Percutaneous repair of moderate-to-severe or severe functional mitral regurgitation in patients with symptomatic heart failure : Baseline characteristics of patients in the RESHAPE-HF2 trial and comparison to COAPT and MITRA-FR trials
Anker, Stefan (German Centre for Cardiovascular Research (DZHK))
Friede, T. (German Centre for Cardiovascular Research (DZHK))
Von Bardeleben, Ralph Stephan (University Medical Center of the Johannes Gutenberg-University Mainz)
Butler, Javed (University of Mississippi (Estats Units d'Amèrica))
Khan, M.S. (Duke University School of Medicine)
Diek, M. (German Centre for Cardiovascular Research (DZHK))
Heinrich, Joachim (University Medical Center Göttingen)
Geyer, Martin (University Medical Center of the Johannes Gutenberg-University Mainz)
Placzek, M. (German Centre for Cardiovascular Research (DZHK))
Ferrari, R. (University of Ferrara)
Abraham, William T. (The Ohio State University)
Alfieri, O. (IRCCS San Raffaele Scientific Institute (Milà, Itàlia))
Auricchio, A. (Cardiocentro Ticino Institute-EOC)
Bayés-Genís, Antoni (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Cleland, J.G.F. (School of Cardiovascular and Metabolic Health. University of Glasgow. British Heart Foundation Glasgow Cardiovascular Research Centre)
Filippatos, Gerasimos (National and Kapodistrian University of Athens)
Gustafsson, Finn (Copenhagen University Hospital - Rigshospitalet)
Haverkamp, W. (Charité-Universitätsmedizin Berlin)
Kelm, M. (Heinrich-Heine University)
Kuck, K.H. (University Heart Center Lübeck)
Landmesser, U. (DZHK (German Centre for Cardiovascular Research). Partner Site Berlin)
Maggioni, Aldo P. (ANMCO Research Center. Heart Care Foundation)
Metra, Marco (University of Brescia)
Ninios, V. (European Interbalkan Medical Center)
Petrie, Mark (University of Glasgow)
Rassaf, T. (University Duisburg-Essen)
Ruschitzka, F. (University of Zurich)
Schäfer, U. (Heart and Vascular Centre)
Schulze, P.C. (Jena University Hospital (Alemania))
Spargias, K. (HYGEIA Hospital)
Vahanian, A. (UFR Medecine. Université de Paris-Cité. site Bichat. GH Bichat)
Zamorano, José Luis (CIBERCV. Instituto de Salud Carlos III (ISCIII))
Zeiher, A. (German Center of Cardiovascular Research (DZHK))
Karakas, M. (German Centre for Cardiovascular Research (DZHK))
Koehler, F. (Charité-Universitätsmedizin Berlin)
Lainscak, M. (Univerza V Ljubljani)
Öner, A. (Rostock University Medical Centre)
Mezilis, N. (St Luke's Hospital)
Theofilogiannakos, E.K. (St Luke's Hospital)
Ninios, I. (European Interbalkan Medical Center)
Chrissoheris, M. (HYGEIA Hospital)
Kourkoveli, P. (HYGEIA Hospital)
Papadopoulos, K. (HYGEIA Hospital)
Smolka, G. (Medical University of Silesia)
Wojakowski, W. (Medical University of Silesia)
Reczuch, K. (Institute of Heart Diseases. Medical University and University Hospital)
Pinto, F.J. (Faculdade de Medicina da Universidade de Lisboa)
Zmudka, K. (Clinic of Interventional Cardiology. John Paul II Hospital)
Kalarus, Z. (Medical University of Silesia)
Adamo, Marianna (University of Brescia)
Santiago Vacas, Evelyn (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Ruf, T.F. (University Medical Center of the Johannes Gutenberg-University Mainz)
Gross, M. (Johanniter Hospital Stendal)
Tongers, J. (University Hospital Halle/Saale)
Hasenfuß, G. (German Centre for Cardiovascular Research (DZHK))
Schillinger, W. (Georg-August-University Göttingen)
Ponikowski, Piotr (Centro Academico de Medicina de Lisboa)

Data:	2024
Resum:	Aim: The RESHAPE-HF2 trial is designed to assess the efficacy and safety of the MitraClip device system for the treatment of clinically important functional mitral regurgitation (FMR) in patients with heart failure (HF). This report describes the baseline characteristics of patients enrolled in the RESHAPE-HF2 trial compared to those enrolled in the COAPT and MITRA-FR trials. Methods and results: The RESHAPE-HF2 study is an investigator-initiated, prospective, randomized, multicentre trial including patients with symptomatic HF, a left ventricular ejection fraction (LVEF) between 20% and 50% with moderate-to-severe or severe FMR, for whom isolated mitral valve surgery was not recommended. Patients were randomized 1:1 to a strategy of delivering or withholding MitraClip. Of 506 patients randomized, the mean age of the patients was 70 ± 10 years, and 99 of them (20%) were women. The median EuroSCORE II was 5. 3 (2. 8-9. 0) and median plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) was 2745 (1407-5385) pg/ml. Most patients were prescribed beta-blockers (96%), diuretics (96%), angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor-neprilysin inhibitors (82%) and mineralocorticoid receptor antagonists (82%). The use of sodium-glucose cotransporter 2 inhibitors was rare (7%). Cardiac resynchronization therapy (CRT) devices had been previously implanted in 29% of patients. Mean LVEF, left ventricular end-diastolic volume and effective regurgitant orifice area (EROA) were 31 ± 8%, 211 ± 76 ml and 0. 25 ± 0. 08 cm, respectively, whereas 44% of patients had mitral regurgitation severity of grade 4+. Compared to patients enrolled in COAPT and MITRA-FR, those enrolled in RESHAPE-HF2 were less likely to have mitral regurgitation grade 4+ and, on average, HAD lower EROA, and plasma NT-proBNP and higher estimated glomerular filtration rate, but otherwise had similar age, comorbidities, CRT therapy and LVEF. Conclusion: Patients enrolled in RESHAPE-HF2 represent a third distinct population where MitraClip was tested in, that is one mainly comprising of patients with moderate-to-severe FMR instead of only severe FMR, as enrolled in the COAPT and MITRA-FR trials. The results of RESHAPE-HF2 will provide crucial insights regarding broader application of the transcatheter edge-to-edge repair procedure in clinical practice.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	MitraClip ; Mitral regurgitation ; Transcatheter edge-to-edge repair
Publicat a:	European Journal of Heart Failure, Vol. 26 Núm. 7 (july 2024) , p. 1608-1615, ISSN 1879-0844

DOI: 10.1002/ejhf.3286
PMID: 38847420

8 p, 406.6 KB

El registre apareix a les col·leccions:
Documents de recerca > Documents dels grups de recerca de la UAB > Centres i grups de recerca (producció científica) > Ciències de la salut i biociències > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
Articles > Articles de recerca
Articles > Articles publicats