Transcatheter Mitral Valve Replacement Versus Medical Therapy for Secondary Mitral Regurgitation: A Propensity Score-Matched Comparison.
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Ludwig Sebastian, Conradi Lenard, Cohen David J, Coisne Augustin, Scotti Andrea, Abraham William T, Ben Ali Walid, Zhou Zhipeng, Li Yanru, Kar Saibal, Duncan Alison, Lim D Scott, Adamo Marianna, Redfors Björn, Muller David W M, Webb John G, Petronio Anna S, Ruge Hendrik, Nickenig Georg, Sondergaard Lars, Adam Matti, Regazzoli Damiano, Garatti Andrea, Schmidt Tobias, Andreas Martin, Dahle Gry, Walther Thomas, Kempfert Joerg, Tang Gilbert H L, Redwood Simon, Taramasso Maurizio, Praz Fabien, Fam Neil, Dumonteil Nicolas, Obadia Jean-François, von Bardeleben Ralph Stephan, Rudolph Tanja K, Reardon Michael J, Metra Marco, Denti Paolo, Mack Michael J, Hausleiter Jörg, Asch Federico M, Latib Azeem, Lindenfeld JoAnn, Modine Thomas, Stone Gregg W, Granada Juan F, CHOICE-MI and the COAPT Trial Investigators
Аннотация
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).