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光学相干断层扫描指导下经皮冠状动脉介入治疗在印度复杂病变患者中的有效性和安全性:一项多中心前瞻性注册研究。

Effectiveness and safety of optical coherence tomography-guided PCI in Indian patients with complex lesions: A multicenter, prospective registry.

机构信息

Interventional and Structural Heart Cardiology, Interventional Cardiology Heart Institute, Medanta-The Medicity, Gurgaon, Haryana, India.

Department of Cardiology, Meenakshi Mission Hospital and Research Centre, Madurai, Tamil Nadu, India.

出版信息

Indian Heart J. 2023 Jul-Aug;75(4):236-242. doi: 10.1016/j.ihj.2023.05.008. Epub 2023 May 26.

Abstract

BACKGROUND

Optical coherence tomography (OCT) is reported to be a feasible and safe imaging modality for the guidance of percutaneous coronary intervention (PCI) of complex lesions.

METHODS

This multicenter, prospective registry assessed the minimum stent area (MSA) achieved under OCT guidance. A performance goal of 24% improvement in MSA over and above the recommendation set by the European Association of Percutaneous Cardiovascular Interventions Consensus 2018 (4.5 mm MSA for non-left main and 3.5 mm for small vessels). The incidence of contrast-induced nephropathy was also assessed. Core lab analysis was conducted.

RESULTS

Five hundred patients (average age: 59.4 ± 10.1 years; 83% males) with unstable angina (36.8%), NSTEMI (26.4%), and STEMI (22%) were enrolled. The primary endpoint was achieved in 93% of lesions with stent diameter ≥2.75 mm (average MSA: 6.44 mm) and 87% of lesions with stent diameter ≤2.5 mm (average MSA: 4.56 mm). The average MSA (with expansion ≥80% cutoff) was 6.63 mm and 4.74 mm with a stent diameter ≥2.75 mm and ≤2.5 mm, respectively. According to the core lab analysis, the average MSA achieved with a stent diameter ≥2.75 mm and ≤2.5 mm was 6.23 mm and 3.95 mm, respectively (with expansion ≥80% cutoff). Clinically significant serum creatinine was noted in two patients (0.45%). Major adverse cardiac events at 1 year were noted in 1.2% (n = 6) of the patients; all were cardiac deaths.

CONCLUSION

PCI under OCT guidance improves procedural and long-term clinical outcomes in patients with complex lesions not just in a controlled trial environment but also in routine clinical practice.

摘要

背景

光学相干断层扫描(OCT)被报道为一种可行且安全的成像方式,可用于指导复杂病变的经皮冠状动脉介入治疗(PCI)。

方法

这项多中心前瞻性注册研究评估了 OCT 指导下实现的最小支架面积(MSA)。以 2018 年欧洲经皮心血管介入协会共识建议(非左主干病变为 4.5mm2,小血管病变为 3.5mm2)为基础,设定了 24%的 MSA 改善作为性能目标。还评估了对比剂肾病的发生率。进行了核心实验室分析。

结果

500 例患者(平均年龄:59.4±10.1 岁;83%为男性)被纳入研究,其中不稳定型心绞痛(36.8%)、非 ST 段抬高型心肌梗死(NSTEMI)(26.4%)和 ST 段抬高型心肌梗死(STEMI)(22%)。主要终点在支架直径≥2.75mm 的 93%病变(平均 MSA:6.44mm)和支架直径≤2.5mm 的 87%病变(平均 MSA:4.56mm)中实现。平均 MSA(扩张≥80%的截断值)分别为 6.63mm 和 4.74mm,支架直径分别为≥2.75mm 和≤2.5mm。根据核心实验室分析,支架直径≥2.75mm 和≤2.5mm 时平均 MSA 分别为 6.23mm 和 3.95mm(扩张≥80%的截断值)。有两名患者(0.45%)出现临床意义的血清肌酐升高。1 年内发生 1.2%(n=6)的主要不良心脏事件,均为心脏死亡。

结论

OCT 指导下的 PCI 不仅在临床试验环境中,而且在常规临床实践中,均可改善复杂病变患者的手术和长期临床结局。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4581/10421993/0b14525d296b/gr1.jpg

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