Ninomiya Kai, Serruys Patrick W, Garg Scot, Masuda Shinichiro, Kageyama Shigetaka, Kotoku Nozomi, Morel Marie Angele, Taylor Charles, Puskas John D, Narula Jagat, Schneider Ulrich, Doenst Torsten, Tanaka Kaoru, De Mey Johan, La Meir Mark, Mushtaq Saima, Bartorelli Antonio L, Pompilio Giulio, Andreini Daniele, Onuma Yoshinobu
Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland.
Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland; Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
Cardiovasc Revasc Med. 2023 May;50:34-40. doi: 10.1016/j.carrev.2023.01.001. Epub 2023 Jan 9.
Personalized long term vital prognosis plays a key role in deciding between percutaneous coronary intervention (PCI) and CABG in patients with complex coronary artery disease. The FASTTRACK CABG trial enrolls patients with the sole guidance of coronary computed tomographic angiography (CCTA) and fractional flow reserve CCTA (FFR). The feasibility/non-feasibility of this approach is determined by the surgeon request to have access to the invasive coronary angiography.
This interim analysis, which was requested by the Data and Safety Monitoring Board (DSMB), compared the treatment decision of the "on site" Heart team to the recommended treatment as per the SYNTAX Score II 2020 (SS-2020), which was prospectively assessed by the central core laboratory in the first 57 consecutive patients (half of the planned population) enrolled in this First in Man study.
The average anatomical SYTAX Score is 35.6 ± 11.5. The SS-2020 predicted 5-year MACE and 10-year all-cause mortality are 14.7 % and 21.6 % following CABG, and 23.0 % and 30.4 % following PCI. Among the enrolled patients the SS-2020 predicts long-term PCI outcomes similar to CABG (absolute risk difference ≤0 % in favor of PCI) in only two patients whilst the remaining 55 patients had a predicted survival benefit with CABG.
According to the SS-2020, the first 57 patients recruited into the FASTTRACK CABG trial received the appropriate modality of revascularization and the DSMB allowed the investigators to complete the study.
在复杂冠状动脉疾病患者中，个性化的长期生存预后在决定采用经皮冠状动脉介入治疗（PCI）还是冠状动脉旁路移植术（CABG）方面起着关键作用。FASTTRACK CABG试验仅在冠状动脉计算机断层血管造影（CCTA）和冠状动脉计算机断层血管造影血流储备分数（FFR CCTA）的指导下纳入患者。这种方法的可行性/不可行性取决于外科医生对侵入性冠状动脉造影的需求。
本次中期分析由数据与安全监测委员会（DSMB）要求进行，将“现场”心脏团队的治疗决策与根据2020年SYNTAX评分II（SS - 2020）推荐的治疗方法进行比较，该评分由中央核心实验室对这项人体首例研究中连续纳入的前57名患者（计划入组人群的一半）进行前瞻性评估。
平均解剖学SYTAX评分为35.6 ± 11.5。SS - 2020预测CABG后5年主要不良心血管事件（MACE）和10年全因死亡率分别为14.7%和21.6%，PCI后分别为23.0%和30.4%。在纳入的患者中，SS - 2020仅预测两名患者的长期PCI结果与CABG相似（有利于PCI的绝对风险差异≤0%），而其余55名患者预测CABG有生存获益。
根据SS - 2020，FASTTRACK CABG试验招募的前57名患者接受了适当的血运重建方式，DSMB允许研究人员完成该研究。
