Transcatheter Mitral Valve Replacement Versus Medical Therapy for Secondary Mitral Regurgitation: A Propensity Score–Matched Comparison
Sebastian Ludwig, Lenard Conradi, David J. Cohen, Augustin Coisne, Andrea Scotti, William T. Abraham, Walid Ben Ali, Zhipeng Zhou, Yanru Li, Saibal Kar, Alison Duncan, D. Scott Lim, Marianna Adamo, Björn Redfors, David W.M. Muller, John G. Webb, Anna Sonia Petronio, Hendrik Ruge, Georg Nickenig, Lars Søndergaard, Matti Adam, Damiano Regazzoli, Andrea Garatti, Tobias Schmidt, Martin Andreas, Gry Dahle, Thomas Walther, Jörg Kempfert, Gilbert H.L. Tang, Simon Redwood, Maurizio Taramasso, Fabien Praz, Neil Fam, Nicolas Dumonteil, Jean‐François Obadia, Ralph Stephan von Bardeleben, Tanja K. Rudolph, Michael J. Reardon, Marco Metra, Paolo Denti, Michael J. Mack, Jörg Hausleiter, Federico M. Asch, Azeem Latib, JoAnn Lindenfeld, Thomas Modine, Gregg W. Stone, Juan F. Granada, on behalf of the CHOICE-MI and the COAPT Trial Investigators
Abstract
Background: Transcatheter mitral valve replacement (TMVR) is an emerging therapeutic alternative for patients with secondary mitral regurgitation (MR). Outcomes of TMVR versus guideline-directed medical therapy (GDMT) have not been investigated for this population. This study aimed to compare clinical outcomes of patients with secondary MR undergoing TMVR versus GDMT alone. Methods: The CHOICE-MI registry (Choice of Optimal Transcatheter Treatment for Mitral Insufficiency) included patients with MR undergoing TMVR using dedicated devices. Patients with MR pathogeneses other than secondary MR were excluded. Patients treated with GDMT alone were derived from the control arm of the COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation). We compared outcomes between the TMVR and GDMT groups, using propensity score matching to adjust for baseline differences. Results: After propensity score matching, 97 patient pairs undergoing TMVR (72.9±8.7 years; 60.8% men; transapical access, 91.8%) versus GDMT (73.1±11.0 years; 59.8% men) were compared. At 1 and 2 years, residual MR was ≤1+ in all patients of the TMVR group compared with 6.9% and 7.7%, respectively, in those receiving GDMT alone (both P <0.001). The 2-year rate of heart failure hospitalization was significantly lower in the TMVR group (32.8% versus 54.4%; hazard ratio, 0.59 [95% CI, 0.35–0.99]; P =0.04). Among survivors, a higher proportion of patients were in the New York Heart Association functional class I or II in the TMVR group at 1 year (78.2% versus 59.7%; P =0.03) and at 2 years (77.8% versus 53.2%; P =0.09). Two-year mortality was similar in the 2 groups (TMVR versus GDMT, 36.8% versus 40.8%; hazard ratio, 1.01 [95% CI, 0.62–1.64]; P =0.98). Conclusions: In this observational comparison, over 2-year follow-up, TMVR using mostly transapical devices in patients with secondary MR was associated with significant reduction of MR, symptomatic improvement, less frequent hospitalizations for heart failure, and similar mortality compared with GDMT. Registration: URL: https://clinicaltrials.gov ; Unique identifier: NCT04688190 (CHOICE-MI) and NCT01626079 (COAPT).