Gabor G Toth, Marianne Brodmann, Sadeek S Kanoun Schnur, Stanislaw Bartus, Mislav Vrsalovic, Oleg Krestianinov, Petr Kala, Jacek Bil, Robert Gil, Jan Kanovsky, Luigi Di Serafino, Luca Paolucci, Emanuele Barbato, Fabio Mangiacapra, Zoltan Ruzsa
{"title":"对因严重肢体缺血而接受外周动脉血管重建术的患者进行意向性冠状动脉血运重建与保守治疗：INCORPORATE 试验。","authors":"Gabor G Toth, Marianne Brodmann, Sadeek S Kanoun Schnur, Stanislaw Bartus, Mislav Vrsalovic, Oleg Krestianinov, Petr Kala, Jacek Bil, Robert Gil, Jan Kanovsky, Luigi Di Serafino, Luca Paolucci, Emanuele Barbato, Fabio Mangiacapra, Zoltan Ruzsa","doi":"10.1007/s00392-024-02487-2","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>INCORPORATE trial was designed to evaluate whether default coronary-angiography (CA) and ischemia-targeted revascularization is superior compared to a conservative approach for patients with treated critical limb ischemia (CLI). Registered at clinicaltrials.gov (NCT03712644) on October 19, 2018.</p><p><strong>Background: </strong>Severe peripheral artery disease is associated with increased cardiovascular risk and poor outcomes.</p><p><strong>Methods: </strong>INCORPORATE was an open-label, prospective 1:1 randomized multicentric trial that recruited patients who had undergone successful CLI treatment. Patients were randomized to either a conservative or invasive approach regarding potential coronary artery disease (CAD). The conservative group received optimal medical therapy alone, while the invasive group had routine CA and fractional flow reserve-guided revascularization. The primary endpoint was myocardial infarction (MI) and 12-month mortality.</p><p><strong>Results: </strong>Due to COVID-19 pandemic burdens, recruitment was halted prematurely. One hundred eighty-five patients were enrolled. Baseline cardiac symptoms were scarce with 92% being asymptomatic. Eighty-nine patients were randomized to the invasive approach of whom 73 underwent CA. Thirty-four percent had functional single-vessel disease, 26% had functional multi-vessel disease, and 90% achieved complete revascularization. Conservative and invasive groups had similar incidences of death and MI at 1 year (11% vs 10%; hazard ratio 1.21 [0.49-2.98]). Major adverse cardiac and cerebrovascular events (MACCE) trended for hazard in the Conservative group (20 vs 10%; hazard ratio 1.94 [0.90-4.19]). In the per-protocol analysis, the primary endpoint remained insignificantly different (11% vs 7%; hazard ratio 2.01 [0.72-5.57]), but the conservative approach had a higher MACCE risk (20% vs 7%; hazard ratio 2.88 [1.24-6.68]).</p><p><strong>Conclusion: </strong>This trial found no significant difference in the primary endpoint but observed a trend of higher MACCE in the conservative arm.</p>","PeriodicalId":10474,"journal":{"name":"Clinical Research in Cardiology","volume":" ","pages":"991-999"},"PeriodicalIF":3.7000,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12283901/pdf/","citationCount":"0","resultStr":"{\"title\":\"Intentional coronary revascularization versus conservative therapy in patients after peripheral artery revascularization due to critical limb ischemia: the INCORPORATE trial.\",\"authors\":\"Gabor G Toth, Marianne Brodmann, Sadeek S Kanoun Schnur, Stanislaw Bartus, Mislav Vrsalovic, Oleg Krestianinov, Petr Kala, Jacek Bil, Robert Gil, Jan Kanovsky, Luigi Di Serafino, Luca Paolucci, Emanuele Barbato, Fabio Mangiacapra, Zoltan Ruzsa\",\"doi\":\"10.1007/s00392-024-02487-2\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>INCORPORATE trial was designed to evaluate whether default coronary-angiography (CA) and ischemia-targeted revascularization is superior compared to a conservative approach for patients with treated critical limb ischemia (CLI). Registered at clinicaltrials.gov (NCT03712644) on October 19, 2018.</p><p><strong>Background: </strong>Severe peripheral artery disease is associated with increased cardiovascular risk and poor outcomes.</p><p><strong>Methods: </strong>INCORPORATE was an open-label, prospective 1:1 randomized multicentric trial that recruited patients who had undergone successful CLI treatment. Patients were randomized to either a conservative or invasive approach regarding potential coronary artery disease (CAD). The conservative group received optimal medical therapy alone, while the invasive group had routine CA and fractional flow reserve-guided revascularization. The primary endpoint was myocardial infarction (MI) and 12-month mortality.</p><p><strong>Results: </strong>Due to COVID-19 pandemic burdens, recruitment was halted prematurely. One hundred eighty-five patients were enrolled. Baseline cardiac symptoms were scarce with 92% being asymptomatic. Eighty-nine patients were randomized to the invasive approach of whom 73 underwent CA. Thirty-four percent had functional single-vessel disease, 26% had functional multi-vessel disease, and 90% achieved complete revascularization. Conservative and invasive groups had similar incidences of death and MI at 1 year (11% vs 10%; hazard ratio 1.21 [0.49-2.98]). Major adverse cardiac and cerebrovascular events (MACCE) trended for hazard in the Conservative group (20 vs 10%; hazard ratio 1.94 [0.90-4.19]). In the per-protocol analysis, the primary endpoint remained insignificantly different (11% vs 7%; hazard ratio 2.01 [0.72-5.57]), but the conservative approach had a higher MACCE risk (20% vs 7%; hazard ratio 2.88 [1.24-6.68]).</p><p><strong>Conclusion: </strong>This trial found no significant difference in the primary endpoint but observed a trend of higher MACCE in the conservative arm.</p>\",\"PeriodicalId\":10474,\"journal\":{\"name\":\"Clinical Research in Cardiology\",\"volume\":\" \",\"pages\":\"991-999\"},\"PeriodicalIF\":3.7000,\"publicationDate\":\"2025-08-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12283901/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical Research in Cardiology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s00392-024-02487-2\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/7/11 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Research in Cardiology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s00392-024-02487-2","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/7/11 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
摘要
试验目的INCORPORATE 试验旨在评估对于接受治疗的危重肢体缺血（CLI）患者，默认冠状动脉造影（CA）和缺血靶向血管再通是否优于保守方法。2018年10月19日在clinicaltrials.gov（NCT03712644）注册。背景：严重外周动脉疾病与心血管风险增加和不良预后有关：INCORPORATE是一项开放标签、前瞻性1:1随机多中心试验，招募成功接受CLI治疗的患者。针对潜在的冠状动脉疾病（CAD），患者被随机分为保守治疗组和侵入治疗组。保守治疗组仅接受最佳药物治疗，而侵入治疗组则接受常规 CA 和分数血流储备引导下的血管再通术。主要终点是心肌梗死（MI）和12个月的死亡率：由于 COVID-19 大流行造成的负担，招募工作提前结束。共招募了 185 名患者。基线心脏症状很少，92%的患者无症状。89名患者被随机分配到有创方法中，其中73人接受了CA治疗。34%的患者为功能性单血管疾病，26%的患者为功能性多血管疾病，90%的患者实现了完全血管再通。保守治疗组和侵入治疗组在一年后的死亡和心肌梗死发生率相似（11% vs 10%；危险比 1.21 [0.49-2.98]）。保守治疗组的主要心脏和脑血管不良事件（MACCE）发病率呈上升趋势（20% vs 10%；危险比 1.94 [0.90-4.19]）。在按方案分析中，主要终点的差异仍然不显著（11% vs 7%；危险比 2.01 [0.72-5.57]），但保守治疗组的 MACCE 风险更高（20% vs 7%；危险比 2.88 [1.24-6.68]）：该试验在主要终点方面没有发现明显差异，但观察到保守治疗组的 MACCE 有升高的趋势。
Intentional coronary revascularization versus conservative therapy in patients after peripheral artery revascularization due to critical limb ischemia: the INCORPORATE trial.
Objectives: INCORPORATE trial was designed to evaluate whether default coronary-angiography (CA) and ischemia-targeted revascularization is superior compared to a conservative approach for patients with treated critical limb ischemia (CLI). Registered at clinicaltrials.gov (NCT03712644) on October 19, 2018.
Background: Severe peripheral artery disease is associated with increased cardiovascular risk and poor outcomes.
Methods: INCORPORATE was an open-label, prospective 1:1 randomized multicentric trial that recruited patients who had undergone successful CLI treatment. Patients were randomized to either a conservative or invasive approach regarding potential coronary artery disease (CAD). The conservative group received optimal medical therapy alone, while the invasive group had routine CA and fractional flow reserve-guided revascularization. The primary endpoint was myocardial infarction (MI) and 12-month mortality.
Results: Due to COVID-19 pandemic burdens, recruitment was halted prematurely. One hundred eighty-five patients were enrolled. Baseline cardiac symptoms were scarce with 92% being asymptomatic. Eighty-nine patients were randomized to the invasive approach of whom 73 underwent CA. Thirty-four percent had functional single-vessel disease, 26% had functional multi-vessel disease, and 90% achieved complete revascularization. Conservative and invasive groups had similar incidences of death and MI at 1 year (11% vs 10%; hazard ratio 1.21 [0.49-2.98]). Major adverse cardiac and cerebrovascular events (MACCE) trended for hazard in the Conservative group (20 vs 10%; hazard ratio 1.94 [0.90-4.19]). In the per-protocol analysis, the primary endpoint remained insignificantly different (11% vs 7%; hazard ratio 2.01 [0.72-5.57]), but the conservative approach had a higher MACCE risk (20% vs 7%; hazard ratio 2.88 [1.24-6.68]).
Conclusion: This trial found no significant difference in the primary endpoint but observed a trend of higher MACCE in the conservative arm.
期刊介绍：
Clinical Research in Cardiology is an international journal for clinical cardiovascular research. It provides a forum for original and review articles as well as critical perspective articles. Articles are only accepted if they meet stringent scientific standards and have undergone peer review. The journal regularly receives articles from the field of clinical cardiology, angiology, as well as heart and vascular surgery.
As the official journal of the German Cardiac Society, it gives a current and competent survey on the diagnosis and therapy of heart and vascular diseases.
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