Final Results from REPRISE III: Long-Term Stroke Risk after TAVR for Severe Aortic Stenosis

A study presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2021 Annual Meeting reported the final five-year results from the REPRISE III randomized trial, which assessed the Lotus Valve transcatheter aortic valve replacement (TAVR) system in severe, symptomatic aortic stenosis.

About REPRISE III

In REPRISE III, 912 high/extreme surgical risk patients were randomized 2:1 to TAVR with either the mechanically expanded Lotus Valve (n=607) or the self-expanding CoreValve (n=305). Patients were included if they had severe aortic stenosis, extreme or high operative risk, Annulus ≥20 mm and ≤27 mm, and transfemoral access.

The Lotus Valve was found to be non-inferior to the CoreValve regarding 30-day safety outcomes (death, stroke, life-threatening/major bleeding, stage ≥2 acute kidney injury, major vascular complications) and was superior in effectiveness outcomes at one year (mortality, disabling stroke, and moderate to severe paravalvular leak). Five-year follow-up is complete, and the current analysis comprises data on final outcomes.

Results of 5 Year Follow-Up

At five years, 95.7% of the Lotus group (n=581) and 93.4% of the CoreValve group (n=285) were available for follow-up. Rates of all-cause mortality or combined risk of mortality/debilitating stroke were comparable between treatment groups. All-cause mortality rates were 50.9% and 52.8% in the Lotus and CoreValve groups, respectively (P=0.59); rates of mortality/stroke were 52.8% and 56.0%, respectively (P=0.24).

Overall, improvements in functional and health status were similar regardless of treatment modality. The researchers noted that more Lotus patients received a new, permanent pacemaker relative to the CoreValve group. The Lotus arm also had higher rates of valve thrombosis relative to CoreValve. Fewer disabling strokes occurred in the Lotus arm, and these patients experienced fewer repeat procedures than patients in the CoreValve arm.

Regarding echocardiographic outcomes, rates of moderate or greater paravalvular leak were low in both groups at final follow-up. However, the incidence of mild paravalvular leak was lower in the Lotus group. Valve areas were smaller and mean gradient was higher with Lotus versus CoreValve.

The authors summarized, “This 5-year analysis from the REPRISE III study demonstrates the durability of safety and effectiveness after Lotus valve implantation through 5 years of follow-up.”

Reference: Reardon MJ, et al. TCT 394: Late Outcomes after Transcatheter Aortic Valve Replacement with a Mechanically-expanded versus Self-Expandable Valve: Final 5-year Results from the REPRISE III Randomized Trial. Presented at TCT 2021, Orlando, FL, Nov. 4–6, 2021.