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aristotle trial

Eva M Marwali, Cindy E Boom, Novik Budiwardhana, Dicky Fakhri, Poppy S Roebiono, Anwar Santoso, Sudigdo Sastroasmoro, April Slee, Michael A Portman
BACKGROUND: This study evaluated the efficacy and safety of oral triiodothyronine (T3; Tetronine, Dalim BioTech, Korea) for infants and children undergoing cardiopulmonary bypass in an Indonesian population. METHODS: We performed a single-center, randomized, double-blind, and placebo-controlled trial in children aged 3 years and younger undergoing congenital heart disease operations with cardiopulmonary bypass. We administered oral T3 (1 μg/kg per body weight/dose) or placebo (saccharum lactis) by nasogastric tube every 6 hours for 60 hours after induction of anesthesia...
February 6, 2017: Annals of Thoracic Surgery
Peter T Hu, Renato D Lopes, Susanna R Stevens, Lars Wallentin, Laine Thomas, John H Alexander, Michael Hanna, Basil S Lewis, Freek W A Verheugt, Christopher B Granger, W Schuyler Jones
BACKGROUND: We studied (1) the rates of stroke or systemic embolism and bleeding in patients with atrial fibrillation and peripheral artery disease (PAD) and (2) the efficacy and safety of apixaban versus warfarin in patients with atrial fibrillation with and without PAD. METHODS AND RESULTS: The Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial randomized 18 201 patients with atrial fibrillation to apixaban or warfarin for stroke/systemic embolism prevention; 884 (4...
January 17, 2017: Journal of the American Heart Association
Ryan E Owens, Rajesh Kabra, Carrie S Oliphant
Direct oral anticoagulants (DOACs) are indicated for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF), which, according to the American College of Cardiology/American Heart Association/Heart Rhythm Society atrial fibrillation (AF) guidelines, excludes patients with rheumatic mitral stenosis, a mechanical or bioprosthetic heart valve, or mitral valve repair. However, the data regarding use of DOACs in AF patients with other types of valvular heart disease (VHD) are unclear. We aimed to summarize and evaluate the literature regarding the safety and efficacy of DOAC use in NVAF patients with other types of VHD...
December 22, 2016: Clinical Cardiology
Kostas Athanasakis, Nadia Boubouchairopoulou, Eleftheria Karampli, Filippos Tarantilis, Paraskevi Savvari, Aikaterini Bilitou, John Kyriopoulos
BACKGROUND: Strokes attributed to atrial fibrillation (AF) represent a major cause of adult disability and a great burden to society and healthcare systems. OBJECTIVES: Our objective was to assess the cost effectiveness of apixaban, a direct acting oral anticoagulant (DOAC), versus warfarin or aspirin for patients with AF in the Greek healthcare setting. METHODS: We used a previously published Markov model to simulate clinical events for patients with AF treated with apixaban, the vitamin K antagonist (VKA) warfarin, or aspirin...
November 23, 2016: American Journal of Cardiovascular Drugs: Drugs, Devices, and Other Interventions
Patrícia O Guimarães, Daniel M Wojdyla, John H Alexander, Laine Thomas, Marco Alings, Greg C Flaker, Sana M Al-Khatib, Michael Hanna, John D Horowitz, Lars Wallentin, Christopher B Granger, Renato D Lopes
BACKGROUND: Evidence supporting use of antithrombotic therapy in atrial fibrillation (AF) is based mainly on data from patients with permanent, persistent, or paroxysmal AF. Less is known about the risk following a new diagnosis of AF and the efficacy and safety of apixaban in these patients. METHODS: Using data from ARISTOTLE, we assessed the relationship between timing of AF diagnosis and clinical outcomes and the efficacy and safety of apixaban versus warfarin in these patients...
January 15, 2017: International Journal of Cardiology
David Wiljer, Alexxa Abi-Jaoude, Andrew Johnson, Genevieve Ferguson, Marcos Sanches, Andrea Levinson, Janine Robb, Olivia Heffernan, Tyson Herzog, Gloria Chaim, Kristin Cleverley, Gunther Eysenbach, Joanna Henderson, Jeffrey S Hoch, Elisa Hollenberg, Huan Jiang, Wanrudee Isaranuwatchai, Marcus Law, Sarah Sharpe, Tim Tripp, Aristotle Voineskos
BACKGROUND: Seventy percent of lifetime cases of mental illness emerge prior to age 24. While early detection and intervention can address approximately 70% of child and youth cases of mental health concerns, the majority of youth with mental health concerns do not receive the services they need. OBJECTIVE: The objective of this paper is to describe the protocol for optimizing and evaluating Thought Spot, a Web- and mobile-based platform cocreated with end users that is designed to improve the ability of students to access mental health and substance use services...
November 4, 2016: JMIR Research Protocols
Inmaculada Hernandez, Kenneth J Smith, Yuting Zhang
INTRODUCTION: The comparative cost-effectiveness of all oral anticoagulants approved up to date has not been evaluated from the US perspective. The objective of this study was to compare the cost-effectiveness of edoxaban 60mg, apixaban 5mg, dabigatran 150mg, dabigatran 110mg, rivaroxaban 20mg and warfarin in stroke prevention in atrial fibrillation patients at high-risk of bleeding (defined as HAS-BLED score≥3). MATERIALS AND METHODS: We constructed a Markov state-transition model to evaluate lifetime costs and quality-adjusted life years (QALYs) with each of the six treatments from the perspective of US third-party payers...
February 2017: Thrombosis Research
Giulia Renda, Fabrizio Ricci, Raffaele De Caterina
BACKGROUND: Non-vitamin K oral anticoagulants are now proven alternatives to vitamin K antagonists for stroke prevention in atrial fibrillation. However, there are few data on the efficacy and safety of their use for cardioversion, in which the risk of thromboembolic events is heightened. METHODS: We performed a random-effects meta-analysis of patients undergoing both electrical and pharmacologic cardioversion for atrial fibrillation in the RE-LY, ROCKET-AF, ARISTOTLE, ENGAGE AF-TIMI 48, X-VeRT, and ENSURE-AF trials...
October 15, 2016: American Journal of Medicine
Kang-Ling Wang, Robert P Giugliano, Shinya Goto, Chun-Chih Chiu, Chun-Yi Lin, En-Yu Lai, Chern-En Chiang
BACKGROUND: Although randomized controlled trials (RCTs) indicated that standard dose non-vitamin K antagonist oral anticoagulants (NOACs) were more compelling, low dose NOACs are commonly used in clinical practice in Asia. OBJECTIVE: The purpose of this study was to assess the relative therapeutic benefit and risk of standard dose vs low dose NOACs in Asian patients enrolled in contemporary RCTs. METHODS: We performed a prespecified meta-analysis of 3155 Asian patients with NOACs in the RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) and ENGAGE AF-TIMI 48 (Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48) trials...
December 2016: Heart Rhythm: the Official Journal of the Heart Rhythm Society
Michael D Ezekowitz, Charles V Pollack, Paul Sanders, Jonathan L Halperin, Judith Spahr, Nilo Cater, William Petkun, Andrei Breazna, Paulus Kirchhof, Jonas Oldgren
BACKGROUND: Stroke prevention in anticoagulation-naïve patients with atrial fibrillation undergoing cardioversion has not been systematically studied. OBJECTIVE: To determine outcomes in anticoagulation-naïve patients (defined as those receiving an anticoagulant for <48 hours during the index episode of atrial fibrillation) scheduled for cardioversion. METHODS: This is a randomized, prospective, open-label, real-world study comparing apixaban to heparin plus warfarin...
September 2016: American Heart Journal
Taru Hallinen, Erkki J Soini, Miika Linna, Samuli I Saarni
BACKGROUND: To reduce the risk of thromboembolic complications, clinical guidelines recommend anticoagulation treatment for almost all atrial fibrillation (AF) patients. Although warfarin has long been the primary treatment alternative, now newer alternatives such as apixaban have proven effective in prevention of the thromboembolic complications of non-valvular AF. The aim of this study is to assess the cost-effectiveness of apixaban when compared with warfarin in the prevention of AF-associated thromboembolic complications in Finland...
2016: SpringerPlus
Vivian Wing-Yan Lee, Ronald Bing-Ching Tsai, Ines Hang-Iao Chow, Bryan Ping-Yen Yan, Mehmet Gungor Kaya, Jai-Wun Park, Yat-Yin Lam
BACKGROUND: Transcatheter left atrial appendage occlusion (LAAO) is a promising therapy for stroke prophylaxis in non-valvular atrial fibrillation (NVAF) but its cost-effectiveness remains understudied. This study evaluated the cost-effectiveness of LAAO for stroke prophylaxis in NVAF. METHODS: A Markov decision analytic model was used to compare the cost-effectiveness of LAAO with 7 pharmacological strategies: aspirin alone, clopidogrel plus aspirin, warfarin, dabigatran 110 mg, dabigatran 150 mg, apixaban, and rivaroxaban...
2016: BMC Cardiovascular Disorders
Jonas Oldgren, Ziad Hijazi, Johan Lindbäck, John H Alexander, Stuart J Connolly, John W Eikelboom, Michael D Ezekowitz, Christopher B Granger, Elaine M Hylek, Renato D Lopes, Agneta Siegbahn, Salim Yusuf, Lars Wallentin
BACKGROUND: Atrial fibrillation is associated with increased but variable risk of stroke. Our aim was to validate the recently developed biomarker-based ABC (age, biomarkers [high-sensitivity troponin and N-terminal fragment B-type natriuretic peptide], and clinical history of prior stroke/transient ischemic attack)-stroke risk score and compare its performance with the CHA2DS2VASc and ATRIA (Anticoagulation and Risk Factors in Atrial Fibrillation) risk scores. METHODS: The ABC-stroke score includes age, biomarkers (N-terminal fragment B-type natriuretic peptide and high-sensitivity cardiac troponin), and clinical history (prior stroke)...
November 29, 2016: Circulation
Amanda Leiter, John Doucette, Susan Krege, Chia-Chia Lin, Noah Hahn, Thorsten Ecke, Guru Sonpavde, Aristotle Bamias, William K Oh, Matthew D Galsky
Background: Obesity has been associated with worse outcomes in patients with clinically localized urothelial cancer. However, this impact has not been evaluated in metastatic disease. Objective: To assess the impact of obesity on outcomes of patients with metastatic urothelial cancer. Methods: Data from 537 patients were aggregated from eight phase II and phase III clinical trials investigating first-line cisplatin-based combination therapy in metastatic urothelial cancer. Chemotherapy regimen, adverse events, treatment response, and survival outcomes were compared across body mass index (BMI) and body surface area (BSA) categories...
2016: Bladder Cancer
John H Alexander, Ulrika Andersson, Renato D Lopes, Ziad Hijazi, Stefan H Hohnloser, Justin A Ezekowitz, Sigrun Halvorsen, Michael Hanna, Patrick Commerford, Witold Ruzyllo, Kurt Huber, Sana M Al-Khatib, Christopher B Granger, Lars Wallentin
IMPORTANCE: In the Apixaban for Reduction of Stroke and Other Thromboembolic Complications in Atrial Fibrillation (ARISTOTLE) trial, the standard dose of apixaban was 5 mg twice daily; patients with at least 2 dose-reduction criteria-80 years or older, weight 60 kg or less, and creatinine level 1.5 mg/dL or higher-received a reduced dose of apixaban of 2.5 mg twice daily. Little is known about patients with 1 dose-reduction criterion who received the 5 mg twice daily dose of apixaban...
September 1, 2016: JAMA Cardiology
Ziad Hijazi, Stefan H Hohnloser, Ulrika Andersson, John H Alexander, Michael Hanna, Matyas Keltai, Alexander Parkhomenko, José L López-Sendón, Renato D Lopes, Agneta Siegbahn, Christopher B Granger, Lars Wallentin
IMPORTANCE: Renal impairment confers an increased risk of stroke, bleeding, and death in patients with atrial fibrillation. Little is known about the efficacy and safety of apixaban in relation to renal function changes over time. OBJECTIVES: To evaluate changes of renal function over time and their interactions with outcomes during a median of 1.8 years of follow-up in patients with atrial fibrillation randomized to apixaban vs warfarin treatment. DESIGN, SETTING, AND PARTICIPANTS: The prospective, randomized, double-blind Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) clinical trial randomized 18 201 patients with atrial fibrillation to apixaban or warfarin...
July 1, 2016: JAMA Cardiology
Xue Li, Vicki C Tse, Wallis C Y Lau, Bernard M Y Cheung, Gregory Y H Lip, Ian C K Wong, Esther W Chan
OBJECTIVES: Many of the cost-effectiveness analyses of apixaban against warfarin focused on Western populations but Asian evidence remains less clear. The present study aims to evaluate the cost-effectiveness of apixaban against warfarin in Chinese patients with non-valvular atrial fibrillation (NVAF) from a public institutional perspective in Hong Kong. METHODS: We used a Markov model incorporating 12 health state transitions, and simulated the disease progression of NVAF in 1,000 hypothetical patients treated with apixaban/warfarin...
2016: PloS One
John M Kittelson, Philippe Gabriel Steg, Jonathan L Halperin, Neil A Goldenberg, Sam Schulman, Alex C Spyropoulos, Craig M Kessler, Alexander G G Turpie, Neal R Cutler, William R Hiatt
Clinical trials of antithrombotic therapy require a cohesive assessment of benefit and risk. A new graphical method to represent the bivariate relation of benefit and risk in trials of antithrombotic drugs is described and illustrated using published data from the four major registration clinical trials of non-vitamin K oral anticoagulants (NOACs) totalling 71,683 patients for prevention of thromboembolic events (TE) in patients with atrial fibrillation (RE-LY, ROCKET AF, ARISTOTLE, and ENGAGE-AF TIMI48). A curve representing a null hypothesis defines a region of benefit on a two-dimensional plane...
August 30, 2016: Thrombosis and Haemostasis
Benjamin E Peterson, Sana M Al-Khatib, Christopher B Granger
Atrial fibrillation is a common, costly and morbid cardiovascular arrhythmia. Stroke prevention remains the mainstay of treatment for atrial fibrillation, and the recent advent of novel oral anticoagulants with direct factor IIa or factor Xa inhibition has significantly revolutionized this aspect of treatment for atrial fibrillation patients. This review focuses on the tolerability and efficacy of apixaban and tackles the generalizability of the findings with apixaban to broader patient populations than those primarily enrolled in the clinical trials, drawing from the AVERROES and ARISTOTLE trials and their subsequent secondary analyses...
June 24, 2016: Therapeutic Advances in Cardiovascular Disease
Jeroen Jaspers Focks, Marc A Brouwer, Daniel M Wojdyla, Laine Thomas, Renato D Lopes, Jeffrey B Washam, Fernando Lanas, Denis Xavier, Steen Husted, Lars Wallentin, John H Alexander, Christopher B Granger, Freek W A Verheugt
OBJECTIVE:  To determine whether the treatment effect of apixaban versus warfarin differs with increasing numbers of concomitant drugs used by patients with atrial fibrillation. DESIGN:  Post hoc analysis performed in 2015 of results from ARISTOTLE (apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation)-a multicentre, double blind, double dummy trial that started in 2006 and ended in 2011. PARTICIPANTS:  18 201 ARISTOTLE trial participants...
June 15, 2016: BMJ: British Medical Journal
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