Pub Date : 2024-09-14Epub Date: 2024-09-02DOI: 10.1016/S0140-6736(24)01454-5
Sung-Jin Hong, Seung-Jun Lee, Sang-Hyup Lee, Jong-Young Lee, Deok-Kyu Cho, Jin Won Kim, Sang Min Kim, Seung-Ho Hur, Jung Ho Heo, Ji-Yong Jang, Jin Sin Koh, Hoyoun Won, Jun-Won Lee, Soon Jun Hong, Dong-Kie Kim, Jeong Cheon Choe, Jin Bae Lee, Soo-Joong Kim, Tae-Hyun Yang, Jung-Hee Lee, Young Joon Hong, Jong-Hwa Ahn, Yong-Joon Lee, Chul-Min Ahn, Jung-Sun Kim, Young-Guk Ko, Donghoon Choi, Myeong-Ki Hong, Yangsoo Jang, Byeong-Keuk Kim
<p><strong>Background: </strong>Despite the detailed imaging information provided by optical coherence tomography (OCT) during percutaneous coronary intervention (PCI), clinical benefits of this imaging technique in this setting remain uncertain. The aim of the OCCUPI trial was to compare the clinical benefits of OCT-guided versus angiography-guided PCI for complex lesions, assessed as the rate of major adverse cardiac events at 1 year.</p><p><strong>Methods: </strong>This investigator-initiated, multicentre, randomised, open-label, superiority trial conducted at 20 hospitals in South Korea enrolled patients aged 19-85 years for whom PCI with drug-eluting stents was clinically indicated. After diagnostic angiography, clinical and angiographic findings were assessed to identify patients who met the criterion of having one or more complex lesions. Patients were randomly assigned 1:1 to receive PCI with OCT guidance (OCT-guidance group) or angiography guidance without OCT (angiography-guidance group). Web-response permuted-block randomisation (mixed blocks of four or six) was used at each participating site to allocate patients. The allocation sequence was computer-generated by an external programmer who was not involved in the rest of the trial. Outcome assessors were masked to group assignment. Patients, follow-up health-care providers, and data analysers were not masked. PCI was done according to conventional standard methods with everolimus-eluting stents. The primary endpoint was major adverse cardiac events (a composite of cardiac death, myocardial infarction, stent thrombosis, or ischaemia-driven target-vessel revascularisation), 1 year after PCI. The primary analysis was done in the intention-to-treat population. The margin used to establish superiority was 1·0 as a hazard ratio. This trial is registered with ClinicalTrials.gov (NCT03625908) and is completed.</p><p><strong>Findings: </strong>Between Jan 9, 2019, and Sept 22, 2022, 1604 patients requiring PCI with drug-eluting stents for complex lesions were randomly assigned to receive either OCT-guided PCI (n=803) or angiography-guided PCI (n=801). 1290 (80%) of 1604 patients were male and 314 (20%) were female. The median age of patients at randomisation was 64 years (IQR 57-70). 1588 (99%) patients completed 1-year follow-up. The primary endpoint occurred in 37 (5%) of 803 patients in the OCT-guided PCI group and 59 (7%) of 801 patients in the angiography-guided PCI group (absolute difference -2·8% [95% CI -5·1 to -0·4]; hazard ratio 0·62 [95% CI 0·41 to 0·93]; p=0·023). Rates of stroke, bleeding events, and contrast-induced nephropathy were not significantly different across the two groups.</p><p><strong>Interpretation: </strong>Among patients who required drug-eluting stent implantation for complex lesions, OCT guidance resulted in a lower incidence of major adverse cardiac events at 1 year compared with angiography guidance. These findings indicate the existence of a therapeutic benefi
背景：尽管光学相干断层扫描（OCT）可在经皮冠状动脉介入治疗（PCI）过程中提供详细的成像信息，但这种成像技术在这种情况下的临床获益仍不确定。OCCUPI 试验的目的是比较 OCT 引导下与血管造影引导下 PCI 治疗复杂病变的临床优势，评估指标为 1 年后主要不良心脏事件的发生率：这项由研究者发起的多中心、随机、开放标签、优越性试验在韩国 20 家医院进行，招募了年龄在 19-85 岁之间、有临床指征使用药物洗脱支架进行 PCI 治疗的患者。在诊断性血管造影后，对临床和血管造影结果进行评估，以确定符合一个或多个复杂病变标准的患者。患者以1:1的比例随机分配接受有OCT引导的PCI（OCT引导组）或无OCT引导的血管造影（血管造影引导组）。每个参与研究的机构都采用了网络响应包块随机分配法（4或6个混合包块）来分配患者。分配序列由外部程序员通过计算机生成，该程序员不参与试验的其他部分。结果评估人员对组别分配进行了屏蔽。患者、随访医护人员和数据分析人员均未蒙面。PCI按照常规标准方法进行，使用依维莫司洗脱支架。主要终点是PCI术后1年的主要心脏不良事件（心脏死亡、心肌梗死、支架血栓或缺血导致的靶血管血运重建的综合）。主要分析是在意向治疗人群中进行的。确定优越性的边际值为1-0，即危险比。该试验已在ClinicalTrials.gov（NCT03625908）注册，并已完成：2019年1月9日至2022年9月22日期间，1604名需要使用药物洗脱支架PCI治疗复杂病变的患者被随机分配接受OCT引导的PCI（803人）或血管造影引导的PCI（801人）。1604名患者中有1290人（80%）为男性，314人（20%）为女性。随机化时患者的中位年龄为 64 岁（IQR 57-70）。1588名（99%）患者完成了为期1年的随访。OCT引导PCI组803例患者中有37例（5%）出现主要终点，血管造影引导PCI组801例患者中有59例（7%）出现主要终点（绝对差异-2-8% [95% CI -5-1 to -0-4]；危险比0-62 [95% CI 0-41 to 0-93]；P=0-023）。中风、出血事件和造影剂诱发肾病的发生率在两组间无显著差异：在需要植入药物洗脱支架治疗复杂病变的患者中，OCT引导与血管造影引导相比，1年后主要不良心脏事件的发生率更低。这些研究结果表明，OCT作为一种血管内成像技术，对复杂冠状动脉病变患者的PCI引导具有治疗效果：雅培血管与心血管研究中心：摘要韩文译文见补充材料部分。
{"title":"Optical coherence tomography-guided versus angiography-guided percutaneous coronary intervention for patients with complex lesions (OCCUPI): an investigator-initiated, multicentre, randomised, open-label, superiority trial in South Korea.","authors":"Sung-Jin Hong, Seung-Jun Lee, Sang-Hyup Lee, Jong-Young Lee, Deok-Kyu Cho, Jin Won Kim, Sang Min Kim, Seung-Ho Hur, Jung Ho Heo, Ji-Yong Jang, Jin Sin Koh, Hoyoun Won, Jun-Won Lee, Soon Jun Hong, Dong-Kie Kim, Jeong Cheon Choe, Jin Bae Lee, Soo-Joong Kim, Tae-Hyun Yang, Jung-Hee Lee, Young Joon Hong, Jong-Hwa Ahn, Yong-Joon Lee, Chul-Min Ahn, Jung-Sun Kim, Young-Guk Ko, Donghoon Choi, Myeong-Ki Hong, Yangsoo Jang, Byeong-Keuk Kim","doi":"10.1016/S0140-6736(24)01454-5","DOIUrl":"10.1016/S0140-6736(24)01454-5","url":null,"abstract":"<p><strong>Background: </strong>Despite the detailed imaging information provided by optical coherence tomography (OCT) during percutaneous coronary intervention (PCI), clinical benefits of this imaging technique in this setting remain uncertain. The aim of the OCCUPI trial was to compare the clinical benefits of OCT-guided versus angiography-guided PCI for complex lesions, assessed as the rate of major adverse cardiac events at 1 year.</p><p><strong>Methods: </strong>This investigator-initiated, multicentre, randomised, open-label, superiority trial conducted at 20 hospitals in South Korea enrolled patients aged 19-85 years for whom PCI with drug-eluting stents was clinically indicated. After diagnostic angiography, clinical and angiographic findings were assessed to identify patients who met the criterion of having one or more complex lesions. Patients were randomly assigned 1:1 to receive PCI with OCT guidance (OCT-guidance group) or angiography guidance without OCT (angiography-guidance group). Web-response permuted-block randomisation (mixed blocks of four or six) was used at each participating site to allocate patients. The allocation sequence was computer-generated by an external programmer who was not involved in the rest of the trial. Outcome assessors were masked to group assignment. Patients, follow-up health-care providers, and data analysers were not masked. PCI was done according to conventional standard methods with everolimus-eluting stents. The primary endpoint was major adverse cardiac events (a composite of cardiac death, myocardial infarction, stent thrombosis, or ischaemia-driven target-vessel revascularisation), 1 year after PCI. The primary analysis was done in the intention-to-treat population. The margin used to establish superiority was 1·0 as a hazard ratio. This trial is registered with ClinicalTrials.gov (NCT03625908) and is completed.</p><p><strong>Findings: </strong>Between Jan 9, 2019, and Sept 22, 2022, 1604 patients requiring PCI with drug-eluting stents for complex lesions were randomly assigned to receive either OCT-guided PCI (n=803) or angiography-guided PCI (n=801). 1290 (80%) of 1604 patients were male and 314 (20%) were female. The median age of patients at randomisation was 64 years (IQR 57-70). 1588 (99%) patients completed 1-year follow-up. The primary endpoint occurred in 37 (5%) of 803 patients in the OCT-guided PCI group and 59 (7%) of 801 patients in the angiography-guided PCI group (absolute difference -2·8% [95% CI -5·1 to -0·4]; hazard ratio 0·62 [95% CI 0·41 to 0·93]; p=0·023). Rates of stroke, bleeding events, and contrast-induced nephropathy were not significantly different across the two groups.</p><p><strong>Interpretation: </strong>Among patients who required drug-eluting stent implantation for complex lesions, OCT guidance resulted in a lower incidence of major adverse cardiac events at 1 year compared with angiography guidance. These findings indicate the existence of a therapeutic benefi","PeriodicalId":18014,"journal":{"name":"Lancet","volume":null,"pages":null},"PeriodicalIF":98.4,"publicationDate":"2024-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142140480","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-14Epub Date: 2024-09-03DOI: 10.1016/S0140-6736(24)01765-3
Gururaj Arakeri, Vishal Rao, Shankargouda Patil
{"title":"A crisis of safety: female health-care workers in India need reforms.","authors":"Gururaj Arakeri, Vishal Rao, Shankargouda Patil","doi":"10.1016/S0140-6736(24)01765-3","DOIUrl":"10.1016/S0140-6736(24)01765-3","url":null,"abstract":"","PeriodicalId":18014,"journal":{"name":"Lancet","volume":null,"pages":null},"PeriodicalIF":98.4,"publicationDate":"2024-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142145919","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-07DOI: 10.1016/S0140-6736(24)01815-4
Gavin Francis
{"title":"Transience and gratitude.","authors":"Gavin Francis","doi":"10.1016/S0140-6736(24)01815-4","DOIUrl":"https://doi.org/10.1016/S0140-6736(24)01815-4","url":null,"abstract":"","PeriodicalId":18014,"journal":{"name":"Lancet","volume":null,"pages":null},"PeriodicalIF":98.4,"publicationDate":"2024-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142145933","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-07Epub Date: 2024-08-12DOI: 10.1016/S0140-6736(24)01599-X
Neil M Vora, Shweta Narayan, Aggrey Aluso, Camila I Donatti, Omnia El Omrani, Lee Hannah, Jemilah Mahmood, Nicaise Ndembi, Mariana M Vale, Elizabeth Willetts
{"title":"Nature-based solutions are essential for climate and health action.","authors":"Neil M Vora, Shweta Narayan, Aggrey Aluso, Camila I Donatti, Omnia El Omrani, Lee Hannah, Jemilah Mahmood, Nicaise Ndembi, Mariana M Vale, Elizabeth Willetts","doi":"10.1016/S0140-6736(24)01599-X","DOIUrl":"10.1016/S0140-6736(24)01599-X","url":null,"abstract":"","PeriodicalId":18014,"journal":{"name":"Lancet","volume":null,"pages":null},"PeriodicalIF":98.4,"publicationDate":"2024-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141988306","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-07Epub Date: 2024-08-26DOI: 10.1016/S0140-6736(24)01603-9
Md Abu Bakkar Siddik
{"title":"Bangladesh protests: law enforcement and public health crisis.","authors":"Md Abu Bakkar Siddik","doi":"10.1016/S0140-6736(24)01603-9","DOIUrl":"10.1016/S0140-6736(24)01603-9","url":null,"abstract":"","PeriodicalId":18014,"journal":{"name":"Lancet","volume":null,"pages":null},"PeriodicalIF":98.4,"publicationDate":"2024-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142108866","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-07DOI: 10.1016/S0140-6736(24)01853-1
Robert E MacLaren
{"title":"Gene therapy in the early stages of retinal degeneration.","authors":"Robert E MacLaren","doi":"10.1016/S0140-6736(24)01853-1","DOIUrl":"10.1016/S0140-6736(24)01853-1","url":null,"abstract":"","PeriodicalId":18014,"journal":{"name":"Lancet","volume":null,"pages":null},"PeriodicalIF":98.4,"publicationDate":"2024-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142145923","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-07DOI: 10.1016/S0140-6736(24)01689-1
Sarah L Perrott, Siddhartha P Kar
{"title":"Polygenic risk scores for genomics and population screening.","authors":"Sarah L Perrott, Siddhartha P Kar","doi":"10.1016/S0140-6736(24)01689-1","DOIUrl":"10.1016/S0140-6736(24)01689-1","url":null,"abstract":"","PeriodicalId":18014,"journal":{"name":"Lancet","volume":null,"pages":null},"PeriodicalIF":98.4,"publicationDate":"2024-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142145929","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-07Epub Date: 2024-08-23DOI: 10.1016/S0140-6736(24)01753-7
Archibong Edem Bassey
{"title":"The health of migrants at the intersection of mpox and HIV.","authors":"Archibong Edem Bassey","doi":"10.1016/S0140-6736(24)01753-7","DOIUrl":"10.1016/S0140-6736(24)01753-7","url":null,"abstract":"","PeriodicalId":18014,"journal":{"name":"Lancet","volume":null,"pages":null},"PeriodicalIF":98.4,"publicationDate":"2024-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142073207","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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