Randomized comparison of 9-month stent strut coverage of biolimus and everolimus drug-eluting stents assessed by optical coherence tomography in patients with ST-segment elevation myocardial infarction. Long-term (5-years) clinical follow-up (ROBUST trial)

Background: The aim of the study was to compare healing (assessed by optical coherence tomography [OCT]) of biolimus A9 (BES) and everolimus drug-eluting stents (EES) at 9-month follow-up in patients with ST-segment elevation myocardial infarction (STEMI) treated by primary percutaneous coronary intervention (pPCI). Nine-month clinical and angiographic data were also compared in both groups as well as clinical data at 5 years of follow-up. Methods: A total of 201 patients with STEMI were enrolled in the study and randomized either to pPCI with BES or EES implantation. All patients were scheduled for 9 months of angiographic and OCT follow-up. Results: The rate of major adverse cardiovascular events (MACE) was comparable at 9 months in both groups (5% in BES vs. 6% in the EES group; p = 0.87). Angiographic data were also comparable between both groups. The main finding at 9-month OCT analysis was the greatly reduced extent of mean neointimal area at the cost of a higher proportion of uncovered struts in the BES group (1.3 mm2 vs. 0.9 mm2; p = 0.0001 and 15.9% vs. 7.0%; p = 0.0001, respectively). At 5 years of clinical follow-up the rate of MACE was comparable between both groups (16.8% vs. 14.0%, p = 0.74). Conclusions: The study demonstrates a very low rate of MACE and good 9-month stent strut coverage of second-generation BES and EES in patients with STEMI. BES showed greatly reduced extent of mean neointimal hyperplasia area at the cost of a higher proportion of uncovered struts when compared to EES. The rate of MACE was low and comparable in both groups at 5 years

Effect of natalizumab on disease progression in secondary progressive multiple sclerosis (ASCEND). a phase 3, randomised, double-blind, placebo-controlled trial with an open-label extension

Background: Although several disease-modifying treatments are available for relapsing multiple sclerosis, treatment effects have been more modest in progressive multiple sclerosis and have been observed particularly in actively relapsing subgroups or those with lesion activity on imaging. We sought to assess whether natalizumab slows disease progression in secondary progressive multiple sclerosis, independent of relapses. Methods: ASCEND was a phase 3, randomised, double-blind, placebo-controlled trial (part 1) with an optional 2 year open-label extension (part 2). Enrolled patients aged 18–58 years were natalizumab-naive and had secondary progressive multiple sclerosis for 2 years or more, disability progression unrelated to relapses in the previous year, and Expanded Disability Status Scale (EDSS) scores of 3·0–6·5. In part 1, patients from 163 sites in 17 countries were randomly assigned (1:1) to receive 300 mg intravenous natalizumab or placebo every 4 weeks for 2 years. Patients were stratified by site and by EDSS score (3·0–5·5 vs 6·0–6·5). Patients completing part 1 could enrol in part 2, in which all patients received natalizumab every 4 weeks until the end of the study. Throughout both parts, patients and staff were masked to the treatment received in part 1. The primary outcome in part 1 was the proportion of patients with sustained disability progression, assessed by one or more of three measures: the EDSS, Timed 25-Foot Walk (T25FW), and 9-Hole Peg Test (9HPT). The primary outcome in part 2 was the incidence of adverse events and serious adverse events. Efficacy and safety analyses were done in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT01416181. Findings: Between Sept 13, 2011, and July 16, 2015, 889 patients were randomly assigned (n=440 to the natalizumab group, n=449 to the placebo group). In part 1, 195 (44%) of 439 natalizumab-treated patients and 214 (48%) of 448 placebo-treated patients had confirmed disability progression (odds ratio [OR] 0·86; 95% CI 0·66–1·13; p=0·287). No treatment effect was observed on the EDSS (OR 1·06, 95% CI 0·74–1·53; nominal p=0·753) or the T25FW (0·98, 0·74–1·30; nominal p=0·914) components of the primary outcome. However, natalizumab treatment reduced 9HPT progression (OR 0·56, 95% CI 0·40–0·80; nominal p=0·001). In part 1, 100 (22%) placebo-treated and 90 (20%) natalizumab-treated patients had serious adverse events. In part 2, 291 natalizumab-continuing patients and 274 natalizumab-naive patients received natalizumab (median follow-up 160 weeks [range 108–221]). Serious adverse events occurred in 39 (13%) patients continuing natalizumab and in 24 (9%) patients initiating natalizumab. Two deaths occurred in part 1, neither of which was considered related to study treatment. No progressive multifocal leukoencephalopathy occurred. Interpretation: Natalizumab treatment for secondary progressive multiple sclerosis did not reduce progression on the primary multicomponent disability endpoint in part 1, but it did reduce progression on its upper-limb component. Longer-term trials are needed to assess whether treatment of secondary progressive multiple sclerosis might produce benefits on additional disability components. Funding: Biogen

Imaging Modalities Used for Frameless and Fiducial-Less Deep Brain Stimulation: A Single Centre Exploratory Study among Parkinson’s Disease Cases

Deep brain stimulation (DBS) is a beneficial procedure for treating idiopathic Parkinson’s disease (PD), essential tremor, and dystonia. The authors describe their set of imaging modalities used for a frameless and fiducial-less method of DBS. CT and MRI scans are obtained preoperatively, and STN parcellation is done based on diffusion tractography. During the surgery, an intraoperative cone-beam computed tomography scan is obtained and merged with the preoperatively-acquired images to place electrodes using a frameless and fiducial-less system. Accuracy is evaluated prospectively. The described sequence of imaging methods shows excellent accuracy compared to the frame-based techniques

Premotor Parkinson's disease: Overview of clinical symptoms and current diagnostic methods

Parkinson's disease (PD) is characterized by typical motor symptoms. However, recent studies show several non-motor features that may precede the development of the motor symptoms of PD. The best known premotor symptoms include hyposmia, REM sleep behavior disorder (RBD), constipation, and depression; other symptoms are excessive daytime somnolence, orthostatic hypotension and symptomatic hypotension, erectile or urinary dysfunction, musculoskeletal symptoms, pain, and global cognitive deficit. In this review, we summarize currently available diagnostic methods for these symptoms. We also briefly summarize neuroimaging, polyneuropathy, peripheral markers, and cerebrospinal fluid biomarkers that may be used in the early diagnosis of PD

Cerebrospinal Fluid Levels of Chromogranin A in Parkinson’s Disease and Multiple System Atrophy

Background: Chromogranin A (CgA) and other peptides from the chromogranin–secretogranin family have been recently studied as potential biomarkers of various neurodegenerative diseases, including Parkinson’s disease (PD). Methods: We measured CgA in the cerebrospinal fluid (CSF) of 119 PD patients, 18 multiple system atrophy (MSA) patients, and 31 age-matched controls. We also correlated the values with disease duration and levodopa dose equivalent. Results: In the PD patients, CSF CgA tended to be lower than the control group (median 124.5 vs. 185.2 µg/L; p = 0.057); however, the results did not reach statistical significance. CSF CgA levels in MSA were significantly lower compared to the control group (median 104.4 vs. 185.2; p = 0.014). There was no significant difference in CSF CgA between PD and MSA patients (p = 0.372). There was no association between CSF CgA and disease duration or levodopa dose equivalent in PD or in MSA. Conclusions: We observed a tendency toward lower CSF CgA levels in both PD and MSA compared to the control group; however, the difference reached statistical significance only in MSA. Based on these results, CgA may have potential as a biomarker in PD and MSA, but further studies on larger numbers of patients are needed to draw conclusions

Radial artery neointimal hyperplasia after transradial PCI-Serial optical coherence tomography volumetric study.

Transradial catheterization (TRC) is a dominant access site for coronary catheterization and percutaneous coronary interventions (PCI) in many centers. Previous studies reported higher intimal thickness of the radial artery (RA) wall in patients with a previous history of TRC. In this investigation the aim was to assess the intimal changes of RA using the optical coherence tomography (OCT) intravascular imaging in a serial manner.100 patients with the diagnosis of non-ST-elevation myocardial infarction (nSTEMI) treated by PCI were enrolled (6 patients were excluded from this analysis because of occluded RA at follow-up [2 patients] and insufficient quality of OCT images [4 patients]). An 54mm long OCT run of the RA was performed immediately after the index PCI and repeated 9 months later. Volumetric analyses of the intimal layer and lumen changes were conducted. Median intimal volume at baseline versus 9 months was 33.9mm3 (19.0; 69.4) versus 39.0mm3 (21.7; 72.6) (p<0.001); and median arterial lumen volume was 356.3mm3 (227.8; 645.3) versus 304.7mm3 (186.1; 582.7) (p<0.001). There was no significant difference in the effect of any clinical factor on the RA volume changes.OCT volumetric analyses at baseline and 9 months showed a significant increase in the radial artery intimal layer volume and a decrease in lumen volume after transradial PCI. No significant factors affecting this process were identified

European consensus statement on the use of botulinum toxin type A in the management of adult spasticity

SCOPUS: no.jinfo:eu-repo/semantics/publishe