PDF(Pubmed)
Abstract：
BACKGROUND: Treatment of chronic total occlusion (CTO) by percutaneous coronary intervention (PCI) is associated with the difficulty of guidewire manipulation through the occluded segment, particularly when there is hard tissue due to calcification. The purpose of this randomised controlled trial is to determine whether improved planning of CTO-PCI using coronary computed tomographic angiography (CCTA) (versus conventional angiography) increases success rates of wire crossing in ≤ 60 min in difficult cases.
METHODS: This is a randomised controlled open-label multi-centre trial in a superiority framework with 1:1 allocation ratio. Participants (n = 130) will be randomised into two groups: the study group who will receive standard of care with the addition of preoperative coronary computed tomographic angiography (CT group), and the control group that will receive standard of care (angiography group). The primary endpoint will be the rate of successful wire crossing in ≤ 60 min in complex CTO (J-CTO ≥ 2). Wire crossing will be considered successful if TIMI flow 3 is restored and residual stenosis is < 30%. The safety endpoint will be mortality due to the intervention or major adverse cardiac events (MACE). Secondary endpoints are success rates at any time; total time of PCI; time of wire crossing; rate of PCI complications; radiation levels during PCI; volume of iodine contrast medium administered; and cost of the PCI.
CONCLUSIONS: This randomised trial will provide insight into whether pre-procedural CCTA as opposed to conventional angiography for planning of CTO-PCI yield higher success rates of wire crossing in ≤ 60 min. Potential benefits of CCTA include shorter successful procedure times of CTO-PCI leading to less irradiation and contrast medium with lower complication rates.
BACKGROUND: Clinical Trials.gov NCT04549896. Registered on December 21, 2021.
METHODS: This is a randomised controlled open-label multi-centre trial in a superiority framework with 1:1 allocation ratio. Participants (n = 130) will be randomised into two groups: the study group who will receive standard of care with the addition of preoperative coronary computed tomographic angiography (CT group), and the control group that will receive standard of care (angiography group). The primary endpoint will be the rate of successful wire crossing in ≤ 60 min in complex CTO (J-CTO ≥ 2). Wire crossing will be considered successful if TIMI flow 3 is restored and residual stenosis is < 30%. The safety endpoint will be mortality due to the intervention or major adverse cardiac events (MACE). Secondary endpoints are success rates at any time; total time of PCI; time of wire crossing; rate of PCI complications; radiation levels during PCI; volume of iodine contrast medium administered; and cost of the PCI.
CONCLUSIONS: This randomised trial will provide insight into whether pre-procedural CCTA as opposed to conventional angiography for planning of CTO-PCI yield higher success rates of wire crossing in ≤ 60 min. Potential benefits of CCTA include shorter successful procedure times of CTO-PCI leading to less irradiation and contrast medium with lower complication rates.
BACKGROUND: Clinical Trials.gov NCT04549896. Registered on December 21, 2021.
摘要：
背景：经皮冠状动脉介入治疗（PCI）慢性完全闭塞（CTO）与通过闭塞段进行导丝操作的困难有关，特别是当有硬组织由于钙化。这项随机对照试验的目的是确定使用冠状动脉计算机断层血管造影（CCTA）（与常规血管造影相比）进行CTO-PCI的改进计划是否会在困难病例中在≤60分钟内增加穿线成功率。
方法：这是一项随机对照的开放标签多中心试验，优势框架为1:1分配比例。参与者（n=130）将被随机分为两组：研究组将接受标准护理，并增加术前冠状动脉CT血管造影（CT组），和将接受标准护理的对照组（血管造影组）。主要终点是复杂CTO（J-CTO≥2）中≤60分钟内成功的导线交叉率。如果TIMI流3恢复且残余狭窄<30%,则认为导线穿越成功。安全性终点将是由于干预或主要不良心脏事件（MACE）导致的死亡率。次要终点是任何时间的成功率；PCI的总时间；导线交叉的时间；PCI并发症的发生率；PCI期间的辐射水平；使用碘造影剂的量；以及PCI的成本。
结论：这项随机试验将深入了解术前CCTA与常规血管造影计划CTO-PCI是否在≤60分钟内获得更高的穿线成功率。CCTA的潜在益处包括CTO-PCI的较短的成功手术时间，导致较少的照射和造影剂，并发症发生率较低。
背景：临床试验.govNCT04549896。2021年12月21日注册。
方法：这是一项随机对照的开放标签多中心试验，优势框架为1:1分配比例。参与者（n=130）将被随机分为两组：研究组将接受标准护理，并增加术前冠状动脉CT血管造影（CT组），和将接受标准护理的对照组（血管造影组）。主要终点是复杂CTO（J-CTO≥2）中≤60分钟内成功的导线交叉率。如果TIMI流3恢复且残余狭窄<30%,则认为导线穿越成功。安全性终点将是由于干预或主要不良心脏事件（MACE）导致的死亡率。次要终点是任何时间的成功率；PCI的总时间；导线交叉的时间；PCI并发症的发生率；PCI期间的辐射水平；使用碘造影剂的量；以及PCI的成本。
结论：这项随机试验将深入了解术前CCTA与常规血管造影计划CTO-PCI是否在≤60分钟内获得更高的穿线成功率。CCTA的潜在益处包括CTO-PCI的较短的成功手术时间，导致较少的照射和造影剂，并发症发生率较低。
背景：临床试验.govNCT04549896。2021年12月21日注册。
