Leone Antonio Maria, Burzotta Francesco, Aurigemma Cristina, Zambrano Aniello, Zimbardo Giuseppe, Galante Domenico, Di Giusto Federico, Bianchini Francesco, Vergallo Rocco, Trani Carlo, Crea Filippo
Dipartimento di Scienze Cardiovascolari, Fondazione Policlinico Universitario A, Gemelli IRCCS, 00168 Roma, Italy.
Dipartimento di Scienze Cardiovascolari , Università Cattolica del Sacro Cuore, 00168 Roma, Italy.
Rev Cardiovasc Med. 2022 Oct 25;23(11):361. doi: 10.31083/j.rcm2311361. eCollection 2022 Nov.
The "FFR or OCT Guidance to Revascularize Intermediate Coronary Stenosis Using Angioplasty" (FORZA) trial showed that in patients with angiographically intermediate coronary lesions (AICLs), optical coherence tomography (OCT) guidance of percutaneous coronary intervention (PCI) reduced the occurrence of the composite endpoint of major adverse cardiac events (MACE) or significant angina at 13 months, while fractional flow reserve (FFR) guidance was associated with a higher rate of medical management and with lower costs. Safety of PCI deferral when FFR 0.80 is known, while data on clinical outcomes using an OCT guidance are lacking. We assessed the safety of PCI deferral based on OCT findings.
This is a subgroups analysis of the FORZA Trial focusing on the clinical outcome of patients in whom PCI was originally deferred. In details, patients with AICLs were randomized to FFR or OCT imaging. In the FFR arm, PCI was deferred if FFR was 0.80 while in the OCT arm in the absence of any of the following conditions: area stenosis 75%, or 50% to 75% with minimum lumen area 2.5 or plaque rupture. Angina status (evaluated using the Seattle Angina Questionnaire, SAQ), MACE (death, myocardial infarction, target vessel revascularization) and rate of patients treated with optimal medical therapy alone were assessed at 24 months.
From a total of 350 patients with 446 AICLs enrolled in the trial (176 randomized to FFR and 174 to OCT), based on the predefined FFR and OCT criteria, PCI was deferred in 119 patients (67.6%) in the FFR arm, and in 82 patients (47.1%) in the OCT arm. At 24-months follow-up, significant residual angina (defined as a value 90 on the angina frequency scale) was observed in 6 patients (5.0%) in the FFR arm, and in 6 patients (7.3%) in the OCT arm ( = 0.55). Rate of MACE was 10.9% in the FFR arm and 6.1% in the OCT arm ( = 0.32). The number of patients managed by optimal medical therapy alone was still significantly higher using FFR than OCT guidance also at 24 months (60.2% vs 44.2%, = 0.0038).
PCI-deferral based on OCT (using the FORZA trial criteria) is safe and associated with numerically less events at 24-months follow up. FFR guidance is still associated with a higher number of patients managed by optimal medical therapy alone.
“FFR 或 OCT 指导下使用血管成形术对中度冠状动脉狭窄进行血运重建”（FORZA）试验表明，在血管造影显示为中度冠状动脉病变（AICL）的患者中，光学相干断层扫描（OCT）指导下的经皮冠状动脉介入治疗（PCI）可降低 13 个月时主要不良心脏事件（MACE）或严重心绞痛复合终点的发生率，而血流储备分数（FFR）指导则与更高的药物治疗率和更低的成本相关。已知 FFR≥0.80 时 PCI 延迟的安全性，而缺乏使用 OCT 指导的临床结局数据。我们基于 OCT 结果评估了 PCI 延迟的安全性。
这是对 FORZA 试验的亚组分析，重点关注最初延迟 PCI 的患者的临床结局。具体而言，AICL 患者被随机分为 FFR 或 OCT 成像组。在 FFR 组中，如果 FFR≥0.80，则延迟 PCI；而在 OCT 组中，若不存在以下任何情况则延迟 PCI：面积狭窄≥75%，或 50%至 75%且最小管腔面积≤2.5mm²或斑块破裂。在 24 个月时评估心绞痛状态（使用西雅图心绞痛问卷，SAQ 进行评估）、MACE（死亡、心肌梗死、靶血管血运重建）以及仅接受最佳药物治疗的患者比例。
在该试验纳入的 350 例有 446 处 AICL 的患者中（176 例随机分配至 FFR 组，174 例至 OCT 组），根据预先定义的 FFR 和 OCT 标准，FFR 组中有 119 例患者（67.6%）延迟了 PCI，OCT 组中有 82 例患者（47.1%）延迟了 PCI。在 24 个月的随访中，FFR 组有 6 例患者（5.0%）出现严重残余心绞痛（定义为心绞痛频率量表上的值≥90），OCT 组有 6 例患者（7.3%）出现（P = 0.55）。FFR 组的 MACE 发生率为 10.9%，OCT 组为 6.1%（P = 0.32）。在 24 个月时，仅接受最佳药物治疗的患者数量在 FFR 指导下仍显著高于 OCT 指导（60.2%对 44.2%，P = 0.0038）。
基于 OCT（使用 FORZA 试验标准）延迟 PCI 是安全的，且在 24 个月的随访中事件数量在数值上较少。FFR 指导仍与更多仅接受最佳药物治疗的患者相关。
