Interventional Cardiology, San Giovanni Hospital, Rome, Italy.
EuroIntervention. 2010 Nov;6(5):575-81. doi: 10.4244/EIJV6I5A97.
The purpose of this single centre registry is to assess safety and feasibility of the frequency domain optical coherence tomography (FD-OCT) system during coronary interventions.
Ninety patients with unstable or stable coronary artery disease were included in this study. OCT imaging was performed in a first group of 40 patients (group 1), to evaluate ambiguous/intermediate lesions (24 patients in group 1 had OCT also done post-PCI, for assessment of stent deployment); and in a second group of 50 patients (group 2), to address the adequacy of stent deployment. Therefore, 74 patients underwent FD-OCT after stent implantation. A complex-lesion population was studied (B2 type lesion=72.2% and C type lesion=20.3%). The mean time of a FD-OCT pull-back (from the set up to the completion of the pull back) was 2.1 min and in all but one (99.1%) the procedure was successful. No patients experienced major complications in terms of death, myocardial infarction, emergency revascularisation, embolisation, life-threatening arrhythmia, coronary dissection, prolonged and severe vessel spasm and contrast induced nephropathy. In the ambiguous lesion group, 60% of patients were treated with PCI, whilst in the others, PCI were deferred. In total, 113 deployed stents (33,6% chromium cobalt stent, 66,4% drug eluting stent) were imaged with OCT. OCT findings led to additional interventions in 24 out of 74 patients (32%): 15 had further balloon inflations, nine had additional stent deployment whilst two had both treatments. At clinical follow-up, (4.6 ± 3.,2 months), there were no death, acute myocardial infarctions and cases of stent thrombosis, whilst two patients underwent revascularisation for recurrence of angina.
The present registry shows that FD-OCT is a feasible and safe technique for guidance of coronary interventions. Randomised studies will confirm whether the use of FD-OCT will improve the clinical outcome.
本单中心登记研究旨在评估频域光学相干断层扫描（FD-OCT）系统在冠状动脉介入治疗中的安全性和可行性。
本研究纳入了 90 例不稳定或稳定型冠心病患者。OCT 成像在第一组 40 例患者（第 1 组）中进行，以评估不明确/中度病变（第 1 组中有 24 例患者在 PCI 后也进行了 OCT，以评估支架置入情况）；在第二组 50 例患者（第 2 组）中进行，以评估支架置入的充分性。因此，74 例患者在支架置入后接受了 FD-OCT 检查。研究了一个复杂病变人群（B2 型病变=72.2%，C 型病变=20.3%）。FD-OCT 回撤的平均时间（从设置到完成回撤）为 2.1 分钟，除 1 例（99.1%）外，所有患者的操作均成功。无患者发生死亡、心肌梗死、紧急血运重建、栓塞、危及生命的心律失常、冠状动脉夹层、长时间严重血管痉挛和对比剂肾病等重大并发症。在不明确病变组，60%的患者接受了 PCI 治疗，而在其他患者中，PCI 被推迟。总共对 113 个置入的支架（33.6%铬钴支架，66.4%药物洗脱支架）进行了 OCT 成像。OCT 结果导致 74 例患者中的 24 例（32%）进行了额外的介入治疗：15 例行进一步球囊扩张，9 例行额外支架置入，2 例两种治疗均采用。在临床随访（4.6±3.2 个月）期间，无死亡、急性心肌梗死和支架血栓形成病例，2 例患者因心绞痛复发而行血运重建。
本注册研究表明，FD-OCT 是一种可行且安全的冠状动脉介入治疗指导技术。随机研究将证实 FD-OCT 的使用是否会改善临床结局。
