Fondazione Policlinico Universitario A. Gemelli IRCCS Rome Italy.
Università Cattolica del Sacro Cuore Rome Italy.
J Am Heart Assoc. 2019 Aug 6;8(15):e012772. doi: 10.1161/JAHA.119.012772. Epub 2019 Jul 23.
Background Fractional flow reserve (FFR) and optical coherence tomography (OCT) may help both in assessment and in percutaneous coronary intervention optimization of angiographically intermediate coronary lesions. We designed a prospective trial comparing the clinical and economic outcomes associated with FFR or OCT in angiographically intermediate coronary lesions. Methods and Results Three hundred fifty patients with angiographically intermediate coronary lesions (n=446) were randomized to FFR or OCT guidance. In the FFR arm, percutaneous coronary intervention was performed if FFR was ≤0.80 aiming for a postprocedure FFR >0.90. In the OCT arm, percutaneous coronary intervention was performed if percentage of area stenosis was ≥75% or 50% to 75% with minimal lumen area <2.5 mm or plaque ulceration. Costs, angina frequency, and major adverse cardiac events were assessed at 1 month and at 13 months. We present early data at 1 month consistent with a prespecified analysis of secondary end points. Patients randomized to FFR, as compared with OCT, were significantly more commonly managed with medical therapy alone (67.7% versus 41.1%; P<0.001), required less contrast media (245±137 versus 280±129 mL; P=0.004), and exhibited a lower occurrence of contrast-induced acute kidney injury (1.7% versus 8.6%; P=0.034). At 1 month, in comparison to FFR, OCT was associated with increased total costs (2831±1288 versus 4292±3844 euros/patient; P<0.001) whereas occurrence of major adverse cardiac events or significant angina was similar. Conclusions In patients with angiographically intermediate coronary lesions, a functional guidance by FFR, as compared with OCT, increased the rate of patients treated with medical therapy alone. This translated into a significant reduction in administered contrast, contrast-induced acute kidney injury, and total costs at 1 month with FFR. Clinical Trial Registration URL: http://www.clinicaltrialsgov. Unique identifier: NCT01824030.
背景 分数血流储备（FFR）和光学相干断层扫描（OCT）可帮助评估和优化经皮冠状动脉介入治疗的血管造影中间病变。我们设计了一项前瞻性试验，比较了血管造影中间病变中 FFR 与 OCT 的临床和经济结果。
方法和结果 350 例血管造影中间病变患者（n=446）随机分为 FFR 或 OCT 指导组。FFR 组中，如果 FFR≤0.80 则行经皮冠状动脉介入治疗，以达到术后 FFR＞0.90。OCT 组中，如果血管狭窄百分比≥75%或 50%至 75%且最小管腔面积＜2.5mm 或斑块溃疡，则行经皮冠状动脉介入治疗。在 1 个月和 13 个月时评估成本、心绞痛频率和主要不良心脏事件。我们呈现了与预先指定的次要终点分析一致的 1 个月早期数据。与 OCT 相比，随机分配至 FFR 组的患者更常见地接受单纯药物治疗（67.7% vs 41.1%；P＜0.001），所需造影剂更少（245±137ml 比 280±129ml；P=0.004），且发生造影剂诱导急性肾损伤的发生率更低（1.7% vs 8.6%；P=0.034）。在 1 个月时，与 FFR 相比，OCT 与更高的总费用相关（2831±1288 欧元 vs 4292±3844 欧元/患者；P＜0.001），但主要不良心脏事件或严重心绞痛的发生率相似。
结论 在血管造影中间病变患者中，与 OCT 相比，FFR 的功能指导增加了单独接受药物治疗的患者比例。这导致 FFR 在 1 个月时的造影剂用量、造影剂诱导急性肾损伤和总费用显著降低。
