Baseline echocardiographic characteristics of patients enrolled in the randomized investigation of MitraClip device in heart failure (RESHAPE HF-2) trial: comparison with COAPT and Mitra-FR
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
Authors
Background: The RESHAPE-HF2 trial is aimed at evaluating the efficacy of the MitraClip device for the treatment of clinically significant functional mitral regurgitation (FMR) in patients with heart failure (HF). This report describes the baseline echocardiographic characteristics of patients enrolled in the RESHAPE-HF2 trial compared to those enrolled in the COAPT and MITRA-FR trials.
Methods: The RESHAPE-HF2 study is a prospective, randomized, multicenter trial involving patients with symptomatic HF, a left ventricular ejection fraction (LVEF) between 20% and 50%, and moderate-to-severe or severe FMR who are ineligible for isolated mitral valve surgery, despite receiving guideline-directed therapy. Patients were randomized 1:1 to either receive the MitraClip or be placed in a control group without the intervention.
Results: For the 505 patients randomized (mean age 70 years, 20% female, mean body mass index 26.8 kg/m2), the mean LVEF in the cohort was 31±8%. The mean regurgitant volume was 37±12 mL, while mean proximal iso-velocity surface area (PISA) radius was 0.72 cm. Less than half of the patients (44%) had MR severity grade 4+. The mean effective regurgitant orifice area (EROA) among patients in RESHAPE-HF2 (0.25 cm2) was lower compared to patients in MITRA-FR (0.31 cm2) and in COAPT (0.40 cm2) trials. Regurgitant volumes in RESHAPE-HF2 were 18% lower than in than in MITRA-FR (45 mL) but 38% higher than in COAPT (27 mL). The mean LV end-diastolic volumes values in the RESHAPE-HF2, COAPT, and MITRA-FR trials were 211 mL, 193 mL, and 250 mL, respectively. Patients in RESHAPE-HF2 (41 mmHg) had a comparatively lower right ventricular systolic pressure than patients in MITRA-FR (54 mmHg) and in COAPT (44 mmHg). Patients in RESHAPE-HF2, MITRA-FR, and COAPT had a similar LVEF of around 31%.
Conclusions: The baseline echocardiographic characteristics of patients in the RESHAPE-HF2 trial differ from patients in the MITRA-FR and COAPT trials. Patients enrolled in RESHAPE-HF2 had moderate-to-severe FMR, characterized by a smaller PISA radius, a lesser proportion of MR severity grade of 4+, and lower mean EROA and regurgitant volumes compared to patients in COAPT and MITRA-FR trials. LVEF was largely similar across all trials. RESHAPE-HF2 is testing TEER in a third distinct cohort of patients who have less severe FMR compared to patients in COAPT trial but have high left atrial volumes. The RESHAPE-HF2 population is also echocardiographically different from the MITRA-FR cohort.
How to Cite
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
PAGEPress has chosen to apply the Creative Commons Attribution NonCommercial 4.0 International License (CC BY-NC 4.0) to all manuscripts to be published.
Most read articles by the same author(s)
- Khawaja M. Talha, Javed Butler, Stephan von Haehling, Mitja Lainscak, Piotr Ponikowski, Stefan D. Anker, Defining iron replete status in patients with heart failure treated with intravenous iron , Global Cardiology: Vol. 1 No. 1 (2023)
- Stephan von Haehling, Wolfram Doehner, Ruben Evertz, Tania Garfias-Veitl, Monika Diek, Mahir Karakas, Ralf Birkemeyer, Gerasimos Fillippatos, Piotr Ponikowski, Michael Böhm, Tim Friede, Stefan D. Anker, Iron deficiency in heart failure with preserved ejection fraction: rationale and design of the FAIR-HFpEF trial , Global Cardiology: Vol. 1 No. 1 (2023)
- Muhammad Shariq Usman, Arsalan Hamid, Shurjeel Uddin Qazi, Mikhail N. Kosiborod, Deepak L. Bhatt, Muhammad Shahzeb Khan, Muthiah Vaduganathan, Javed Butler, The effect of SGLT2 inhibitors on health status in patients with heart failure: a systematic review and meta-analysis , Global Cardiology: Vol. 2 No. 2 (2024)
- Stefan D. Anker, Javed Butler, Khawaja M. Talha, Tim Friede, Using multiple primary endpoints in clinical trials with a focus on heart failure , Global Cardiology: Vol. 2 No. 2 (2024)
- Javed Butler, Sanjiv J. Shah, Melissa Magwire, Carlos Campos, Muhammad Shariq Usman, Anthony Hoovler, Anup Sabharwal, Barry A. Borlaug, Treatment pathways in patients with heart failure with preserved ejection fraction and obesity: perspectives from cardiology specialists and patients , Global Cardiology: Vol. 2 No. 2 (2024)
- Sven Christopher Aland, Christoph Gertler, Hannah Leonie Bräunig, Timo Schröder, Frank Edelmann, Rolf Wachter, Christoph Herrmann-Lingen, Gerd Hasenfuß, Anja Sandek, Exercise capacity, iron deficiency and depressive symptoms in patients with asymptomatic chronic systolic heart failure , Global Cardiology: Vol. 2 No. 2 (2024)
- Tariq Jamal Siddiqi, Javed Butler, Andrew J.S. Coats, Subodh Verma, Tim Friede, Gerasimos Filippatos, Stefan D. Anker, SGLT2 inhibitors and risk reduction for mortality in high-risk patients: a meta-analysis of randomized controlled trials , Global Cardiology: Vol. 1 No. 1 (2023)