Long-term clinical outcomes of everolimus-eluting bioresorbable scaffolds versus everolimus-eluting stents:final five-year results of the AIDA randomised clinical trial

Background: Absorb bioresorbable vascular scaffold (BVS)-related events have been reported between 1 and 3 years – the period of active scaffold bioresorption. Data on the performance of the Absorb BVS in daily clinical practice beyond this time point are scarce. Aims: This report aimed to provide the final five-year clinical follow-up of the Absorb BVS in comparison with the XIENCE everolimus-eluting stent (EES). In addition, we evaluated the effect of prolonged dual antiplatelet therapy (DAPT) administration on events in the scaffold group. Methods: AIDA was a multicentre, investigator-initiated, non-inferiority trial, in which 1,845 unselected patients with coronary artery disease were randomly assigned to either the Absorb BVS (n=924) or the XIENCE EES (n=921). Target vessel failure (TVF), a composite of cardiac death, target vessel myocardial infarction or target vessel revascularisation, was the primary endpoint. Scaffold thrombosis cases were matched with controls and tested for the effect of prolonged DAPT. Results: Up to five-year follow-up, there was no difference in TVF between the Absorb BVS (17.7%) and the XIENCE EES (16.1%) (hazard ratio [HR] 1.31, 95% confidence interval [CI]: 0.90-1.41; p=0.302). Definite or probable device thrombosis (DT) occurred in 43 patients (4.8%) in the scaffold group compared to 13 patients (1.5%) in the stent group (HR 3.32, 95% CI: 1.78-6.17; p<0.001). DT between 3 and 4 years occurred six times in the Absorb arm versus three times in the XIENCE arm. Between 4 and 5 years, the incidence was three versus two, respectively. Of those three DT in the scaffold group, two occurred in XIENCE EES-treated lesions. The odds ratio of scaffold thrombosis in patients on DAPT compared to off DAPT throughout five-year follow-up was 0.36 (95% CI: 0.15-0.86). Conclusions: The excess risk of the Absorb BVS on late adverse events, in particular device thrombosis, in routine PCI continues up to 4 years and seems to plateau afterwards

Development and validation of a prediction model for tube feeding dependence after curative (chemo-) radiation in head and neck cancer

BACKGROUND: Curative radiotherapy or chemoradiation for head and neck cancer (HNC) may result in severe acute and late side effects, including tube feeding dependence. The purpose of this prospective cohort study was to develop a prediction model for tube feeding dependence 6 months (TUBEM6) after curative (chemo-) radiotherapy in HNC patients. PATIENTS AND METHODS: Tube feeding dependence was scored prospectively. To develop the multivariable model, a group LASSO analysis was carried out, with TUBEM6 as the primary endpoint (n = 427). The model was then validated in a test cohort (n = 183). The training cohort was divided into three groups based on the risk of TUBEM6 to test whether the model could be extrapolated to later time points (12, 18 and 24 months). RESULTS: Most important predictors for TUBEM6 were weight loss prior to treatment, advanced T-stage, positive N-stage, bilateral neck irradiation, accelerated radiotherapy and chemoradiation. Model performance was good, with an Area under the Curve of 0.86 in the training cohort and 0.82 in the test cohort. The TUBEM6-based risk groups were significantly associated with tube feeding dependence at later time points (p<0.001). CONCLUSION: We established an externally validated predictive model for tube feeding dependence after curative radiotherapy or chemoradiation, which can be used to predict TUBEM6

Robust estimation of bacterial cell count from optical density

Optical density (OD) is widely used to estimate the density of cells in liquid culture, but cannot be compared between instruments without a standardized calibration protocol and is challenging to relate to actual cell count. We address this with an interlaboratory study comparing three simple, low-cost, and highly accessible OD calibration protocols across 244 laboratories, applied to eight strains of constitutive GFP-expressing E. coli. Based on our results, we recommend calibrating OD to estimated cell count using serial dilution of silica microspheres, which produces highly precise calibration (95.5% of residuals &lt;1.2-fold), is easily assessed for quality control, also assesses instrument effective linear range, and can be combined with fluorescence calibration to obtain units of Molecules of Equivalent Fluorescein (MEFL) per cell, allowing direct comparison and data fusion with flow cytometry measurements: in our study, fluorescence per cell measurements showed only a 1.07-fold mean difference between plate reader and flow cytometry data

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

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Paclitaxel-eluting balloon versus everolimus-eluting stent in patients with diabetes mellitus and in-stent restenosis: Insights from the randomized DARE trial

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Routine use of the transradial approach in primary percutaneous coronary intervention: procedural aspects and outcomes in 2209 patients treated in a single high-volume centre

To examine the feasibility of a routine transradial approach (TRA) in primary percutaneous coronary intervention (PPCI) for acute ST-segment elevation myocardial infarction (STEMI). A single-centre observational study with prospective data collection. A high-volume interventional centre in Amsterdam, The Netherlands. Procedural data were analysed for 2209 consecutive patients presenting with STEMI without cardiogenic shock, between January 2001 and December 2008. PPCI routinely performed by the TRA. Main The primary outcomes of interest were the need for crossover to another vascular access site, the achievement of procedural success and their trends over time. Secondary outcome measures were trends in total procedural duration, fluoroscopy times and use of equipment. In a total of 2209 procedures the radial artery was the primary access site, comprising 96.1% of all procedures performed during the study period. In 84 cases (3.8%) access site crossover was needed. Crossover rates decreased from 5.9% in 2001-2 to 1.5% in 2007-8 (p=0.001). The procedural success rate was 94.1%, which remained stable over the years. Despite an increased complexity of PPCI (more non-left anterior descending infarct-related arteries, thrombus aspiration and multivessel PPCI), total procedural duration decreased from 38 min (IQR 28-50) in 2001-2 to 24 min (18-33) in 2007-8, p <0.001 for trend. Systematic use of the TRA in PPCI yields low access site crossover, high procedural success rates and excellent procedural performances. It can therefore represent the primary access site in the vast majority of STEMI patient

Recovery of right ventricular function and strain in patients with ST-segment elevation myocardial infarction and concurrent chronic total occlusion

The right ventricle (RV) is frequently involved in ST-segment elevation myocardial infarction (STEMI) when the culprit or concurrent chronic total occlusion (CTO) is located in the right coronary artery (RCA). We investigated RV function recovery in STEMI-patients with concurrent CTO. In EXPLORE, STEMI-patients with concurrent CTO were randomized to CTO percutaneous coronary intervention (PCI) or no CTO-PCI. We analyzed 174 EXPLORE patients with serial cardiovascular magnetic resonance imaging RV data (baseline and 4-month follow-up), divided into three groups: CTO-RCA (CTO in RCA, culprit in non-RCA; n = 89), IRA-RCA (infarct related artery [IRA] in RCA, CTO in non-RCA; n = 56), and no-RCA (culprit and CTO not in RCA; n = 29). Tricuspid annular plane systolic excursion (TAPSE), RV ejection fraction (RVEF), RV global longitudinal strain (GLS) and free wall longitudinal strain (FWLS) were measured. We found that RV strain and TAPSE improved in IRA-RCA and CTO-RCA (irrespective of CTO-PCI) at follow-up, but not in no-RCA. Only RV FWLS was different among groups at baseline, which was lower in IRA-RCA than no-RCA (− 26.0 ± 8.3% versus − 31.0 ± 6.4%, p = 0.006). Baseline RVEF, RV end-diastolic volume and TAPSE were associated with RVEF at 4 months. RV function parameters were not predictive of 4 year mortality, although RV GLS showed additional predictive value for New York Heart Association Classification > 1 at 4 months. In conclusion, RV parameters significantly improved in patients with acute or chronic RCA occlusion, but not in no-RCA patients. RV FWLS was the only RV parameter able to discriminate between acute ischemic and non-ischemic myocardium. Moreover, RV GLS was independently predictive for functional status

Prognostic value of admission hemoglobin levels in ST-segment elevation myocardial infarction patients presenting with cardiogenic shock

Even in the era of primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock (CS), mortality remains high. Whether admission hemoglobin (Hb) concentration is a predictor of mortality in patients with CS treated with primary PCI is unexplored. We assessed the relation between admission Hb concentration and 1-year mortality in patients with STEMI and CS who were treated with PCI at admission. We investigated a cohort of 265 patients with STEMI with CS on admission. Patients were categorized in 3 groups according to plasma Hb levels at admission: 9.6 g/dl (group I, n = 22), 9.6 to 12 g/dl (group II, n = 59), and >12 g/dl (group III, n = 184). All-cause mortality at 1 year was 64%, 46%, and 35% for groups I, II, and III, respectively (p = 0.007). Multivariate logistic regression analysis showed that the odds for mortality increased 17% for every 1.0 g/dl decrease in plasma Hb (odds ratio 1.17, 95% confidence interval 1.01 to 1.35, p = 0.042). In conclusion, admission Hb concentration is an independent predictor for 1-year mortality in patients with STEMI undergoing primary PC