St Francis Hospital and Heart Center, Roslyn, New York, USA; Clinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA; New York Institute of Technology, Old Westbury, New York, USA.
Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum Charité, Charité-Universitätsmedizin Berlin, Berlin, Germany; Berlin Institute of Health, Berlin, Germany; Deutsches Zentrum für Herz-Kreislaufforschung, Partner Site Berlin, Berlin, Germany.
J Am Coll Cardiol. 2024 Jul 23;84(4):368-378. doi: 10.1016/j.jacc.2024.04.037. Epub 2024 May 15.
ILUMIEN IV was the first large-scale, multicenter, randomized trial comparing optical coherence tomography (OCT)-guided vs angiography-guided stent implantation in patients with high-risk clinical characteristics and/or complex angiographic lesions.
The authors aimed to specifically examine outcomes in the complex angiographic lesions subgroup.
From the original trial population (N = 2,487), high-risk patients without complex angiographic lesions were excluded (n = 514). Complex angiographic lesion characteristics included: 1) long or multiple lesions with intended total stent length ≥28 mm; 2) bifurcation lesion with intended 2-stent strategy; 3) severely calcified lesion; 4) chronic total occlusion; or 5) in-stent restenosis. The study endpoints were: 1) final minimal stent area (MSA); 2) 2-year composite of serious major adverse cardiovascular events (MACEs) (cardiac death, target-vessel myocardial infarction [MI], or stent thrombosis); and 3) 2-year effectiveness, defined as target-vessel failure (TVF), a composite of cardiac death, target-vessel MI, or ischemia-driven target-vessel revascularization.
The postpercutaneous coronary intervention (PCI) MSA was larger in the OCT-guided (n = 992) vs angiography-guided (n = 981) group (5.56 ± 1.95 mm vs 5.26 ± 1.81 mm; difference, 0.30; 95% CI: 0.14-0.47; P < 0.001). Compared with angiography-guided PCI, OCT-guided PCI resulted in a lower risk of serious MACE (3.1% vs 4.9%; HR: 0.63; 95% CI: 0.40-0.99; P = 0.04). TVF was not significantly different between groups (7.3% vs 8.8%; HR: 0.82; 95% CI: 0.59-1.12; P = 0.20).
In complex angiographic lesions, OCT-guided PCI led to a larger MSA and reduced the serious MACE, the composite of cardiac death, target-vessel MI, or stent thrombosis, compared with angiography-guided PCI at 2 years, but did not significantly improve TVF. (Optical Coherence Tomography Guided Coronary Stent Implantation Compared to Angiography: A Multicenter Randomized Trial in PCI; NCT03507777).
ILUMIEN IV 是第一项比较光学相干断层扫描（OCT）指导与血管造影指导支架植入治疗高危临床特征和/或复杂血管病变患者的大规模、多中心、随机试验。
作者旨在专门研究复杂血管病变亚组的结果。
从原始试验人群（N=2487）中，排除无复杂血管病变的高危患者（n=514）。复杂血管病变特征包括：1）预期总支架长度≥28mm 的长或多病变；2）打算采用双支架策略的分叉病变；3）严重钙化病变；4）慢性完全闭塞；或 5）支架内再狭窄。研究终点为：1）最终最小支架面积（MSA）；2）2 年严重主要不良心血管事件（MACE）（心脏死亡、靶血管心肌梗死[MI]或支架血栓形成）的复合终点；和 3）2 年有效性，定义为靶血管失败（TVF），即心脏死亡、靶血管 MI 或缺血驱动的靶血管血运重建的复合终点。
在经皮冠状动脉介入治疗（PCI）后，OCT 指导组（n=992）的 MSA 大于血管造影指导组（n=981）（5.56±1.95mm 比 5.26±1.81mm；差值，0.30；95%置信区间：0.14-0.47；P<0.001）。与血管造影指导 PCI 相比，OCT 指导 PCI 导致严重 MACE 的风险降低（3.1%比 4.9%；HR：0.63；95%置信区间：0.40-0.99；P=0.04）。两组之间 TVF 无显著差异（7.3%比 8.8%；HR：0.82；95%置信区间：0.59-1.12；P=0.20）。
在复杂的血管病变中，与血管造影指导 PCI 相比，OCT 指导 PCI 在 2 年内可导致更大的 MSA 和降低严重 MACE（心脏死亡、靶血管 MI 或支架血栓形成的复合终点），但并未显著改善 TVF。（光学相干断层扫描指导的冠状动脉支架置入与血管造影比较：一项多中心随机临床试验；NCT03507777）。
