BACKGROUND Outcomes in women after fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) using current-generation drug-eluting stents (DES) compared with coronary artery bypass grafting (CABG) are unknown. OBJECTIVES This study sought to evaluate differences in clinical outcomes according to sex after FFR-guided PCI with current generation DES compared with CABG. METHODS The FAME 3 trial was an investigator-initiated, randomized controlled trial, comparing FFR-guided PCI with current generation DES or CABG in patients with 3-vessel coronary artery disease. This prespecified subgroup analysis compared the incidence of major adverse cardiac and cerebrovascular events (MACCE) according to sex, defined as the composite of all-cause death, myocardial infarction, stroke, or repeat revascularization at 3 years. RESULTS Of 1,500 patients included in the FAME 3 trial, 265 (17.7%) were women. Women had a significantly higher risk of MACCE at 3 years compared with men after CABG (18.1% vs 11.7%; adjusted HR: 2.07; 95% CI: 1.19-3.60), whereas women had a similar risk of MACCE at 3 years compared with men after PCI (18.2% vs 19.1%; adjusted HR: 1.27; 95% CI: 0.79-2.03). Regarding treatment effects by sex, women undergoing PCI had a similar risk of MACCE at 3 years compared with CABG (adjusted HR: 1.15; 95% CI: 0.62-2.11). By contrast, men undergoing PCI had a higher risk of MACCE at 3 years compared with CABG (adjusted HR: 1.68; 95% CI: 1.25-2.25; Pinteraction = 0.142), which was mainly driven by a higher risk of myocardial infarction (adjusted HR: 2.11; 95% CI: 1.26-3.56; Pinteraction = 0.102) and repeat revascularization (adjusted HR: 2.26; 95% CI: 1.47-3.47; Pinteraction = 0.071). CONCLUSIONS In the FAME 3 trial, at 3 years, women had similar outcomes with FFR-guided PCI compared with CABG, whereas men had improved outcomes with CABG. (A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease [FAME 3]; NCT02100722).

中文翻译：

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FAME 3 试验中接受 FFR 引导的 PCI 或 CABG 的患者的性别差异。


背景 与冠状动脉旁路移植术 （CABG） 相比，使用当前一代药物洗脱支架 （DES） 进行血流储备分数 （FFR） 引导的经皮冠状动脉介入治疗 （PCI） 后女性的结果尚不清楚。目的 本研究旨在评估与CABG相比，当前一代DES的FFR引导PCI后临床结局的性别差异。方法 FAME 3 试验是一项由研究者发起的随机对照试验，在 3 支冠状动脉疾病患者中比较 FFR 引导的 PCI 与当前一代 DES 或 CABG。该预先指定的亚组分析根据性别比较了主要不良心脑血管事件 （MACCE） 的发生率，定义为 3 年时全因死亡、心肌梗死、中风或重复血运重建的复合。结果 在 FAME 3 试验纳入的 1,500 名患者中，265 名 （17.7%） 为女性。与 CABG 后男性相比，女性在 3 年时发生 MACCE 的风险显著更高（18.1% 对 11.7%;调整后 HR：2.07;95% CI：1.19-3.60），而女性在 PCI 后 3 年时发生 MACCE 的风险与男性相似（18.2% 对 19.1%;调整后 HR：1.27;95% CI：0.79-2.03）。关于性别治疗效果，与 CABG 相比，接受 PCI 的女性在 3 年时发生 MACCE 的风险相似 （校正 HR： 1.15;95% CI： 0.62-2.11）。相比之下，与 CABG 相比，接受 PCI 的男性在 3 年时发生 MACCE 的风险更高 （校正 HR： 1.68;95% CI： 1.25-2.25;Pinteraction = 0.142），这主要是由心肌梗死风险较高驱动 （校正 HR： 2.11;95% CI： 1.26-3.56;Pinteraction = 0.102）和重复血运重建 （调整后的 HR： 2.26;95% CI： 1.47-3.47;Pinteraction = 0.071）。 结论在 FAME 3 试验中，与 CABG 相比，女性在 3 岁时接受 FFR 引导的 PCI 的结局相似，而男性接受 CABG 的结局有所改善。（血流储备引导下经皮冠状动脉介入治疗与冠状动脉旁路移植手术在多支冠状动脉疾病患者中的比较 [FAME 3];NCT02100722）。