Long-Term Outcomes of Left Bundle-Branch Pacing vs Biventricular Pacing in Heart Failure: The HeartSync-LBBP Randomized Clinical Trial.

However, robust clinical evidence from randomized clinical trials is lacking.

然而，缺乏来自随机临床试验的强有力的临床证据。

Background

To evaluate the long-term clinical outcomes of LBBP and BiVP.

评估左束支起搏(LBBP)和双室起搏(BiVP)的长期临床结果。

DESIGN, SETTING, AND PARTICIPANTS: This multicenter, prospective, randomized clinical trial enrolled 200 patients at 6 centers in China with a left ventricular ejection fraction (LVEF) of 35% or less and LBBB from October 2020 to March 2022.

设计、环境和参与者：这项多中心、前瞻性、随机临床试验从2020年10月至2022年3月在中国的6个中心招募了200名左心室射血分数(LVEF)为35%或以下且存在左束支传导阻滞(LBBB)的患者。

This study was took place from October 2020 to September 2024.

本研究从2020年10月开始，至2024年9月结束。

These data were analyzed September 2024 to December 2024.

这些数据在2024年9月至2024年12月期间进行了分析。

Methods

Patients were randomly assigned in a 1:1 ratio to receive either LBBP or BiVP.

患者以1:1的比例随机分配接受LBBP或BiVP治疗。

main_outcomes_and_measures

The primary end point was the time to death from any cause or heart failure hospitalization (HFH).

主要终点是任何原因导致的死亡或因心力衰竭住院（HFH）的时间。

The secondary end points included all-cause death, HFH, echocardiographic response (absolute increase in LVEF ≥5%), and super response (absolute increase in LVEF ≥15% or improvement of LVEF to ≥50%) rates.

次要终点包括全因死亡、心力衰竭住院、超声心动图反应（LVEF绝对增加≥5%）和超反应（LVEF绝对增加≥15%或LVEF改善至≥50%）的比率。

Results

Of the 200 included patients, 136 were male and 64 were female.

在纳入的200名患者中，136名为男性，64名为女性。

The success rate was 98% in the LBBP group and 94% in the BiVP group (P = .28).

LBBP组的成功率为98%，BiVP组为94%（P = .28）。

The median follow-up duration was 36 (range, 33-39) months.

中位随访时间为36（范围，33-39）个月。

The primary end point of time to death or HFH was significantly lower in the LBBP group compared with BiVP (8% vs 28%; hazard ratio[HR], 0.26; 95% CI, 0.12-0.57; P < .001).

与 BiVP 相比，LBBP 组的死亡或心力衰竭住院时间的主要终点显著降低（8% 对比 28%；风险比 [HR]，0.26；95% 置信区间，0.12-0.57；P < .001）。

There was no significant difference in all-cause mortality between the groups (2.0% vs 5.0%; HR, 0.40; 95% CI, 0.08-2.04; P = .25).

两组之间的全因死亡率没有显著差异（2.0% 对比 5.0%；风险比 [HR]，0.40；95% 置信区间，0.08-2.04；P = .25）。

However, LBBP significantly reduced the risk of HFH (7.0% vs 28.0%; HR, 0.23; 95% CI, 0.10-0.52; P < .001).

然而，左束支区域起搏（LBBP）显著降低了心力衰竭住院的风险（7.0%对比28.0%；风险比，0.23；95%置信区间，0.10-0.52；P < .001）。

The echocardiographic response rates were similar in both groups (86.0% vs 81.0%; P = .34) but the super-response rate was higher in the LBBP group (55.0% vs 36.0%; P < .007).

两组的超声心动图反应率相似（86.0%对比81.0%；P = .34），但左束支区域起搏（LBBP）组的超反应率更高（55.0%对比36.0%；P < .007）。

conclusions_and_relevance

In this study, LBBP was superior to BiVP in reducing the risk of death or HFH in patients with LBBB and severely reduced LVEF.

本研究中，对于左束支传导阻滞（LBBB）和左心室射血分数（LVEF）严重降低的患者，左束支起搏（LBBP）在降低死亡或心力衰竭住院（HFH）风险方面优于双心室起搏（BiVP）。

Further trials are warranted in this patient population.

在这一患者群体中，有必要进行进一步的临床试验。

trial_registration

Chinese Clinical Trial Registry identifier: ChiCTR2000036554.

中国临床试验注册中心注册号：ChiCTR2000036554。