doi:10.1016/j.jsha.2014.07.003 REFERENCE #3: Tefferi A, Rumi E, Finazzi G, et al. Survival and prognosis among 1545 patients with contemporary polycythemia vera: An international study. Leukemia. 2013;27(9):1874-1881. doi:10.1038/leu.2013.163 DISCLOSURES: No relevant relationships by Madeeha Banu, source=Web Response No relevant relationships by Rohan Bodapati, source=Web Response No relevant relationships by palak desai, source=Web Response No relevant relationships by Brendan Gilmore, source=Web Response No relevant relationships by Kenneth Joseph, source=Web Response No relevant relationships by nitish singh nandu, source=Web Response No relevant relationships by Swetha Paduri, source=Web Response No relevant relationships by Nehal Patel, source=Web Response

Ultrasound- guided balloon angioplasty of occluded artery accompanied by combined focused ultrasound sonodynamic therapy and catheter- based 125I- mediated gamma brachytherapy

Background and Aims: Three mechanisms are responsible for the development of restenosis: elastic recoil, intimal hyperplasia and late vascular constriction, all grouped under the catch phrase “negative remodeling”. Neointimal hyperplasia is usually defined in an artery as thickening of the intimal layer after an injury such as balloon angioplasty methods. The aim of this study was to evaluate the effect of combined ultrasound sonodynamic therapy and catheter- based 125I- mediated gamma brachytherapy on restenosis reduction after balloon angioplasty.

Intervention with selution SLR™ Agent Balloon for Endovascular Latent Limus therapy for failing AV Fistulas (ISABELLA) Trial: Protocol for a pilot clinical study and pre-clinical results.

The aim of this pilot clinical study is to evaluate the safety and efficacy of the Selution Sustained Limus Release (SLR)™ sirolimus-coated balloon (M.A. MedAlliance SA, Nyon, Switzerland) for improving the patency of failing arterio-venous fistulas (AVF) in hemodialysis patients. We also present herein a pre-clinical pharmacokinetic and safety evaluation of Selution™ to justify its first use in hemodialysis patients for endovascular access salvage. This is an investigator-initiated prospective single-center, non-blinded single-arm trial. Forty patients with clinically significant de novo or recurrent stenoses in a mature AVF circuit will be recruited. All stenotic lesions will be prepared with high pressure non-compliant conventional balloon angioplasty (CBA) prior to deployment of the Sustained-Release Selution™ sirolimus drug-eluting balloon. The primary efficacy endpoint is 6-month target lesion primary patency and the primary safety endpoint is freedom from localized or systemic serious adverse events through 30 days. Secondary endpoints of interest include technical and clinical success rates and circuit access patency at 3 and 6 months. Follow-up will occur for 2 years for those patients whose AVFs remain patent. Pharmacokinetic and histological animal safety studies performed with the Selution™ coating formulation showed prolonged arterial tissue retention of sirolimus with therapeutic levels up to 60 days and non-toxic and rapidly declining blood levels. Histological results in animal models demonstrated safety, freedom from intraluminal thrombus, reduction in restenosis by sirolimus elution compared to CBA, and no evidence of embolic phenomena indicative of adverse particulate effects. Long release sirolimus coated balloons may serve as a promising novel alternative therapy to paclitaxel-based technology for treating conduit stenosis secondary to neointimal hyperplasia. Pre-clinical pharmacokinetic and histological animal data are encouraging and provide suggestion of safety and efficacy in this setting. This single-center trial will provide a first step toward demonstration of efficacy and safety of this device for treatment of stenotic fistulas.

Safety, Efficacy and Acute Angiographic Outcome of the New Everolimus Eluting Stent with Correlation to Short-Term Clinical Follow-up in Patient with Acute Coronary Syndrome

Abstract Background: Drug-eluting stents are used in 80%. To 90% of revascularization procedures in the United States. Everolimus embedded in a durable polymer on a cobalt chromium Stent has shown superiority compared with Bare Metal Stents (BMS), and paclitaxel eluting stent for reduction of both late loss and binary restenosis. Aim of Study: To study the safety, efficacy and acute angiographic outcome of the new Everolimus Eluting Stent in correlation with short-term clinical follow-up in patient with Acute Coronary Syndrome (ACS). Patients and Methods: A prospective study in which ninety-five patients with (ACS), Scheduled for PCI in the cardiac catheterization laboratory in Cairo University Hospitals or NHI, using Everolimus DES, were enrolled from Jan. 2009 to June 2009. Their clinical, angiographic, interventional and follow-up data were collected and analyzed. Results: Acute success was achieved in all the cases with no device failure, after six month of follow-up, patients (94.5%) had expressed no events or chest pain, 1 patient had stable angina and refused to redo the coronary angiography, 3 patients had redo the coronary angiography due to recurrent chest pain (two of them had redo PCI in remote vessel and the other had no significant lesion), and 1 patient died because of retroperitoneal hematoma. Conclusion: The everolimus eluting stent are a safe type of drug eluting stent in clinical Practice with favorable short term outcomes in patients with acute coronary syndromes.

Cilostazol: a Review of Basic Mechanisms and Clinical Uses.

Primarily used in the treatment of intermittent claudication, cilostazol is a 2-oxyquinolone derivative that works through the inhibition of phosphodiesterase III and related increases in cyclic adenosine monophosphate (cAMP) levels. However, cilostazol has been implicated in a number of other basic pathways including the inhibition of adenosine reuptake, the inhibition of multidrug resistance protein 4, among others. It has been observed to exhibit antiplatelet, antiproliferative, vasodilatory, and ischemic-reperfusion protective properties. As such, cilostazol has been investigated for clinical use in a variety of settings including intermittent claudication, as an adjunctive for reduction of restenosis after coronary and peripheral endovascular interventions, and in the prevention of secondary stroke, although its widespread implementation for indications other than intermittent claudication has been limited by relatively modest effect sizes and lack of studies in western populations. In this review, we highlight the pleiotropic effects of cilostazol and the evidence for its clinical use.

Late endothelial progenitor cell-capture stents with CD146 antibody and nanostructure reduce in-stent restenosis and thrombosis

The restoration of damaged endothelium is promising to reduce side effects, including restenosis and thrombosis, in the stent treatment for vascular diseases. Current technologies based on drug delivery for these complications still do not satisfy patients due to invariant recurrence rate. Recently, even if one approach was applied to clinical trial to develop the firstly commercialized stent employing circulating endothelial progenitor cells (EPCs) in blood vessels, it resulted in failure in clinical trial. Based on instruction of the failed case, we designed an advanced EPC-capture stent covered with anti-CD146 antibody (Ab) immobilized silicone nanofilament (SiNf) for the highly efficient and specific capture of not early but late stage of EPCs. In vitro cell capture test demonstrates enhanced capture efficiency and adhesion morphology of late EPCs on the modified substrate. The modified substrates could capture 8 times more late EPCs and even 3 times more mesenchymal stem cells (MSCs) as compared to unmodified one. A porcine model with high similarity to human reproduced in vivo results ideally translated from in vitro cell capture results. As restenosis indicators, lumen area, neointimal rate and stenosis area for modified stents were reduced at the range of 30-60% as compared to those for bare metal stent (BMS). Fibrin score indicating thrombosis was lowered less than half as comparing to that on BMS. These inspiring results are attributed to ~2-fold increased endothelial coverage, determined by immuno-histological staining. Taken together, the CD146 Ab-armed nanofilamentous stent could show great performance in the reduction of thrombosis and restenosis through re-endothelialization due to highly efficient specific cell capture. Statement of SignificanceStents have been developed from simple metal stents to functionalized stents for past decades. However, they have still risks to relapse the occlusion in stented arteries. In this paper, we describe the fabrication and optimization of cell capturing stents to maximize the effective re-endothelialization through the serial coating of silicone nanofilaments and anti-CD146 antibody. The nanofilaments increase the amount of coated antibodies and provide the anchoring points of circulating angiogenic cells for strong focal adhesion. We demonstrate high immobilizing ability of circulating angiogenic cells (endotheliali progenitor cells and mesenchymal stem cells) in vitro under similar shear stress to coronary arteries (15 dyne/cm2). Also, we show accelerating re-endothelialization and the efficient prevention of restenosis in porcine coronary arteries in vivo.

Capturing Endothelial Cells by Coronary Stents - From Histology to Clinical Outcomes

Abstract Introduction of drug-eluting stents (DES) in the therapy of patients with coronary artery disease resulted in the significant reduction of in-stent restenosis compared to bare-metal stent (BMS) treatment. However, the high incidence of late stent thrombosis with DES emerged as one of the safety concerns after their implantation. Enhancing stent endothelization by improved early healing and neointimal strut coverage emerged as possible solution for this late complication. Endothelial progenitor cells (EPC) capturing stents are designed to promote in situ endothelization with immobilized, antihuman, anti-CD34 antibodies attached to the luminal stent surface. Anti-CD34 antibodies target and capture EPC from circulation, which further differentiate into vascular endothelial cells and form functional endothelial layer on the stent surface. These cells are also capable of secreting pro-angiogenic factors that stimulate local endothelial cells to proliferate and migrate. Preclinical and clinical studies proved feasibility, efficacy and safety of EPC capturing stents in stable and high-risk patients with coronary artery disease. Rapid and extensive endothelization of EPC capturing stents translated into favorable profile of clinical outcomes, comparable to efficacy of BMSs and DESs. Therefore, we here present the most important results from the experimental and clinical studies that explored ECP capturing strategy to enhance endothelization, reduce the incidence of instent thrombosis and improve outcomes of patients with coronary artery disease, along with the future perspectives in this promising therapeutic approach.

TCT-487 Analysis of outcomes of drug coating balloon use for of symptomatic femoropopliteal arterial disease treatment

The use of balloon angioplasty for the treatment of femoropopliteal arterial disease can be limited by the events of restenosis and need of lesion revascularization. Drug (Paclitaxel) coating balloons can improve vessel patency and restenosis reduction. Results can vary depending on different

In vivo and in vitro analyses of the effects of a novel high-nitrogen low-nickel coronary stent on reducing in-stent restenosis.

Currently, percutaneous coronary intervention is an important treatment for coronary heart disease. However, the in-stent restenosis rate is still approximately 10-30% after stenting. Nickel ions from the stent are considered to be associated with in-stent restenosis. Therefore, in the present study, we quantitatively evaluated in-stent restenosis after implanting the novel high-nitrogen low-nickel coronary stent (HNS) and studied the mechanism underlying the reduction in in-stent restenosis by using ELISA and Western blot. The in vivo results showed that the HNS could significantly reduce neointima formation and inflammation as compared to SUS316L stents (316L) at 180 days after implantation in porcine coronary arteries and that vascular endothelial growth factor-A expression in porcine coronary arteries after HNS implantation also decreased. The in vitro results showed that, in the case of the HNS, human umbilical vein endothelial cell (HUVEC) proliferation was lower and lesser IL-6 release was noted from HUVECs at one and three days after culture than in the 316L group. Furthermore, p-STAT3 expression in HUVECs on the HNS surface was downregulated after culture for seven days. Thus, we conclude that the HNS could be a promising alternative coronary stent for percutaneous coronary intervention.

Drug-coated balloon in superficial femoral artery in-stent restenosis.

The femoropopliteal artery is one of the commonest sites of involvement in peripheral artery disease (PAD) leading to intermittent claudication and/or critical limb ischemia. Endovascular therapy for superficial femoral artery (SFA) disease has been recognized as a safe and efficient therapy and is recommended by current guidelines as the first-line approach. Although the widespread use of new-generation, self-expanding, nitinol stents in SFA stenosis has reduced the shortcomings associated with plain old balloon angioplasty (POBA), lumen renarrowing at the stented (in-stent restenosis – ISR) level still represents a relevant clinical problem, because of higher risk of recurrent ISR, occlusion and surgical revascularization compared to de-novo lesions. In this setting, different treatment options are available and drug-coated balloons (DCBs) have shown good results in terms of safety and effectiveness. In this review we examine the results of different trials exploring the outcome of using DCBs for the treatment of SFA ISR. The available data demonstrate that SFA ISR can be safely treated with percutaneous transluminal angioplasty with a DCB, with a reduction in recurrent restenosis and target lesion revascularization (TLR) at least at 1 year after POBA. The consistent and positive results of different registries and randomized trials support the use of DCB to reduce SFA ISR recurrence.

Effectiveness of Tongguan capsules on restenosis after coronary stent implantation: a randomised controlled trial

BackgroundAlthough percutaneous coronary intervention (PCI) has become a widely used therapeutic procedure for coronary artery disease, stent restenosis limits the benefits of this revascularisation. The question of how to prevent such events remains unresolved. Empirical evidence suggests that Tongguan capsules, a patented Chinese Medicine, can decrease frequency and duration of angina pectoris attacks; however, evidence supporting its efficacy on restenosis remains inadequate. We aimed to determine whether Tongguan capsules could reduce restenosis incidence in patients after successful stent implantation. MethodsIn this single-centre, open-label randomised controlled trial, patients undergoing percutaneous coronary stent deployment who were aged 18–80 years were enrolled from Guangdong Provincial Hospital of Chinese Medicine and randomly assigned (1:1) to receive either Tongguan capsules for 3 months (4·5 g/day; Tongguan group) or nothing (control group). All patients received standard anti-platelet, anti-coagulation, and lipid-decreasing treatments, concurrently. The Clinical Research Centre from Guangzhou University of Chinese Medicine generated separate randomisation schedules using a random number generator. All attending physicians, investigators, and the biostatisticians performing the analysis were masked to treatment assignment. The primary clinical endpoint was the 12-month incidence of any major adverse cardiovascular event (defined as cardiac death, myocardial infarction, or recurrence of symptoms requiring additional revascularisation). The primary angiographic endpoint was restenosis incidence at 6 months. The Clinical Research Ethical Committee at Guangdong Provincial Hospital of Chinese Medicine approved the research protocol (Z2017008-01). This trial was registered in ChiCTR (ChiCTR-IIR-17011407). All participants provided written informed consent before enrolment. FindingsWe enrolled 326 patients between Aug 1, 2014, and Dec 1, 2015. Of these patients, 163 were randomly assigned to the Tongguan group and 163 to the control group. Four patients were excluded leaving 322 patients (160 in the Tongguan group and 162 in the control group) for analysis. Compared with the control group, 12-month incidence of major adverse cardiovascular events was reduced in patients treated with Tongguan capsules (12·5% [20 of 160] vs 23·5% [38 of 162], p<0·0001); 6-month restenosis incidence did not differ between groups (3·1% [five of 160] in the Tongguan group vs 4·3% [seven of 162] in the control group, p=0·779). InterpretationAlthough not significant, there was a trend towards a reduction in restenosis and therefore more research is needed to establish whether Tongguan capsules can improve clinical outcomes. Further higher quality and more rigorous randomised trials with larger sample size are needed to attain more robust clinical evidences of Tongguan capsules. FundingNational Science Foundation (81473471, 81202782, 81573708).

Safety and Effectiveness of a Bioabsorbable Steroid-Releasing Implant for the Paranasal Sinus Ostia

Suboptimal outcomes of endoscopic sinus surgery (ESS) are often associated with restenosis and inflammation of frontal sinus ostia. Steroid-releasing sinus implants have been shown to maintain sinus patency by minimizing inflammation and scar tissue formation. An hourglass-shaped, bioabsorbable, steroid-releasing implant was developed to provide mechanical support and optimize drug delivery to paranasal sinus ostia. To assess the safety and efficacy of the hourglass-shaped, bioabsorbable, steroid-releasing sinus implant in improving postoperative outcomes when placed in the frontal sinus ostia (FSO) following ESS in patients with chronic rhinosinusitis (CRS). In a prospective, multicenter, randomized clinical trial using an intrapatient control design (ESS followed by implant placement within 1 FSO vs ESS alone on the contralateral side) 80 adult patients, with a mean (SD) age of 49.5 (13.4) years and consisting of 53 (66%) men and 27 (34%) women, were enrolled and underwent bilateral frontal sinusotomies with 1 frontal sinus randomized to receive a steroid-releasing implant. The study was carried out in 12 US centers between July 2015 and March 2016. A bioabsorbable steroid-releasing implant with hourglass shape containing 370 µg of mometasone furoate. All patients received standardized postoperative care. The need for postoperative interventions, medical and surgical, in the FSO at day 30, as determined based on review of video endoscopic findings by an independent blinded surgeon. Also, endoscopic grading by the independent reviewer and clinical investigators at day 30 and day 90 and computed tomographic scan at day 90. The mean (SD) age of patients was 49.5 (13.4) years, 53 (66%) were men. Implants were successfully placed in all 80 randomized treatment sinuses. At day 30, steroid-releasing implants significantly reduced the need for postoperative interventions to 11.5% compared with 32.8% by surgery alone (mean difference, -21.3%; 95% CI, -35.1% to -7.6%), as assessed by the independent reviewer. Real-time endoscopic assessment by clinical investigators at day 30 demonstrated significant reduction in need for postoperative intervention (mean difference, -17.3%; 95% CI, -27.9% to -6.7%), significant reduction in inflammation score (mean difference, -12.3 mm; 95% CI, -18.3 to -6.4 mm), and significant reduction in rate of frontal restenosis or occlusion (mean difference, -22.7%; 95% CI, -33.5% to -11.9%) on treated compared with control sides. The results favoring the treatment sides were sustained through day 90: reduced need for postoperative interventions (mean difference, -11.7%; 95% CI, -21.0% to -2.4%) and reduction in restenosis and/or occlusion of the frontal ostium (mean difference, -17.4%; 95% CI, -28.6% to -6.1%). No implant-related adverse events were observed. The hourglass-shaped steroid-releasing sinus implant was safe and more effective in maintaining FSO patency and improving surgical outcomes compared with surgery alone in the setting where no other immediate postoperative corticosteroids were administered. ClinicalTrials.gov identifier: NCT02266810.