Department of Cardiology, Second Affiliated Hospital of Zhejiang University School of Medicine, State Key Laboratory of Transvascular Implantation Devices, Hangzhou, China.
Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Korea.
JAMA Netw Open. 2024 Jun 3;7(6):e2418072. doi: 10.1001/jamanetworkopen.2024.18072.
The associations between angiographic findings and post-percutaneous coronary intervention (PCI) fractional flow reserve (FFR) and their clinical relevance according to residual functional disease burden have not been thoroughly investigated.
To evaluate the association of angiographic and physiologic parameters according to residual functional disease burden after drug-eluting stent implantation.
DESIGN, SETTING, AND PARTICIPANTS: This cohort study population was from the International Post-PCI FFR registry, which incorporated 4 registries from Korea, China, and Japan. Patients who underwent angiographically successful second-generation drug-eluting stent implantation and post-PCI FFR measurement were included in the analysis. The patients were divided into 3 groups according to the residual disease burden (post-PCI FFR ≤0.80 [residual ischemia], 0.81-0.86 [suboptimal], and >0.86 [optimal]). The data were collected from August 23, 2018, to June 11, 2019, and the current analysis was performed from January 11, 2022, to October 7, 2023.
Angiographic parameters and post-PCI FFR.
The primary outcome was target vessel failure (TVF), defined as a composite of cardiac death, target vessel-related myocardial infarction, and target vessel revascularization (TVR) at 2 years.
In this cohort of 2147 patients, the mean (SD) age was 64.3 (10.0) years, and 1644 patients (76.6%) were men. Based on the post-PCI physiologic status, 269 patients (12.5%) had residual ischemia, 551 (25.7%) had suboptimal results, and 1327 (61.8%) had optimal results. Angiographic parameters had poor correlations with post-PCI FFR (r < 0.20). Post-PCI FFR was isolated from all angiographic parameters in the unsupervised hierarchical cluster analysis. Post-PCI FFR was associated with the occurrence of TVF (adjusted hazard ratio [AHR] per post-PCI FFR 0.01 increase, 0.94 [95% CI, 0.92-0.97]; P < .001), but angiographic parameters were not. The residual ischemia group had a significantly higher rate of TVF than the suboptimal group (AHR, 1.75 [95% CI, 1.08-2.83]; P = .02) and the optimal group (AHR, 2.94 [95% CI, 1.82-4.73]; P < .001). The TVR in the residual ischemia group was predominantly associated with TVR in the nonstented segment (14 [53.8%]), unlike the other 2 groups (3 [10.0%] in the suboptimal group and 13 [30.2%] in the optimal group).
In this cohort study of the International Post-PCI FFR registry, a low degree of associations were observed between angiographic and physiologic parameters after PCI. Post-PCI FFR, unlike angiographic parameters, was associated with clinical events and the distribution of clinical events. The current study supports the use of post-PCI FFR as a procedural quality metric and further prospective study is warranted.
经皮冠状动脉介入治疗(PCI)后,血管造影表现与血流储备分数(FFR)之间的相关性及其与残留功能病变负担的临床相关性尚未得到深入研究。
评估药物洗脱支架植入后根据残留功能病变负担的血管造影和生理参数之间的相关性。
设计、地点和参与者:本队列研究人群来自国际 PCI 后 FFR 注册研究,该研究纳入了来自韩国、中国和日本的 4 个注册研究。纳入的患者均行血管造影成功的第二代药物洗脱支架植入术和 PCI 后 FFR 测量。根据残留病变负担(PCI 后 FFR≤0.80[残留缺血]、0.81-0.86[次优]和>0.86[最优])将患者分为 3 组。数据收集时间为 2018 年 8 月 23 日至 2019 年 6 月 11 日,目前的分析时间为 2022 年 1 月 11 日至 2023 年 10 月 7 日。
血管造影参数和 PCI 后 FFR。
主要结局为靶血管失败(TVF),定义为 2 年内心脏死亡、靶血管相关心肌梗死和靶血管血运重建(TVR)的复合终点。
在这项来自国际 PCI 后 FFR 注册研究的队列中,患者的平均(标准差)年龄为 64.3(10.0)岁,1644 名患者(76.6%)为男性。根据 PCI 后的生理状态,269 名患者(12.5%)存在残留缺血,551 名患者(25.7%)存在次优结果,1327 名患者(61.8%)存在最佳结果。血管造影参数与 PCI 后 FFR 的相关性较差(r<0.20)。在无监督层次聚类分析中,PCI 后 FFR 与所有血管造影参数分离。PCI 后 FFR 与 TVF 的发生相关(每增加 0.01 个 PCI 后 FFR,调整后的危险比[AHR]为 0.94[95%CI,0.92-0.97];P<0.001),而血管造影参数则没有。与次优组(AHR,1.75[95%CI,1.08-2.83];P=0.02)和最优组(AHR,2.94[95%CI,1.82-4.73];P<0.001)相比,残留缺血组的 TVF 发生率明显更高。残留缺血组的 TVR 主要与非支架段的 TVR 相关(14 例[53.8%]),而其他 2 组则不然(次优组 3 例[10.0%],最优组 13 例[30.2%])。
在这项来自国际 PCI 后 FFR 注册研究的队列研究中,观察到 PCI 后血管造影和生理参数之间的相关性较低。与血管造影参数不同,PCI 后 FFR 与临床事件及其分布相关。本研究支持将 PCI 后 FFR 作为一种程序质量指标,并需要进一步的前瞻性研究。