Fractional Flow Reserve or Optical Coherence Tomography to Guide Management of Angiographically Intermediate Coronary Stenosis: A Single-Center Trial.,JACC: Cardiovascular Interventions

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Fractional Flow Reserve or Optical Coherence Tomography to Guide Management of Angiographically Intermediate Coronary Stenosis: A Single-Center Trial.
JACC: Cardiovascular Interventions ( IF 11.7 ) Pub Date : 2020-01-13 , DOI: 10.1016/j.jcin.2019.09.034
Francesco Burzotta ₁ , Antonio Maria Leone ₂ , Cristina Aurigemma ₂ , Aniello Zambrano ₁ , Giuseppe Zimbardo ₂ , Manfredi Arioti ₁ , Rocco Vergallo ₁ , Giovanni Luigi De Maria ₃ , Emma Cerracchio ₁ , Enrico Romagnoli ₁ , Carlo Trani ₁ , Filippo Crea ₁

Affiliation

OBJECTIVES The aim of this study was to compare optical coherence tomographic (OCT) guidance and fractional flow reserve (FFR) guidance in patients with angiographically intermediate coronary lesions (AICLs) in a single-center, prospective, 1:1 randomized trial. BACKGROUND FFR and OCT imaging may help both in the assessment of AICLs and in percutaneous coronary intervention optimization. METHODS Patients with AICLs were randomized to FFR or OCT imaging. In the FFR arm, PCI was performed if FFR was ≤0.80. In the OCT imaging arm, PCI was performed if area stenosis was ≥75% or 50% to 75% with minimal luminal area <2.5 mm2 or plaque rupture. Angina (evaluated using the Seattle Angina Questionnaire), major adverse cardiac events, and cost were assessed at the end of follow-up. The pre-defined primary endpoint was the composite of major adverse cardiac events or significant angina (defined as Seattle Angina Questionnaire frequency scale score <90) at 13 months. RESULTS A total of 350 patients (with 446 AICLs) were enrolled (176 randomized to FFR and 174 to OCT imaging). The primary endpoint of major adverse cardiac events or significant angina at 13 months occurred in 14.8% of patients in the FFR arm and in 8.0% in the OCT imaging arm (p = 0.048). This result was driven by a statistically nonsignificant lower occurrence of all primary endpoint components. Up to 13 months, the rate of medically managed patients was significantly higher (p < 0.001) and total cost significantly lower (p < 0.001) with FFR in comparison with OCT imaging. CONCLUSIONS In patients with AICLs, OCT guidance is associated with lower occurrence of the composite of major adverse cardiac events or significant angina. FFR guidance is associated with a higher rate of medical management and lower costs. FFR or OCT Guidance to Revascularize Intermediate Coronary Stenosis Using Angioplasty [FORZA]; NCT01824030).

中文翻译：

分数血流储备或光学相干断层扫描术指导血管造影术冠状动脉狭窄的治疗：单中心试验。

目的本研究的目的是在一项单中心，前瞻性，1：1随机试验中比较血管造影术中度冠状动脉病变（AICL）患者的光学相干断层扫描（OCT）指导和分流储备（FFR）指导。背景技术FFR和OCT成像可能有助于AICL的评估和经皮冠状动脉介入治疗的优化。方法将AICL患者随机分为FFR或OCT成像。在FFR组中，如果FFR≤0.80，则进行PCI。在OCT成像臂中，如果区域狭窄≥75％或50％至75％，且最小管腔面积<2.5 mm2或斑块破裂，则进行PCI。在随访结束时评估了心绞痛（使用西雅图心绞痛问卷进行评估），主要的不良心脏事件和费用。预定义的主要终点指标是在13个月时发生的主要不良心脏事件或严重心绞痛（定义为“西雅图心绞痛问卷调查频率评分” <90）的复合物。结果共纳入350例患者（446例AICL）（176例随机分配到FFR，174例随机分配到OCT成像）。FFR组中有14.8％的患者发生严重不良心脏事件或严重心绞痛的主要终点发生在13个月，OCT成像组中为8.0％（p = 0.048）。该结果是由所有主要终点成分的统计学上较低的较低发生率所驱动的。与OCT成像相比，在长达13个月的时间里，FFR的药物治疗患者比率显着更高（p <0.001），总费用显着更低（p <0.001）。结论对于AICL患者，OCT指南与主要不良心脏事件或严重心绞痛的发生率降低相关。FFR指导与更高的医疗管理率和更低的成本相关。FFR或OCT指导使用血管成形术对中度冠状动脉狭窄进行血运重建[FORZA]；NCT01824030）。

更新日期：2020-01-07

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