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【文献导读】Lancet丨预防性经皮冠状动脉介入治疗与单纯最佳药物治疗对冠状动脉易损斑块的治疗方案的比较（PREVENT）

文章来源：IE-learning　IElearning急危重发布时间：2024-06-14 11:34

编译：高璐瑶，IE-learning翻译团队、中国心脏骤停与复苏研究联盟

摘要

Summary

Background

Acute coronary syndrome and sudden cardiac death are often caused by rupture and thrombosis of lipidrich atherosclerotic coronary plaques (known as vulnerable plaques), many of which are non-flow-limiting. The safety and effectiveness of focal preventive therapy with percutaneous coronary intervention of vulnerable plaques in reducing adverse cardiac events are unknown. We aimed to assess whether preventive percutaneous coronary intervention of non-flow-limiting vulnerable plaques improves clinical outcomes compared with optimal medical therapy alone.
背景

急性冠状动脉综合征和心原性猝死通常由富含脂质的冠状动脉粥样硬化斑块（称为易损斑块）的破裂和血栓形成引起，其中许多斑块是非血流限制性的。针对易损斑块进行局部预防性经皮冠状动脉介入治疗在减少不良心脏事件方面的安全性和有效性尚不清楚。我们的目的是评估非血流限制性易损斑块的预防性经皮冠状动脉介入治疗与最佳药物治疗相比是否能改善临床疗效。

Methods

PREVENT was a multicentre, open-label, randomised controlled trial done at 15 research hospitals in four countries (South Korea, Japan, Taiwan, and New Zealand). Patients aged 18 years or older with non-flow-limiting (fractional flow reserve >0·80) vulnerable coronary plaques identified by intracoronary imaging were randomly assigned (1:1) to either percutaneous coronary intervention plus optimal medical therapy or optimal medical therapy alone, in block sizes of 4 or 6, stratified by diabetes status and the performance of percutaneous coronary intervention in a non-study target vessel. Follow-up continued annually in all enrolled patients until the last enrolled patient reached 2 years after randomisation. The primary outcome was a composite of death from cardiac causes, targetvessel myocardial infarction, ischaemia-driven target-vessel revascularisation, or hospitalisation for unstable or progressive angina, assessed in the intention-to-treat population at 2 years. Time-to-first-event estimates were calculated with the Kaplan–Meier method and were compared with the log-rank test. This report is the principal analysis from the trial and includes all long-term analysed data. The trial is registered at ClinicalTrials.gov, NCT02316886, and is complete.

方法

PREVENT 是一项多中心、开放标签、随机对照试验，在四个国家（韩国、日本、台湾和新西兰）的 15 家研究医院进行。通过冠状动脉内成像确定患有非血流限制性（分数血流储备>0.80）易损冠状动脉斑块的 18 岁或以上患者被1:1随机分配至经皮冠状动脉介入治疗加最佳药物治疗或单独最佳药物治疗，每组 4 或 6 人，根据糖尿病状况和非研究靶血管中经皮冠状动脉介入治疗效果进行分层。每年对所有入组患者进行随访，直至末例入组患者达到随机化后2年。主要研究结果是2年时在意向治疗人群中心脏原因导致的死亡、靶血管心肌梗死、缺血导致的靶血管血运重建或因不稳定或进展性心绞痛住院的综合结果。采用Kaplan-Meier方法计算至首次事件时间估计值，并与对数秩检验进行比较。本报告是该试验的主要分析报告，包括所有长期分析数据。该试验已在 ClinicalTrials.gov 上注册，编号为 NCT02316886，并已完成。

Findings

Between Sept 23, 2015, and Sept 29, 2021, 5627 patients were screened for eligibility, 1606 of whom were enrolled and randomly assigned to percutaneous coronary intervention (n=803) or optimal medical therapy alone (n=803). 1177 (73%) patients were men and 429 (27%) were women. 2-year follow-up for the primary outcome assessment was completed in 1556 (97%) patients (percutaneous coronary intervention group n=780; optimal medical therapy group n=776). At 2 years, the primary outcome occurred in three (0.4%) patients in the percutaneous coronary intervention group and in 27 (3.4%) patients in the medical therapy group (absolute difference –3·0 percentage points [95% CI –4.4 to –1.8]; p=0.0003). The effect of preventive percutaneous coronary intervention was directionally consistent for each component of the primary composite outcome. Serious clinical or adverse events did not differ between the percutaneous coronary intervention group and the medical therapy group: at 2 years, four (0.5%) versus ten (1.3%) patients died (absolute difference –0·8 percentage points [95% CI –1.7 to 0.2]) and nine (1.1%) versus 13 (1.7%) patients had myocardial infarction (absolute difference –0.5 percentage points [–1.7 to 0.6]).

研究结果

2015年9月23日至2021年9月29日期间，共筛选出5627名符合条件的患者，其中1606名患者入选并随机分配到经皮冠状动脉介入治疗（803人）或单纯最佳药物治疗（803人）。1177名患者（73%）为男性，429名患者（27%）为女性。1556名（97%）患者完成了主要结果评估的2年随访（经皮冠状动脉介入治疗组，人数=780；最佳药物治疗组，人数=776）。2 年后，经皮冠状动脉介入治疗组有 3 例（0.4%）患者出现主要结局，单纯药物治疗组有 27 例（3.4%）患者出现主要结局（绝对差异为 -3.0 个百分点 [95% CI, -4.4到-1.8]; p=0.0003）。预防性经皮冠状动脉介入治疗对主要复合结果的每个组成部分的影响方向一致。经皮冠状动脉介入治疗组和单纯药物治疗组的严重临床或不良事件没有差异：2年后，4例（0.5%）患者死亡，10例（1.3%）患者死亡（绝对差异-0.8个百分点[95% CI -1.7 to 0.2]）；9例（1.1%）患者发生心肌梗死，13例（1.7%）患者发生心肌梗死（绝对差异-0.5个百分点[-1.7 to 0.6]）。

Interpretation

In patients with non-flow-limiting vulnerable coronary plaques, preventive percutaneous coronary intervention reduced major adverse cardiac events arising from high-risk vulnerable plaques, compared with optimal medical therapy alone. Given that PREVENT is the first large trial to show the potential effect of the focal treatment for vulnerable plaques, these findings support consideration to expand indications for percutaneous coronary intervention to include non-flow-limiting, high-risk vulnerable plaques.

结论

在非血流限制性易损冠状动脉斑块患者中，与单纯的最佳药物治疗相比，预防性经皮冠状动脉介入治疗可减少高危易损斑块引起的主要不良心脏事件。鉴于 PREVENT 是首个显示易损斑块病灶治疗潜在效果的大型试验，这些研究结果支持将经皮冠状动脉介入治疗的适应证扩大到非血流限制性高风险易损斑块。