Comparison of a Novel Biodegradable Polymer Sirolimus-Eluting Stent With a Durable Polymer Everolimus-Eluting Stent: 5-Year Outcomes of the Randomized BIOFLOW-II Trial

Objectives

The authors aimed to compare long-term data of an ultrathin cobalt-chromium stent with passive silicon carbide coating and an active biodegradable polymer that releases sirolimus (O-SES) (Orsiro, BIOTRONIK, Bülach, Switzerland) with the durable polymer-based Xience Prime everolimus-eluting stent (X-EES) (Abbott Vascular, Santa Clara, California).

A Randomized Trial Comparing the NeoVas Sirolimus-Eluting Bioresorbable Scaffold and Metallic Everolimus-Eluting Stents

Objectives

The authors sought to evaluate the safety and effectiveness of the NeoVas bioresorbable scaffold (BRS) compared with metallic drug-eluting stents.

Prophylactic Pancreatic Stents: Does Size Matter? A Comparison of 4-Fr and 5-Fr Stents in Reference to Post-ERCP Pancreatitis and Migration Rate

Background and Aims  

The ideal pancreatic stent to prevent post-ERCP pancreatitis (PEP) has yet to be determined. The aim of our study was to assess the relative benefit of 4-Fr versus 5-Fr stents in a population at high risk for post-ERCP pancreatitis, and the relative frequency of spontaneous migration.     

A Randomized Comparison of Chloroquine versus Dihydroartemisinin–Piperaquine for the Treatment of Plasmodium vivax Infection in Vietnam

A total of 128 Vietnamese patients with symptomatic Plasmodium vivax mono-infections were enrolled in a prospective, open-label, randomized trial to receive either chloroquine or dihydroartemisinin–piperaquine (DHA-PPQ). The proportions of patients with adequate clinical and parasitological responses were 47% in the chloroquine arm (31 of 65 patients) and 66% in the DHA-PPQ arm (42 of 63 patients) in the Kaplan–Meier intention-to-treat analysis (absolute difference 19%, 95% confidence interval = 0–37%), thus establishing non-inferiority of DHA-PPQ. Fever clearance time (median 24 versus 12 hours, P = 0.02), parasite clearance time (median 36 versus 18 hours, P < 0.001), and parasite clearance half-life (mean 3.98 versus 1.80 hours, P < 0.001) were all significantly shorter in the DHA-PPQ arm. All cases of recurrent parasitemia in the chloroquine arm occurred from day 33 onward, with corresponding whole blood chloroquine concentration lower than 100 ng/mL in all patients. Chloroquine thus remains efficacious for the treatment of P. vivax malaria in southern Vietnam, but DHA-PPQ provides more rapid symptomatic and parasitological recovery.     

Pharmacology and Pharmacokinetics of A Novel Nonpeptide Angiotensin II Receptor Antagonist–DMP 811

DMP 811 exhibited high binding affinity for the angiotensin II subtype receptor AT₁ in rat adrenal tissues with an IC₅₀ of 6 nM, but not for the subtype receptor AT₂. In the isolated rabbit aorta, DMP 811 inhibited the contractile response to angiotensin II selectively and noncompetitively with a K_B value of 0.1 nM. In conscious renal hypertensive rats, DMP 811 decreased blood pressure with i.v. and p.o. ED3_30s of 0.005 and 0.03 mg/kg, respectively (p.o. ED₃₀ for losartan=0.59 mg/kg). In conscious furosemide-treated dogs, DMP 811 given either at 0.3 or 1 mg/kg p.o. decreased blood pressure. DMP 811 has oral bioavailabilities of 7 and 29% in rats and dogs, respectively, after a solution dose and 8 and 13%, respectively, after a suspension or capsule dosing. Our study indicates that DMP 811 is a selective and insurmountable AT₁ receptor antagonist and is a 20-fold more potent orally-active antihypertensive agent than losartan.     

Comparison of UHPLC and HPLC in Benzodiazepines Analysis of Postmortem Samples: A Case–Control Study

The aim of this study was to compare system efficiency and analysis duration regarding the solvent consumption and system maintenance in high-pressure liquid chromatography (HPLC) and ultra high-pressure liquid chromatography (UHPLC).In a case–control study, standard solutions of 7 benzodiazepines (BZs) and 73 biological samples such as urine, tissue, stomach content, and bile that screened positive for BZs were analyzed by HPLC and UHPLC in laboratory of forensic toxicology during 2012 to 2013. HPLC analysis was performed using a Knauer by 100-5 C-18 column (250 mm × 4.6 mm) and Knauer photodiode array detector (PAD). UHPLC analysis was performed using Knauer PAD detector with cooling autosampler and Eurospher II 100-3 C-18 column (100 mm × 3 mm) and also 2 pumps. The mean retention time, standard deviation, flow rate, and repeatability of analytical results were compared by using 2 methods.Routine runtimes in HPLC and UHPLC took 40 and 15 minutes, respectively. Changes in mobile phase composition of the 2 methods were not required. Flow rate and solvent consumption in UHPLC decreased. Diazepam and flurazepam were detected more frequently in biological samples.In UHPLC, small particle size and short length of column cause effective separation of BZs in a very short time. Reduced flow rate, solvent consumption, and injection volume cause more efficiency and less analysis costs. Thus, in the detection of BZs, UHPLC is an accurate, sensitive, and fast method with less cost of analysis.     

Efficacy and Safety of Lumen-Apposing Metal Stents in Management of Pancreatic Fluid Collections: Are They Better Than Plastic Stents? A Systematic Review and Meta-Analysis

Background and Aims

Endoscopic ultrasound (EUS)-guided transmural drainage has been increasingly utilized as a first-line therapeutic modality for drainage of pancreatic fluid collections (PFC). Recently, lumen-apposing metal stents (LAMS) have been utilized for management of PFCs. We conducted a systematic review and meta-analysis to evaluate the cumulative efficacy and safety of LAMS in the management of PFC (primary outcome). We also compared the efficacy and safety of LAMS with multiple plastic stents (MPS) in the management of PFC (secondary outcome).

Methods

We searched Medline, Embase and Cochrane databases from inception to November 5, 2016, to identify studies (with ≥ 10 patients) reporting technical success, clinical success, and adverse events (AE) of EUS-guided transmural drainage of PFC using LAMS. Weighted pooled rates (WPR) were calculated for technical success, clinical success and AE. Risk ratios (RR) were calculated and pooled to compare LAMS with MPS in terms of technical success, clinical success, and AE. Pooled mean difference (MD) was calculated to compare the number of endoscopic sessions required by each type of stent to achieve clinical success. All analyses were done using random effects model.

Results

Eleven studies with 688 patients were included in this meta-analysis. WPR for technical success of LAMS in PFC management was 98% (96, 99%), (I ² = 15%). WPR for clinical success was 93% (89, 96%) with moderate heterogeneity (I ² = 50%). There was no difference in clinical success for pseudocysts (PP) versus walled-off pancreatic necrosis (WON) (P = 0.51). WPR for AE was 13% (9, 20%), (I ² = 64%). AE were 10% more in WON as compared to PP (P = 0.009). Most common AE requiring intervention was stent migration (4.2%), followed by infection (3.8%), bleeding (2.4%), and stent occlusion (1.9%). Six studies with 504 patients compared the performance of LAMS with MPS. Pooled RR for technical success was 1.71 (0.38, 7.37). Pooled RR for clinical success was 0.37 (0.20, 0.67) in favor of LAMS. Pooled RR for AE was 0.39 (0.18, 0.84), (I ² = 50%). Pooled MD for number of endoscopic sessions was ? 0.84 (? 1.69, 0.01).

Conclusions

LAMS seem to have excellent efficacy and safety in the management of PFCs. They may be preferred over plastic stents as they are associated with better clinical success and lesser adverse events.

     

A Comparison of Clinical Manifestations and Prognoses Between Patients with Hepatocellular Carcinoma and Child–Pugh Scores of 5 or 6

The objective of this work is to compare the outcomes between the Child–Pugh score 5 (A5 group) and Child–Pugh score 6 (A6 group) in patients with hepatocellular carcinoma (HCC).Whether HCC patients with A5 and A6 groups have different prognoses is still obscure.We enrolled 2462 consecutive treatment-naive HCC patients from 2007 to 2012. Among them, 1486 patients had Child–Pugh grade A, including 1016 in the A5 group and 470 in the A6 group. Factors in the prognoses were analyzed by multivariate analysis.Compared with those in the A6 group, patients in the A5 group were younger, had higher proportions of tumors within the Milan criteria, and more of them underwent curative therapies. The cumulative survival rates at 5 years were 51.3% and 37.1% for patients in the A5 and A6 groups, respectively (P < 0.001). Multivariate analysis showed that the independent risk factors associated with poor overall survival were nonhepatitis C virus carrier, serum albumin ≤4 g/dL, aspartate aminotransferase >45 U/L, α-fetoprotein >20 ng/mL, multinodularity, tumor size >3 cm, vascular invasion, and noncurative therapies, but not the Child–Pugh numeric score. The Child–Pugh numeric score had a significant prognostic effect only in patients who had tumors beyond the Milan criteria and received noncurative therapies.HCC patients with A5 group had a better overall survival rate than those with A6 group due to the early tumor stage and higher rate of receiving curative treatments. Tumor factors and treatment modalities were more important than the Child–Pugh numeric score.     

Comparison of the epidemiology and microbiology of peripheral line– and central line–associated bloodstream infections

We retrospectively studied the epidemiology and microbiology of peripheral line–associated bloodstream infection (PLABSI) in comparison with central line–associated bloodstream infection (CLABSI). Among 2,208 bacteremia episodes, 106 (4.8%) PLABSI and 229 (10.4%) CLABSI were identified. In PLABSI, gram-negative rods, especially Enterobacteriaceae, were more frequently identified than in CLABSI, and infectious disease consultation was more frequently involved. The 7-day mortality rate was similar between the 2 groups, suggesting similar adverse effects of PLABSI and CLABSI on patient outcomes.     

Leptin in Pituitary Adenomas–A Novel Paracrine

A growing number of physiological and pathophysiological processes have been shown to be influenced by leptin apart from its first recognised role as a modulator of hypothalamic appetite and weight control centers. We investigated the presence and pattern of distribution of leptin mRNA and the mRNA of the long isoform of the leptin receptor in the normal pituitary and in different types of pituitary adenomas. We also studied leptin secretion from human pituitary tumors in culture, and the in vitro pituitary hormone release following stimulation with human leptin. Leptin mRNA expression was detected at a low level of expression in 50% of tumors but in none of the normal pituitaries. By immunohistochemistry, leptin was present in occasional scattered cells in the normal pituitary and in pituitary tumors. The leptin receptor long isoform was detected in the majority (65%) of pituitary tumors and in all normal pituitaries. It did not segregate with any particular tumor type, and varying levels of expression were detected between the tissues studied. 34% of pituitary adenomas showed leptin release into the incubation media during in vitro culture. Leptin mRNA, the mRNA of the long isoform of the receptor, or in vitro leptin release, did not correlate with tumor type or with any of the other pituitary hormones released. In vitro leptin stimulation of pituitary tumors caused stimulation of FSH and -subunit secretion from a non-functioning adenoma and TSH secretion from a somatotroph adenoma. As the co-localisation of ACTH and leptin in corticotroph cells was previously suggested, we investigated whether in vivo ACTH release is accompanied by a simultaneous plasma leptin level rise (i) in peripheral plasma samples after food intake-induced ACTH rise in healthy obese and nonobese individuals and (ii) in petrosal sinus samples after CRH injection in Cushing's disease patients. Our data suggest that a rise in ACTH levels is not accompanied by detectable rise in leptin levels in peripheral and in petrosal sinus blood samples. In summary, leptin is synthesized and stored within the pituitary and may modulate other pituitary hormone secretion, although probably do not contribute to plasma leptin level changes. Pituitary leptin may therefore be a novel paracrine regulator of pituitary function.     

A Randomized Comparison of Paclitaxel-Eluting Balloon Versus Everolimus-Eluting Stent for the Treatment of Any In-Stent Restenosis: The DARE Trial

Objectives

The authors sought to evaluate the relative performance of a drug-eluting balloon (DEB) and a drug-eluting stent (DES) in patients with any (bare-metal or drug-eluting stent) in-stent restenosis (ISR).

3-Year Clinical Follow-Up of the RIBS IV Clinical Trial: A Prospective Randomized Study of Drug-Eluting Balloons Versus Everolimus-Eluting Stents in Patients With In-Stent Restenosis in Coronary Arteries Previously Treated With Drug-Eluting Stents

Objectives

This study sought to compare the long-term safety and efficacy of drug-eluting balloons (DEB) and everolimus-eluting stents (EES) in patients with in-stent restenosis (ISR) of drug-eluting stents (DES).