Abstract：
OBJECTIVE: 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]).
CONCLUSIONS: This trial found no significant difference in the primary endpoint but observed a trend of higher MACCE in the conservative arm.
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]).
CONCLUSIONS: This trial found no significant difference in the primary endpoint but observed a trend of higher MACCE in the conservative arm.
摘要：
目的：INCORPORATE试验旨在评估对于严重肢体缺血（CLI）治疗的患者，默认冠状动脉造影（CA）和缺血靶向血运重建是否优于保守方法。2018年10月19日在clinicaltrials.gov（NCT03712644）注册。
背景：严重的外周动脉疾病与心血管风险增加和预后不良相关。
方法：公司是一个开放标签，前瞻性1:1随机多中心试验招募了成功接受CLI治疗的患者.对于潜在的冠状动脉疾病（CAD），患者被随机分为保守或侵入性方法。保守组单独接受最佳药物治疗，侵入性组进行常规CA和血流储备分数引导的血运重建。主要终点是心肌梗死（MI）和12个月死亡率。
结果：由于COVID-19大流行的负担，招聘过早停止。招募了一百八十五名患者。基线心脏症状很少，92％无症状。89例患者被随机分配到侵入性方法中，其中73例接受了CA。34%的人患有功能性单血管疾病，26%患有功能性多血管疾病，90%实现了完全血运重建。保守组和侵入性组在1年时的死亡和MI发生率相似（11％vs10％；风险比1.21[0.49-2.98]）。主要不良心脑血管事件（MACCE）在保守组的危险趋势（20比10％；风险比1.94[0.90-4.19]）。在符合方案的分析中，主要终点保持无显著差异(11%vs7%；风险比2.01[0.72-5.57])，但保守方法的MACCE风险较高(20%vs7%;风险比2.88[1.24-6.68]).
结论：该试验发现主要终点没有显着差异，但在保守组观察到较高的MACCE趋势。
背景：严重的外周动脉疾病与心血管风险增加和预后不良相关。
方法：公司是一个开放标签，前瞻性1:1随机多中心试验招募了成功接受CLI治疗的患者.对于潜在的冠状动脉疾病（CAD），患者被随机分为保守或侵入性方法。保守组单独接受最佳药物治疗，侵入性组进行常规CA和血流储备分数引导的血运重建。主要终点是心肌梗死（MI）和12个月死亡率。
结果：由于COVID-19大流行的负担，招聘过早停止。招募了一百八十五名患者。基线心脏症状很少，92％无症状。89例患者被随机分配到侵入性方法中，其中73例接受了CA。34%的人患有功能性单血管疾病，26%患有功能性多血管疾病，90%实现了完全血运重建。保守组和侵入性组在1年时的死亡和MI发生率相似（11％vs10％；风险比1.21[0.49-2.98]）。主要不良心脑血管事件（MACCE）在保守组的危险趋势（20比10％；风险比1.94[0.90-4.19]）。在符合方案的分析中，主要终点保持无显著差异(11%vs7%；风险比2.01[0.72-5.57])，但保守方法的MACCE风险较高(20%vs7%;风险比2.88[1.24-6.68]).
结论：该试验发现主要终点没有显着差异，但在保守组观察到较高的MACCE趋势。
