Survival benefit in patients with native aortic regurgitation using a dedicated transcatherter valve vs non-dedicated transcatheter valves.

BACKGROUND

Until recently, no standard of care has been established for patients with symptomatic native aortic regurgitation (AR) who are unsuitable for surgery. Transcatheter aortic valve implantation (TAVI) has been explored in this setting using off-label, non-dedicated valves originally designed for aortic stenosis. The recent ALIGN-AR trial evaluated the Trilogy valve, a dedicated transcatheter device specifically designed for native AR.

METHODS

We performed an indirect comparison between the overall survival (OS) reported for the Trilogy valve in ALIGN-AR and OS from seven single-arm studies using non-dedicated valves. Individual patient data were reconstructed from published Kaplan-Meier curves using the IPDfromKM method. To ensure homogeneity, the follow-up period for the survival analysis was truncated at 24 months. Survival was analyzed using both hazard ratios (HR) and restricted mean survival time (RMST).

RESULTS

The analysis included 492 patients treated with the Trilogy valve and 867 treated with non-dedicated valves. OS was significantly improved with the Trilogy valve (HR 0.399; 95% CI 0.275-0.578; p = 0.0000011). RMST at 12 months was 11.4 months for the Trilogy valve versus 10.4 months for non-dedicated valves, corresponding to an OS gain of 1.0 months (95% CI 0.72-1.32) over the first year.

CONCLUSIONS

In patients with native AR undergoing TAVI, use of the dedicated Trilogy valve was associated with a highly significant survival advantage compared with non-dedicated devices, corresponding to an approximate 1-month gain in OS during the first 12 months after implantation.