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
Authors: Anker Stefan D. , Friede Tim , von Bardeleben Ralph Stephan , Butler Javed , Khan Muhammad Shahzeb , Diek Monika , Heinrich Jutta , Geyer Martin , Placzek Marius , Ferrari Roberto , Abraham William T. , Alfieri Ottavio , Auricchio Angelo , Bayes‐Genis Antoni , Cleland John G.F. , Filippatos Gerasimos , Gustafsson Finn , Haverkamp Wilhelm , Kelm Malte , Kuck Karl‐Heinz , Landmesser Ulf , Maggioni Aldo P. , Metra Marco , Ninios Vlasis , Petrie Mark C. , Rassaf Tienush , Ruschitzka Frank , Schäfer Ulrich , Schulze P. Christian , Spargias Konstantinos , Vahanian Alec , Zamorano Jose Luis , Zeiher Andreas , Karakas Mahir , Koehler Friedrich , Lainscak Mitja , Öner Alper , Mezilis Nikolaos , Theofilogiannakos Efstratios K , Ninios Ilias , Chrissoheris Michael , Kourkoveli Panagiota , Papadopoulos Konstantinos , Smolka Grzegorz , Wojakowski Wojciech , Reczuch Krzysztof , Pinto Fausto J. , Zmudka Krzysztof , Kalarus Zbigniew , Adamo Marianna , Santiago‐Vacas Evelyn , Ruf Tobias Friedrich , Gross Michael , Tongers Joern , Hasenfuß Gerd , Schillinger Wolfgang , Ponikowski Piotr 
Published: June 2024

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 cm2, 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.