Shammas Andrew N, Jeon-Slaughter Haekyung, Tsai Shirling, Khalili Houman, Ali Mujtaba, Xu Hao, Rodriguez Gerardo, Cawich Ian, Armstrong Ehrin J, Brilakis Emmanouil S, Banerjee Subhash
1 Midwest Cardiovascular Research Foundation, Davenport, IA, USA.
2 University of Texas Southwestern Medical Center, Dallas, TX, USA.
J Endovasc Ther. 2017 Jun;24(3):376-382. doi: 10.1177/1526602817705135. Epub 2017 Apr 25.
To determine whether diabetes mellitus has an independent impact on major limb outcomes at 1 year after endovascular treatment of lower extremity peripheral artery disease (PAD).
The study involved 1906 consecutive patients (mean age 66 years; 1469 men) enrolled in the observational Excellence in Peripheral Artery Disease (XLPAD) registry ( ClinicalTrials.gov identifier NCT01904851) between January 2005 and October 2015 after undergoing index endovascular procedures in 2426 limbs for arterial occlusive disease. Patient outcomes included 12-month target limb amputation (above ankle) and target limb revascularization as well as all-cause death. Kaplan-Meier analysis and adjusted Cox proportional hazard models were used for time-to-event analysis of outcomes for the entire study sample as well as for the critical limb ischemia (CLI) and claudication subgroups. Results of the Cox regression models are reported as the hazard ratio (HR) and 95% confidence interval (CI).
Diabetics undergoing endovascular procedures had higher rates of comorbid conditions (p<0.001), CLI (p<0.001), heavily calcified lesions (p=0.002), multivessel disease (p=0.030), and fewer infrapopliteal runoff vessels (p<0.001). Regression analysis after adjusting for confounders revealed significantly higher target limb major amputation in diabetics compared with nondiabetics (HR 5.02, 95% CI 1.44 to 17.56, p=0.011). However, repeat revascularization rates were similar. When considering CLI and claudication subgroups, diabetes was associated with a nonsignificant increased risk of 12-month major amputation only for patients presenting with CLI (HR 3.48, 95% CI 0.97 to 12.51, p=0.056). Diabetes was also associated with an increased risk of 12-month all-cause mortality in the overall study sample (HR 4.64, 95% CI 2.01 to 10.70, p<0.001) and in the CLI subgroup (HR 14.15, 95% CI 3.16 to 63.32, p<0.001) but not in the claudication subgroup (HR 1.42, 95% CI 0.45 to 4.54, p=0.552).
Diabetes increases the risk of major amputation and all-cause death at 12 months following endovascular revascularization in patients with symptomatic PAD. These risks are especially heightened in patients presenting with CLI.
确定糖尿病对下肢外周动脉疾病（PAD）血管内治疗后1年时主要肢体结局是否有独立影响。
该研究纳入了2005年1月至2015年10月期间连续入选外周动脉疾病卓越研究（XLPAD）登记处（ClinicalTrials.gov标识符NCT01904851）的1906例患者（平均年龄66岁；1469例男性），这些患者在2426条肢体上接受了针对动脉闭塞性疾病的初次血管内手术。患者结局包括12个月时目标肢体截肢（踝关节以上）、目标肢体血管再通以及全因死亡。采用Kaplan-Meier分析和校正后的Cox比例风险模型对整个研究样本以及严重肢体缺血（CLI）和间歇性跛行亚组的结局进行事件发生时间分析。Cox回归模型的结果以风险比（HR）和95%置信区间（CI）表示。
接受血管内手术的糖尿病患者合并症发生率更高（p<0.001）、CLI发生率更高（p<0.001）、严重钙化病变发生率更高（p=0.002）、多支血管病变发生率更高（p=0.030），而腘动脉以下流出道血管更少（p<0.001）。校正混杂因素后的回归分析显示，与非糖尿病患者相比，糖尿病患者的目标肢体大截肢率显著更高（HR 5.02，95%CI 1.44至17.56，p=0.011）。然而，再次血管再通率相似。在考虑CLI和间歇性跛行亚组时，糖尿病仅与CLI患者12个月时大截肢风险非显著增加相关（HR 3.48，95%CI 0.97至12.51，p=0.056）。糖尿病还与整个研究样本（HR 4.64，95%CI 2.01至10.70，p<0.001）以及CLI亚组（HR 14.15，95%CI 3.16至63.32，p<0.001）12个月时全因死亡率增加相关，但与间歇性跛行亚组无关（HR 1.42，95%CI 0.45至4.54，p=0.552）。
糖尿病增加了有症状PAD患者血管内血管再通后12个月时大截肢和全因死亡的风险。这些风险在CLI患者中尤其升高。
