Kennedy Mark W, Kaplan Eliza, Hermanides Rik S, Fabris Enrico, Hemradj Veemal, Koopmans Petra C, Dambrink Jan-Hank E, Marcel Gosselink A T, Van't Hof Arnoud W J, Ottervanger Jan Paul, Roolvink Vincent, Remkes Wouter S, van der Sluis Aize, Suryapranata Harry, Kedhi Elvin
Isala Hartcentrum, Docter Van Heesweg 2, Zwolle, The Netherlands.
Diagram CRO, Zwolle, The Netherlands.
Cardiovasc Diabetol. 2016 Jul 19;15:100. doi: 10.1186/s12933-016-0417-2.
Deferred revascularisation based upon fractional flow reserve (FFR >0.80) is associated with a low incidence of target lesion failure (TLF). Whether deferred revascularisation is also as safe in diabetes mellitus (DM) patients is unknown.
All DM patients and the next consecutive Non-DM patients who underwent a FFR-assessment between 1/01/2010 and 31/12/2013 were included, and followed until 1/07/2015. Patients with lesions FFR >0.80 were analysed according to the presence vs. absence of DM, while patients who underwent index revascularisation in FFR-assessed or other lesions were excluded. The primary endpoint was the incidence of TLF; a composite of target lesion revascularisation (TLR) and target vessel myocardial infarction (TVMI).
A total of 250 patients (122 DM, 128 non-DM) who underwent deferred revascularisation of all lesions (FFR >0.80) were compared. At a mean follow up of 39.8 ± 16.3 months, DM patients compared to non-DM had a higher TLF rate, 18.1 vs 7.5 %, logrank p ≤ 0.01, Cox regression-adjusted HR 3.65 (95 % CI 1.40-9.53, p < 0.01), which was largely driven by a higher incidence of TLR (17.2 vs. 7.5 %, HR 3.52, 95 % CI 1.34-9.30, p = 0.01), whilst a non-significant but numerically higher incidence of TVMI (6.1 vs. 2.0 %, HR 3.34, 95 % CI 0.64-17.30, p = 0.15) was observed.
This study, the largest to directly compare the clinical outcomes of FFR-guided deferred revascularisation in patients with and without DM, shows that DM patients are associated with a significantly higher TLF rate. Whether intravascular imaging, additional invasive haemodynamics or stringent risk factor modification may impact on this higher TLF rate remains unknown.
基于血流储备分数（FFR>0.80）的延迟血运重建与较低的靶病变失败（TLF）发生率相关。延迟血运重建在糖尿病（DM）患者中是否同样安全尚不清楚。
纳入2010年1月1日至2013年12月31日期间接受FFR评估的所有DM患者以及下一批连续的非DM患者，并随访至2015年7月1日。对FFR>0.80的病变患者根据是否患有DM进行分析，排除在FFR评估病变或其他病变中接受首次血运重建的患者。主要终点是TLF的发生率；靶病变血运重建（TLR）和靶血管心肌梗死（TVMI）的复合终点。
共比较了250例接受所有病变延迟血运重建（FFR>0.80）的患者（122例DM患者，128例非DM患者）。平均随访39.8±16.3个月，DM患者与非DM患者相比，TLF发生率更高，分别为18.1%和7.5%，对数秩检验p≤0.01，Cox回归调整后的HR为3.65（95%CI 1.40-9.53，p<0.01），这主要是由较高的TLR发生率（17.2%对7.5%，HR 3.52，95%CI 1.34-9.30，p = 0.01）驱动的，同时观察到TVMI发生率虽无统计学意义但数值上更高（6.1%对2.0%，HR 3.34，95%CI 0.64-17.30，p = 0.15）。
本研究是直接比较有DM和无DM患者中FFR指导的延迟血运重建临床结局的最大规模研究，表明DM患者的TLF发生率显著更高。血管内成像、额外的有创血流动力学检查或严格的危险因素修正是否会影响这种较高的TLF发生率仍不清楚。
