439 research outputs found
10.1177_1358863X19864172_Supplementary_tables – Supplemental material for Chronic kidney disease and risk for cardiovascular and limb outcomes in patients with symptomatic peripheral artery disease: The EUCLID trial
No full textSupplemental material, 10.1177_1358863X19864172_Supplementary_tables for Chronic kidney disease and risk for cardiovascular and limb outcomes in patients with symptomatic peripheral artery disease: The EUCLID trial by Charles W Hopley, Sarah Kavanagh, Manesh R Patel, Cara Ostrom, Iris Baumgartner, Jeffrey S Berger, Juuso I Blomster, F Gerry R Fowkes, W Schuyler Jones, Brian G Katona, Kenneth W Mahaffey, Lars Norgren, Frank W Rockhold and William R Hiatt in Vascular Medicine</p
sj-pdf-1-vmj-10.1177_1358863X211038620 – Supplemental material for World regional differences in outcomes for patients with peripheral artery disease: Insights from the EUCLID trial
No full textSupplemental material, sj-pdf-1-vmj-10.1177_1358863X211038620 for World regional differences in outcomes for patients with peripheral artery disease: Insights from the EUCLID trial by Lars Norgren, Rebecca North, Iris Baumgartner, Jeffrey S Berger, Juuso I Blomster, William R Hiatt, W Schuyler Jones, Brian G Katona, Kenneth W Mahaffey, Hillary Mulder, Manesh R Patel, Frank W Rockhold and F Gerry R Fowkes in Vascular Medicine</p
VMJ775594_Supplementary_material – Supplemental material for Ticagrelor versus clopidogrel in patients with symptomatic peripheral artery disease and prior coronary artery disease: Insights from the EUCLID trial
No full textSupplemental material, VMJ775594_Supplementary_material for Ticagrelor versus clopidogrel in patients with symptomatic peripheral artery disease and prior coronary artery disease: Insights from the EUCLID trial by Jeffrey S Berger, Beth L Abramson, Renato D Lopes, Gretchen Heizer, Frank W Rockhold, Iris Baumgartner, F Gerry R Fowkes, Peter Held, Brian G Katona, Lars Norgren, W Schuyler Jones, Marcus Millegård, Juuso Blomster, Craig Reist, William R Hiatt, Manesh R Patel and Kenneth W Mahaffey in Vascular Medicine</p
sj-pdf-1-vmj-10.1177_1358863X221084360 – Supplemental material for Impact of risk factor control on peripheral artery disease outcomes and health disparities
No full textSupplemental material, sj-pdf-1-vmj-10.1177_1358863X221084360 for Impact of risk factor control on peripheral artery disease outcomes and health disparities by F Will Pohlman, Cassie B Ford, E Hope Weissler, Michelle M Smerek, N Chantelle Hardy, Dennis I Narcisse, Steven J Lippmann, Melissa A Greiner, Chandler Long, Jennifer A Rymer, J Antonio Gutierrez, Manesh R Patel and W Schuyler Jones in Vascular Medicine</p
Integrating ancillary studies in a large clinical trial: The design and rationale of the APEX library
No full textNovember 2008Abstract not availableKenneth W. Mahaffey, Craig J. Reist, Yuling Fu, Sorin J. Brener, Pierre Theroux, Manesh R. Patel, Amanda Stebbins, Cynthia M. Westerhout, Thomas G. Todaro, Peter X. Adams, Christopher B. Granger, Paul W. Armstrong, on behalf of the APEX Library Study Investigator
sj-pdf-1-vmj-10.1177_1358863X241228542 – Supplemental material for Methods, design, and initial results of an angiographic core lab from VOYAGER-PAD
No full textSupplemental material, sj-pdf-1-vmj-10.1177_1358863X241228542 for Methods, design, and initial results of an angiographic core lab from VOYAGER-PAD by R Kevin Rogers, Joerg Herold, Nicholas Govsyeyev, Roberto Iezzi, Justin Morrison, Shea E Hogan, Mark Nehler, Rory Bricker, Brice Andring, Brian Bergmark, Matt Cavender, Emily Malgor, Donald Jacobs, Michael N Young, Warren Capell, Joseph W Yčas, Sonia S Anand, Scott D Berkowitz, E Sebastian Debus, Lloyd P Haskell, Eva Muehlhofer, Manesh R Patel, Connie N Hess, Rupert M Bauersachs, Victoria Anderson and Marc P Bonaca in Vascular Medicine</p
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ACCF/ACR/SCCT/SCMR/ASNC/NASCI/SCAI/SIR 2006 Appropriateness Criteria for Cardiac Computed Tomography and Cardiac Magnetic Resonance Imaging.sup. Developed in accordance with the principles and methodology outlined by ACCF: Patel MR, Spertus JA, Brindis RG, Hendel RC, Douglas PS, Peterson ED, Wolk MJ, Allen JM, Raskin IE. ACCF proposed method for evaluating the appropriateness of cardiovascular imaging. J Am Coll Cardiol 2005;46:1606-13
No full textByline: Robert C. Hendel, Manesh R. Patel, Christopher M. Kramer, Michael Poon, Robert C. Hendel, James C. Carr, Nancy A. Gerstad, Linda D. Gillam, John McB. Hodgson, Raymond J. Kim, Christopher M. Kramer, John R. Lesser, Edward T. Martin, Joseph V. Messer, Rita F. Redberg, Geoffrey D. Rubin, John S. Rumsfeld, Allen J. Taylor, Wm. Guy Weigold, Pamela K. Woodard, Ralph G. Brindis, Robert C. Hendel, Pamela S. Douglas, Eric D. Peterson, Michael J. Wolk, Joseph M. Allen, Manesh R. Patel Article Note: (footnote) This document was approved by the American College of Cardiology Board of Trustees in June 2006. When citing this document, the American College of Cardiology requests that the following citation format be used: Hendel RC, Patel MR, Kramer CM, Poon M. ACCF/ACR/SCCT/SCMR/ASNC/NASCI/SCAI/SIR 2006 appropriateness criteria for cardiac computed tomography and cardiac magnetic resonance imaging: a report of the American College of Cardiology Foundation/American College of Radiology, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, American Society of Nuclear Cardiology, North American Society for Cardiac Imaging, Society for Cardiovascular Angiography and Interventions, and Society of Interventional Radiology. J Am Coll Cardiol 2006;48:1475-97. Copies: This document is available from the American College of Cardiology Web site at www.acc.org. Single copies of this document may be purchased for $10.00 each by calling 1-800-253-4636 or by writing to the American College of Cardiology, Resource Center, 2400 N St. NW, Washington, DC 20037. Permissions: Multiple copies, modification, alteration, enhancement, and/or distribution of this document are not permitted without the express permission of the American College of Cardiology Foundation. Please direct requests to [email protected]
Efficacy and Safety of Non-Vitamin K Antagonist Oral Anticoagulants After Cardioversion for Nonvalvular Atrial Fibrillation
No full textSafety of the oral factor XIa inhibitor asundexian compared with apixaban in patients with atrial fibrillation (PACIFIC-AF): a multicentre, randomised, double-blind, double-dummy, dose-finding phase 2 study.
No full textBACKGROUND
Direct-acting oral anticoagulant use for stroke prevention in atrial fibrillation is limited by bleeding concerns. Asundexian, a novel, oral small molecule activated coagulation factor XIa (FXIa) inhibitor, might reduce thrombosis with minimal effect on haemostasis. We aimed to determine the optimal dose of asundexian and to compare the incidence of bleeding with that of apixaban in patients with atrial fibrillation.
METHODS
In this randomised, double-blind, phase 2 dose-finding study, we compared asundexian 20 mg or 50 mg once daily with apixaban 5 mg twice daily in patients aged 45 years or older with atrial fibrillation, a CHA2DS2-VASc score of at least 2 if male or at least 3 if female, and increased bleeding risk. The study was conducted at 93 sites in 14 countries, including 12 European countries, Canada, and Japan. Participants were randomly assigned (1:1:1) to a treatment group using an interactive web response system, with randomisation stratified by whether patients were receiving a direct-acting oral anticoagulant before the study start. Masking was achieved using a double-dummy design, with participants receiving both the assigned treatment and a placebo that resembled the non-assigned treatment. The primary endpoint was the composite of major or clinically relevant non-major bleeding according to International Society on Thrombosis and Haemostasis criteria, assessed in all patients who took at least one dose of study medication. This trial is registered with ClinicalTrials.gov, NCT04218266, and EudraCT, 2019-002365-35.
FINDINGS
Between Jan 30, 2020, and June 21, 2021, 862 patients were enrolled. 755 patients were randomly assigned to treatment. Two patients (assigned to asundexian 20 mg) never took any study medication, resulting in 753 patients being included in the analysis (249 received asundexian 20 mg, 254 received asundexian 50 g, and 250 received apixaban). The mean age of participants was 73·7 years (SD 8·3), 309 (41%) were women, 216 (29%) had chronic kidney disease, and mean CHA2DS2-VASc score was 3·9 (1·3). Asundexian 20 mg resulted in 81% inhibition of FXIa activity at trough concentrations and 90% inhibition at peak concentrations; asundexian 50 mg resulted in 92% inhibition at trough concentrations and 94% inhibition at peak concentrations. Ratios of incidence proportions for the primary endpoint were 0·50 (90% CI 0·14-1·68) for asundexian 20 mg (three events), 0·16 (0·01-0·99) for asundexian 50 mg (one event), and 0·33 (0·09-0·97) for pooled asundexian (four events) versus apixaban (six events). The rate of any adverse event occurring was similar in the three treatment groups: 118 (47%) with asundexian 20 mg, 120 (47%) with asundexian 50 mg, and 122 (49%) with apixaban.
INTERPRETATION
The FXIa inhibitor asundexian at doses of 20 mg and 50 mg once daily resulted in lower rates of bleeding compared with standard dosing of apixaban, with near-complete in-vivo FXIa inhibition, in patients with atrial fibrillation.
FUNDING
Bayer
Lower extremity amputation in peripheral artery disease: improving patient outcomes
No full textAparna Swaminathan,1 Sreekanth Vemulapalli,1,2 Manesh R Patel,1,2 W Schuyler Jones1,2 1Department of Medicine, Duke University Medical Center, Durham, NC, USA; 2Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA Abstract: Peripheral artery disease affects over eight million Americans and is associated with an increased risk of mortality, cardiovascular disease, functional limitation, and limb loss. In its most severe form, critical limb ischemia, patients are often treated with lower extremity (LE) amputation (LEA), although the overall incidence of LEA is declining. In the US, there is significant geographic variation in the performing of major LEA. The rate of death after major LEA in the US is approximately 48% at 1 year and 71% at 3 years. Despite this significant morbidity and mortality, the use of diagnostic testing (both noninvasive and invasive testing) in the year prior to LEA is low and varies based on patient, provider, and regional factors. In this review we discuss the significance of LEA and methods to reduce its occurrence. These methods include improved recognition of the risk factors for LEA by clinicians and patients, strong advocacy for noninvasive and/or invasive imaging prior to LEA, improved endovascular revascularization techniques, and novel therapies. Keywords: peripheral artery disease, lower extremity amputation, mortalit
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