Dynamic circadian fluctuations of glycemia in patients with type 2 diabetes mellitus.

BACKGROUND: Diabetes mellitus (DM) has glucose variability that is of such relevance that the appearance of vascular complications in patients with DM has been attributed to hyperglycemic and dysglycemic events. It is known that T1D patients mainly have glycemic variability with a specific oscillatory pattern with specific circadian characteristics for each patient. However, it has not yet been determined whether an oscillation pattern represents the variability of glycemic in T2D. This is why our objective is to determine the characteristics of glycemic oscillations in T2D and generate a robust predictive model. RESULTS: Showed that glycosylated hemoglobin, glycemia, and body mass index were all higher in patients with T2D than in controls (all p < 0.05). In addition, time in hyperglycemia and euglycemia was markedly higher and lower in the T2D group (p < 0.05), without significant differences for time in hypoglycemia. Standard deviation, coefficient of variation, and total power of glycemia were significantly higher in the T2D group than Control group (all p < 0.05). The oscillatory patterns were significantly different between groups (p = 0.032): the control group was mainly distributed at 2-3 and 6 days, whereas the T2D group showed a more homogeneous distribution across 2-3-to-6 days. CONCLUSIONS: The predictive model of glycemia showed that it is possible to accurately predict hyper- and hypoglycemia events. Thus, T2D patients exhibit specific oscillatory patterns of glycemic control, which are possible to predict. These findings may help to improve the treatment of DM by considering the individual oscillatory patterns of patients.

"Readiness to Change" Predicts Efficacy of Reduction among Smokers with Severe Mental Illness.

AIMS: Smoking cessation in subjects with a severe mental illness (SMI) is a challenging but attainable goal. Furthermore, the identification of variables involved in the quitting process is a highly relevant factor in clinical practice. This study aimed to analyze the influence of smokers' motivation in smoking reduction and cessation and select the most suitable way of measuring motivation. METHODS: This is a secondary analysis of a 9-month, multicenter trial examining a Multicomponent Smoking Cessation Program in 82 adult outpatients with SMI. At the end of the preparation stage, the smokers' motivational level was evaluated with the University of Rhode Island Change Assessment Scale. This allowed us to rate subjects using a continuous measure ("Readiness to Change," RTC) and group them in "Stages of Change" (SOC). Regression analyses were carried out to identify predictors of the efficacy outcomes: a reduction in at least 50% of the cigarettes smoked per day (CPD), a reduction in the expired carbon monoxide (CO), and complete abstinence from smoking. RESULTS: We studied differences in measurements of motivational levels independently (RTC and SOC) for patients who had a reduction in at least 50% of the CPD and for patients who achieved complete abstinence from smoking. However, these differences did not reach statistical significance during the follow-up study with a logistic mixed-effects model. In a linear mixed-effects model, the reduction of expired CO was significantly associated with RTC, at the end of the active treatment phase and during follow-up (ß: -1.51; SD 0.82; p < 0.01). CONCLUSION: The motivation level achieved in the preparation phase predicted the reduction of expired CO over a given period when calculated by a continuous measure (RTC).

TIOMAX: A Spanish Multicenter Registry of the real-world use of the TItanium OptiMAX® biostent: TIOMAX: Registro Español Multicéntrico Del Biostent De Titanio OptiMAX® En La Vida Real.

OBJECTIVES: To compare the safety and efficacy of the new cobalt-chromium bioactive stent Titan Optimax® (Hexacath, France) with its predecessor, Titan-2® . BACKGROUND: The TIOMAX registry includes 784 patients who underwent percutaneous coronary intervention with these stents in 21 Spanish hospitals. METHODS: Analysis of all patients in the registry without exclusion criteria, candidates for revascularization (March-2013/July-2014). Initially 273 patients received Titan-2® , and the next 511 received the Optimax® after its launch. RESULTS: Mean age was 65.8 ± 13.0 (78.1% men); 49.2% were STEACS patients (n = 322), 29.8% NSTEACS, and 27.3% had stable angina or silent ischemia. Most STEACS patients (76.4% of n = 322) were treated <24 hr after developing symptoms. All-cause death (D), cardiac death (CD), acute myocardial infarction (AMI), and stent thrombosis (ST) at 1 month were 1.1, 0.8, 0.1, and 0.5%, respectively, with no significant differences between groups. At 1 year, the death rate was 5.5% for Titan-2 vs. 4.1% for Optimax® , CD was 1.8% for both groups, ST 1.1 vs. 0.6%, new AMI 3.3 vs. 2.5% and target lesion revascularization (TLR) 3.7 vs. 2.9%. The primary endpoint of the composite event (CE) of D/AMI/TLR/ST occurred in 10.3% vs. 7.6% (p = 0.211). Patients with STEACS (N = 322: Titan-2/Optimax: 103/209) had better outcomes for secondary events, device-oriented failure CD/AMI/TLR (7.8% vs. 5.0%; p = 0.330), and non-fatal CE of AMI/ST/TLR (7.8% vs. 2.7%, p = 0.039). CONCLUSIONS: The Titan Optimax retains the efficacy and safety of Titan 2. It appears to perform better in the subgroup of STEACS patients, by reducing the non-fatal CE of AMI/ST/TLR.

Impact of Calcified Target Lesions on the Outcome of Percutaneous Coronary Intervention for Acute Coronary Syndrome: Insights From the BASE ACS Trial.

OBJECTIVES: We performed a post hoc analysis of outcome in patients with, versus those without, calcified target lesions from the BASE ACS trial. BACKGROUND: The outcome of contemporary stent implantation in patients with calcified lesions presenting with acute coronary syndrome is unknown. METHODS: The BASE ACS trial randomized 827 patients (1:1) presenting with acute coronary syndrome to receive either titanium-nitride-oxide-coated stents or everolimus-eluting stents. Calcified lesions were defined as moderate or severe calcification in the vessel wall by coronary angiography. The primary endpoint was major adverse cardiac events (MACE): a composite of cardiac death, non-fatal myocardial infarction or ischemia-driven target lesion revascularization. Follow-up was planned at 12 months, and yearly thereafter for up to 7 years. RESULTS: Of 827 patients enrolled in the trial, 352 (42.6%) had calcified target lesions. Median follow-up was 5.0 years. The incidence of MACE was higher in patients with, versus those without, calcified target lesions (19.6% vs. 12.2%, respectively, P = 0.004). This was driven by more frequent cardiac death and non-fatal myocardial infarction events (P < 0.05, both). The rates of ischemia-driven target lesion revascularization were comparable (P > 0.05). MACE and the other endpoints were comparable between the 2 propensity-score matched subgroups (P > 0.05 for all). Hypertension and smaller vessel size independently predicted MACE in patients treated for calcified lesions. CONCLUSIONS: Patients presenting with acute coronary syndrome who were treated for calcified lesions had worse long-term clinical outcome, compared with those treated for non-calcified lesions, mainly due to more frequent safety events. In the propensity score-matched analysis, the outcome was comparable.

4-Year outcome of bioactive stents versus everolimus-eluting stents in acute coronary syndrome.

OBJECTIVES: The BASE-ACS trial demonstrated non-inferiority of titanium-nitride-oxide-coated bioactive stents (BAS), versus everolimus-eluting stents (EES), for major adverse cardiac events (MACE) at 1- and 2-year follow-up, in patients with acute coronary syndrome (ACS). We presented the 4-year outcome of the BASE-ACS trial. DESIGN: We randomized 827 patients with ACS to receive either BAS (417) or EES (410). MACE was a composite of cardiac death, non-fatal myocardial infarction (MI) or ischemia-driven target lesion revascularization (TLR) at 12-month follow-up. Analyses were performed by intention to treat. Follow-up was planned at 12 months, and yearly thereafter for 5 years. RESULTS: Four-year clinical follow-up was completed in 753 (91.1%) patients. At 4 years, BAS were non-inferior to EES for MACE (14.7% versus 17.8%, respectively; p = 0.24 for superiority; p = 0.001 for non-inferiority). Non-fatal MI was less frequent with BAS (5.0% versus 9.2%, respectively; p = 0.025). Cardiac death and ischemia-driven TLR were comparable (2.9% versus 3.5%, and 8.6% versus 9.2%; p = 0.62 and p = 0.80, respectively). Independent predictors of MACE were calcified lesions (HR 1.54, p = 0.021), the number of vessels treated (HR 1.53, p = 0.025), and reference vessel diameter (HR 0.54, p = 0.006). CONCLUSIONS: In patients presenting with ACS, BAS was associated with a clinical outcome non-inferior to EES at 4-year follow-up.

Braden Scale and Norton Scale modified by INSALUD in an acute care hospital: validity and cutoff point.

OBJECTIVE: The objective of this article was to determine the most suitable cutoff point (CP) for the Braden Scale and Norton Modified Scale by INSALUD Scale (Norton-MI) in an acute care hospital. DESIGN: The authors have designed a prospective, descriptive study of patients from their hospital. From December 2008 to March 2009, a nurse collected and recorded adult patient data daily, including the appearance of pressure ulcers. PATIENTS: Adult patients in medical and surgical wards. MAIN OUTCOMES MEASURE: The parameters used in both scales are sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), area under curve (AUC) of receiver operating characteristic (ROC). MAIN RESULTS: In the end, the authors have evaluated a total of 1001 patients and obtained 4486 measurements with both the Norton-MI and the Braden scales. The rates for the recommended CP of the Norton-MI scale (CP 14) are as follows: sensitivity: 67.91% (62.42-73.39), specificity: 78.66% (77.41-79.92), PPV: 18.36%, NPV: 97.20%. Those for Braden (CP 16) are as follows: sensitivity: 65.69% (64.19-75), specificity: 79.62% (78.39-80.85), PPV: 19.43%, NPV: 97.37%. The Norton-MI scale offers an AUC-ROC of 0.828 with a 95% confidence interval of 0.811-0.854, and the Braden Scale presents an AUC-ROC of 0.832 with a 95% confidence interval of 0.807 to 0.849. CONCLUSION: Both scales show good validity data. If the CP is raised: MI-Norton (CP 15): sensitivity: 77.36 (72.43-82.30), specificity 74.27 (72.94-75.61), PPV: 17.52 (15.42-19.62), NPV: 97.89 (97.38-98.41). The Braden scale with a CP of 17 presents sensitivity: 78.38 (73.52-83.24), specificity: 73.44 (72.09-74.79), PPV: 17.25 (15.19-19.31), NPV: 97.96 (97.45-98.47). These CPs improved the predictive capacity of both scales in the authors' hospital environment.

Validation of Quantitative Flow Ratio-Derived Virtual Angioplasty with Post-Angioplasty Fractional Flow Reserve-The QIMERA-I Study.

Background: Quantitative flow ratio (QFR) virtual angioplasty with pre-PCI residual QFR showed better results compared with an angiographic approach to assess post-PCI functional results. However, correlation with pre-PCI residual QFR and post-PCI fractional flow reserve (FFR) is lacking. Methods: A multicenter prospective study including consecutive patients with angiographically 50-90% coronary lesions and positive QFR results. All patients were evaluated with QFR, hyperemic and non-hyperemic pressure ratios (NHPR) before and after the index PCI. Pre-PCI residual QFR (virtual angioplasty) was calculated and compared with post-PCI fractional flow reserve (FFR), QFR and NHPR. Results: A total of 84 patients with 92 treated coronary lesions were included, with a mean age of 65.5 ± 10.9 years and 59% of single vessel lesions being the left anterior descending artery in 69%. The mean vessel diameter was 2.82 ± 0.41 mm. Procedural success was achieved in all cases, with a mean number of implanted stents of 1.17 ± 0.46. The baseline QFR value was 0.69 ± 0.12 and baseline FFR and NHPR were 0.73 ± 0.08 and 0.82 ± 0.11, respectively. Mean post-PCI FFR increased to 0.87 ± 0.05 whereas residual QFR had been estimated as 0.95 ± 0.05, showing poor correlation with post-PCI FFR (0.163; 95% CI:0.078-0.386) and low diagnostic accuracy (30.9%, 95% CI:20-43%). Conclusions: In this analysis, the results of QFR-based virtual angioplasty did not seem to accurately correlate with post-PCI FFR.

Continuous Thermodilution Method to Assess Coronary Flow Reserve.

Coronary flow reserve (CFR) is a well-validated flow-based physiological parameter that has shown value in clinical risk stratification. CFR can be invasively assessed, classically by Doppler and, more recently, by thermodilution with saline boluses (CFRthermo-bolus). Alternatively, continuous thermodilution is a novel operator-independent, highly-reproducible technique to invasively quantify maximum absolute coronary flow (AF). This study aimed to assess the feasibility of this method to quantify resting AF and to determine CFR (CFRThermo-infusion) as compared with CFRthermo-bolus. Sixty-two consecutive patients with suspicion of coronary disease and absence of significant epicardial lesions were prospectively investigated. AF at maximal hyperemia (20 mL/min) and at lower infusion rates (6-8-10-12 mL/min) were systematically measured using a dedicated catheter and a temperature/pressure guidewire. The absence of baseline Pd/Pa decrease at 6 (0.15 ± 0.2%), 8 (0.17 ± 0.18%) and 10 mL/min (0.2 ± 0.12%) demonstrated absence of hyperemia at ≤10 mL/min (all p = NS). However, at 12 mL/min hyperemia was confirmed by a significant decrease in Pd/Pa (1.3 ± 1.5%, p <0.01) and increase in AF from 10 mL/min to 12 mL/min (31.4 ± 28.1 mL, p <0.05). All curve tracings at 10 mL/min (129/129, 100%) were adequate versus only (7/15, 53%) and (15/18, 17%) at 6 mL/min, and 8 mL/min, respectively, and this infusion-rate was considered to determine resting-AF. CFRThermo-infusion was determined as the ratio of hyperemic-AF (20 mL/min) by resting-AF (10 mL/min). Mean CFRThermo-infusion was 2.56 ± 0.9 and CFRthermo-bolus 2.49 ± 1. Both parameters showed a good correlation (r = 0.76; p <0.001) and intraclass agreement (ICC = 0.76; p <0.001).The continuous thermodilution method enables to quantify resting-AF providing a novel clinical tool to determine CRF. CFRThermo-infusion shows a good correlation with CFRthermo-bolus..

Oscillatory pattern of glycemic control in patients with diabetes mellitus.

Daily glucose variability is higher in diabetic mellitus (DM) patients which has been related to the severity of the disease. However, it is unclear whether glycemic variability displays a specific pattern oscillation or if it is completely random. Thus, to determine glycemic variability pattern, we measured and analyzed continuous glucose monitoring (CGM) data, in control subjects and patients with DM type-1 (T1D). CGM data was assessed for 6 days (day: 08:00-20:00-h; and night: 20:00-08:00-h). Participants (n = 172; age = 18-80 years) were assigned to T1D (n = 144, females = 65) and Control (i.e., healthy; n = 28, females = 22) groups. Anthropometry, pharmacologic treatments, glycosylated hemoglobin (HbA1c) and years of evolution were determined. T1D females displayed a higher glycemia at 10:00-14:00-h vs. T1D males and Control females. DM patients displays mainly stationary oscillations (deterministic), with circadian rhythm characteristics. The glycemia oscillated between 2 and 6 days. The predictive model of glycemia showed that it is possible to predict hyper and hypoglycemia (R2 = 0.94 and 0.98, respectively) in DM patients independent of their etiology. Our data showed that glycemic variability had a specific oscillation pattern with circadian characteristics, with episodes of hypoglycemia and hyperglycemia at day phases, which could help therapeutic action for this population.

Biochemical changes in the cingulum in patients with schizophrenia and chronic bipolar disorder.

Biochemical changes have been reported in vivo in the brain in schizophrenia patients using 1H-magnetic resonance spectroscopy (MRS). The aim of this study was to assess the specificity of biochemical changes occurring in schizophrenia patients, in a direct comparison with bipolar disorder patients. Fourteen patients with chronic paranoid schizophrenia, 17 euthymic type I bipolar patients with no previous history of psychotic symptoms and 15 healthy controls were included, most of them were female. They underwent a study with MRS: proton spectra were acquired using a Signa 1.5 T CVI scanner, with a localised single voxel PRESS sequence. N-acetyl aspartate (NAA), Creatine (Cr), and Choline (Cho) metabolite resonance intensities were all quantified in the cingulum, a region of interest in schizophrenia and bipolar disorder. Schizophrenia patients showed a significantly higher Cho/Cre as well as lower NAA/Cho ratios as compared with controls and bipolar patients. No significant differences were found among the three groups as regards NAA/Cre levels. These data are consistent with an increase in the concentration of choline in the cingulum in chronic schizophrenia, at least in this predominantly female group. Such an increase seems to be more intense than in psychosis-free bipolar disorder patients.

Simultaneous Modeling of Disease Status and Clinical Phenotypes To Increase Power in Genome-Wide Association Studies.

Genome-wide association studies have identified thousands of variants implicated in dozens of complex diseases. Most studies collect individuals with and without disease and search for variants with different frequencies between the groups. For many of these studies, additional disease traits are also collected. Jointly modeling clinical phenotype and disease status is a promising way to increase power to detect true associations between genetics and disease. In particular, this approach increases the potential for discovering genetic variants that are associated with both a clinical phenotype and a disease. Standard multivariate techniques fail to effectively solve this problem, because their case-control status is discrete and not continuous. Standard approaches to estimate model parameters are biased due to the ascertainment in case-control studies. We present a novel method that resolves both of these issues for simultaneous association testing of genetic variants that have both case status and a clinical covariate. We demonstrate the utility of our method using both simulated data and the Northern Finland Birth Cohort data.

Dynamic circadian fluctuations of glycemia in patients with type 2 diabetes mellitus

BACKGROUND: Diabetes mellitus (DM) has glucose variability that is of such relevance that the appearance of vascular complications in patients with DM has been attributed to hyperglycemic and dysglycemic events. It is known that T1D patients mainly have glycemic variability with a specific oscillatory pattern with specific circadian characteristics for each patient. However, it has not yet been determined whether an oscillation pattern represents the variability of glycemic in T2D. This is why our objective is to determine the characteristics of glycemic oscillations in T2D and generate a robust predictive model. RESULTS: Showed that glycosylated hemoglobin, glycemia, and body mass index were all higher in patients with T2D than in controls (all p < 0.05). In addition, time in hyperglycemia and euglycemia was markedly higher and lower in the T2D group (p < 0.05), without significant differences for time in hypoglycemia. Standard deviation, coefficient of variation, and total power of glycemia were significantly higher in the T2D group than Control group (all p < 0.05). The oscillatory patterns were significantly different between groups (p = 0.032): the control group was mainly distributed at 2-3 and 6 days, whereas the T2D group showed a more homogeneous distribution across 2-3-to-6 days. CONCLUSIONS: The predictive model of glycemia showed that it is possible to accurately predict hyper- and hypo-glycemia events. Thus, T2D patients exhibit specific oscillatory patterns of glycemic control, which are possible to predict. These findings may help to improve the treatment of DM by considering the individual oscillatory patterns of patients.

[Imbalance between the supply and demand for cardiologists in Spain. Analysis of the current situation, future prospects, and possible solutions]. / Desequilibrio entre la oferta y las necesidades de cardiólogos en España. Análisis de la situación actual, previsiones futuras y propuestas de solución.

Planning cardiology provision in Spain requires knowledge of the resources available and the demand, both now and in the future. In this report, we present the results of a study carried out by the Spanish Society of Cardiology on the availability of and demand for cardiologists in the country. The current situation is characterized by an imbalance of around 14% between the number of active cardiologists and the estimated number required. The demographic distribution of cardiologists shows that they are predominantly male and middle-aged. Expectations are that the situation will get worse until the year 2020. To correct this imbalance, alternative forms of training or clinical department organization, or both, are required. Some possible alternatives are presented in the final part of this document, as proposals for open discussion.

Modeling Verdict Outcomes Using Social Network Measures: The Watergate and Caviar Network Cases.

Modelling criminal trial verdict outcomes using social network measures is an emerging research area in quantitative criminology. Few studies have yet analyzed which of these measures are the most important for verdict modelling or which data classification techniques perform best for this application. To compare the performance of different techniques in classifying members of a criminal network, this article applies three different machine learning classifiers-Logistic Regression, Naïve Bayes and Random Forest-with a range of social network measures and the necessary databases to model the verdicts in two real-world cases: the U.S. Watergate Conspiracy of the 1970's and the now-defunct Canada-based international drug trafficking ring known as the Caviar Network. In both cases it was found that the Random Forest classifier did better than either Logistic Regression or Naïve Bayes, and its superior performance was statistically significant. This being so, Random Forest was used not only for classification but also to assess the importance of the measures. For the Watergate case, the most important one proved to be betweenness centrality while for the Caviar Network, it was the effective size of the network. These results are significant because they show that an approach combining machine learning with social network analysis not only can generate accurate classification models but also helps quantify the importance social network variables in modelling verdict outcomes. We conclude our analysis with a discussion and some suggestions for future work in verdict modelling using social network measures.

Long-term clinical outcome of titanium-nitride-oxide-coated stents versus everolimus-eluting stents in acute coronary syndrome: Final report of the BASE ACS trial.

BACKGROUND: The BASE ACS randomized trial demonstrated non-inferiority of titanium-nitride-oxide-coated bioactive stents (BAS), compared with everolimus-eluting stents (EES), for the primary endpoint of major adverse cardiac events (MACE) in patients presenting with acute coronary syndrome (ACS) at 12-month follow-up. We report the final long-term clinical outcome of the trial. METHODS: We randomly assigned 827 patients with ACS to receive either BAS (417) or EES (410). The primary endpoint was MACE: a composite of cardiac death, non-fatal myocardial infarction (MI) or ischemia-driven target lesion revascularization (TLR) at 12-month follow-up. Analysis was performed by intention to treat. Follow-up was planned at 12months, and yearly thereafter through 7years. RESULTS: Mean follow-up duration was 4.2±1.9years (median 5.0years). At 5-year follow-up, BAS was non-inferior to EES for the primary endpoint of MACE (14.4% versus 17.8%, respectively; hazard ratio for BAS versus EES, 0.82; 95% confidence interval, 0.58-1.16; p=0.26 for superiority; p<0.001 for non-inferiority). The rate of non-fatal MI was lower in the BAS group (5.9% versus 9.7%, respectively, p=0.028). The rates of cardiac death and ischemia-driven TLR were comparable (2.8% versus 3.8%, and 8.3% versus 9.9%; p=0.76 and p=0.58, respectively). CONCLUSIONS: In the current final report of the randomized BASE ACS trial in patients with ACS, BAS implantation was associated with a rate of cumulative MACE at long-term follow-up that was statistically non-inferior to EES.

Dual Antiplatelet Therapy for 6 Months vs 12 Months After New-generation Drug-eluting Stent Implantation: Matched Analysis of ESTROFA-DAPT and ESTROFA-2.

INTRODUCTION AND OBJECTIVES: The recommendation for dual antiplatelet therapy following drug-eluting stent implantation ranges from 6 months to 12 months or beyond. Recent trials have suggested the safety of a 6-month dual antiplatelet therapy regimen, yet certain caveats to these studies limit the applicability of this shorter duration dual antiplatelet therapy strategy in real world settings. METHODS: A registry was constructed with consecutive recruitment of patients undergoing new-generation drug-eluting stent implantation and prescribed 6 months of dual antiplatelet therapy. Propensity score matching was undertaken with a historical cohort of patients treated with second-generation drug-eluting stents who received 12 months of dual antiplatelet therapy from the ESTROFA-2 registry. The sample size was calculated using a noninferiority basis and the primary endpoint was the combination of cardiac death, myocardial infarction, revascularization, or major bleeding at 12 months. RESULTS: The analysis included 1286 patients in each group, with no significant differences in baseline characteristics. The primary endpoint occurred in 5.0% and 6.6% in the 6-month and 12-month groups, respectively (P = .001 for noninferiority). The incidence of definite or probable stent thrombosis was 0.5% and 0.7% in the 6-month and 12-month groups, respectively (P = .4). Major bleeding events were lower in the 6-month group than in the 12-month group (0.8% vs 1.4%; P = .2) CONCLUSIONS: In selected patients in this large multicenter study, the safety and efficacy of a 6-month dual antiplatelet therapy regimen after implantation of new-generation drug-eluting stents appeared to be noninferior to those of a 12-month dual antiplatelet therapy regimen.

Stent-oriented versus patient-oriented outcome in patients undergoing early percutaneous coronary intervention for acute coronary syndrome: 2-year report from the BASE-ACS trial.

BACKGROUND: The BASE-ACS trial demonstrated an outcome of the titanium-nitride-oxide-coated bioactive stents (BAS) statistically non-inferior to that of the everolimus-eluting stents (EES) at 12-month follow-up in patients presenting with acute coronary syndrome (ACS). We performed a post hoc analysis of the BASE-ACS trial with particular focus on stent-oriented versus patient-oriented outcome at 24-month follow-up. METHODS: A total of 827 patients with ACS were randomly assigned to receive either BAS (417) or EES (410). Stent-oriented outcome was defined as a composite of cardiac death, target vessel-related non-fatal myocardial infarction, or ischemia-driven target lesion revascularization. Patient-oriented outcome was defined as a composite of all-cause death, any non-fatal myocardial infarction, or any revascularization. RESULTS: Clinical follow-up for 24 months was completed in 406 (97.4%) patients in the BAS group and in 398 (97.1%) in the EES group. Stent-oriented outcome at 24-month follow-up occurred at similar frequencies in the two stent groups (10.1% for BAS versus 11.2% for EES, P=0.53). Likewise, patient-oriented outcome at 24-month follow-up was similar in the two groups (16.3% versus 19.8%, respectively, P=0.2). CONCLUSIONS: In patients presenting with ACS, the rates of both stent-oriented and patient-oriented outcomes at 24-month follow-up in the BAS group were similar to those in the EES group.

Can nutraceuticals prevent Alzheimer's disease? Potential therapeutic role of a formulation containing shilajit and complex B vitamins.

Alzheimer's disease (AD) is a brain disorder displaying a prevalence and impact in constant expansion. This expansive and epidemic behavior is concerning medical and public opinion while focusing efforts on its prevention and treatment. One important strategy to prevent this brain impairment is based on dietary changes and nutritional supplements, functional foods and nutraceuticals. In this review we discuss the potential contributions of shilajit and complex B vitamins to AD prevention. We analyze the status of biological studies and present data of a clinical trial developed in patients with mild AD. Studies suggest that shilajit and its active principle fulvic acid, as well as a formula of shilajit with B complex vitamins, emerge as novel nutraceutical with potential uses against this brain disorder.

A prospective randomised comparison of titanium-nitride-oxide-coated bioactive stents with everolimus-eluting stents in acute coronary syndrome: the BASE-ACS trial.

AIMS: Titanium-nitride-oxide-coated bioactive stents (BAS) have demonstrated a favourable outcome when compared with paclitaxel-eluting stents in patients with acute myocardial infarction (MI). In a prospective randomised non-inferiority study design, we compared the safety and efficacy of BAS versus everolimus-eluting stents (EES) in patients with acute coronary syndrome (ACS). METHODS AND RESULTS: We randomised 827 patients with ACS (1:1) to either BAS (417) or EES (410). The primary endpoint was a composite of cardiac death, non-fatal MI or ischaemia-driven target lesion revascularisation (TLR) at 12-month follow-up. Analyses were performed by intention to treat. At 12-month follow-up, the primary composite endpoint occurred in 9.6% of patients in the BAS group and 9.0% of those in the EES group (HR [hazard ratio] 1.04, 95% CI [confidence interval] 0.81-1.32, p=0.81, p for non-inferiority =0.001). Non-fatal MI was significantly less frequent in the BAS as compared with the EES group (2.2% vs. 5.9%, p=0.007). However, the individual rates of cardiac death and ischaemia-driven TLR were similar between the two groups (1.9% vs. 1.0%, p=0.39, and 6.5% vs. 4.9%, p=0.37, respectively). CONCLUSIONS: In patients presenting with ACS, BAS achieved a clinical outcome that was non-inferior to EES at 12-month follow-up.