Survival After Initial Stress Testing vs Anatomic Testing in Suspected Coronary Artery Disease: Long-Term Follow-Up of the PROMISE Randomized Clinical Trial.

Background

To determine long-term outcomes in patients randomized to functional (stress) vs anatomic (coronary computed tomographic angiography [CTA]) initial testing.

为了确定随机分配到功能（压力）测试与解剖（冠状动脉计算机断层扫描血管造影[CTA]）初始测试的患者长期结果。

DESIGN, SETTING, AND PARTICIPANTS: This study is a 2025 follow-up analysis of mortality of participants in the PROMISE (Prospective Multicenter Imaging Study for Evaluation of Chest Pain) randomized clinical trial, which was conducted from 2009 to 2014, using a 2024 National Death Index search.

设计、环境和参与者：本研究是对PROMISE（用于评估胸痛的前瞻性多中心影像学研究）随机临床试验参与者的2025年随访分析，该试验从2009年到2014年进行，使用了2024年国家死亡指数搜索。

Median (IQR) follow-up duration was 10.6 (9.9-11.3) years; maximum follow-up was 12.4 years.

中位数（四分位数间距）随访持续时间为10.6（9.9-11.3）年；最大随访时间为12.4年。

PROMISE was conducted at 193 multispecialty outpatient sites in North America among 10 003 symptomatic patients requiring testing for suspected CAD.

PROMISE研究在美国和加拿大的193个多专科门诊中心进行，涉及10,003名有症状的患者，这些患者需要进行疑似冠状动脉疾病(CAD)的检测。

Data analysis was conducted from August 2024 to March 2025.

数据分析是从2024年8月到2025年3月进行的。

intervention

Participants were randomized 1:1 to initial CTA or stress testing.

参与者按1:1的比例随机分配接受初始CTA或应激测试。

Testing and subsequent care were performed by sites according to usual practices.

测试及随后的护理由各站点根据常规实践进行。

main_outcomes_and_measures

The PROMISE trial's original primary end point was death, myocardial infarction, unstable angina hospitalization, or major procedural complication.

PROMISE试验的最初主要终点是死亡、心肌梗死、不稳定型心绞痛住院或主要程序并发症。

The primary end point for extended follow-up was all-cause death, with cardiovascular (CV) death as a secondary end point.

延长随访的主要终点是全因死亡，心血管（CV）死亡作为次要终点。

Results

At enrollment, mean (SD) participant age was 61 (8) years, 5270 participants (52.7%) were women, and 8762 (87.6%) had chest pain or dyspnea.

入组时，参与者的平均年龄为61（8）岁，5270名参与者（52.7%）为女性，8762名（87.6%）有胸痛或呼吸困难。

Death occurred in 1128 participants (14.4%), including 558 (14.3%) in the CTA arm and 570 (14.5%) in the stress arm (unadjusted hazard ratio[HR], 0.98; 95% CI, 0.87-1.10).

在1128名参与者（14.4%）中发生了死亡，其中CTA组有558名（14.3%），压力组有570名（14.5%）（未调整的风险比[HR]为0.98；95%置信区间为0.87-1.10）。

There was no demonstrable difference in cardiovascular mortality, although the point estimate favored CTA (HR, 0.84; 95% CI, 0.67-1.05; adjusted HR, 0.89; 95% CI, 0.41-1.94).

尽管点估计值倾向于CTA（风险比，0.84；95%置信区间，0.67-1.05；调整后风险比，0.89；95%置信区间，0.41-1.94），但心血管死亡率没有显著差异。

There were no significant interactions between all-cause death or CV death and study arm by age (<60 or ≥60 years) (P value for interaction = .19), gender (P value for interaction = .60), or race and ethnicity (P value for interaction = .47).

在年龄（<60岁或≥60岁）、性别、种族和民族方面，全因死亡或心血管死亡与研究组之间没有显著的相互作用（年龄P值为.19，性别P值为.60，种族和民族P值为.47）。

A CTA indicating any degree of abnormality, including mild (nonobstructive CAD), moderate, and severe findings, conferred elevated adjusted HRs of death (1.99-3.44; all P < .001) compared to normal study results.

任何程度的异常CTA，包括轻度（非阻塞性冠状动脉疾病）、中度和重度发现，与正常研究结果相比，调整后的死亡风险比（HRs）升高（1.99-3.44；所有P < .001）。

Among stress testing results, only a severe abnormality was prognostically significant (HR, 1.45; 95% CI, 1.10-1.91).

在压力测试结果中，只有重度异常具有预后意义（HR，1.45；95% CI，1.10-1.91）。

In landmark analyses of those alive at 90 days, there were no interactions between randomized testing and use of statins (P value for interaction = .22), β-blockers (P value for interaction = .76), or antiplatelet agents (P value for interaction = .49).

在那些在90天时仍然存活的患者中，随机化测试与使用他汀类药物（交互作用的P值=0.22）、β受体阻滞剂（交互作用的P值=0.76）或抗血小板药物（交互作用的P值=0.49）之间没有交互作用。

conclusions_and_relevance

In long-term follow-up of the PROMISE randomized clinical trial, initial noninvasive test selection in patients with stable symptoms of suspected CAD did not affect all-cause or CV mortality at 10 years.

在PROMISE随机临床试验的长期随访中，对于有稳定症状的疑似冠状动脉疾病患者，初始非侵入性测试的选择并未影响10年内的全因死亡率或心血管死亡率。

trial_registration

ClinicalTrials.gov Identifier: NCT01174550.

临床试验注册号：NCT01174550。