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Atrial shunt device for heart failure with preserved and mildly reduced ejection fraction (REDUCE LAP-HF II)

التفاصيل البيبلوغرافية
العنوان: Atrial shunt device for heart failure with preserved and mildly reduced ejection fraction (REDUCE LAP-HF II)
المؤلفون: Sanjiv J Shah, Barry A Borlaug, Eugene S Chung, Donald E Cutlip, Philippe Debonnaire, Peter S Fail, Qi Gao, Gerd Hasenfuß, Rami Kahwash, David M Kaye, Sheldon E Litwin, Philipp Lurz, Joseph M Massaro, Rajeev C Mohan, Mark J Ricciardi, Scott D Solomon, Aaron L Sverdlov, Vijendra Swarup, Dirk J van Veldhuisen, Sebastian Winkler, Martin B Leon, Joseph Akar, Jiro Ando, Toshihisa Anzai, Masanori Asakura, Steven Bailey, Anupam Basuray, Fabrice Bauer, Martin Bergmann, John Blair, Jeffrey Cavendish, Eugene Chung, Maja Cikes, Ira Dauber, Erwan Donal, Jean-Christophe Eicher, Peter Fail, James Flaherty, Xavier Freixa, Sameer Gafoor, Zachary Gertz, Robert Gordon, Marco Guazzi, Cesar Guerrero-Miranda, Deepak Gupta, Finn Gustafsson, Cyrus Hadadi, Emad Hakemi, Louis Handoko, Moritz Hass, Jorg Hausleiter, Christopher Hayward, Gavin Hickey, Scott Hummel, Imad Hussain, Richard Isnard, Chisato Izumi, Guillaume Jondeau, Elizabeth Juneman, Koichiro Kinugawa, Robert Kipperman, Bartek Krakowiak, Selim Krim, Joshua Larned, Gregory Lewis, Erik Lipsic, Anthony Magalski, Sula Mazimba, Jeremy Mazurek, Michele McGrady, Scott Mckenzie, Shamir Mehta, John Mignone, Hakim Morsli, Ajith Nair, Thomas Noel, James Orford, Kishan Parikh, Tiffany Patterson, Martin Penicka, Mark Petrie, Burkert Pieske, Martijn Post, Philip Raake, Alicia Romero, John Ryan, Yoshihiko Saito, Takafumi Sakamoto, Yasushi Sakata, Michael Samara, Kumar Satya, Andrew Sindone, Randall Starling, Jean-Noël Trochu, Bharathi Upadhya, Jan van der Heyden, Vanessa van Empel, Amit Varma, Amanda Vest, Tobias Wengenmayer, Ralf Westenfeld, Dirk Westermann, Kazuhiro Yamamoto, Andreas Zirlik
المساهمون: Cardiovascular Centre (CVC), Cardiology, ACS - Heart failure & arrhythmias, APH - Personalized Medicine, ACS - Pulmonary hypertension & thrombosis
المصدر: LANCET, 399(10330), 1130-1140. ELSEVIER SCIENCE INC
REDUCE LAP-HF II investigators 2022, ' Atrial shunt device for heart failure with preserved and mildly reduced ejection fraction (REDUCE LAP-HF II) : a randomised, multicentre, blinded, sham-controlled trial ', The Lancet, vol. 399, no. 10330, pp. 1130-1140 . https://doi.org/10.1016/S0140-6736(22)00016-2
The Lancet, 399(10330), 1130-1140. Elsevier Limited
بيانات النشر: ELSEVIER SCIENCE INC, 2022.
سنة النشر: 2022
مصطلحات موضوعية: Adult, Heart Failure, Male, Cardiac Catheterization, Stroke Volume, General Medicine, ASSOCIATION, PRESSURE, PRECISION MEDICINE, Flavins, Humans, Heart Atria, Luciferases, CLINICAL-TRIALS, CITY CARDIOMYOPATHY QUESTIONNAIRE
الوصف: Background Placement of an interatrial shunt device reduces pulmonary capillary wedge pressure during exercise in patients with heart failure and preserved or mildly reduced ejection fraction. We aimed to investigate whether an interatrial shunt can reduce heart failure events or improve health status in these patients.Methods In this randomised, international, blinded, sham-controlled trial performed at 89 health-care centres, we included patients (aged >= 40 years) with symptomatic heart failure, an ejection fraction of at least 40%, and pulmonary capillary wedge pressure during exercise of at least 25 mm Hg while exceeding right atrial pressure by at least 5 mm Hg. Patients were randomly assigned (1:1) to receive either a shunt device or sham procedure. Patients and outcome assessors were masked to randomisation. The primary endpoint was a hierarchical composite of cardiovascular death or non-fatal ischemic stroke at 12 months, rate of total heart failure events up to 24 months, and change in Kansas City Cardiomyopathy Questionnaire overall summary score at 12 months. Pre-specified subgroup analyses were conducted for the heart failure event endpoint. Analysis of the primary endpoint, all other efficacy endpoints, and safety endpoints was conducted in the modified intention-to-treat population, defined as all patients randomly allocated to receive treatment, excluding those found to be ineligible after randomisation and therefore not treated. This study is registered with ClinicalTrials.gov, NCT03088033.Findings Between May 25, 2017, and July 24, 2020, 1072 participants were enrolled, of whom 626 were randomly assigned to either the atrial shunt device (n=314) or sham procedure (n=312). There were no differences between groups in the primary composite endpoint (win ratio 1.0 [95% CI 0.8-1.2]; p=0.85) or in the individual components of the primary endpoint. The prespecified subgroups demonstrating a differential effect of atrial shunt device treatment on heart failure events were pulmonary artery systolic pressure at 20W of exercise (p(interaction)=0.002 [>70 mm Hg associated with worse outcomes]), right atrial volume index (p(interaction)=0.012 [>= 29.7 mL/m(2), worse outcomes]), and sex (p(interaction=)0.02 [men, worse outcomes]). There were no differences in the composite safety endpoint between the two groups (n=116 [38%] for shunt device vs n=97 [31%] for sham procedure; p=0.11).Interpretation Placement of an atrial shunt device did not reduce the total rate of heart failure events or improve health status in the overall population of patients with heart failure and ejection fraction of greater than or equal to 40%. Copyright (C) 2022 Elsevier Ltd. All rights reserved.
وصف الملف: application/pdf
اللغة: English
تدمد: 1474-547X
0140-6736
URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1a234b151fc7802938519888819ed3f8
https://research.rug.nl/en/publications/45900625-7796-416c-9dcb-916faecdcff6
حقوق: OPEN
رقم الأكسشن: edsair.doi.dedup.....1a234b151fc7802938519888819ed3f8
قاعدة البيانات: OpenAIRE
الوصف
تدمد:1474547X
01406736