Ulf Landmesser, Ziad A Ali, Akiko Maehara, Mitsuaki Matsumura, Richard A Shlofmitz, Giulio Guagliumi, Matthew J Price, Jonathan M Hill, Takashi Akasaka, Francesco Prati, Hiram G Bezerra, William Wijns, David Leistner, Paolo Canova, Fernando Alfonso, Franco Fabbiocchi, Giuseppe Calligaris, Rohit M Oemrawsingh, Stephan Achenbach, Carlo Trani, Balbir Singh, Robert J McGreevy, Robert W McNutt, Shih-Wa Ying, Jana Buccola, Gregg W Stone
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The present analysis sought to determine the OCT predictors of clinical outcomes from the large-scale ILUMIEN IV trial.</p><p><strong>Methods: </strong>ILUMIEN IV was a prospective, single-blind trial of 2487 patients with diabetes or high-risk lesions randomized to OCT-guided versus angiography-guided DES implantation. All patients underwent final OCT imaging (blinded in the angiography-guided arm). From more than 20 candidates, the independent OCT predictors of 2-year target lesion failure (TLF; the primary endpoint), cardiac death or target-vessel myocardial infarction (TV-MI), ischaemia-driven target lesion revascularization (ID-TLR), and stent thrombosis were analysed by multivariable Cox proportional hazard regression in single treated lesions.</p><p><strong>Results: </strong>A total of 2128 patients had a single treated lesion with core laboratory-analysed final OCT. The 2-year Kaplan-Meier rates of TLF, cardiac death or TV-MI, ID-TLR, and stent thrombosis were 6.3% (n = 130), 3.3% (n = 68), 4.3% (n = 87), and 0.9% (n = 18), respectively. The independent predictors of 2-year TLF were a smaller minimal stent area (per 1 mm2 increase: hazard ratio 0.76, 95% confidence interval 0.68-0.89, P < .0001) and proximal edge dissection (hazard ratio 1.77, 95% confidence interval 1.20-2.62, P = .004). The independent predictors of cardiac death or TV-MI were smaller minimal stent area and longer stent length; of ID-TLR were smaller intra-stent flow area and proximal edge dissection; and of stent thrombosis was smaller minimal stent expansion.</p><p><strong>Conclusions: </strong>In the ILUMIEN IV trial, the most important OCT-derived post-DES predictors of both safety and effectiveness outcomes were parameters related to stent area, expansion and flow, proximal edge dissection, and stent length.</p>","PeriodicalId":11976,"journal":{"name":"European Heart Journal","volume":null,"pages":null},"PeriodicalIF":37.6000,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Optical coherence tomography predictors of clinical outcomes after stent implantation: the ILUMIEN IV trial.\",\"authors\":\"Ulf Landmesser, Ziad A Ali, Akiko Maehara, Mitsuaki Matsumura, Richard A Shlofmitz, Giulio Guagliumi, Matthew J Price, Jonathan M Hill, Takashi Akasaka, Francesco Prati, Hiram G Bezerra, William Wijns, David Leistner, Paolo Canova, Fernando Alfonso, Franco Fabbiocchi, Giuseppe Calligaris, Rohit M Oemrawsingh, Stephan Achenbach, Carlo Trani, Balbir Singh, Robert J McGreevy, Robert W McNutt, Shih-Wa Ying, Jana Buccola, Gregg W Stone\",\"doi\":\"10.1093/eurheartj/ehae521\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background and aims: </strong>Observational registries have suggested that optical coherence tomography (OCT) imaging-derived parameters may predict adverse events after drug-eluting stent (DES) implantation. 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引用次数: 0
摘要
背景和目的：观察登记表明，光学相干断层扫描（OCT）成像衍生参数可预测药物洗脱支架（DES）植入后的不良事件。本分析旨在确定大规模 ILUMIEN IV 试验中临床结果的 OCT 预测因素：ILUMIEN IV是一项前瞻性单盲试验，2487名糖尿病或高风险病变患者在OCT引导下随机接受了DES植入术，而血管造影引导下接受了DES植入术。所有患者都接受了最终的OCT成像（血管造影引导组为盲法）。从20多名候选者中，通过单个治疗病变的多变量Cox比例危险回归分析了2年靶病变失败（TLF；主要终点）、心源性死亡或靶血管心肌梗死（TV-MI）、缺血驱动的靶病变血管再通（ID-TLR）和支架血栓形成的独立OCT预测因素：共有 2128 名患者的病变得到了单一治疗，最终 OCT 由核心实验室分析。2年的TLF、心源性死亡或TV-MI、ID-TLR和支架血栓形成的Kaplan-Meier率分别为6.3%（n = 130）、3.3%（n = 68）、4.3%（n = 87）和0.9%（n = 18）。2 年 TLF 的独立预测因素是较小的最小支架面积（每增加 1 mm2：危险比 0.76，95% 置信区间 0.68-0.89，P < .0001）和近端边缘夹层（危险比 1.77，95% 置信区间 1.20-2.62，P = .004）。预测心源性死亡或 TV-MI 的独立因素是较小的最小支架面积和较长的支架长度；预测 ID-TLR 的独立因素是较小的支架内血流面积和近端边缘夹层；预测支架血栓形成的独立因素是较小的最小支架扩张：在 ILUMIEN IV 试验中，OCT 导出的 DES 后安全性和有效性结果的最重要预测指标是与支架面积、扩张和血流、近端边缘夹层和支架长度相关的参数。
Optical coherence tomography predictors of clinical outcomes after stent implantation: the ILUMIEN IV trial.
Background and aims: Observational registries have suggested that optical coherence tomography (OCT) imaging-derived parameters may predict adverse events after drug-eluting stent (DES) implantation. The present analysis sought to determine the OCT predictors of clinical outcomes from the large-scale ILUMIEN IV trial.
Methods: ILUMIEN IV was a prospective, single-blind trial of 2487 patients with diabetes or high-risk lesions randomized to OCT-guided versus angiography-guided DES implantation. All patients underwent final OCT imaging (blinded in the angiography-guided arm). From more than 20 candidates, the independent OCT predictors of 2-year target lesion failure (TLF; the primary endpoint), cardiac death or target-vessel myocardial infarction (TV-MI), ischaemia-driven target lesion revascularization (ID-TLR), and stent thrombosis were analysed by multivariable Cox proportional hazard regression in single treated lesions.
Results: A total of 2128 patients had a single treated lesion with core laboratory-analysed final OCT. The 2-year Kaplan-Meier rates of TLF, cardiac death or TV-MI, ID-TLR, and stent thrombosis were 6.3% (n = 130), 3.3% (n = 68), 4.3% (n = 87), and 0.9% (n = 18), respectively. The independent predictors of 2-year TLF were a smaller minimal stent area (per 1 mm2 increase: hazard ratio 0.76, 95% confidence interval 0.68-0.89, P < .0001) and proximal edge dissection (hazard ratio 1.77, 95% confidence interval 1.20-2.62, P = .004). The independent predictors of cardiac death or TV-MI were smaller minimal stent area and longer stent length; of ID-TLR were smaller intra-stent flow area and proximal edge dissection; and of stent thrombosis was smaller minimal stent expansion.
Conclusions: In the ILUMIEN IV trial, the most important OCT-derived post-DES predictors of both safety and effectiveness outcomes were parameters related to stent area, expansion and flow, proximal edge dissection, and stent length.
期刊介绍：
The European Heart Journal is a renowned international journal that focuses on cardiovascular medicine. It is published weekly and is the official journal of the European Society of Cardiology. This peer-reviewed journal is committed to publishing high-quality clinical and scientific material pertaining to all aspects of cardiovascular medicine. It covers a diverse range of topics including research findings, technical evaluations, and reviews. Moreover, the journal serves as a platform for the exchange of information and discussions on various aspects of cardiovascular medicine, including educational matters.
In addition to original papers on cardiovascular medicine and surgery, the European Heart Journal also presents reviews, clinical perspectives, ESC Guidelines, and editorial articles that highlight recent advancements in cardiology. Additionally, the journal actively encourages readers to share their thoughts and opinions through correspondence.
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