Tricuspid-Valve Intervention in Heart Failure.

Methods

We randomly assigned patients with symptomatic severe tricuspid regurgitation and an increased risk of future heart-failure events in a 2:1 ratio to tricuspid-valve repair plus medical therapy (tricuspid-repair group) or medical therapy alone (medical-therapy group).

我们将有症状的严重三尖瓣反流患者和未来心力衰竭事件风险增加的患者以2:1的比例随机分配到三尖瓣修复加药物治疗（三尖瓣修复组）或仅药物治疗（药物治疗组）。

The first primary end point was a hierarchical composite of death from any cause, hospitalization for heart failure, and quality-of-life improvement at 1 year, assessed by win ratio.

第一个主要终点是一个层次化的复合终点，包括1年内全因死亡、因心力衰竭住院和生活质量改善，通过胜率评估。

If the between-group difference was significant, a second primary end point would be tested: a composite of death from any cause or hospitalization for heart failure through 3 years.

如果组间差异显著，将测试第二个主要终点：一个复合终点，包括3年内全因死亡或因心力衰竭住院。

Results

A total of 360 patients underwent randomization (237 patients were assigned to the tricuspid-repair group and 123 to the medical-therapy group).

共有360名患者进行了随机分配（237名患者被分配到三尖瓣修复组，123名患者被分配到药物治疗组）。

The mean (±SD) age of the patients was 80.3±6.4 years, and 56.4% were women.

患者的平均（±SD）年龄为80.3±6.4岁，56.4%为女性。

The win ratio for the first primary end point was 2.42 (95% confidence interval[CI], 1.76 to 3.33; P<0.001), favoring tricuspid-valve repair.

第一个主要终点的胜率为2.42（95%置信区间[CI]，1.76至3.33；P<0.001），有利于三尖瓣修复。

The Kaplan-Meier estimate for freedom from death from any cause or hospitalization for heart failure (second primary end point) through 3 years was 52.4% (95% CI, 43.2 to 63.6) in the tricuspid-repair group and 21.0% (95% CI, 12.7 to 34.6) in the medical-therapy group (hazard ratiofor death from any cause or hospitalization for heart failure, 0.40; 95% CI, 0.29 to 0.55; P<0.001).

Kaplan-Meier估计显示，3年内无全因死亡或因心力衰竭住院的自由率为三尖瓣修复组的52.4%（95% CI，43.2至63.6）和药物治疗组的21.0%（95% CI，12.7至34.6）（全因死亡或因心力衰竭住院的风险比为0.40；95% CI，0.29至0.55；P<0.001）。

Major adverse events within 30 days occurred in 14 patients (5.9%) in the tricuspid-repair group.

在三尖瓣修复组中，有14名患者（5.9%）在30天内发生了重大不良事件。

Conclusions

Among patients with symptomatic severe tricuspid regurgitation, transcatheter tricuspid-valve repair plus medical therapy was superior to medical therapy alone with respect to a hierarchical composite of death from any cause, hospitalization for heart failure, and quality-of-life improvement at 1 year and was also associated with a lower risk of a composite of death from any cause or hospitalization for heart failure through 3 years.

对于有症状的重度三尖瓣反流患者，经导管三尖瓣修复加药物治疗在1年内对死亡、心力衰竭住院和生活质量改善的层次复合结果方面优于单独的药物治疗，并且在3年内与较低的死亡或心力衰竭住院复合风险相关。

(Funded by the German Center for Cardiovascular Research and others; TRIC-I-HF ClinicalTrials.gov number, NCT04634266.).

该项目由德国心血管研究中心和其他机构资助；TRIC-I-HF临床试验注册号为NCT04634266。