心力衰竭中的三尖瓣干预
完整摘要 · 中文译文
背景：经导管三尖瓣修复术对严重三尖瓣反流患者临床结局（包括死亡和心力衰竭住院）的影响仍不确定。 方法：我们将有症状的重度三尖瓣反流且未来心力衰竭事件风险增加的患者按2:1的比例随机分配至三尖瓣修复术联合药物治疗组（三尖瓣修复组）或单独药物治疗组（药物治疗组）。第一个主要终点是采用胜率比评估的1年时全因死亡、心力衰竭住院和生活质量改善的分层复合终点。如果组间差异显著，则检验第二个主要终点：3年内全因死亡或心力衰竭住院的复合终点。 结果：共有360名患者接受了随机分组（237名患者被分配至三尖瓣修复组，123名分配至药物治疗组）。患者平均年龄（±SD）为80.3±6.4岁，女性占56.4%。第一个主要终点的胜率比为2.42（95%置信区间[CI]，1.76至3.33；P<0.001），支持三尖瓣修复。三尖瓣修复组3年内免于全因死亡或心力衰竭住院（第二个主要终点）的Kaplan-Meier估计值为52.4%（95% CI，43.2至63.6），药物治疗组为21.0%（95% CI，12.7至34.6）（全因死亡或心力衰竭住院的风险比为0.40；95% CI，0.29至0.55；P<0.001）。三尖瓣修复组30天内发生主要不良事件的患者有14例（5.9%）。 结论：在有症状的重度三尖瓣反流患者中，经导管三尖瓣修复联合药物治疗在1年时由全因死亡、心力衰竭住院和生活质量改善构成的分层复合终点方面优于单独药物治疗，并且还与3年内全因死亡或心力衰竭住院复合终点的较低风险相关。（由德国心血管研究中心等资助；TRIC-I-HF ClinicalTrials.gov注册号，NCT04634266。）
完整摘要 · 英文原文
BACKGROUND: The effect of transcatheter tricuspid-valve repair on clinical outcomes, including death and hospitalization for heart failure, in patients with severe tricuspid regurgitation remains uncertain. 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). 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. 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. RESULTS: A total of 360 patients underwent randomization (237 patients were assigned to the tricuspid-repair group and 123 to the medical-therapy group). The mean (±SD) age of the patients was 80.3±6.4 years, and 56.4% were women. 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. 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 ratio for death from any cause or hospitalization for heart failure, 0.40; 95% CI, 0.29 to 0.55; P<0.001). Major adverse events within 30 days occurred in 14 patients (5.9%) in the tricuspid-repair group. 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. (Funded by the German Center for Cardiovascular Research and others; TRIC-I-HF ClinicalTrials.gov number, NCT04634266.).