Cardiovascular Medicine and Stanford Cardiovascular Institute, Stanford University, CA (H.O., K.T., A.C.Y., W.F.F.).
Catharina Hospital, Eindhoven, the Netherlands (F.M.Z., N.H.J.P.).
Circ Cardiovasc Interv. 2024 Nov;17(11):e014300. doi: 10.1161/CIRCINTERVENTIONS.124.014300. Epub 2024 Nov 6.
The clinical impact of a chronic total occlusion (CTO) in patients with 3-vessel coronary artery disease undergoing fractional flow reserve-guided percutaneous coronary intervention (PCI) with current-generation drug-eluting stents or coronary artery bypass grafting (CABG) is unclear.
The FAME 3 trial (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation 3) compared fractional flow reserve-guided PCI with CABG in patients with 3-vessel coronary artery disease. The primary end point was major adverse cardiac and cerebrovascular events, a composite of death, myocardial infarction, stroke, or repeat revascularization at 1 year. In this substudy, the 3-year outcomes were analyzed in patients with or without a CTO.
Of the patients randomized to PCI or CABG in the FAME 3 trial, 305 (21%) had a CTO. In the PCI arm, revascularization of the CTO was attempted in 61% with a procedural success rate of 88%. The incidence of major adverse cardiac and cerebrovascular events at 3 years was not significantly different between those with or without a CTO in both the PCI (15.2% versus 20.1%; adjusted hazard ratio, 0.62 [95% CI, 0.38-1.03]; =0.07) and the CABG (13.0% versus 12.9%; adjusted hazard ratio, 0.96 [95% CI, 0.55-1.66]; =0.88) arms. In those without a CTO, PCI was associated with a significantly higher risk of major adverse cardiac and cerebrovascular events compared with CABG (adjusted hazard ratio, 1.61 [95% CI, 1.20-2.17]; <0.01) but not in those with a CTO (adjusted hazard ratio, 1.21 [95% CI, 0.64-2.28]; =0.56; =0.31).
The presence of a CTO did not significantly impact the treatment effect of PCI versus CABG at 3 years in patients with 3-vessel coronary artery disease.
URL: https://www.clinicaltrials.gov; Unique identifier: NCT02100722.
在接受新一代药物洗脱支架或冠状动脉旁路移植术（CABG）的 3 支血管病变患者中，慢性完全闭塞（CTO）的临床影响尚不清楚。
FAME 3 试验（血流储备分数与多支血管评估的血管造影 3）比较了 3 支血管病变患者中血流储备分数指导下的 PCI 与 CABG 的疗效。主要终点是 1 年时的主要不良心脑血管事件，包括死亡、心肌梗死、卒中和再次血运重建的复合终点。在这项亚研究中，分析了 FAME 3 试验中接受 PCI 或 CABG 治疗的患者中有无 CTO 的 3 年结果。
在 FAME 3 试验中随机分到 PCI 或 CABG 的患者中，305 例（21%）存在 CTO。在 PCI 组中，61%的 CTO 进行了血运重建，手术成功率为 88%。在 PCI 组和 CABG 组中，有无 CTO 的患者 3 年时主要不良心脑血管事件的发生率无显著差异（PCI 组：15.2% vs 20.1%；校正后 HR，0.62 [95%CI，0.38-1.03]；=0.07；CABG 组：13.0% vs 12.9%；校正后 HR，0.96 [95%CI，0.55-1.66]；=0.88）。在没有 CTO 的患者中，与 CABG 相比，PCI 与主要不良心脑血管事件的风险显著增加（校正后 HR，1.61 [95%CI，1.20-2.17]；<0.01），但在有 CTO 的患者中，两者无显著差异（校正后 HR，1.21 [95%CI，0.64-2.28]；=0.56；=0.31）。
在 3 支血管病变患者中，CTO 的存在对 PCI 与 CABG 的 3 年治疗效果无显著影响。
