Clinical Outcomes With Personalized Accelerated Physiologic Pacing in Heart Failure With Preserved Ejection Fraction: Follow-up of the myPACE Trial.

Background

To compare adverse eventaccrual between personalized accelerated pacing and usual care in HFpEF.

在HFpEF中，比较个性化加速起搏与常规护理之间的不良事件累积。

DESIGN, SETTING, AND PARTICIPANTS: This was an observational extension of the myPACE randomized clinical trial with up to 4 years of follow-up in 100 patients with stage B or C HFpEF and preexisting physiologic pacemakers treated at the University of Vermont Medical Center.

设计、环境和参与者：这是myPACE随机临床试验的观察性延伸，对100名患有B期或C期HFpEF且已有生理起搏器的患者进行了长达4年的随访，这些患者在佛蒙特大学医学中心接受治疗。

The myPACE study was conducted from June 2019 to December 2021; follow-up for this report was concluded in June 2023.

myPACE研究从2019年6月开始至2021年12月结束；本报告的随访在2023年6月结束。

intervention

Participants in the original myPACE trial were randomly assigned to either personalized accelerated pacing (myPACE) or 60 bpm (usual care).

原始 myPACE 试验的参与者被随机分配到个性化加速起搏（myPACE）或每分钟60次（常规护理）。

main_outcomes_and_measures

The primary outcome was the accrual of first and recurrent adverse clinical events during the open-label follow-up phase-including urgent visits or hospitalizations for heart failure or atrial fibrillation, myocardial infarction, stroke, or death-assessed using an intention-to-treat(ITT) analysis and a prespecified per-protocol (PP) analysis of patients who continued their assigned treatment.

主要结果是在开放标签随访阶段累积的首次和复发性不良临床事件，包括因心力衰竭或房颤、心肌梗死、中风或死亡而紧急就诊或住院，使用意向治疗（ITT）分析和预先设定的按方案（PP）分析评估继续接受指定治疗的患者。

Secondary outcomes included event-free survival in both ITT and PP analyses.

次要结果包括意向治疗(ITT)和按方案处理(PP)分析中的无事件生存期。

Results

Among the 100 original trial participants (48 in myPACE and 52 in usual care), the ITT analysis demonstrated a trend toward slower event accrual with the myPACE intervention (15 vs 33 events; Lin-Wei-Ying-Yang estimate [LWYY], 0.48; 95% CI, 0.22-1.06; P = .07) and longer event-free survival (hazard ratio[HR], 0.63; 95% CI, 0.31-1.29; P = .20) but did not reach statistical significance.

在最初的100名试验参与者中（48名在我的PACE干预组，52名在常规护理组），意向治疗分析显示，与我的PACE干预相比，事件累积趋势较慢（15比33个事件；林-魏-英-阳估计[LWYY]，0.48；95%置信区间，0.22-1.06；P = .07），并且无事件生存期更长（风险比[HR]，0.63；95%置信区间，0.31-1.29；P = .20），但未达到统计学意义。

In the prespecified PP analysis, 87 remained on their assigned heart rate setting over the 4-year follow-up (39 in myPACE and 48 in usual care).

在预先设定的PP分析中，87名患者在4年的随访期间保持了他们被分配的心率设置（39名在myPACE组，48名在常规护理组）。

The mean (SD) age was 74 (10) years, and 48 participants (55%) were male.

平均（标准差）年龄为74（10）岁，48名参与者（55%）为男性。

In this PP analysis, myPACE was associated with a slower accrual of clinical events (5 vs 31 events; LWYY, 0.16; 95% CI, 0.04-0.67; P = .01) and longer event-free survival (HR, 0.30; 95% CI, 0.11-0.80; P = .02) compared to usual care.

在这项PP分析中，myPACE与临床事件的缓慢累积（5比31事件；LWYY，0.16；95%置信区间，0.04-0.67；P = .01）以及较长时间的无事件生存（HR，0.30；95%置信区间，0.11-0.80；P = .02）相关，与常规护理相比。

These results were primarily driven by heart failure-related events.

这些结果主要是由与心力衰竭相关事件驱动的。

conclusions_and_relevance

In this observational clinical events analysis of the myPACE trial, analysis by ITT did not achieve statistical significance between study arms.

在这项myPACE试验的临床事件观察性分析中，按意向治疗(ITT)分析两组间未达到统计学显著性。

However, PP analysis showed that personalized accelerated physiologic pacing was associated with a slower accrual of adverse clinical events compared with the standard 60-bpm setting.

然而，按方案分析(PP)显示，个性化加速生理起搏与标准60次/分钟设置相比，不良临床事件的累积速度较慢。

These results are hypothesis generating and warrant confirmation in larger multicenter trials.

这些结果具有假设生成性，并需要在更大规模的多中心试验中得到验证。

trial_registration

ClinicalTrials.gov Identifier: NCT04721314.

ClinicalTrials.gov注册号：NCT04721314。