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aristotle trial

Renato D Lopes, Roberto Rordorf, Gaetano M De Ferrari, Sergio Leonardi, Laine Thomas, Daniel M Wojdyla, Peter Ridefelt, John H Lawrence, Raffaele De Caterina, Dragos Vinereanu, Michael Hanna, Greg Flaker, Sana M Al-Khatib, Stefan H Hohnloser, John H Alexander, Christopher B Granger, Lars Wallentin
BACKGROUND: Digoxin is widely used in patients with atrial fibrillation (AF). OBJECTIVES: The goal of this paper was to explore whether digoxin use was independently associated with increased mortality in patients with AF and if the association was modified by heart failure and/or serum digoxin concentration. METHODS: The association between digoxin use and mortality was assessed in 17,897 patients by using a propensity score-adjusted analysis and in new digoxin users during the trial versus propensity score-matched control participants...
March 13, 2018: Journal of the American College of Cardiology
Nicole VanHeerwaarden, Genevieve Ferguson, Alexxa Abi-Jaoude, Andrew Johnson, Elisa Hollenberg, Gloria Chaim, Kristin Cleverley, Gunther Eysenbach, Joanna Henderson, Andrea Levinson, Janine Robb, Sarah Sharpe, Aristotle Voineskos, David Wiljer
BACKGROUND: Seventy percent of lifetime cases of mental illness emerge before the age of 24 years, but many youth are unable to access the support and services they require in a timely and appropriate way. With most youth using the internet, electronic health (eHealth) interventions are promising tools for reaching this population. Through participatory design research (PDR) engagement methods, Thought Spot, a Web- and mobile-based platform, was redeveloped to facilitate access to mental health services by transition-aged youth (aged 16-29 years) in postsecondary settings...
March 6, 2018: Journal of Medical Internet Research
Pribadi Wiranda Busro, Harvey Romolo, Sudigdo Sastroasmoro, Jusuf Rachmat, Mohammad Sadikin, Anwar Santoso, Cindy Elfira Boom, Suhendro Suwarto, Ahmad Aulia Jusuf
Introduction Myocardial protection is vital to ensure successful open heart surgery. Cardioplegic solution is one method to achieve good myocardial protection. Inevitably, ischemia-reperfusion injury occurs with aortic crossclamping. Histidine-tryptophan-ketoglutarate solution is a frequently used cardioplegia for complex congenital heart surgery. We postulated that addition of terminal warm blood cardioplegia before removal of the aortic crossclamp might improve myocardial protection. Method A randomized controlled trial was conducted on 109 cyanotic patients aged, 1 to 5 years who underwent complex biventricular repair...
January 1, 2018: Asian Cardiovascular & Thoracic Annals
David Kopin, W Schuyler Jones, Matthew W Sherwood, Daniel M Wojdyla, Lars Wallentin, Basil S Lewis, Freek W A Verheugt, Dragos Vinereanu, M Cecilia Bahit, Sigrun Halvorsen, Kurt Huber, Alexander Parkhomenko, Christopher B Granger, Renato D Lopes, John H Alexander
BACKGROUND: We assessed antiplatelet therapy use and outcomes in patients undergoing percutaneous coronary intervention (PCI) during the ARISTOTLE trial. METHODS: Patients were categorized based on the occurrence of PCI during follow-up (median 1.8 years); PCI details and outcomes post-PCI are reported. Of the 18,201 trial participants, 316 (1.7%) underwent PCI (152 in apixaban group, 164 in warfarin group). RESULTS: At the time of PCI, 84% (267) were on study drug (either apixaban or warfarin)...
March 2018: American Heart Journal
O Itzhaki, B Zadok, A Eisen
AIMS: To examine the efficacy and safety of non-vitamin K oral anticoagulants in people with both atrial fibrillation and diabetes mellitus. METHODS: We reviewed efficacy and safety data from the warfarin-controlled phase III non-vitamin K oral anticoagulants trials (ARISTOTLE, RE-LY, ROCKET-AF, ENGAGE and AF-TIMI 48) and their post hoc analyses with regard to diabetes status. We also reviewed the updated literature regarding this population. RESULTS: At baseline 20-40% of the participants in the phase III non-vitamin K oral anticoagulants trials had diabetes mellitus at baseline...
February 13, 2018: Diabetic Medicine: a Journal of the British Diabetic Association
Tymon Pol, Claes Held, Johan Westerbergh, Johan Lindbäck, John H Alexander, Marco Alings, Cetin Erol, Shinya Goto, Sigrun Halvorsen, Kurt Huber, Michael Hanna, Renato D Lopes, Witold Ruzyllo, Christopher B Granger, Ziad Hijazi
BACKGROUND: Dyslipidemia is a major risk factor for cardiovascular events. The prognostic importance of lipoproteins in patients with atrial fibrillation is not well understood. We aimed to explore the association between apolipoprotein A1 (ApoA1) and B (ApoB) and cardiovascular events in patients with atrial fibrillation receiving oral anticoagulation. METHODS AND RESULTS: Using data from the ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) trial, ApoA1 and ApoB plasma levels were measured at baseline in 14 884 atrial fibrillation patients...
February 1, 2018: Journal of the American Heart Association
Natale Daniele Brunetti, Nicola Tarantino, Luisa De Gennaro, Michele Correale, Francesco Santoro, Matteo Di Biase
Pharmacological or electrical cardioversion allows immediate symptoms improvement in the setting of paroxysmal or persistent atrial fibrillation (AF), although the periprocedural risk of systemic embolism should be considered. Recently, there was a great interest on the safety and efficacy of direct oral anticoagulants (DOACs) when used for the cardioversion of non-valvular AF. We performed a random-effects meta-analysis of patients undergoing both electrical and pharmacologic cardioversion for non-valvular AF in the RE-LY, ROCKET-AF, ARISTOTLE, ENGAGE AF-TIMI 48, X-VeRT, ENSURE-AF, and EMANATE trials...
February 5, 2018: Journal of Thrombosis and Thrombolysis
Dragos Vinereanu, Alice Wang, Hillary Mulder, Renato D Lopes, Petr Jansky, Basil S Lewis, Bernard J Gersh, Alvaro Avezum, Michael Hanna, Claes Held, Lars Wallentin, Christopher B Granger, John H Alexander
OBJECTIVE: To assess stroke/systemic embolism, major bleeding and other outcomes, and treatment effect of apixaban versus warfarin, in patients with atrial fibrillation (AF) and different types of valvular heart disease (VHD), using data from the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation trial. METHODS: There were 14 793 patients with known VHD status, categorised as having moderate or severe mitral regurgitation (MR) (n=3382), aortic regurgitation (AR) (n=842) or aortic stenosis (AS) (n=324); patients with moderate or severe mitral stenosis were excluded from the trial...
January 19, 2018: Heart: Official Journal of the British Cardiac Society
Andrew S Tseng, J William Schleifer, Win-Kuang Shen, Robert McBane, Sunil Mankad, Heidi Esser, Darko Vucicevic, Fadi E Shamoun
BACKGROUND: Patients with heart failure (HF) have increased risk for thromboembolic events. Real-world incidences of efficacy and safety outcomes of direct oral anticoagulants (DOACs) in patients with left ventricular systolic dysfunction (LVSD) are of growing clinical interest. HYPOTHESIS: Real-world efficacy and safety outcomes of DOACs in patients with LVSD will be similar to those of LVSD or HF subgroups in the RE-LY, ROCKET-AF, and ARISTOTLE trials. METHODS: We performed a retrospective review of adult patients with LVSD (left ventricular ejection fraction ≤40%) on DOAC therapy between 2010 and 2016...
December 16, 2017: Clinical Cardiology
Meena P Rao, Dragos Vinereanu, Daniel M Wojdyla, John H Alexander, Dan Atar, Elaine M Hylek, Michael Hanna, Lars Wallentin, Renato D Lopes, Bernard J Gersh, Christopher B Granger
PURPOSE: We assessed outcomes among anticoagulated patients with atrial fibrillation (AF) and a history of falling, and whether the benefits of apixaban versus warfarin are consistent in this population. METHODS: Of the 18,201 patients in ARISTOTLE, 16,491 had information about history of falling - 753 with history of falling and 15,738 without history of falling. The primary efficacy outcome was stroke or systemic embolism; the primary safety outcome was major bleeding...
November 6, 2017: American Journal of Medicine
Tina Roostaei, Daniel Felsky, Arash Nazeri, Philip L De Jager, Julie A Schneider, David A Bennett, Aristotle N Voineskos
Observational studies have consistently reported elevated plasma homocysteine as a risk factor for Alzheimer's disease (AD). However, results from clinical trials of homocysteine-lowering treatments are inconsistent. This discrepancy may be explained by a lack of causal association between homocysteine and AD. Mendelian randomization studies have the potential to provide insight into the causality of this association through studying the effect of genetic predisposition to high homocysteine on AD. Our analyses using summarized (n = 54,162) and individual participant (n = 6987) data from Caucasian participants did not show an effect of plasma homocysteine genetic risk on susceptibility to AD...
October 13, 2017: Neurobiology of Aging
Dragos Vinereanu, Renato D Lopes, Hillary Mulder, Bernard J Gersh, Michael Hanna, Pedro G M de Barros E Silva, Dan Atar, Lars Wallentin, Christopher B Granger, John H Alexander
BACKGROUND AND PURPOSE: Few data exist on the long-term outcomes of patients with spontaneous echo contrast (SEC), left atrial/left atrial appendage (LA/LAA) thrombus, and complex aortic plaque (CAP), in patients with atrial fibrillation receiving oral anticoagulation. We explored the relationship between these 3 echocardiographic findings and clinical outcomes, and the comparative efficacy and safety of apixaban and warfarin for each finding. METHODS: Patients from the ARISTOTLE trial (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) with SEC, LA/LAA thrombus, or CAP diagnosed by either transthoracic or transesophageal echocardiography were compared with patients with none of these findings on transesophageal echocardiography...
December 2017: Stroke; a Journal of Cerebral Circulation
Steven Deitelzweig, Xuemei Luo, Kiran Gupta, Jeffrey Trocio, Jack Mardekian, Tammy Curtice, Melissa Lingohr-Smith, Brandy Menges, Jay Lin
BACKGROUND: The clinical trial ARISTOTLE showed that apixaban was superior to warfarin in reducing the risks of stroke and bleeding among patients with nonvalvular atrial fibrillation (NVAF). Further study of the effect of apixaban versus warfarin use on health care resource utilization (HCRU) and associated costs in the real-world setting is warranted, especially among elderly patients who are at higher risk of stroke and bleeding. OBJECTIVE: To compare HCRU and costs among elderly NVAF patients treated with apixaban versus warfarin in the United States...
November 2017: Journal of Managed Care & Specialty Pharmacy
Cornelia Merki-Künzli, Marta Kerstan-Huber, Denise Switalla, David Gisi, Dimitri Aristotle Raptis, Nicola Greco, Giuseppe Mungo, Markus Wirz, Severin Gloor, Merima Misirlic, Stefan Breitenstein, Christoph Tschuor
BACKGROUND: A key element in the postoperative phase of the standardized Enhanced Recovery After Surgery (ERAS) treatment pathways is mobilization. Currently, there are no recommendations in the ERAS guidelines for preoperative physical activity. Patients undergoing major surgery are prone to functional decline due to the impairment of muscle, cardiorespiratory, and neurological function as a response to surgical stress. It has been shown that preoperative physical training reduces postoperative complications...
October 27, 2017: JMIR Research Protocols
Laura Fanning, Jenni Ilomäki, J Simon Bell, Pēteris Dārziņš
PURPOSE: Trials of the direct oral anticoagulants (DOACs) dabigatran, rivaroxaban and apixaban provide the basis for prescribing for the prevention of stroke and systemic embolism in atrial fibrillation (AF). The objective of this study was to assess the representativeness of the three pivotal DOAC randomized controlled trials of dabigatran, rivaroxaban and apixaban for unselected hospitalized patients with AF. METHODS: A cross-sectional study was undertaken. All patients discharged with AF between 2012 and 2015 from a large public hospital network in Melbourne, Australia, were identified...
November 2017: European Journal of Clinical Pharmacology
Katherine Victoria Hurst, John Matthew O'Callaghan, Ashok Handa
Direct oral anticoagulants (DOACs) are being increasingly used in the clinical setting for patients at risk of venous thromboembolism (VTE) and/or stroke. These medications offer valued benefits for long-term use, including a fast onset of anticoagulation, fixed anticoagulation profile (and consequent prescription of specified doses) and no requirement for routine monitoring. Apixaban is a selective factor Xa inhibitor, approved for use in the prevention of stroke in patients with nonvalvular atrial fibrillation and in the prevention and treatment of acute VTE...
2017: Vascular Health and Risk Management
Chiara Melloni, Allison Dunning, Christopher B Granger, Laine Thomas, Michel G Khouri, David A Garcia, Elaine M Hylek, Michael Hanna, Lars Wallentin, Bernard J Gersh, Pamela S Douglas, John H Alexander, Renato D Lopes
BACKGROUND: Cancer is associated with a prothrombotic state and increases the risk of thrombotic events in patients with atrial fibrillation. We described the clinical characteristics and outcomes and assessed the safety and efficacy of apixaban versus warfarin in patients with atrial fibrillation and cancer in the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial. METHODS: The association between cancer and clinical outcomes was assessed using Cox regression models...
December 2017: American Journal of Medicine
Ziad Hijazi, Bertil Lindahl, Jonas Oldgren, Ulrika Andersson, Johan Lindbäck, Christopher B Granger, John H Alexander, Bernard J Gersh, Michael Hanna, Veli-Pekka Harjola, Elaine M Hylek, Renato D Lopes, Agneta Siegbahn, Lars Wallentin
BACKGROUND: Cardiac biomarkers are independent risk markers in atrial fibrillation, and the novel biomarker-based ABC stroke score (age, biomarkers, and clinical history of prior stroke) was recently shown to improve the prediction of stroke risk in patients with atrial fibrillation. Our aim was to investigate the short-term variability of the cardiac biomarkers and evaluate whether the ABC stroke risk score provides a stable short-term risk estimate. METHODS AND RESULTS: According to the study protocol, samples were obtained at entry and also at 2 months in 4796 patients with atrial fibrillation followed for a median of 1...
June 23, 2017: Journal of the American Heart Association
Aristotle Bamias, Bernard Escudier, Cora N Sternberg, Flora Zagouri, Athanasios Dellis, Bob Djavan, Kimon Tzannis, Loukas Kontovinis, Konstantinos Stravodimos, Athanasios Papatsoris, Dionysios Mitropoulos, Charalampos Deliveliotis, Meletios-Athanasios Dimopoulos, Constantine A Constantinides
The landscape of local and systemic therapy of renal cell carcinoma (RCC) is rapidly changing. The increase in the incidental finding of small renal tumors has increased the application of nephron-sparing procedures, while ten novel agents targeting the vascular endothelial growth factor (VEGF) or the mammalian target of rapamycin pathways, or inhibiting the interaction of the programmed death 1 receptor with its ligand, have been approved since 2006 and have dramatically improved the prognosis of metastatic RCC (mRCC)...
June 2017: Oncologist
Patrícia O Guimarães, Renato D Lopes, Daniel M Wojdyla, Azmil H Abdul-Rahim, Stuart J Connolly, Greg C Flaker, Junyuan Wang, Michael Hanna, Christopher B Granger, Lars Wallentin, Kennedy R Lees, John H Alexander, John J V McMurray
PURPOSE: Vitamin K antagonists (VKAs) are the standard of care for stroke prevention in patients with atrial fibrillation (AF); therefore, there is not equipoise when comparing newer oral anticoagulants with placebo in this setting. METHODS: To explore the effect of apixaban on mortality in patients with AF, we performed a meta-analysis of apixaban versus placebo using a putative placebo analysis based on randomized controlled clinical trials that compared warfarin, aspirin, and no antithrombotic control...
June 2017: Cardiovascular Drugs and Therapy
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