PDF(Pubmed)
Abstract：
UNASSIGNED: Data are limited regarding the effects of intravascular imaging guidance during complex percutaneous coronary intervention (PCI) in patients with diabetes.
UNASSIGNED: To compare the clinical outcomes of intravascular imaging-guided vs angiography-guided complex PCI in patients with or without diabetes.
UNASSIGNED: This prespecified secondary analysis of a subgroup of patients in RENOVATE-COMPLEX-PCI (Randomized Controlled Trial of Intravascular Imaging Guidance Versus Angiography-Guidance on Clinical Outcomes After Complex Percutaneous Coronary Intervention), an investigator-initiated, open-label multicenter trial, analyzed enrolled patients who underwent complex PCI at 20 sites in Korea from May 2018 through May 2021. Eligible patients were randomly assigned in a 2:1 ratio to undergo either the intravascular imaging-guided PCI or angiography-guided PCI. Data analyses were performed from June 2023 to April 2024.
UNASSIGNED: Percutaneous coronary intervention was performed either under the guidance of intravascular imaging or angiography alone.
UNASSIGNED: The primary end point was target vessel failure (TVF), defined as a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization.
UNASSIGNED: Among the 1639 patients included in the analysis (mean [SD] age, 65.6 [10.2] years; 1300 males [79.3%]), 617 (37.6%) had diabetes. The incidence of TVF was significantly higher in patients with diabetes than patients without diabetes (hazard ratio [HR], 1.86; 95% CI, 1.33-2.60; P < .001). Among patients without diabetes, the intravascular imaging-guided PCI group had a significantly lower incidence of TVF compared with the angiography-guided PCI group (4.7% vs 12.2%; HR, 0.41 [95% CI, 0.25-0.67]; P < .001). Conversely, in patients with diabetes, the risk of TVF was not significantly different between the 2 groups (12.9% vs 12.3%; HR, 0.97 [95% CI, 0.60-1.57]; P = .90). There was a significant interaction between the use of intravascular imaging and diabetes for the risk of TVF (P for interaction = .02). Among patients with diabetes, only those with good glycemic control (hemoglobin A1c level ≤7.5%) and who achieved stent optimization by intravascular imaging showed a lower risk of future ischemic events (HR, 0.31; 95% CI, 0.12-0.82; P = .02).
UNASSIGNED: In this secondary analysis of a subgroup of patients in the RENOVATE-COMPLEX-PCI trial, intravascular imaging guidance reduced the risk of TVF compared with angiography guidance in patients without diabetes (but not in patients with diabetes) during complex PCI. In patients with diabetes undergoing complex PCI, attention should be paid to stent optimization using intravascular imaging and glycemic control to improve outcomes.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT03381872.
UNASSIGNED: To compare the clinical outcomes of intravascular imaging-guided vs angiography-guided complex PCI in patients with or without diabetes.
UNASSIGNED: This prespecified secondary analysis of a subgroup of patients in RENOVATE-COMPLEX-PCI (Randomized Controlled Trial of Intravascular Imaging Guidance Versus Angiography-Guidance on Clinical Outcomes After Complex Percutaneous Coronary Intervention), an investigator-initiated, open-label multicenter trial, analyzed enrolled patients who underwent complex PCI at 20 sites in Korea from May 2018 through May 2021. Eligible patients were randomly assigned in a 2:1 ratio to undergo either the intravascular imaging-guided PCI or angiography-guided PCI. Data analyses were performed from June 2023 to April 2024.
UNASSIGNED: Percutaneous coronary intervention was performed either under the guidance of intravascular imaging or angiography alone.
UNASSIGNED: The primary end point was target vessel failure (TVF), defined as a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization.
UNASSIGNED: Among the 1639 patients included in the analysis (mean [SD] age, 65.6 [10.2] years; 1300 males [79.3%]), 617 (37.6%) had diabetes. The incidence of TVF was significantly higher in patients with diabetes than patients without diabetes (hazard ratio [HR], 1.86; 95% CI, 1.33-2.60; P < .001). Among patients without diabetes, the intravascular imaging-guided PCI group had a significantly lower incidence of TVF compared with the angiography-guided PCI group (4.7% vs 12.2%; HR, 0.41 [95% CI, 0.25-0.67]; P < .001). Conversely, in patients with diabetes, the risk of TVF was not significantly different between the 2 groups (12.9% vs 12.3%; HR, 0.97 [95% CI, 0.60-1.57]; P = .90). There was a significant interaction between the use of intravascular imaging and diabetes for the risk of TVF (P for interaction = .02). Among patients with diabetes, only those with good glycemic control (hemoglobin A1c level ≤7.5%) and who achieved stent optimization by intravascular imaging showed a lower risk of future ischemic events (HR, 0.31; 95% CI, 0.12-0.82; P = .02).
UNASSIGNED: In this secondary analysis of a subgroup of patients in the RENOVATE-COMPLEX-PCI trial, intravascular imaging guidance reduced the risk of TVF compared with angiography guidance in patients without diabetes (but not in patients with diabetes) during complex PCI. In patients with diabetes undergoing complex PCI, attention should be paid to stent optimization using intravascular imaging and glycemic control to improve outcomes.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT03381872.
摘要：
■关于糖尿病患者复杂经皮冠状动脉介入治疗（PCI）期间血管内成像指导的影响的数据有限。
■目的比较血管内成像引导与血管造影引导复合PCI治疗糖尿病患者的临床结果。
■这是对RENOVATE-COMPLEX-PCI患者亚组（血管内成像指导与血管造影的随机对照试验-复杂经皮冠状动脉介入治疗后临床结果的指导），一个调查员发起的，开放标签多中心试验，分析了2018年5月至2021年5月在韩国20个地点接受复杂PCI的入选患者.符合条件的患者以2：1的比例随机分配接受血管内成像引导的PCI或血管造影引导的PCI。从2023年6月至2024年4月进行了数据分析。
■在血管内成像或血管造影的指导下进行经皮冠状动脉介入治疗。
■主要终点是目标血管故障（TVF），定义为心脏死亡的复合物，靶血管相关心肌梗死,或目标血管血运重建。
■在分析中包括的1639名患者中（平均[SD]年龄，65.6[10.2]岁；1300名男性[79.3％]），617（37.6％）患有糖尿病。糖尿病患者的TVF发生率明显高于非糖尿病患者（危险比[HR]，1.86；95%CI，1.33-2.60；P<.001）。在没有糖尿病的患者中，与血管造影引导的PCI组相比，血管内成像引导的PCI组的TVF发生率显着降低（4.7％vs12.2％；HR，0.41[95%CI，0.25-0.67]；P<.001）。相反，在糖尿病患者中，TVF的风险在两组之间没有显着差异（12.9％vs12.3％；HR，0.97[95%CI，0.60-1.57]；P=.90）。使用血管内成像和糖尿病对TVF的风险有显著的交互作用(P=.02)。在糖尿病患者中，只有那些血糖控制良好(血红蛋白A1c水平≤7.5%)且通过血管内成像实现支架优化的患者显示未来缺血事件的风险较低(HR,0.31；95%CI，0.12-0.82；P=.02）。
■在对RENOVATE-COMPLEX-PCI试验中的一个亚组患者的二次分析中，在复杂PCI过程中,无糖尿病患者(但无糖尿病患者)与血管造影指导相比,血管内成像指导降低了TVF的风险.在接受复杂PCI的糖尿病患者中，应注意使用血管内成像和血糖控制来优化支架以改善预后。
■ClinicalTrials.gov标识符：NCT03381872。
■目的比较血管内成像引导与血管造影引导复合PCI治疗糖尿病患者的临床结果。
■这是对RENOVATE-COMPLEX-PCI患者亚组（血管内成像指导与血管造影的随机对照试验-复杂经皮冠状动脉介入治疗后临床结果的指导），一个调查员发起的，开放标签多中心试验，分析了2018年5月至2021年5月在韩国20个地点接受复杂PCI的入选患者.符合条件的患者以2：1的比例随机分配接受血管内成像引导的PCI或血管造影引导的PCI。从2023年6月至2024年4月进行了数据分析。
■在血管内成像或血管造影的指导下进行经皮冠状动脉介入治疗。
■主要终点是目标血管故障（TVF），定义为心脏死亡的复合物，靶血管相关心肌梗死,或目标血管血运重建。
■在分析中包括的1639名患者中（平均[SD]年龄，65.6[10.2]岁；1300名男性[79.3％]），617（37.6％）患有糖尿病。糖尿病患者的TVF发生率明显高于非糖尿病患者（危险比[HR]，1.86；95%CI，1.33-2.60；P<.001）。在没有糖尿病的患者中，与血管造影引导的PCI组相比，血管内成像引导的PCI组的TVF发生率显着降低（4.7％vs12.2％；HR，0.41[95%CI，0.25-0.67]；P<.001）。相反，在糖尿病患者中，TVF的风险在两组之间没有显着差异（12.9％vs12.3％；HR，0.97[95%CI，0.60-1.57]；P=.90）。使用血管内成像和糖尿病对TVF的风险有显著的交互作用(P=.02)。在糖尿病患者中，只有那些血糖控制良好(血红蛋白A1c水平≤7.5%)且通过血管内成像实现支架优化的患者显示未来缺血事件的风险较低(HR,0.31；95%CI，0.12-0.82；P=.02）。
■在对RENOVATE-COMPLEX-PCI试验中的一个亚组患者的二次分析中，在复杂PCI过程中,无糖尿病患者(但无糖尿病患者)与血管造影指导相比,血管内成像指导降低了TVF的风险.在接受复杂PCI的糖尿病患者中，应注意使用血管内成像和血糖控制来优化支架以改善预后。
■ClinicalTrials.gov标识符：NCT03381872。
