Association between Green Tea Consumption and In-Stent Restenosis in a Chinese Population after Percutaneous Coronary Intervention.

In spite of the remarkable advances in novel drug and revascularization procedure, in-stent restenosis (ISR) remains a major complication of percutaneous coronary intervention (PCI). The aim of this study was to investigate the association between green tea consumption and the incidence of ISR. The study population consisted of 1,509 patients who underwent PCI with drug-eluting stent (DES) implantation from January 2017 to December 2019. Patients were divided into ISR and non-ISR group according to the results of coronary angiography reexamination about 1 y after PCI. Multivariate logistic regression analysis was used to determine the relationship between green tea consumption and the risk of ISR. ISR occurred in 157/1,509 patients (10.4%) by follow-up coronary angiography. After adjusting for other confounding factors, green tea consumption was associated with a reduced risk of ISR (OR 0.653, 95%CI 0.460-0.926, p=0.017). The risk of ISR tended to decline with an increase in the quantity of green tea consumed (adjusted p for trend=0.006). The adjusted ORs for those consuming 125-249 g and ≥250 g of dried green tea leaves per month were 0.579 (95%CI, 0.346-0.970, p=0.038) and 0.501 (95%CI, 0.270-0.932, p=0.029), respectively, compared with non-tea drinkers. Moreover, significant dose-response relationships were also observed for both frequency (adjusted p for trend=0.011) and concentration (adjusted p for trend=0.004) of green tea intake on the risk of ISR. Green tea consumption can protect against the development of ISR in a Chinese population.

Effect of Rivaroxaban and Clopidogrel Combination Therapy on In-Stent Responses After Everolimus-Eluting Stent Implantation in a Porcine Coronary Model.

AIM: According to recent clinical trials, a combination of direct oral anticoagulants with antiplatelet drugs is often recommended for atrial fibrillation patients who receive drug-eluting stents (DESs). Although the optimal combination comprises direct factor Xa inhibitors and a P2Y12 receptor antagonist (or aspirin), their influence on vascular responses to DESs remains unclear. METHODS: Pigs were given either aspirin and clopidogrel (dual antiplatelet therapy [DAPT] group), aspirin and rivaroxaban (AR group), or clopidogrel and rivaroxaban (CR group), followed by everolimus-eluting stent (Promus Element) implantation into the coronary artery. Stented coronary arteries were evaluated via intravascular optical coherence tomography (OCT) and histological analysis at 1 and 3 months. RESULTS: OCT revealed lower neointimal thickness in the DAPT group and comparable thickness among all groups at 1 and 3 months, respectively. Histological analyses revealed comparable neointimal area among all groups and the smallest neointimal area in the CR group at 1 and 3 months, respectively. In the DAPT and AR groups, the neointima continued to grow from 1 to 3 months. A shortened time course for neointima growth was observed in the CR group, with rapid growth within a month (maintained for 3 months). A higher incidence of in-stent thrombi was observed in the AR group at 1 month; no thrombi were found in either group at 3 months. More smooth muscle cells with contractile features were found in the CR group at both 1 and 3 months. CONCLUSIONS: Our results proved the noninferiority of the combination of rivaroxaban with an antiplatelet drug, particularly the dual therapy using rivaroxaban and clopidogrel, compared to DAPT after DES implantation.

Limitations and Possibilities of Transarterial Chemotherapeutic Treatment of Hepatocellular Carcinoma.

Because diagnostic tools for discriminating between hepatocellular carcinoma (HCC) and advanced cirrhosis are poor, HCC is often detected in a stage where transarterial chemoembolization (TACE) is the best treatment option, even though it provides a poor survival gain. Despite having been used worldwide for several decades, TACE still has many limitations. First, there is a vast heterogeneity in the cellular composition and metabolism of HCCs as well as in the patient population, which renders it difficult to identify patients who would benefit from TACE. Often the delivered drug does not penetrate sufficiently selectively and deeply into the tumour and the drug delivery system is not releasing the drug at an optimal clinical rate. In addition, therapeutic effectiveness is limited by the crosstalk between the tumour cells and components of the cirrhotic tumour microenvironment. To improve this widely used treatment of one of our most common and deadly cancers, we need to better understand the complex interactions between drug delivery, local pharmacology, tumour targeting mechanisms, liver pathophysiology, patient and tumour heterogeneity, and resistance mechanisms. This review provides a novel and important overview of clinical data and discusses the role of the tumour microenvironment and lymphatic system in the cirrhotic liver, its potential response to TACE, and current and possible novel DDSs for locoregional treatment.

Preclinical Evaluation of a Novel Polymer-free Everolimus-eluting Stent in a Mid-term Porcine Coronary Restenosis Model.

BACKGROUND: Titanium dioxide films exhibit good biocompatibility and may be effective as drug-binding matrices for drug-eluting stents. We conducted a mid-term evaluation of a novel polymer-free everolimus-eluting stent using nitrogen-doped titanium dioxide film deposition (TIGEREVOLUTION®) in comparison with a commercial durable polymer everolimus-eluting stent (XIENCE Alpine®) in a porcine coronary restenosis model. METHODS: Twenty-eight coronary arteries from 14 mini-pigs were randomly allocated to TIGEREVOLUTION® stent and XIENCE Alpine® stent groups. The stents were implanted in the coronary artery at a 1.1-1.2:1 stent-to-artery ratio. Eleven stented coronary arteries in each group were finally analyzed using coronary angiography, optical coherence tomography, and histopathologic evaluation 6 months after stenting. RESULTS: Quantitative coronary analysis showed no significant differences in the pre-procedural, post-procedural, and 6-month lumen diameters between the groups. In the volumetric analysis of optical coherence tomography at 6 months, no significant differences were observed in stent volume, lumen volume, and percent area stenosis between the groups. There were no significant differences in injury score, inflammation score, or fibrin score between the groups, although the fibrin score was zero in the TIGEREVOLUTION® stent group (0 vs. 0.07 ± 0.11, P = 0.180). CONCLUSION: Preclinical evaluation, including optical coherence tomographic findings 6 months after stenting, demonstrated that the TIGEREVOLUTION® stent exhibited efficacy and safety comparable with the XIENCE Alpine® stent, supporting the need for further clinical studies on the TIGEREVOLUTION® stent.

Assessment of utility values and QALYs after primary PCI with DP-Xience and BP-Biomatrix stents.

BACKGROUND: Primary percutaneous coronary intervention (PPCI) is the recommended treatment in ST elevated myocardial infarction (STEMI). The determination of Quality of life (QoL) for various options of coronary revascularization is important for establishment of a comprehensive care plan. Studies of QoL in interventional cardiology are scarce. Our study has compared utility scores and quality adjusted life year (QALY) of 2nd and 3rd generation drug eluting stents (DES). METHODS: An observational cohort study was conducted to evaluate QoL and QALY using EQ-5D-5L questionnaire. Patients undergoing PPCI between July-Dec 2019 were evaluated after completion of one year of procedure. RESULTS: Total 334 patients were evaluated, study population consisted of a greater number of males (87.13%) than females. Mean utility value was more in 3rd G Biomatrix stents; 0.829 ± 0.11 than 2nd G Xience stents; 0.794 ± 0.11 (p < 0.05). Visual analogue scale (VAS) value was also high in 3rd G DES (81.84 ± 8.29) as compared to 2nd G DES (77.81 ± 9.01); p< 0.05. A significant association was found between utility scores/VAS and age, DM, HTN, Current smoking, family history and CAD diagnosis. There was a gain of 0.035 QALY with the use of Biomatrix DES. CONCLUSION: Health related quality of life (HRQOL) is a leading support in the decision making of therapeutic interventions. Our study has found that Biodegradable polymer (BP) Biomatrix DES are superior to the Durable polymer (DP) Xience DES having better QoL and QALY.

A randomized comparison of a novel iopromide-based paclitaxel-coated balloon Shenqi versus SeQuent Please for the treatment of in-stent restenosis.

BACKGROUND: Treatment of coronary in-stent restenosis (ISR) remains challenging in contemporary clinical applications. Drug-coated balloon (DCB) angioplasty offers an effective treatment for ISR. Shenqi is a novel iopromide-based paclitaxel-coated balloon and its clinical safety, effectiveness and angiographic efficacy in patients with ISR have not been investigated. METHODS: A total of 216 subjects with the first occurrence of ISR at 11 investigational sites in China were randomly allocated in a 1:1 fashion to treatment with DCB SeQuent Please or Shenqi. Clinical follow-up was planned at 1, 6, 9 and 12 months, and angiographic follow-up was planned at 9 months. The study was powered for the primary endpoint of 9-month in-segment late loss. RESULTS: At 9-month follow-up, the in-segment late loss was 0.29 ± 0.43 mm with Shenqi versus 0.30 ± 0.46 mm with SeQuent Please, and the one-sided 97.5% upper confidence limit of the difference was 0.14 mm, achieving noninferiority of Shenqi compared with SeQuent Please (P = 0.002). In total, 12 patients developed target lesion failure (TLF) in the Shenqi group compared with 16 patients in the SeQuent Please group (10.91% versus 15.09%; P = 0.42) within 1 year. TLF was mainly driven by target lesion revascularization (9.09%) followed by target vessel-related myocardial infarction (1.82%) and cardiovascular death (0.91%) in the Shenqi group. CONCLUSIONS: Shenqi DCB was noninferior to SeQuent Please DCB for the primary endpoint of 9-month in-segment late loss. Shenqi DCB may become an attractive alternative treatment for patients with coronary ISR, withholding the need for additional stent implantation.

Preclinical investigation of neoatherosclerosis in magnesium-based bioresorbable scaffolds versus thick-strut drug-eluting stents.

AIMS: Neoatherosclerosis is a frequent finding after implantation of permanent metallic stents. Bioresorbable scaffolds (BRS) are considered to reduce the incidence of neoatherosclerosis owing to their dissolution and consequent vascular restoration. The aim of this study was to evaluate the formation of neoatherosclerosis between magnesium-based BRS and thick-strut metallic drug-eluting stents (DES) in a rabbit model of neoatherosclerosis and in proportion to the effect of high-dose statin medication. METHODS AND RESULTS: Fully bioresorbable magnesium scaffolds (BRS, n=45) and thick-strut permanent metallic DES of equivalent geometry and design (n=45) were implanted into the iliac arteries of New Zealand White rabbits (n=45) following endothelial balloon injury and exposure to a cholesterol diet. Endothelialisation was assessed in 12 animals after 35 days using scanning electron microscopy (SEM), showing significantly enhanced re-endothelialisation above struts in the BRS (n=13) compared to DES (n=10). Eleven (11) animals were terminated for baseline assessment after 91 days while the remaining 22 animals were randomised to receive high-dose statin treatment (3 mg/kg) or placebo. BRS-treated vessels showed a significant reduction in foam cell infiltration as a sign of early neoatherosclerosis by histology and OCT when compared to thick-strut DES-treated vessels. Statin treatment resulted in significant reduction of foam cell infiltration in BRS and DES by histology. CONCLUSIONS: Our findings suggest reduced neoatherosclerosis formation in magnesium-based BRS relative to thick-strut DES. High-dose statin treatment may be a promising measure to reduce neoatherosclerosis progression, both on its own and in synergy with site-targeted device-based treatment.

Injectable Pasty Biodegradable Polyesters Derived from Castor Oil and Hydroxyl-Acid Lactones.

Pasty polymers offer a platform for injectable implants for drug delivery. A library of biodegradable pasty polymers was synthesized by bulk ring-opening polymerization of lactide, glycolide, trimethylene carbonate, or caprolactone using castor oil or 12-hydroxy stearic acid as hydroxyl initiators and stannous octoate as the catalyst. Some of the polymers behaved as Newtonian liquids. Pasty polymers of poly(caprolactone) and poly(trimethylene carbonate) were stable under physiologic conditions for over 1 month in vitro, whereas polymers of poly(lactic-co-glycolic acid) degraded within 10 days. These pasty polymers offer a platform for pasty injectable biodegradable carriers for drugs and fillers. SIGNIFICANCE STATEMENT: New injectable pasty, in situ forming drug delivery systems are described and are advantageous due to their ease of administration, tunable viscosity, and biodegradability. Polyesters based on lactide, glycolide, trimethylene carbonate, and caprolactone, which are commonly used as absorbable implants and drug carriers, were conjugated onto natural hydroxyl fatty acids. These polymers have potential use as wrinkle fillers and drug carriers.

Long-Term Clinical and Angiographic Outcomes After Implantation of New-Generation Drug-Eluting Stents for Patients on Maintenance Hemodialysis.

Prior research has revealed poorer clinical outcomes after drug-eluting stent (DES) implantation for hemodialysis patients. This study aims to investigate the long-term clinical and angiographic outcomes after new-generation DES implantation for hemodialysis patients.We retrospectively enrolled 91 consecutive patients (118 lesions) who underwent successful new-generation DES (everolimus-, zotarolimus-, and biolimus-eluting stents) implantation for the first time. We measured the serum calcium and phosphorus levels in the blood samples obtained just before hemodialysis. The follow-up period of clinical events was, at least, 1.5 years. In this study, major adverse cardiac and cerebrovascular events (MACCE) and clinically driven target lesion revascularization were reported in 36 (39.6%) and 11 (12.1%) patients, respectively. The prevalence of peripheral artery disease was significantly higher in the MACCE group (41.7% versus 14.5%, P = 0.006). The serum calcium level was significantly higher in the MACCE group (9.34 ± 0.92 mg/dL versus 8.77 ± 0.88 mg/dL; P = 0.004). The multivariate Cox proportional hazards model revealed that the serum calcium level (hazard ratio, 1.86; 95% confidence interval [CI]: 1.26-2.77; P = 0.002), suboptimal (over 55 mg2/dL2) calcium-phosphorus product (hazard ratio, 3.27; 95% CI: 1.41-7.61; P = 0.006) and the coexistence of peripheral artery disease (hazard ratio, 3.15; 95% CI: 1.49-6.65; P = 0.003) were independent predictors of MACCE.For hemodialysis patients, MACCE remains a frequent occurrence after new-generation DES implantation and is associated with calcium-phosphate metabolism and peripheral artery disease.

Biomimetic engineering endothelium-like coating on cardiovascular stent through heparin and nitric oxide-generating compound synergistic modification strategy.

Co-immobilization of two or more molecules with different and complementary functions to prevent thrombosis, suppress smooth muscle cell (SMC) proliferation, and support endothelial cell (EC) growth is generally considered to be promising for the re-endothelialization on cardiovascular stents. However, integration of molecules with distinct therapeutic effects does not necessarily result in synergistic physiological functions due to the lack of interactions among them, limiting their practical efficacy. Herein, we apply heparin and nitric oxide (NO), two key molecules of the physiological functions of endothelium, to develop an endothelium-mimetic coating. Such coating is achieved by sequential conjugation of heparin and the NO-generating compound selenocystamine (SeCA) on an amine-bearing film of plasma polymerized allylamine. The resulting surface combines the anti-coagulant (anti-FXa) function provided by the heparin and the anti-platelet activity of the catalytically produced NO. It also endows the stents with the ability to simultaneously up-regulate α-smooth muscle actin (α-SMA) expression and to increase cyclic guanylate monophosphate (cGMP) synthesis of SMC, thereby significantly promoting their contractile phenotype and suppressing their proliferation. Importantly, this endothelium-biomimetic coating creates a favorable microenvironment for EC over SMC. These features impressively improve the antithrombogenicity, re-endothelialization and anti-restenosis of vascular stents in vivo.

Safety and efficacy of zotarolimus-eluting stents in the treatment of diabetic coronary lesions in Chinese patients: The RESOLUTE-DIABETES CHINA Study.

BACKGROUND: The RESOLUTE-DIABETES CHINA study was specifically designed to investigate the safety and efficacy of Resolute zotarolimus-eluting stents (ZES; Medtronic, Santa Rosa, CA, USA) in the treatment of diabetic coronary lesions in the Chinese population. METHODS: In all, 945 patients with de novo native coronary lesions and type 2 diabetes mellitus were recruited at 32 cardiac centers across the Chinese mainland and were implanted with Resolute ZES. The primary endpoint was target vessel failure (TVF); secondary endpoints were clinical outcomes, namely all-cause death, stroke, bleeding, target lesion revascularization (TLR), target vessel revascularization (TVR), non-TVR, and stent thrombosis (ST). The follow-up period for all endpoints was 12 months after the procedure. RESULTS: In all, 933 patients (98.73%) had clinical follow-up at 12 months. The rate of TVF was 11.60%, whereas the rate of occurrence of secondary endpoints was 5.47%, with four patients (0.43%) having subacute or late ST. There were no significant differences in TVF rates comparing patients with different HbA1c levels or receiving different glucose control treatments (all P > 0.05). Patients with multivessel lesions had higher TVF rates (95% confidence intervals) than those with single-vessel lesions (16.76% [12.10%-22.97%) vs 9.72% [7.79%-12.11%], respectively; P = 0.006). There were no significant differences in TVF rates in patients with or without small vessels, bifurcated lesions, or chronic total occlusions (all P > 0.05). [Correction added on 17 January 2019, after first online publication: in the second sentence of Results section, "TLF" was changed to "TVF".]. CONCLUSIONS: Resolute ZES may perform well in the Chinese diabetic population, especially in those with poor glucose control, complex lesions, and certain unfavorable clinical features. Further studies are needed to determine why ZES perform well in this population.

A Biodegradable Stent with Surface Functionalization of Combined-Therapy Drugs for Colorectal Cancer.

In-stent restenosis caused by tumor ingrowth is a major problem for patients undergoing stent placement because conventional stents often lack sustainable antitumor capabilities. The aim of this work is to develop a silk fibroin (SF)-based nanofibrous membrane that is loaded with combined-therapy drugs by using electrospinning technologies, which is further coated on a polydioxanone (PDO) stent and used for the treatment of colorectal cancer (CRC). In order to improve treatment effectiveness, a combination of therapeutic drugs, i.e., curcumin (CUR) and 5-fluorouracil (5-FU), is dissolved into SF solution and then eletrospun onto the surface of the PDO stent. The morphology, secondary structure, and in vitro drug release profiles of the membranes are characterized. The antitumor efficacy is assessed in vitro and in vivo using a human CRC cell line and normal cells, and tumor-bearing nude mice. In vitro and in vivo studies on the nanofibrous memembrane-coating demonstrate improved antitumor effects for the CUR/5-FU dual drug system which can be attributed to cell cycle arrest in the S phase in association with induced apoptosis in tumor cells by blocking signal transducer and activator of transcription3 (Stat3) and nuclear factor kappa beta (NF-kB) signaling pathways, suggesting potential in the treatment of CRC in the future.

The Effect of Hyperbaric Oxygen Therapy on Myocardial Perfusion after the Implantation of Drug-Eluting Stents.

AIM: The study is to investigate hyperbaric oxygen therapy (HBOT) on myocardial perfusion of patients after the implantation of drug-eluting stents (DES) METHODS: From December 2013 to December 2015, a total of 115 patients with CAD who received DES implantation were included in this retrospective study. They were divided into HBOT group (n=55) and control group (n=60) according to different treatments retrospectively. Gated myocardial perfusion single photon emission computed tomography (SPECT) was conducted in all the patients. Endothelin-1 (ET-1), high sensitivity C reactive protein (hs-CRP) and nitric oxide (NO) were detected by the corresponding assay kits. RESULTS: After HBOT treatment in HBOT group, SPECT results showed that the improvement rate of impaired sub-segments in patients of HBOT was significantly higher than that in control group (P<0.05), and the parameters of PFR, TPFR, MFR/3 were displayed with marked differences between the two groups (P<0.05). The laboratory results demonstrated a statistically increased level of NO and decreased levels of ET-1 and hs-CRP between the two groups (P<0.05). CONCLUSIONS: HBO may improve myocardial blood perfusion, reduce inflammation and vascular endothelial dysfunction, and further improve myocardial microcirculation in patients after the implantation of drug-eluting stents.

5-Year Outcome Following Randomized Treatment of All-Comers With Zotarolimus-Eluting Resolute Integrity and Everolimus-Eluting PROMUS Element Coronary Stents: Final Report of the DUTCH PEERS (TWENTE II) Trial.

OBJECTIVES: The study sought to evaluate for the first time the 5-year outcomes after treating an all-comers population with newer-generation cobalt chromium-based Resolute Integrity zotarolimus-eluting stents (ZES) (Medtronic, Santa Rosa, California) versus platinum chromium-based PROMUS Element everolimus eluting stents (EES) (Boston Scientific, Natick, Massachusetts). BACKGROUND: The DUTCH PEERS (TWENTE II) (DUrable polymer-based sTent CHallenge of Promus ElemEnt versus ReSolute integrity: TWENTE II) trial is a randomized, multicenter, single-blinded, investigator-initiated all-comers trial that found at its main analysis similar 1-year safety and efficacy for both drug-eluting stents. It is the first randomized trial ever to investigate the Resolute Integrity ZES and the first trial to compare both devices. METHODS: In total, 1,811 patients were 1:1 randomized to ZES versus EES. We performed a pre-specified assessment of the 5-year clinical outcomes in terms of safety and efficacy. The main endpoint target vessel failure (TVF) is a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization. Secondary endpoints included the individual components of TVF, and stent thrombosis. The study was independently monitored, and adverse clinical events were independently adjudicated. RESULTS: Five-year clinical follow-up data was available in 1,798 (99.3%) patients. The ZES and EES groups showed favorable outcomes, with similar 5-year incidence of TVF (13.2% vs. 14.2%; plog-rank = 0.62) and its individual components: cardiac death (4.5% vs. 4.9%; plog-rank = 0.69), target vessel-related myocardial infarction (3.1% vs. 2.6%; plog-rank = 0.47), and target vessel revascularization (7.6% vs. 8.6%; plog-rank = 0.46). The 5-year incidence of definite or probable stent thrombosis was similar (1.5% vs. 1.3%; plog-rank = 0.83). CONCLUSIONS: At 5-year follow-up, the Resolute Integrity ZES and PROMUS Element EES showed similar and sustained results in terms of safety and efficacy for treating a broad population of all-comers.

Comparison of the 9-month intra-stent conditions and 2-year clinical outcomes after Resolute zotarolimus-eluting stent implantation between 3-month and standard dual antiplatelet therapy.

BACKGROUND: The use of short-duration dual antiplatelet therapy (DAPT) remains controversial. To investigate efficacy and safety of short-duration DAPT, we performed a detailed comparison of intra-stent conditions by optical coherence tomography (OCT) after second-generation drug-eluting stent implantation with short-term and standard DAPT. METHODS AND RESULTS: Eighty-two consecutive patients with stable angina pectoris who received Resolute zotarolimus-eluting stents (R-ZESs; Medtronic Cardiovascular, Santa Rosa, CA, USA) were enrolled. Patients were assigned to 3-month (3M group: 41 patients) and standard (standard group: 41 patients) DAPT. In the 3M group, clopidogrel was discontinued 3 months after stent implantation. In the standard group, DAPT was maintained until follow-up OCT. At 9 months, neointimal proliferation was significantly larger in the 3M group, but there were no significant between-group differences in the proportion of uncovered and malapposed strut. The prevalence of abnormal intra-stent tissue (AIT) at 9 months was equivalent between groups. A multiple regression analysis revealed malapposition at 9 months as the strongest independent predictor of AIT at 9 months, and the prevalence of AIT was not associated with DAPT duration. Over 2 years, cardiac events were equal between groups; however, major bleeding was higher tendency in the standard group than in the 3M group. CONCLUSION: This OCT study indicated that reducing DAPT's duration may provide acceptable arterial healing in patients with implanted R-ZESs.

In vivo serial invasive imaging of the second-generation drug-eluting absorbable metal scaffold (Magmaris - DREAMS 2G) in de novo coronary lesions: Insights from the BIOSOLVE-II First-In-Man Trial.

RATIONALE: Bioresorbable scaffolds may confer clinical benefit in long-term studies; early mechanistic studies using intravascular imaging have provided insightful information about the immediate and mid-term local serial effects of BRS on the coronary vessel wall. OBJECTIVES: We assessed baseline, 6- and 12-month imaging data of the drug-eluting absorbable metal scaffold (DREAMS 2G). METHODS AND RESULTS: The international, first-in-man BIOSOLVE-II trial enrolled 123 patients with up to 2 de novo lesions (in vessels of 2.2 to 3.7mm). Angiographic based vasomotion, curvature and angulation were assessed; intravascular ultrasound (IVUS) derived radiofrequency (RF) data analysis and echogenicity were evaluated; optical coherence tomography (OCT) attenuation and backscattering analysis were also performed. There was hardly any difference in curvature between pre-procedure and 12months (-0.0019; p=0.48). The change in angulation from pre- to 12months was negligible (-3.58°; 95% CI [-5.97, -1.20]), but statistically significant. At 6months, the change in QCA based minimum lumen diameter in response to high dose of acetylcholine and IVUS-RF necrotic core percentage showed an inverse relationship (estimate of -0.489; p=0.055) and with fibrous volume a positive relationship (estimate of 0.53, p=0.035). Bioresorption analysis by OCT showed that the maximum attenuation values decreased significantly from post-procedure at 6months (Δ 6months vs. post-proc. is -13.5 [95% CI -14.6, -12.4]) and at 12months (Δ 12months vs. post-proc. is -14.0 [95% CI -15.4, -12.6]). By radiofrequency data, the percentage of dense calcium decreased significantly from post-procedure at 6months and at 12months. Likewise, by echogenicity, hyperechogenic structures decreased significantly from post-procedure at 6months; thereafter, they remained unchanged. CONCLUSION: Following implantation of DREAMS 2G, restoration of the vessel geometry, vasomotion and bioresorption signs were observed at up to 12months; importantly, these changes occurred with preservation of the lumen size between 6 and 12months. NCT01960504.

Preclinical therapeutic efficacy of the ciprofloxacin-eluting sinus stent for Pseudomonas aeruginosa sinusitis.

BACKGROUND: The ciprofloxacin-coated sinus stent (CSS) has unique therapeutic potential to deliver antibiotics to the sinuses. The objective of this study is to evaluate the efficacy of the CSS stent in eliminating Pseudomonas aeruginosa infection in a rabbit model of sinusitis. METHODS: A ciprofloxacin-eluting sinus stent was created by coating ciprofloxacin/Eudragit RS100 on biodegradable poly-D/L-lactic acid (2 mg). After analyzing in-vitro inhibition of P aeruginosa (PAO-1 strain) biofilm formation, a total of 8 stents (4 shams, 4 CSSs) were placed unilaterally in rabbit maxillary sinuses via dorsal sinusotomy after inducing infection for 1 week with PAO-1. Animals were assessed 2 weeks after stent insertion with nasal endoscopy, sinus culture, computed tomography (CT) scan, histopathology, and scanning electron microscopy (SEM). RESULTS: PAO-1 biofilm formation was significantly reduced in vitro with exposure to the CSS (p < 0.0001). Insertion of the stent in PAO-1-infected rabbits for 2 weeks resulted in significant improvement in sinusitis according to endoscopy scoring (p < 0.0001) and CT scoring (p < 0.002). Histology and SEM revealed marked improvement in the structure of the mucosa and submucosa with no detection of biofilm structures in the CSS cohort. CONCLUSION: Although this study had a small sample size, we identified robust therapeutic efficacy of the CSS by reducing bacterial load and biofilm formation of P aeruginosa in a preclinical model of sinusitis after placement for 2 weeks.

Impact of Serum Phosphorus Levels on Outcomes After Implantation of Drug-Eluting Stents in Patients on Hemodialysis.

BACKGROUND: Elevated serum phosphorus level is an important risk factor for cardiovascular death in general patients on hemodialysis (HD). However, the effect of serum phosphorus levels on outcomes after drug-eluting stent (DES) implantation in HD patients is unknown.Methods and Results:This was a post-hoc study of the OUCH study series, a series of prospective multicenter registries of HD patients who underwent DES implantation comprising 359 patients from 31 centers in Japan. Patients were categorized into 3 groups according to their preprocedural serum phosphorus levels. The 1-year clinical outcomes of the 336 patients treated for de novo lesions were evaluated. Compared with patients with high (>5.5 mg/dL; n=65) or normal (3.5-5.5 mg/dL; n=219) serum phosphorus levels, those with low serum phosphorus levels (<3.5 mg/dL; n=52) had significantly fewer target lesion revascularization events (13.9% vs. 16.9% vs. 1.9%; P=0.0090) and major adverse cardiac and cerebrovascular events (29.2% vs. 31.1% vs. 13.5%; P=0.032). Multivariate logistic regression analysis revealed that low serum phosphorus level was an independent negative predictor for major adverse cardiac and cerebrovascular events (adjusted odds ratio, 0.31; 95% confidence interval, 0.12-0.70; P=0.0036). CONCLUSIONS: Lowering of serum phosphorus levels beyond the current recommended range may be considered in HD patients who undergo DES implantation.

Acute myocardial infarction in yellow oleander poisoning.

Self-harm by consuming yellow oleander seeds has become more frequent in South Asian countries, especially Sri Lanka and in southern parts of India. Yellow oleander poisoning usually presents with gastrointestinal, cardiovascular, and neurological manifestations as well as electrolyte abnormalities. Cardiac effects can manifest as nearly any type of dysrhythmia and sudden death with very few premonitory signs. To our knowledge yellow oleander poisoning related acute myocardial infarction has not yet been reported. We report a 37-year-old man with yellow oleander poisoning who had normal sinus rhythm at presentation but within few hours developed acute ST-segment myocardial infarction.