Takahashi Kuniaki, Otsuki Hisao, Zimmermann Frederik M, Ding Victoria Y, Piroth Zsolt, Oldroyd Keith G, Wendler Olaf, Reardon Michael J, Desai Manisha, Woo Y Joseph, Yeung Alan C, De Bruyne Bernard, Pijls Nico H J, Fearon William F
Stanford University School of Medicine and Stanford Cardiovascular Institute, Stanford University, California, USA.
St. Antonius Hospital, Nieuwegein, the Netherlands; Catharina Hospital, Eindhoven, the Netherlands.
JACC Cardiovasc Interv. 2025 Apr 14;18(7):838-848. doi: 10.1016/j.jcin.2025.01.434.
There are limited data comparing coronary artery bypass grafting (CABG) with percutaneous coronary intervention (PCI) in patients presenting with non-ST-segment elevation acute coronary syndrome (NSTE-ACS).
The aim of this study was to evaluate differences in outcomes in patients presenting with or without NSTE-ACS after CABG compared with fractional flow reserve (FFR)-guided PCI using current generation drug-eluting stents.
The FAME 3 trial (Fractional flow reserve versus Angiography for Multivessel Evaluation; NCT02100722) was an investigator-initiated, randomized controlled trial to attest noninferiority of FFR-guided PCI using the current-generation drug-eluting stents to CABG with respect to the primary endpoint, defined as a composite of death, myocardial infarction (MI), stroke, or repeat revascularization at 1 year, in 1,500 patients with 3-vessel coronary artery disease. The prespecified key secondary endpoint was a composite of death, MI, or stroke at 3 years.
Of 1,500 patients enrolled, 587 (39.2%) presented with NSTE-ACS. Patients were followed up for a median of 1,080 days (Q1-Q3: 1,080-1,080 days). At 3 years, the risk of the composite of death, MI, or stroke was similar between patients presenting with NSTE-ACS and with chronic coronary syndrome (CCS) (11.8% vs 10.0%; adjusted HR [aHR]: 1.20; 95% CI: 0.81-1.77; P = 0.37). Patients presenting with NSTE-ACS had a similar risk of death, MI, or stroke at 3 years after CABG as compared with PCI (aHR: 0.98; 95% CI: 0.60-1.60; P = 0.94), whereas patients presenting with CCS had a significantly reduced risk after CABG compared with PCI (aHR: 0.58; 95% CI: 0.38-0.90; P = 0.02; P = 0.11), which was driven by a lower risk of MI (aHR: 0.32; 95% CI: 0.15-0.64; P = 0.002; P = 0.01).
The risk of death, MI, or stroke at 3 years was similar after CABG compared with FFR-guided PCI in patients presenting with NSTE-ACS, but reduced by CABG in patients presenting with CCS. (Fractional flow reserve versus Angiography for Multivessel Evaluation [FAME 3]; NCT02100722).
在非ST段抬高型急性冠状动脉综合征(NSTE-ACS)患者中,比较冠状动脉旁路移植术(CABG)与经皮冠状动脉介入治疗(PCI)的资料有限。
本研究旨在评估使用当代药物洗脱支架,在CABG后出现或未出现NSTE-ACS的患者与血流储备分数(FFR)引导的PCI相比,结局的差异。
FAME 3试验(多支血管评估的血流储备分数与血管造影术对比试验;NCT02100722)是一项研究者发起的随机对照试验,在1500例三支血管冠状动脉疾病患者中,就主要终点(定义为1年时死亡、心肌梗死(MI)、中风或再次血运重建的复合终点)证明使用当代药物洗脱支架的FFR引导的PCI不劣于CABG。预先设定的关键次要终点是3年时死亡、MI或中风的复合终点。
在纳入的1500例患者中,587例(39.2%)出现NSTE-ACS。患者的中位随访时间为1080天(四分位间距:1080 - 1080天)。在3年时,出现NSTE-ACS的患者与慢性冠状动脉综合征(CCS)患者相比,死亡、MI或中风复合终点的风险相似(11.8%对10.0%;校正风险比[aHR]:1.20;95%置信区间[CI]:0.81 - 1.77;P = 0.37)。与PCI相比,CABG后3年出现NSTE-ACS的患者死亡、MI或中风的风险相似(aHR:0.98;95% CI:0.60 - 1.60;P = 0.94),而与PCI相比,出现CCS的患者CABG后风险显著降低(aHR:0.58;95% CI:0.38 - 0.90;P = 0.02;P = 0.11),这是由较低的MI风险驱动的(aHR:0.32;95% CI:0.