Kennedy Mark W, Hermanides Rik S, Kaplan Emel, Hemradj Veemal, Fabris Enrico, Koopmans Petra C, Dambrink Jan-Henk E, Gosselink A T Marcel, Van't Hof Arnoud W J, Ottervanger Jan Paul, Roolvink Vincent, Remkes Wouter S, van der Sluis Aize, Suryapranata Harry, Kedhi Elvin
Isala Hartcentrum, Zwolle, The Netherlands; Diagram CRO, Zwolle, The Netherlands.
Isala Hartcentrum, Zwolle, The Netherlands.
Am J Cardiol. 2016 Nov 1;118(9):1293-1299. doi: 10.1016/j.amjcard.2016.07.059. Epub 2016 Aug 13.
To assess the safety and efficacy of deferred versus complete revascularization using a fractional flow reserve (FFR)-guided strategy in patients with diabetes mellitus (DM), we analyzed all DM patients who underwent FFR-guided revascularization from January 1, 2010, to December 12, 2013. Patients were divided into 2 groups: those with ≥1 remaining FFR-negative (>0.80) medically treated lesions [FFR(-)MT] and those with only FFR-positive lesions (≤0.80) who underwent complete revascularization [FFR(+)CR] and were followed until July 1, 2015. The primary end point was the incidence of major adverse cardiovascular events (MACE), a composite of death, myocardial infarction (MI), target lesion (FFR assessed) revascularization, and rehospitalization for acute coronary syndrome. A total of 294 patients, 205 (69.7%) versus 89 (30.3%) in FFR(-)MT and FFR(+)CR, respectively, were analyzed. At a mean follow-up of 32.6 ± 18.1 months, FFR(-)MT was associated with higher MACE rate 44.0% versus 26.6% (log-rank p = 0.02, Cox regression-adjusted hazard ratio [HR] 2.01, 95% confidence interval [CI] 1.21 to 3.33, p <0.01), and driven by both safety and efficacy end points: death/MI (HR 2.02, 95% CI 1.06 to 3.86, p = 0.03), rehospitalization for acute coronary syndrome (HR 2.06, 95% CI 1.03 to 4.10, p = 0.04), and target lesion revascularization (HR 3.38, 95% CI 1.19 to 9.64, p = 0.02). Previous MI was a strong effect modifier within the FFR(-)MT group (HR 1.98, 95% CI 1.26 to 3.13, p <0.01), whereas this was not the case in the FFR(+)CR group (HR 0.66, 95% CI 0.27 to 1.62, p = 0.37). Significant interaction for MACE was present between FFR groups and previous MI (p = 0.03). In conclusion, in patients with DM, particularly those with previous MI, deferred revascularization is associated with poor medium-term outcomes. Combining FFR with imaging techniques may be required to guide our treatment strategy in these patients with high-risk, fast-progressing atherosclerosis.
为评估在糖尿病(DM)患者中使用血流储备分数(FFR)指导策略进行延迟血运重建与完全血运重建的安全性和有效性,我们分析了2010年1月1日至2013年12月12日期间接受FFR指导下血运重建的所有DM患者。患者被分为两组:有≥1个FFR阴性(>0.80)且接受药物治疗的病变的患者[FFR(-)MT],以及仅有FFR阳性病变(≤0.80)并接受完全血运重建的患者[FFR(+)CR],并随访至2015年7月1日。主要终点是主要不良心血管事件(MACE)的发生率,MACE是死亡、心肌梗死(MI)、靶病变(FFR评估)血运重建和急性冠状动脉综合征再住院的复合终点。共分析了294例患者,FFR(-)MT组和FFR(+)CR组分别为205例(69.7%)和89例(30.3%)。在平均随访32.6±18.1个月时,FFR(-)MT组的MACE发生率更高,分别为44.0%和26.6%(对数秩检验p = 0.02,Cox回归调整后的风险比[HR]为2.01,95%置信区间[CI]为1.21至3.33,p<0.01),且由安全性和有效性终点共同驱动:死亡/MI(HR 2.02,95% CI 1.06至3.86,p = 0.03)、急性冠状动脉综合征再住院(HR 2.06,95% CI 1.03至4.10,p = 0.04)和靶病变血运重建(HR 3.38, 9,5% CI 1.