Drug-coated balloons offer a potentially beneficial treatment strategy for the management of coronary in-stent restenosis. However, none have been previously evaluated or approved for use in coronary ...circulation in the United States.
To evaluate whether a paclitaxel-coated balloon is superior to an uncoated balloon in patients with in-stent restenosis undergoing percutaneous coronary intervention.
AGENT IDE, a multicenter randomized clinical trial, enrolled 600 patients with in-stent restenosis (lesion length <26 mm and reference vessel diameter >2.0 mm to ≤4.0 mm) at 40 centers across the United States between May 2021 and August 2022. One-year clinical follow-up was completed on October 2, 2023.
Participants were randomized in a 2:1 allocation to undergo treatment with a paclitaxel-coated (n = 406) or an uncoated (n = 194) balloon.
The primary end point of 1-year target lesion failure-defined as the composite of ischemia-driven target lesion revascularization, target vessel-related myocardial infarction, or cardiac death-was tested for superiority.
Among 600 randomized patients (mean age, 68 years; 157 females 26.2%; 42 Black 7%, 35 Hispanic 6% individuals), 574 (95.7%) completed 1-year follow-up. The primary end point at 1 year occurred in 17.9% in the paclitaxel-coated balloon group vs 28.6% in the uncoated balloon group, meeting the criteria for superiority (hazard ratio HR, 0.59 95% CI, 0.42-0.84; 2-sided P = .003). Target lesion revascularization (13.0% vs 24.7%; HR, 0.50 95% CI, 0.34-0.74; P = .001) and target vessel-related myocardial infarction (5.8% vs 11.1%; HR, 0.51 95% CI, 0.28-0.92; P = .02) occurred less frequently among patients treated with paclitaxel-coated balloon. The rate of cardiac death was 2.9% vs 1.6% (HR, 1.75 95% CI, 0.49-6.28; P = .38) in the coated vs uncoated balloon groups, respectively.
Among patients undergoing coronary angioplasty for in-stent restenosis, a paclitaxel-coated balloon was superior to an uncoated balloon with respect to the composite end point of target lesion failure. Paclitaxel-coated balloons are an effective treatment option for patients with coronary in-stent restenosis.
ClinicalTrials.gov Identifier: NCT04647253.
Abstract Purpose To study incidence of radiation-related heart disease in a large population of breast cancer patients followed for up to 30 years. Material and methods 72,134 women diagnosed with ...breast cancer in Denmark or Sweden during 1976–2006 and followed prospectively. Radiation-related risk was studied by comparing women with left-sided and right-sided tumours. Results 34,825 women (48%) received radiotherapy. Among unirradiated women tumour laterality had little relevance to heart disease. Among irradiated women mean dose to the whole heart was 6.3 Gy for left-sided tumours and 2.7 Gy for right-sided tumours. Mortality was similar in irradiated women with left-sided and right-sided tumours, but incidence ratios, left-sided versus right-sided, were raised: acute myocardial infarction 1.22 (95% CI 1.06–1.42), angina 1.25 (1.05–1.49), pericarditis 1.61 (1.06–2.43), valvular heart disease 1.54 (1.11–2.13). Incidence ratios for all heart disease were as high for women irradiated since 1990 (1.09 1.00–1.19) as for women irradiated during 1976–1989 (1.08 0.99–1.17), and were higher for women diagnosed with ischaemic heart disease prior to breast cancer than for other women (1.58 1.19–2.10 versus 1.08 1.01–1.15, p for difference = 0.01). Conclusions Breast cancer radiotherapy has, at least until recently, increased the risk of developing ischaemic heart disease, pericarditis and valvular disease. Women with ischaemic heart disease before breast cancer diagnosis may have incurred higher risks than others.
•Nightly variability in total sleep time is associated with odds of relapse.•Nightly variability in sleep midpoint is related to odds of completing treatment.•Nightly variability is a better ...predictor of outcomes than average patterns.
Poor sleep health is common among individuals in early treatment for substance use disorders (SUDs) and may serve an important role in predicting SUD outcomes. However, sleep parameters have been inconsistently linked with risk of relapse, perhaps because previous research has focused on mean values of sleep parameters (e.g., total sleep time TST, sleep efficiency SE, and sleep midpoint SM) across multiple nights rather than night-to-night fluctuations (i.e., intraindividual variability IIV). The current study assessed sleep across the first week of SUD treatment, with the aim of prospectively examining the relationship between mean and IIV of TST, SE, and SM and treatment completion and relapse within one-month post-treatment.
Treatment-seeking adults (N = 23, Mage = 40.1, 39% female) wore an actigraph to assess sleep for one week at the beginning of an intensive outpatient program treatment. Electronic medical record and follow-up interviews were utilized to determine treatment outcomes.
Greater IIV in TST was associated with higher odds of relapse (OR = 3.55, p =.028). Greater IIV in SM was associated with lower odds of treatment completion, but only when removing mean SM from the model (OR = 0.75, p =.046).
Night-to-night variability in actigraphy-measured TST is more strongly associated with SUD treatment outcomes than average sleep patterns across the week. Integrating circadian regulation into treatment efforts to improve SUD treatment outcomes may be warranted. Given the small sample size utilized in the present study, replication of these analyses with a larger sample is warranted.
The laboratory mouse shares the majority of its protein-coding genes with humans, making it the premier model organism in biomedical research, yet the two mammals differ in significant ways. To gain ...greater insights into both shared and species-specific transcriptional and cellular regulatory programs in the mouse, the Mouse ENCODE Consortium has mapped transcription, DNase I hypersensitivity, transcription factor binding, chromatin modifications and replication domains throughout the mouse genome in diverse cell and tissue types. By comparing with the human genome, we not only confirm substantial conservation in the newly annotated potential functional sequences, but also find a large degree of divergence of sequences involved in transcriptional regulation, chromatin state and higher order chromatin organization. Our results illuminate the wide range of evolutionary forces acting on genes and their regulatory regions, and provide a general resource for research into mammalian biology and mechanisms of human diseases.
Venovenous extracorporeal membrane oxygenation (VV ECMO) can support trauma patients with severe respiratory failure. Use in traumatic brain injury (TBI) may raise concerns of worsening complications ...from intracranial bleeding. However, VV ECMO can rapidly correct hypoxemia and hypercarbia, possibly preventing secondary brain injury. We hypothesize that adult trauma patients with TBI on VV ECMO have comparable survival with trauma patients without TBI.
A single-center, retrospective cohort study involving review of electronic medical records of trauma admissions between July 1, 2014, and August 30, 2022, with discharge diagnosis of TBI who were placed on VV ECMO during their hospital course was performed.
Seventy-five trauma patients were treated with VV ECMO; 36 (48%) had TBI. Of those with TBI, 19 (53%) had a hemorrhagic component. Survival was similar between patients with and without a TBI (72% vs. 64%, p = 0.45). Traumatic brain injury survivors had a higher admission Glasgow Coma Scale (7 vs. 3, p < 0.001) than nonsurvivors. Evaluation of prognostic scoring systems on initial head computed tomography demonstrated that TBI VV ECMO survivors were more likely to have a Rotterdam score of 2 (62% vs. 20%, p = 0.03) and no survivors had a Marshall score of ≥4. Twenty-nine patients (81%) had a repeat head computed tomography on VV ECMO with one incidence of expanding hematoma and one new focus of bleeding. Neither patient with a new/worsening bleed received anticoagulation. Survivors demonstrated favorable neurologic outcomes at discharge and outpatient follow-up, based on their mean Rancho Los Amigos Scale (6.5; SD, 1.2), median Cerebral Performance Category (2; interquartile range, 1-2), and median Glasgow Outcome Scale-Extended (7.5; interquartile range, 7-8).
In this series, the majority of TBI patients survived and had good neurologic outcomes despite a low admission Glasgow Coma Scale. Venovenous extracorporeal membrane oxygenation may minimize secondary brain injury and may be considered in select patients with TBI.
Prognostic and Epidemiological; Level IV.
A distinctive organic-rich marine mudstone of Late Paleocene age occurs in most of New Zealand's sedimentary basins and has been identified as a potential source rock for oil and gas. Identified as ...the Waipawa Formation in the East Coast Basin and the Tartan Formation in the Great South and Canterbury Basins, the unit is a relatively uniform massive mudstone that varies greatly in thickness (2–70m) and grades laterally into distinctive facies equivalents, notably greensand and a thin-bedded siliceous mudstone. All these facies are characterised by relatively high TOC (0.5–10wt.%) and 13C enrichment (δ13CTOC>−24‰), and we refer to them collectively as “Waipawa organofacies”. Our detailed stratigraphic and geochemical studies refine the age (58.7 to 59.4Ma), distribution and nature of the Waipawa organofacies. We have determined that deposition occurred in continental margin settings throughout much of the southwest Pacific under cool, dysoxic conditions associated with a significant influx of terrestrial organic matter, high marine productivity, a global fall in sea level, and a regional unconformity across shallow and deep marine settings. The combination of cool temperatures, lowered sea level and bathyal erosion suggests that deposition was linked to short-lived growth of an Antarctic ice sheet in the earliest Late Paleocene (~59Ma).
The application of rapidly applied length steps to actively contracting muscle is a classic method for synchronizing the response of myosin cross-bridges so that the average response of the ensemble ...can be measured. Alternatively, electron tomography (ET) is a technique that can report the structure of the individual members of the ensemble. We probed the structure of active myosin motors (cross-bridges) by applying 0.5% changes in length (either a stretch or a release) within 2 ms to isometrically contracting insect flight muscle (IFM) fibers followed after 5-6 ms by rapid freezing against a liquid helium cooled copper mirror. ET of freeze-substituted fibers, embedded and thin-sectioned, provides 3-D cross-bridge images, sorted by multivariate data analysis into ~40 classes, distinct in average structure, population size and lattice distribution. Individual actin subunits are resolved facilitating quasi-atomic modeling of each class average to determine its binding strength (weak or strong) to actin. ~98% of strong-binding acto-myosin attachments present after a length perturbation are confined to "target zones" of only two actin subunits located exactly midway between successive troponin complexes along each long-pitch helical repeat of actin. Significant changes in the types, distribution and structure of actin-myosin attachments occurred in a manner consistent with the mechanical transients. Most dramatic is near disappearance, after either length perturbation, of a class of weak-binding cross-bridges, attached within the target zone, that are highly likely to be precursors of strong-binding cross-bridges. These weak-binding cross-bridges were originally observed in isometrically contracting IFM. Their disappearance following a quick stretch or release can be explained by a recent kinetic model for muscle contraction, as behaviour consistent with their identification as precursors of strong-binding cross-bridges. The results provide a detailed model for contraction in IFM that may be applicable to contraction in other types of muscle.
We compute the bispectrum of the 2dF Galaxy Redshift Survey (2dFGRS) and use it to measure the bias parameter of the galaxies. This parameter quantifies the strength of clustering of the galaxies ...relative to the mass in the Universe. By analysing 80 × 106 triangle configurations in the wavenumber range 0.1 < k < 0.5 h Mpc−1 (i.e. on scales roughly between 5 and 30 h−1 Mpc) we find that the linear bias parameter is consistent with unity: b1= 1.04 ± 0.11, and the quadratic (non-linear) bias is consistent with zero: b2=−0.054 ± 0.08. Thus, at least on large scales, optically selected galaxies do indeed trace the underlying mass distribution. The bias parameter can be combined with the 2dFGRS measurement of the redshift distortion parameter β≃Ωm0.6/b1, to yield Ωm= 0.27 ± 0.06 for the matter density of the Universe, a result that is determined entirely from this survey, independent of other data sets. Our measurement of the matter density of the Universe should be interpreted as Ωm at the effective redshift of the survey (z= 0.17).
Heart failure (HF) is a common condition affecting more than 10% of those over 70 years of age. Reliable estimates of survival following a diagnosis of HF are important to guide management and ...facilitate advanced care planning. Most existing research has focused on survival rates for patients admitted to hospital with acute HF. However, the majority of patients with HF are diagnosed in the outpatient setting and can have periods of sustained symptom stability in the chronic phase of their illness. There has not been a systematic review of the literature to determine the prognosis of patients with chronic HF in the community.
We will undertake a comprehensive search of the following databases: CINAHL, Database of Abstracts of Reviews of Effects, Embase, MEDLINE and the Clinical Trials Register ( clinicaltrials.gov ). Two reviewers will independently complete screening, data extraction and quality appraisal with the option of input from a third reviewer to arbitrate. We will include data from observational or database studies conducted in either community or outpatient settings. Studies of acute HF or specific subgroups of patients will be excluded. There is no restriction by geographical setting, publication language or study date. We will complete QUIPS and GRADE assessments to systematically appraise the quality of evidence within and between studies. Where possible, we will seek to pool results to conduct a meta-analysis and undertake relevant subgroup analysis including by study setting, participant age and study decade. The primary outcome will be survival time from diagnosis. The secondary outcomes will be HF-related hospital admissions, symptom burden and measures of morbidity.
This systematic review will provide up to date evidence on the current survival rates and prognostic indicators for patients with chronic HF. We will put this into historical perspective, comparing outcomes across time to help understand the impact of advances in evidence-based treatment on average survival. This information is important in facilitating informed decision-making for patients and health professionals as well as highlighting areas to focus resources and improve public health planning.
PROSPERO 2017 CRD42017075680.
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