Mitraclip Versus Medical Therapy or Surgery in Patients With Mitral Regurgitation: Long-Term Outcomes Determined by the Reconstruction of Individual Patient Data.

Abstract

Although MitraClip has been studied in numerous trials, its evidence in the long term is basedon a few original studies. We used an original technique of evidence synthesis to review long-termcomparative trialsevaluating MitraClip. We searched the PubMed database to select long-term comparative trials of MitraClip. The endpoint was all-cause mortality (minimum follow-up, one year). Included trials were analyzed using theIPDfromKM (reconstruct Individual Patient Data from published Kaplan-Meier survival curves)method to reconstruct individual patient data from Kaplan-Meier curves. Standard survivalstatistics were used to interpret these long-term efficacy data. The survival benefit per patient was estimatedfrom the restricted mean survival time (RMST). Six comparative studies of MitraClip were included; 973 patients were treated with MitraClip (six arms), 717 with medical therapy (five arms), and 80 with surgical repair or replacement (one arm). In our mainanalysis, the outcomes observed in patients treated with MitraClip were significantly better than thoseof medical therapy (hazard ratio for all-cause mortality, 0.5276; 95% confidence interval, 0.4412 to 0.6309;p < 0.001); the number of patients treated with surgery was too small to make reliable comparisons. Mediansurvival was 30.4 months for medical therapy versus not reached for the other two groups. RMST was 43.931 and33.756 monthsfor MitraClip and controls, respectively, yielding a gain per patient of 10.17 months (95%confidence interval, 7.47 to 12.88). In our simplified cost-effectiveness evaluation, a gain of approximately10 months per patient compared favorably with the device cost.Our analysis provided an original interpretation of the long-termevidence available on MitraClip.