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Background: Prevention of bilirubin encephalopathy in healthy near-term and term neonates is the primary focus of newborn care. This study aims to assess the predictive accuracy of transcutaneous bilirubin (TcB) and total serum bilirubin (TSB) measured before discharge for subsequent readmission because of significant hyperbilirubinemia in near-term and term neonates during the first postnatal week and to analyze the risk factors associated with readmission because of significant hyperbilirubinemia. Methods: TcB with BiliChek device and TSB measurements with bilirubinometer were obtained prior to discharge in all healthy near-term and term neonates delivered and admitted in the postnatal wards during the study period. Postnatal age (in hours) was recorded during bilirubin measurement. Results: The predictive ability of predischarge TcB measurement for the optimum cutoff of 104 µmol/L derived from the area under the receiver operating characteristic curve has a negative predictive value of 99.3% with a negative likelihood ratio (LR) of 0.15 and sensitivity of 91.7%, whereas the predictive ability of predischarge TSB measurement for the optimum cutoff of 109 µmol/L derived from the area under the receiver operating characteristic curve has 100% sensitivity and 100% negative predictive value with a negative LR of 0.0 for no readmission because of significant hyperbilirubinemia. The predischarge TSB level of those readmitted neonates had a very high odds for high-risk zone [OR (95% CI) 358.4 (96.39, 1332.59)] and 7.8 folds higher odds for intermediate-risk zone compared to those neonates who did not require readmission in Bhutani’s predischarge nomogram. Conclusion: The result of our study showed that both TcB obtained by using BiliChek device and TSB measurements obtained by bilirubinometer for the optimum cutoffs of 104 µmol/L and 109 µmol/L, respectively, and with negative LR of 0.15 and 0.0, respectively, can be used as a safe predischarge tool for no readmission because of significant hyperbilirubinemia after 24 h of postnatal age. The existing Bhutani’s predischarge nomogram for predicting significant hyperbilirubinemia should be an additional screening tool to reduce the rate of subsequent readmission because of hyperbilirubinemia.

High-quality and efficient sign-outs are essential to ensure patient safety. To evaluate the impact of a new handoff tool by objective measures of handoff quality and residents' subjective experiences. Internal medicine residents working on a medical ward service completed a handoff clinical evaluation exercise (CEX) questionnaire and an anonymous survey on handoff quality and experiences prior to implementing a new handoff tool and at 2 and 6 weeks after implementation. CEX scores significantly improved from 5.3 ± 1.1 to 6.9 ± 0.7 in 6 weeks ( P0.05). Residents reported that they were contacted less frequently after work, information needed by the receiving resident was more often found in the sign-out, and that tasks signed out to the oncoming team were more often executed. Before implementing the new handoff tool, 87% of residents reported that they were contacted after work hours 1-2 times per week with questions, while 75% of participants reported that they were almost never contacted after work hours after the new tool was implemented. A standardized handoff tool that utilizes smart phrases to provide residents with templates for sign-out significantly improved the quality and experience of sign-out in a short time period.

An elevated white blood cell (WBC) count is associated with an increased risk of ischemic events among acute coronary syndrome (ACS) patients, but the association between WBC count and bleeding in ACS patients is not well established. The aim of this analysis was to assess and compare the association between WBC count and the occurrence of short- and long-term bleeding and ischemic events. This was a post hoc analysis of the ATLAS ACS2-TIMI 51 trial. A subset of patients had a WBC count measurement at baseline (n = 14,231, 91.6%). Univariate and multivariable Cox proportional hazard models were constructed to determine if there is an association between WBC count at baseline and a composite outcome of Thrombolysis in Myocardial Infarction (TIMI) major and minor bleeds at 30 days and 1 year. Variables with a p0.2 in the univariate analysis were included as potential parameters in the backward selection process A similar multivariable model was constructed to assess the association between WBC count and a composite ischemic endpoint of cardiovascular death, myocardial infarction and stroke. An increased risk of bleeding per a 1 × 10

Background The identification of acutely ill patients at high risk for venous thromboembolism (VTE) may be determined clinically or by use of integer‐based scoring systems. These scores demonstrated modest performance in external data sets. Objectives To evaluate the performance of machine learning models compared to the IMPROVE score. Methods The APEX trial randomized 7513 acutely medically ill patients to extended duration betrixaban vs. enoxaparin. Including 68 variables, a super learner model (ML) was built to predict VTE by combining estimates from 5 families of candidate models. A “reduced” model (rML) was also developed using 16 variables that were thought, a priori, to be associated with VTE. The IMPROVE score was calculated for each patient. Model performance was assessed by discrimination and calibration to predict a composite VTE end point. The frequency of predicted risks of VTE were plotted and divided into tertiles. VTE risks were compared across tertiles. Results The ML and rML algorithms outperformed the IMPROVE score in predicting VTE (c‐statistic: 0.69, 0.68 and 0.59, respectively). The Hosmer‐Lemeshow goodness‐of‐fit P‐value was 0.06 for ML, 0.44 for rML, and

Introduction: Cerebrovascular disease occurs because of a complex interplay between vascular, environmental, and genetic factors. It is the second leading cause of disability worldwide. Understanding who may be genetically predisposed to cerebrovascular disease can help guide preventative efforts. We aim to utilize the UK Biobank to identify genetic variants associated with an increased risk of cerebrovascular disease. Methods: The UK Biobank is a prospective cohort containing clinical and genetic data gathered from over 500,000 individuals. We used Plink’s GLM options to analyze associations between genotypes and phenotypic manifestations of the disease. We defined cerebrovascular disease by selecting the ICD-10 codes G45, G46, I63-I67 and I69. We compared cases to age- and gender-matched controls with a case-to-control ratio of 20:1. Related individuals and those with confounding diagnoses such as coronary artery disease and other atherosclerotic conditions were excluded from the controls. Results: There were 9,726 and 6,699 instances of cerebrovascular disease as a primary or secondary diagnosis. We identified 189 variants in 8 different genes with p ≤ 1x 10 -6 . Identified genes have a minor allele frequency ≥ 0.5%. Variants with the highest significance were identified in close proximity to sequences encoding PITX2 (Paired like homeodomain 2; p = 2.4 x 10 -9 , OR = 1.1), LPA (Lipoprotein(a); p = 6.1 x 10 -9 , OR = 7.3), LRRTM4 (leucine rich repeat transmembrane neuronal 4; p = 1.8 x 10 -8 , OR = 1.08), and CDKN2B-AS1 (CDKN2B antisense RNA 1; p = 4.5 x 10 -8 , OR = 0.93). Conclusions: Through genome-wide analysis using ICD-10 codes as a phenotype for cerebrovascular diseases, we identified several novel genetic variants that are significantly associated with the incidence of cerebrovascular disease in the UK Biobank. Some of the associated genes were previously shown to be associated with atrial fibrillation ( PITX2 ), and atherosclerosis ( LPA and CDKN2B-AS1 ), solidifying the contribution of these two clinical risk factors to cerebrovascular accidents. LRRTM4 was previously associated with cognitive impairment, supporting a biologically plausible link to cerebrovascular disease. Future studies are warranted to confirm the findings of this analysis.

Introduction: Atherosclerotic renal artery stenosis (ARAS) is one of the most common pathologies affecting the renal vessels and accounts for 90% of all renovascular lesions. ARAS is associated with renovascular hypertension and nephropathy. ARAS tends to be a progressive disease that has a significant impact on a patient’s overall prognosis. ARAS is likely to occur because of a complex interaction between environmental and genetic factors. We aim to utilize the UK Biobank to identify novel genetic markers associated with renal artery atherosclerosis. Methods: The UK Biobank is a prospective cohort containing clinical and genetic data gathered from over 500,000 individuals. We used Plink’s GLM options for analyzing associations between genotypes and phenotypic manifestations of the disease. We defined renal artery atherosclerosis by selecting ICD-10 code I70.1 and compared cases to age- and gender-matched controls with a case-to-control ratio of 20:1. Related individuals and those with confounding diagnoses such as coronary artery disease, ischemic cerebrovascular disease, and peripheral artery disease were excluded from the controls. Results: There are 80 and 131 instances of I70.1 as a primary or secondary diagnosis, respectively. We identified 32 variants in 22 different genes with p ≤ 1 x 10 -6 . Identified genes have a minor allele frequency ≥ 0.5%. Variants achieving genome-wide significance (p < 5 x 10 -8 ) tightly linked, representing a single haplotype on chromosome 22 near the L3MBTL2 (L3MBTL histone methyl-lysine binding protein 2; p = 3.2 x 10 -8 , OR = 8.0) and EP300-AS1 (EP300 antisense RNA 1; p = 3.5 x 10 -8 , OR = 7.9) genes. Conclusions: Genome wide analysis using ICD-10 codes as a phenotype has the potential to identify previously unknown gene loci that may contribute to an increased risk of ARAS. Future studies are warranted to confirm the association of the chromosome 22 loci to ARAS.

Obesity is associated with cardiovascular complications such as diabetes and hypertension. However, obesity and high body mass index (BMI) can also be linked to improved clinical outcomes in certain patient populations. This counterintuitive observation is called the "obesity paradox." The effect of BMI on the risk of developing venous thromboembolism (VTE) in acutely ill medical patients remains unclear. In the Acute Medically Ill VTE Prevention with Extended Duration Betrixaban (APEX) trial, acutely ill hospitalized medical patients were randomized to receive either extended-duration betrixaban or shorter-duration enoxaparin and followed for 77 days. A total of 7372 patients with evaluable VTE endpoints had BMI measured at baseline. The association between BMI and VTE risk was assessed after adjusting for potential confounders. The multivariable adjusted ORs of VTE risk associated with BMI levels referencing the median BMI value (15, 18.5, 28.3 [reference], 35, 40, 45) were: 2.82 (95% CI, 1.32-6.04, [change from 28.3 to 15]), 1.85 (95% CI, 1.14-2.99, [change from 28.3 to 18.5]), 1.30 (95% CI, 1.04-1.63, [change from 28.3 to 35]), 1.13 (95% CI, 0.84-1.52, [change from 28.3 to 40]), and 0.91 (95% CI, 0.57-1.47, [change from 28.3 to 45]), respectively (p = 0.022). In conclusion, acutely ill hospitalized patients with lower BMI had a higher VTE risk through 77 days, which appears to be a manifestation of the BMI paradox.

D-dimer has been used as both a diagnostic and prognostic biomarker in the assessment of patients with venous thromboembolism, but its prognostic value in the setting of arterial acute coronary syndromes (ACS) and the ability of pharmacotherapy to reduce D-dimer in ACS is less well characterized. It was hypothesized that elevated baseline D-dimer would be associated with poor clinical outcomes in ACS, and that Factor Xa inhibition with Rivaroxaban would reduce D-dimer acutely and chronically. The ATLAS ACS TIMI-46 trial assessed the safety and efficacy of rivaroxaban compared with placebo in ACS patients. A subset of subjects had a D-dimer measured at baseline (n = 1,834, 52.5%). A univariate and multivariable logistic regression assessed the relation between baseline D-dimer and a composite end point of cardiovascular death, myocardial infarction, or stroke through 6 months. The Wilcoxon rank sum test was used to compare change in D-dimer level between the treatment groups from baseline. Baseline D-dimer was associated with the composite efficacy outcome in a univariate logistic regression (odds ratio 1.15, 95% confidence interval 1.03 to 1.29, p = 0.015) and a multivariable logistic regression (odds ratio 1.13, 95% confidence interval 1.00 to 1.28, p = 0.048). Rivaroxaban administration lowered D-dimer levels compared wth placebo after administration of the first dose of study drug (p = 0.026), at day 30 (p < 0.001) and day 180 (p < 0.001). In conclusion, elevated baseline D-dimer was associated with an increased risk of the composite outcome within 6 months of the ACS event and administration of the Factor Xa inhibitor rivaroxaban was associated with lower D-dimer levels compared with placebo after the first dose, at day 30 and day 180.

INTRODUCTION Compared to other direct oral anticoagulants, betrixaban has a longer half-life, smaller peak-trough variance, minimal renal clearance, and minimal hepatic Cytochrome P (CYP) metabolism. The Acute Medically Ill VTE Prevention with Extended Duration Betrixaban (APEX) trial evaluated the efficacy and safety of extended duration betrixaban compared to standard duration enoxaparin in acutely ill hospitalized patients. Areas covered: This article describes the role of betrixaban in the prevention of venous thromboembolism (VTE) in acutely ill medical patients. This article provides a consolidated summary of the primary APEX study findings as well as prespecified and exploratory substudies. This article also provides a review of the results of studies in which other direct factor Xa inhibitors have been evaluated in an extended duration regimen in this patient population. Expert commentary: While previous agents have demonstrated that extended duration VTE prophylaxis can be efficacious, betrixaban is the first agent to demonstrate efficacy without an increase in major bleeding. The totality of the data from the APEX trial supports extended duration betrixaban for VTE prophylaxis in the acute medically ill patient population. As such, betrixaban has been approved in the USA for extended VTE prophylaxis in at-risk acute medically ill patients.

Objectives This study sought to assess whether there were significant interactions of procedural access strategies and lesion characteristics with bleeding and ischemic events among atrial fibrillation (AF) patients anticoagulated with rivaroxaban or warfarin following a percutaneous coronary intervention. Background Among stented AF patients, the impact of procedural access strategies or lesion characteristics on antithrombotic safety and efficacy outcomes is unclear. Methods In the PIONEER AF-PCI (An Open-label, Randomized, Controlled, Multicenter Study Exploring Two Treatment Strategies of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention) trial, 2,124 patients were randomized to 3 groups and followed for 12 months: 1) rivaroxaban 15 mg once daily plus a P2Y12 inhibitor (n = 709); 2) rivaroxaban 2.5 mg twice a day plus dual antiplatelet therapy (DAPT) (n = 709); and 3) dose-adjusted warfarin plus DAPT (n = 706). Kaplan-Meier rates of clinically significant bleeding and major adverse cardiovascular events were compared between treatments stratified by subgroups of procedure type and lesion characteristics. Results Compared with warfarin, both rivaroxaban regimens consistently reduced clinically significant bleeding across subgroups of radial versus femoral arterial access and by vascular closure device use. Treatment effect of rivaroxaban on major adverse cardiovascular events did not vary when stratified by ischemia-driven revascularization, urgency of revascularization, location of culprit artery, presence of bifurcation lesion, presence of thrombus, type, and length of stent or number of stents (interaction p > 0.05 for all subgroups). Conclusions Among stented AF patients requiring long-term oral anticoagulation, there was no effect modification by procedure or lesion characteristics of either clinically significant bleeding or major adverse cardiovascular events. Rivaroxaban-based therapy was superior to warfarin plus DAPT in bleeding outcomes regardless of the type of stent or arterial access during the index coronary revascularization. (A Study Exploring Two Strategies of Rivaroxaban [JNJ39039039; BAY-59-7939] and One of Oral Vitamin K Antagonist in Patients With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention [PIONEER AF-PCI]; NCT01830543)

Contains fulltext : 196178.pdf (Publisher’s version ) (Closed access) Among atrial fibrillation (AF) patients undergoing percutaneous coronary intervention (PCI), rivaroxaban with background antiplatelet therapy significantly reduced the first occurrence of bleeding compared to triple therapy with warfarin. This study hypothesized that total bleeding events, including those beyond the first event, would be reduced with rivaroxaban-based regimens. In the PIONEER AF-PCI trial, 2099 patients in the modified intention-to-treat population were randomized to three groups and followed for 12 months: (1) rivaroxaban 15 mg once daily plus a P2Y12 inhibitor (N = 696); (2) rivaroxaban 2.5 mg twice daily plus dual antiplatelet therapy (DAPT) (N = 706); and (3) dose-adjusted warfarin plus DAPT (N = 697). Descriptive statistics for the number of subjects who experienced one or more bleeding events were calculated. The total number of bleeding events was compared across treatment groups using the Wei, Lin, and Weissfeld method. A total of 514 and 439 events of clinically significant bleeding and bleeding requiring medical attention occurred throughout the study. Compared to triple therapy with warfarin, rivaroxaban-based regimen was associated with a reduction in total events of clinically significant bleeding (Group 1 vs. Group 3: HR 0.64 [95% CI 0.49-0.85], p < 0.001, NNT = 11; Group 2 vs. Group 3: HR 0.62 [95% CI 0.48-0.80], p < 0.001, NNT = 10). Similarly, rivaroxaban reduced the total bleeding events requiring medical attention (Group 1 vs. Group 3: HR 0.66 [95% CI 0.49-0.89], p < 0.001, NNT = 14; Group 2 vs. Group 3: HR 0.64 [95% CI 0.48-0.85], p = 0.002, NNT = 13). Rivaroxaban-based regimen reduced the total bleeding events compared with VKA-based triple therapy in stented AF patients. One clinically significant bleeding event could be prevented with rivaroxaban use for every 10-11 patients treated, and one bleeding requiring medical attention could be prevented with rivaroxaban for every 13-14 patients treated. These data provide evidence that total bleeding events, including those beyond the first event, are reduced with rivaroxaban-based antithrombotic regimens. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov . Unique identifier: NCT01830543 (PIONEER AF-PCI).

Background Elevated D-dimer concentrations are associated with an increased risk of venous thromboembolism (VTE). However, they may also provide prognostic value. The present analysis sought to study the association of D-dimer levels with VTE event rates and the efficacy of betrixaban versus enoxaparin in the APEX trial. Methods Hospitalized acutely medically ill subjects (n = 7,513) were randomized in a double-dummy double-blind fashion to either extended-duration oral betrixaban (80 mg once daily for 35–42 days) or standard dose subcutaneous enoxaparin (40 mg once daily for 10 ± 4 days) for venous thromboprophylaxis. D-dimer was assessed using a central core laboratory measurement. Results For every 0.25 µg/mL increase in D-dimer concentration, there was a 2% increase in the relative risk of experiencing the primary efficacy endpoint (asymptomatic deep vein thrombosis [DVT], symptomatic DVT, nonfatal pulmonary embolism, or VTE-related death) in both the betrixaban (p Conclusion Extended-duration betrixaban was superior to standard-duration enoxaparin, irrespective of D-dimer level at baseline. To prevent one VTE event, 46 D-dimer-positive patients would need to be treated with betrixaban.

Tinea pedis, known as athletics foot, is defined as a dermatophyte infection leading to a condition called dermatophytosis. Usually, the mode of infection is fungal. Trichophyton rubrum is the most common organism which is responsible for the infection. This fungus is endemic in some geographical regions as in Asia and Africa. The mode of transmission and risk factors depends on several factors: the weather, type of clothes and shoes, body response to different organisms, present history, family history, and endemic geographical areas. Increased temperature and humidity were correlated in the literature to the increased incidence and prevalence of tinea pedis compared to those areas which have low temperature, wearing specific types of shoes or clothes might be associated with an increased rate of infection, especially if the shoes are adherent to the foot and occlusive, prolonged exposure to humidity and water was also shown to be among the causes for tinea pedis infections. The clinical presentation of tinea pods varies according to the site and severity of infection. Generally, antifungal drugs are effective in most cases. The application of antifungals may be in oral form or local form, or mixed form. Terbinafine was proven to be effective in mild cases to fully treat the infection within a period of one week, extending to four weeks in more aggressive cases. This was a brief look at the article. This article aimed to review tinea pedis from different prospections clinically.

Hospitalized acute medically ill patients with a history of venous thromboembolism (VTE) are at increased risk for recurrent VTE. We characterized the efficacy and safety of betrixaban for prevention of recurrent VTE in these high risk patients. The APEX trial randomized 7513 acutely ill hospitalized medical patients at risk for developing VTE to receive either betrixaban for 35-42 days or enoxaparin for 10 ± 4 days to prevent VTE. This exploratory post-hoc analysis assessed the efficacy and safety of betrixaban versus enoxaparin among subjects with and without prior VTE. Time-to-multiple symptomatic VTE events was also calculated. Approximately 8% of subjects in both arms had prior VTE, which was associated with a fourfold increase in adjusted risk of VTE [MV OR 4.03, 95% CI 3.06-5.30, p 0.001]. Betrixaban reduced VTE compared with enoxaparin among subjects with prior VTE [32 (10.4%) vs. 55 (18.9%), RR 0.57, 95% CI 0.38-0.86, p = 0.006, ARR 8.5%, NNT 12] and without prior VTE [133 (3.9%) vs. 168 (4.9%), RR 0.79, 95% CI 0.64-0.99, p = 0.042, ARR 1.0%, NNT 100] (interaction p 0.05). Additionally, four subjects in the enoxaparin arm and one subject in the betrixaban arm experienced a recurrent VTE. Compared with enoxaparin, betrixaban use was associated with reduction of recurrent VTE events through the active treatment period [36 vs. 57, HR 0.63, 95% CI 0.41-0.97, p = 0.045] and through the end of study [38 vs. 71, HR 0.54, 95% CI 0.36-0.81, p = 0.004]. Prior VTE is associated with a fourfold increase in the risk of VTE among hospitalized medically ill patients. Only 12 such patients would need to be treated with betrixaban versus enoxaparin to prevent an additional VTE endpoint. Betrixaban reduced not only the first but also all recurrent VTE events in a time-to-any-event analysis.http://www.clinicaltrials.gov , Unique identifier: NCT01583218.

Background Anemia is a common finding and independent predictor for adverse outcomes in hospitalized patients with medical illness. It remains unclear whether anemia is a risk factor for venous thromboembolism and whether the presence of anemia can refine risk assessment for prediction of venous thromboembolism, thereby adding incremental utility to a validated model. Methods In the Acute Medically Ill Venous Thromboembolism Prevention with Extended Duration Betrixaban trial (APEX), 7513 hospitalized medical patients were randomized to receive either betrixaban or standard-of-care enoxaparin for thromboprophylaxis. Baseline hemoglobin concentrations were obtained in 6861 patients, with a follow-up of 77 days. Symptomatic venous thromboembolism events, including symptomatic deep vein thrombosis, pulmonary embolism, and venous thromboembolism–related mortality, were compared between low-hemoglobin and normal-hemoglobin groups (normal range: 12.5-17.0 g/dL for males and 11.0-15.5 g/dL for females). The relationship between anemia and venous thromboembolism events was assessed by fitting a univariable and multivariable logistic regression model composed of thromboprophylaxis and risk factors. Venous thromboembolism risk refinement by hemoglobin measurement was evaluated in the International Medical Prevention Registry on Venous Thromboembolism (IMPROVE) risk assessment model. Results Low hemoglobin at baseline was associated with a greater risk of symptomatic venous thromboembolism (relative risk [RR] 1.94 [95% confidence interval, 1.27-2.98]; P = .002), symptomatic deep vein thrombosis (RR 2.29 [1.12-4.68]; P = .019), and nonfatal pulmonary embolism (RR 2.63 [1.22-5.65]; P = .010) but not venous thromboembolism–related mortality (RR 1.47 [0.71-3.04]; P = .30). After adjusting for thromboprophylaxis, history of previous venous thromboembolism, intensive or coronary unit admission, and D-dimer, low hemoglobin (as a categorical or continuous variable) remained associated with an increased likelihood of venous thromboembolism (adjusted odds ratio 1.71 [95% confidence interval, 1.09-2.69]; P = .020). Low hemoglobin also improved risk discrimination and reclassification after inclusion in the IMPROVE model. Conclusions Anemia was independently associated with a greater risk of symptomatic venous thromboembolism among acutely ill medical patients despite the provision of thromboprophylaxis. Hemoglobin measurement also improved risk stratification by the IMPROVE venous thromboembolism risk score.

This study sought to assess whether there were significant interactions of procedural access strategies and lesion characteristics with bleeding and ischemic events among atrial fibrillation (AF) patients anticoagulated with rivaroxaban or warfarin following a percutaneous coronary intervention.Among stented AF patients, the impact of procedural access strategies or lesion characteristics on antithrombotic safety and efficacy outcomes is unclear.In the PIONEER AF-PCI (An Open-label, Randomized, Controlled, Multicenter Study Exploring Two Treatment Strategies of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention) trial, 2,124 patients were randomized to 3 groups and followed for 12 months: 1) rivaroxaban 15 mg once daily plus a P2YCompared with warfarin, both rivaroxaban regimens consistently reduced clinically significant bleeding across subgroups of radial versus femoral arterial access and by vascular closure device use. Treatment effect of rivaroxaban on major adverse cardiovascular events did not vary when stratified by ischemia-driven revascularization, urgency of revascularization, location of culprit artery, presence of bifurcation lesion, presence of thrombus, type, and length of stent or number of stents (interaction p0.05 for all subgroups).Among stented AF patients requiring long-term oral anticoagulation, there was no effect modification by procedure or lesion characteristics of either clinically significant bleeding or major adverse cardiovascular events. Rivaroxaban-based therapy was superior to warfarin plus DAPT in bleeding outcomes regardless of the type of stent or arterial access during the index coronary revascularization. (A Study Exploring Two Strategies of Rivaroxaban [JNJ39039039; BAY-59-7939] and One of Oral Vitamin K Antagonist in Patients With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention [PIONEER AF-PCI]; NCT01830543).

Background Approximately 15%-30% of patients in trials of medical thromboprophylaxis will have missing compression ultrasound (CUS) data. The goal of the present analysis was to perform analyses to minimize missing data. Methods The APEX trial randomized 7,513 acutely medically ill hospitalized patients to thromboprophylaxis with either betrixaban for 35-42 days or enoxaparin for 6-14 days. A modified intent-to-treat (mITT) analysis was performed and included all subjects administered study drug, irrespective of CUS performance, and an analysis of symptomatic events which do not require performance of a CUS (symptomatic deep vein thrombosis, nonfatal pulmonary embolism, and venous thromboembolism (VTE)–related mortality). Results In the mITT population, betrixaban significantly reduced the primary end point (which included both symptomatic and CUS events) (165 [4.4%] vs 223 [6.0%]; relative risk = 0.75; 95% CI 0.61-0.91; P = .003; absolute risk reduction [ARR] = 1.6%; number needed to treat [NNT] = 63). Betrixaban also reduced symptomatic VTE through day 42 (35 [1.28%] vs 54 [1.88%], hazard ratio [HR] = 0.65; 95% CI 0.42-0.99; P = .044; ARR = 0.6%; NNT=167) as well as through day 77 (37 [1.02%] vs 67 [1.89%]; HR= 0.55; 95% CI 0.37-0.83; P = .003; ARR = 0.87%; NNT=115) as well as the individual end point of nonfatal pulmonary embolism (9 [0.25%] vs 20 [0.55%]; HR= 0.45; 95% CI 0.21-0.99; P = .041; ARR = 0.30%; NNT=334). On an “as-treated” basis, 80 mg of betrixaban reduced VTE-related mortality through day 77 (10 [0.34%] vs. 22 [0.79%]; HR=0.46; 95% CI 0.22-0.96; P = .035; ARR = 0.45%; NNT=223). Conclusion In an mITT analysis of all patients administered study drug, extended-duration betrixaban reduced the primary end point as well as symptomatic events. In an as-treated analysis, 80 mg of betrixaban reduced VTE-related death.

Introduction Optimal surgical strategy for patients with tremor remains uncertain. We conducted a systematic review and meta-analysis evaluating randomized controlled trials of deep brain stimulation (DBS) and lesion surgery (LS) in the treatment of tremor. Methods We searched PubMed, Embase, and the Cochrane database to include randomized clinical trials with either LS, deep brain stimulation, or controls. The outcomes were the change in tremor score, quality of life, cognitive function, and neuropsychiatric function. We used standardized mean differences (SMDs) to pool the outcomes. Results Fifteen trials, including 1508 patients, met eligibility criteria. We observed no significant difference in change of tremor scale (SMD −0.07, 95% confidence interval [CI]: −0.38 to 0.24), quality of life (SMD −0.21, 95% CI: −0.69 to 0.27), cognitive function (SMD 0.06, 95% CI: −0.27 to 0.39), or neuropsychiatric function (SMD −0.15, 95% CI: −0.49 to 0.19) between LS and stimulation surgery. We observed heterogeneity across studies during indirect comparison of quality of life. We identified a possible effect modifier: improvement in quality of life correlated with duration of disease (P = 0.035). We found that focused-ultrasound LS was associated with a 0.70 SMD increase (P = 0.014) in quality of life versus DBS in an exploratory subgroup analysis by separating 2 studies with focused-ultrasound LS from other LS studies. Conclusions Although the main analysis showed that LS and DBS were equally effective in the treatment of patients with tremor, an exploratory subgroup analysis indicated an improvement in quality of life with noninvasive focused-ultrasound surgery.