{"title":"光学频域成像引导与血管内超声引导经皮冠状动脉介入治疗急性冠状动脉综合征：OPINION ACS 随机试验。","authors":"Hiromasa Otake, Takashi Kubo, Kiyoshi Hibi, Makoto Natsumeda, Masaru Ishida, Toru Kataoka, Tomofumi Takaya, Masamichi Iwasaki, Shinjo Sonoda, Toshiro Shinke, Gaku Nakazawa, Yu Takahashi, Tetsuya Ioji, Takashi Akasaka, Opinion Acs Investigators","doi":"10.4244/EIJ-D-24-00314","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The clinical benefits of optical frequency domain imaging (OFDI)-guided percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) remain unclear.</p><p><strong>Aims: </strong>We sought to compare intravascular ultrasound (IVUS)- and OFDI-guided PCI in patients with ACS.</p><p><strong>Methods: </strong>OPINION ACS is a multicentre, prospective, randomised, non-inferiority trial that compared OFDI-guided PCI with IVUS-guided PCI using current-generation drug-eluting stents in ACS patients (n=158). The primary endpoint was in-stent minimum lumen area (MLA), assessed using 8-month follow-up OFDI.</p><p><strong>Results: </strong>Patients presented with ST-segment elevation myocardial infarction (55%), non-ST-segment elevation myocardial infarction (29%), or unstable angina pectoris (16%). PCI procedural success was achieved in all patients, with comparably low periprocedural complications rates in both groups. Immediately after PCI, the minimum stent area (p=0.096) tended to be smaller for OFDI versus IVUS guidance. Proximal stent edge dissection (p=0.012) and irregular protrusion (p=0.03) were significantly less frequent in OFDI-guided procedures than in IVUS-guided procedures. Post-PCI coronary flow, assessed using corrected Thrombolysis in Myocardial Infarction frame counts, was significantly better in the OFDI-guided group than in the IVUS-guided group (p<0.001). The least squares mean (95% confidence interval [CI]) in-stent MLA at 8 months was 4.91 (95% CI: 4.53-5.30) mm<sup>2</sup> and 4.76 (95% CI: 4.35-5.17) mm<sup>2</sup> in the OFDI- and IVUS-guided groups, respectively, demonstrating the non-inferiority of OFDI guidance (pnon-inferiority<0.001). The average neointima area tended to be smaller in the OFDI-guided group. The frequency of major adverse cardiac events was similar.</p><p><strong>Conclusions: </strong>Among ACS patients, OFDI-guided PCI and IVUS-guided PCI were equally safe and feasible, with comparable in-stent MLA at 8 months. OFDI guidance may be a potential option in ACS patients. This study was registered in the Japan Registry of Clinical Trials (jrct.niph.go.jp: jRCTs052190093).</p>","PeriodicalId":54378,"journal":{"name":"Eurointervention","volume":"20 17","pages":"e1086-e1097"},"PeriodicalIF":7.6000,"publicationDate":"2024-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11352543/pdf/","citationCount":"0","resultStr":"{\"title\":\"Optical frequency domain imaging-guided versus intravascular ultrasound-guided percutaneous coronary intervention for acute coronary syndromes: the OPINION ACS randomised trial.\",\"authors\":\"Hiromasa Otake, Takashi Kubo, Kiyoshi Hibi, Makoto Natsumeda, Masaru Ishida, Toru Kataoka, Tomofumi Takaya, Masamichi Iwasaki, Shinjo Sonoda, Toshiro Shinke, Gaku Nakazawa, Yu Takahashi, Tetsuya Ioji, Takashi Akasaka, Opinion Acs Investigators\",\"doi\":\"10.4244/EIJ-D-24-00314\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>The clinical benefits of optical frequency domain imaging (OFDI)-guided percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) remain unclear.</p><p><strong>Aims: </strong>We sought to compare intravascular ultrasound (IVUS)- and OFDI-guided PCI in patients with ACS.</p><p><strong>Methods: </strong>OPINION ACS is a multicentre, prospective, randomised, non-inferiority trial that compared OFDI-guided PCI with IVUS-guided PCI using current-generation drug-eluting stents in ACS patients (n=158). The primary endpoint was in-stent minimum lumen area (MLA), assessed using 8-month follow-up OFDI.</p><p><strong>Results: </strong>Patients presented with ST-segment elevation myocardial infarction (55%), non-ST-segment elevation myocardial infarction (29%), or unstable angina pectoris (16%). PCI procedural success was achieved in all patients, with comparably low periprocedural complications rates in both groups. Immediately after PCI, the minimum stent area (p=0.096) tended to be smaller for OFDI versus IVUS guidance. Proximal stent edge dissection (p=0.012) and irregular protrusion (p=0.03) were significantly less frequent in OFDI-guided procedures than in IVUS-guided procedures. Post-PCI coronary flow, assessed using corrected Thrombolysis in Myocardial Infarction frame counts, was significantly better in the OFDI-guided group than in the IVUS-guided group (p<0.001). The least squares mean (95% confidence interval [CI]) in-stent MLA at 8 months was 4.91 (95% CI: 4.53-5.30) mm<sup>2</sup> and 4.76 (95% CI: 4.35-5.17) mm<sup>2</sup> in the OFDI- and IVUS-guided groups, respectively, demonstrating the non-inferiority of OFDI guidance (pnon-inferiority<0.001). The average neointima area tended to be smaller in the OFDI-guided group. The frequency of major adverse cardiac events was similar.</p><p><strong>Conclusions: </strong>Among ACS patients, OFDI-guided PCI and IVUS-guided PCI were equally safe and feasible, with comparable in-stent MLA at 8 months. OFDI guidance may be a potential option in ACS patients. This study was registered in the Japan Registry of Clinical Trials (jrct.niph.go.jp: jRCTs052190093).</p>\",\"PeriodicalId\":54378,\"journal\":{\"name\":\"Eurointervention\",\"volume\":\"20 17\",\"pages\":\"e1086-e1097\"},\"PeriodicalIF\":7.6000,\"publicationDate\":\"2024-09-02\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11352543/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Eurointervention\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.4244/EIJ-D-24-00314\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Eurointervention","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.4244/EIJ-D-24-00314","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
Optical frequency domain imaging-guided versus intravascular ultrasound-guided percutaneous coronary intervention for acute coronary syndromes: the OPINION ACS randomised trial.
Background: The clinical benefits of optical frequency domain imaging (OFDI)-guided percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) remain unclear.
Aims: We sought to compare intravascular ultrasound (IVUS)- and OFDI-guided PCI in patients with ACS.
Methods: OPINION ACS is a multicentre, prospective, randomised, non-inferiority trial that compared OFDI-guided PCI with IVUS-guided PCI using current-generation drug-eluting stents in ACS patients (n=158). The primary endpoint was in-stent minimum lumen area (MLA), assessed using 8-month follow-up OFDI.
Results: Patients presented with ST-segment elevation myocardial infarction (55%), non-ST-segment elevation myocardial infarction (29%), or unstable angina pectoris (16%). PCI procedural success was achieved in all patients, with comparably low periprocedural complications rates in both groups. Immediately after PCI, the minimum stent area (p=0.096) tended to be smaller for OFDI versus IVUS guidance. Proximal stent edge dissection (p=0.012) and irregular protrusion (p=0.03) were significantly less frequent in OFDI-guided procedures than in IVUS-guided procedures. Post-PCI coronary flow, assessed using corrected Thrombolysis in Myocardial Infarction frame counts, was significantly better in the OFDI-guided group than in the IVUS-guided group (p<0.001). The least squares mean (95% confidence interval [CI]) in-stent MLA at 8 months was 4.91 (95% CI: 4.53-5.30) mm2 and 4.76 (95% CI: 4.35-5.17) mm2 in the OFDI- and IVUS-guided groups, respectively, demonstrating the non-inferiority of OFDI guidance (pnon-inferiority<0.001). The average neointima area tended to be smaller in the OFDI-guided group. The frequency of major adverse cardiac events was similar.
Conclusions: Among ACS patients, OFDI-guided PCI and IVUS-guided PCI were equally safe and feasible, with comparable in-stent MLA at 8 months. OFDI guidance may be a potential option in ACS patients. This study was registered in the Japan Registry of Clinical Trials (jrct.niph.go.jp: jRCTs052190093).
期刊介绍：
EuroIntervention Journal is an international, English language, peer-reviewed journal whose aim is to create a community of high quality research and education in the field of percutaneous and surgical cardiovascular interventions.
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