Tricuspid valve replacement outcomes by baseline tricuspid regurgitation severity: the TRISCEND II trial.

This work reports 1-year and 18-month outcomes in patients stratified by baseline TR severity.

本项研究报告了根据基线三尖瓣反流严重程度分层的患者在1年和18个月时的治疗结果。

Methods

The multicentre, prospective TRISCEND II trial enrolled 400 patients with symptomatic, ≥severe TR, and randomized 2:1 to TTVR (n = 267) or control (n = 133).

多中心前瞻性TRISCEND II试验招募了400名有症状的、≥重度三尖瓣反流(TR)患者，并按2:1的比例随机分为TTVR组(n = 267)或对照组(n = 133)。

In a post hoc analysis, patients were stratified into severe TR (n = 172) and massive/torrential TR (n = 220) cohorts.

在事后分析中，患者被分为重度三尖瓣反流(TR)组(n = 172)和大量/急流型TR组(n = 220)。

Clinical and quality-of-life outcomes were reported at 1 year, with Kaplan-Meier estimates for all-cause mortality and heart failure (HF) hospitalization assessed at 18 months.

在1年时报告了临床和生活质量结果，所有原因的死亡率和心力衰竭（HF）住院率的Kaplan-Meier估计值在18个月时进行了评估。

Study oversight included an independent echocardiographic core laboratory, clinical events committee, and data safety monitoring board.

研究监督包括一个独立的超声心动图核心实验室、临床事件委员会和数据安全监测委员会。

Results

One year after TTVR, TR was ≤mild in 95.2% of severe TR and 95.3% of massive/torrential TR patients.

在TTVR治疗后一年，95.2%的重度TR患者和95.3%的大量/急流TR患者的TR程度为≤轻度。

The primary safety and effectiveness endpoint (win ratio) favoured TTVR over control regardless of baseline TR severity: severe {1.64 [95% confidence interval(CI): 1.11, 2.43]} and massive/torrential [2.20 (1.55, 3.14)].

主要的安全性和有效性终点（胜率）无论基线TR严重程度如何，均支持TTVR优于对照组：重度TR的胜率为1.64 [95%置信区间（CI）: 1.11, 2.43]，大量/急流TR的胜率为2.20 [95%置信区间（CI）: 1.55, 3.14]。

At 18 months, TTVR patients had similar mortality to controls [rate difference: severe 0.2% (-11.6, 11.9), massive/torrential -5.8% (-17.6, 6.0)], whereas HF hospitalization rates favoured TTVR in the massive/torrential cohort [vs control, severe 9.8% (-3.0, 22.7), massive/torrential -15.2% (-28.9, -1.5)].

在18个月时，TTVR患者的死亡率与对照组相似[死亡率差异：严重0.2%（-11.6, 11.9），巨大/洪流型-5.8%（-17.6, 6.0）]，而在巨大/洪流型队列中，HF住院率有利于TTVR[与对照组相比，严重9.8%（-3.0, 22.7），巨大/洪流型-15.2%（-28.9, -1.5）]。

Conclusions

Patients with ≥severe TR benefit from TTVR, experiencing improvements in TR severity, functional capacity, and quality of life regardless of baseline TR severity, with a signal for greater benefit in patients with more advanced disease.

患有≥严重TR的患者从TTVR中受益，无论基线TR严重程度如何，都能体验到TR严重程度、功能能力和生活质量的改善，对于疾病更晚期的患者显示出更大的益处。