Department of Cardiovascular Medicine, Wakayama Medical University, 811-1 Kimiidera, Wakayama, 641-8509, Japan.
Division of Cardiovascular and Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan.
Eur Heart J. 2017 Nov 7;38(42):3139-3147. doi: 10.1093/eurheartj/ehx351.
Optical frequency domain imaging (OFDI) is a recently developed, light-based, high-resolution intravascular imaging technique. Intravascular ultrasound (IVUS) is a widely used, conventional imaging technique for guiding percutaneous coronary intervention (PCI). We aimed to demonstrate the non-inferiority of OFDI-guided PCI compared with IVUS-guided PCI in terms of clinical outcomes.
We did a prospective, multicentre, randomized (ratio 1:1), active-controlled, non-inferiority study to compare head-to-head OFDI vs. IVUS in patients undergoing PCI with a second generation drug-eluting stent. The primary endpoint was target vessel failure defined as a composite of cardiac death, target-vessel related myocardial infarction, and ischaemia-driven target vessel revascularization until 12 months after the PCI. The major secondary endpoint was angiographic binary restenosis at 8 months. We randomly allocated 829 patients to receive OFDI-guided PCI (n = 414) or IVUS-guided PCI (n = 415). Target vessel failure occurred in 21 (5.2%) of 401 patients undergoing OFDI-guided PCI, and 19 (4.9%) of 390 patients undergoing IVUS-guided PCI, demonstrating non-inferiority of OFDI-guided PCI to IVUS-guided PCI (hazard ratio 1.07, upper limit of one-sided 95% confidence interval 1.80; Pnon-inferiority = 0.042). With 89.8% angiographic follow-up, the rate of binary restenosis was comparable between OFDI-guided PCI and IVUS-guided PCI (in-stent: 1.6% vs. 1.6%, P = 1.00; and in-segment: 6.2% vs. 6.0%, P = 1.00).
The 12-month clinical outcome in patients undergoing OFDI-guided PCI was non-inferior to that of patients undergoing IVUS-guided PCI. Both OFDI-guided and IVUS-guided PCI yielded excellent angiographic and clinical results, with very low rates of 8-month angiographic binary restenosis and 12-month target vessel failure.
ClinicalTrials.gov, number NCT01873027.
光学频域成像（OFDI）是一种最近开发的基于光的高分辨率血管内成像技术。血管内超声（IVUS）是一种广泛用于指导经皮冠状动脉介入治疗（PCI）的常规成像技术。我们旨在证明 OFDI 引导的 PCI 在临床结果方面不劣于 IVUS 引导的 PCI。
我们进行了一项前瞻性、多中心、随机（比例 1:1）、主动对照、非劣效性研究，以比较第二代药物洗脱支架置入术患者中行 OFDI 与 IVUS 引导的 PCI。主要终点是定义为心脏死亡、靶血管相关心肌梗死和缺血驱动的靶血管血运重建的复合终点的靶血管失败，直至 PCI 后 12 个月。主要次要终点是 8 个月时的血管造影二元再狭窄。我们随机分配 829 例患者接受 OFDI 引导的 PCI（n=414）或 IVUS 引导的 PCI（n=415）。接受 OFDI 引导的 PCI 的 401 例患者中有 21 例（5.2%）发生靶血管失败，接受 IVUS 引导的 PCI 的 390 例患者中有 19 例（4.9%）发生靶血管失败，表明 OFDI 引导的 PCI 不劣于 IVUS 引导的 PCI（危险比 1.07，单侧 95%置信区间上限 1.80；Pnon-inferiority=0.042）。在 89.8%的血管造影随访中，OFDI 引导的 PCI 和 IVUS 引导的 PCI 的二元再狭窄率相当（支架内：1.6%对 1.6%，P=1.00；节段内：6.2%对 6.0%，P=1.00）。
接受 OFDI 引导的 PCI 的患者 12 个月的临床结果不劣于接受 IVUS 引导的 PCI 的患者。OFDI 引导和 IVUS 引导的 PCI 均产生了出色的血管造影和临床结果，8 个月时的血管造影二元再狭窄率和 12 个月时的靶血管失败率均非常低。
ClinicalTrials.gov，编号 NCT01873027。
Zotero 插件