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血流储备分数指导下的经皮冠状动脉介入治疗优化策略:以高分辨率血管内超声为指导与标准治疗的比较(FFR REACT 试验)。

FFR-Guided PCI Optimization Directed by High-Definition IVUS Versus Standard of Care: The FFR REACT Trial.

机构信息

Department of Cardiology, Erasmus University Medical Center, Rotterdam, the Netherlands.

Department of Cardiology, Erasmus University Medical Center, Rotterdam, the Netherlands.

出版信息

JACC Cardiovasc Interv. 2022 Aug 22;15(16):1595-1607. doi: 10.1016/j.jcin.2022.06.018.

DOI:10.1016/j.jcin.2022.06.018
PMID:35981832
Abstract

BACKGROUND

Post-percutaneous coronary intervention (PCI) fractional flow reserve (FFR) <0.90 is common and has been related to impaired patient outcome.

OBJECTIVES

The authors sought to evaluate if PCI optimization directed by intravascular ultrasound (IVUS) in patients with post-PCI FFR <0.90 could improve 1-year target vessel failure (TVF) rates.

METHODS

In this single-center, randomized, double-blind trial, patients with a post-PCI FFR <0.90 at the time of angiographically successful PCI were randomized to IVUS-guided optimization or the standard of care (control arm). The primary endpoint was TVF (a composite of cardiac death, spontaneous target vessel myocardial infarction, and clinically driven target vessel revascularization) at 1 year.

RESULTS

A total of 291 patients with post-PCI FFR <0.90 were randomized (IVUS-guided optimization arm: n = 145/152 vessels, control arm: n = 146/157 vessels). The mean post-PCI FFR was 0.84 ± 0.05. A total of 104 (68.4%) vessels in the IVUS-guided optimization arm underwent additional optimization including additional stenting (34.9%) or postdilatation only (33.6%), resulting in a mean increase in post-PCI FFR in these vessels from 0.82 ± 0.06 to 0.85 ± 0.05 (P < 0.001) and a post-PCI FFR ≥0.90 in 20% of the vessels. The 1-year TVF rate was comparable between the 2 study arms (IVUS-guided optimization arm: 4.2%, control arm: 4.8%; P = 0.79). There was a trend toward a lower incidence of clinically driven target vessel revascularization in the IVUS-guided optimization arm (0.7% vs. 4.2%, P = 0.06).

CONCLUSIONS

IVUS-guided post-PCI FFR optimization significantly improved post-PCI FFR. Because of lower-than-expected event rates, post-PCI FFR optimization did not significantly lower TVF at the 1-year follow-up.

摘要

背景

经皮冠状动脉介入治疗(PCI)后,血流储备分数(FFR)<0.90 较为常见,且与患者预后不良有关。

目的

作者旨在评估 PCI 后 FFR<0.90 的患者行血管内超声(IVUS)指导的 PCI 优化治疗能否改善 1 年靶血管失败(TVF)率。

方法

这是一项单中心、随机、双盲临床试验,对经血管造影成功的 PCI 后 FFR<0.90 的患者进行随机分组,分别接受 IVUS 指导的优化治疗或标准治疗(对照组)。主要终点为 1 年时的 TVF(包括心源性死亡、自发性靶血管心肌梗死和临床驱动的靶血管血运重建)。

结果

共 291 例 PCI 后 FFR<0.90 的患者被随机分组(IVUS 指导优化组:145/152 支血管;对照组:146/157 支血管)。平均 PCI 后 FFR 为 0.84±0.05。IVUS 指导优化组中有 104 支(68.4%)血管接受了进一步的优化治疗,包括追加支架植入(34.9%)或单纯后扩张(33.6%),结果这些血管的 PCI 后 FFR 平均从 0.82±0.06 增加至 0.85±0.05(P<0.001),20%的血管的 PCI 后 FFR≥0.90。两组患者 1 年 TVF 率相当(IVUS 指导优化组:4.2%;对照组:4.8%;P=0.79)。IVUS 指导优化组临床驱动的靶血管血运重建发生率有降低趋势(0.7% vs. 4.2%,P=0.06)。

结论

IVUS 指导的 PCI 后 FFR 优化显著改善了 PCI 后的 FFR。由于事件发生率低于预期,PCI 后 FFR 优化并未显著降低 1 年随访时的 TVF。

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