Hicks Caitlin W, Najafian Alireza, Farber Alik, Menard Matthew T, Malas Mahmoud B, Black James H, Abularrage Christopher J
Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, The Johns Hopkins Hospital, Baltimore, Md.
Center for Surgical Trials and Outcomes Research, Department of Surgery, The Johns Hopkins Hospital, Baltimore, Md.
J Vasc Surg. 2016 Dec;64(6):1667-1674.e1. doi: 10.1016/j.jvs.2016.07.107.
Both open surgery and endovascular peripheral interventions have been shown to effectively improve outcomes in patients with peripheral arterial disease, but minimal data exist comparing outcomes performed at and below the knee among patients with diabetes (DM) specifically. The purpose of this study is to compare outcomes following open bypass (lower extremity bypass [LEB]) and peripheral vascular intervention (PVI) at and below the knee in patients with DM vs patients without DM (non-DM) with critical limb ischemia.
Data from the 2008-2014 Vascular Quality Initiative (VQI) were analyzed. All patients undergoing LEB or PVI at or below the knee for rest pain or tissue loss were included. One-year primary patency, major amputation, and mortality were compared for patients with DM vs patients without DM stratified by treatment approach.
Overall, 2566 patients were included, including 500 patients (19%) undergoing LEB (DM = 355 vs non-DM = 145) and 2066 patients (81%) undergoing PVI (DM = 1463 vs non-DM = 603). Patients with DM were more frequently black (18% vs 14%), had more comorbidities, and more frequently underwent revascularization for tissue loss (85% vs 58%) compared with patients without DM (all, P < .001). Within the LEB group, there were no significant differences in 1-year primary patency (74% vs 71%; P =.52), major amputation (16% vs 12%; P = .39), or mortality (10% vs 6%; P =.16) between DM vs non-DM patients. There were also no significant differences in 1-year primary patency (81% vs 79%; P = .36), major amputation (14% vs 11%; P =.09) or mortality (6% vs 7%; P =.30) among patients with DM vs patients without DM undergoing PVI. Multivariable analysis adjusting for baseline differences between groups demonstrated a nonsignificant trend toward better primary patency in the DM group following both LEB (hazard ratio, 1.55; 95% confidence interval, 1.00-2.42; P = .05) and PVI (hazard ratio, 1.23; 95% confidence interval, 0.97-1.56; P = .09). There were no significant differences in 1-year major amputation or mortality comparing patients with DM vs patients without DM for either LEB or PVI after risk adjustment (all, P ≥ .16).
Critical limb ischemia resulting from arterial occlusive disease at or below the knee can be treated successfully with either open surgical bypass or endovascular interventions in both DM and non-DM patients. Aggressive attempts at limb salvage among patients with critical limb ischemia should be pursued regardless of DM status.
开放手术和血管腔内周围血管介入治疗均已被证明能有效改善外周动脉疾病患者的预后,但专门比较糖尿病(DM)患者膝部及以下部位治疗效果的数据极少。本研究的目的是比较糖尿病合并严重肢体缺血患者与非糖尿病(非DM)患者在膝部及以下部位进行开放旁路手术(下肢旁路手术[LEB])和周围血管介入治疗(PVI)后的预后。
分析2008 - 2014年血管质量倡议(VQI)的数据。纳入所有因静息痛或组织缺损而在膝部及以下部位接受LEB或PVI的患者。按治疗方法对糖尿病患者和非糖尿病患者的1年主要通畅率、大截肢率和死亡率进行比较。
总体而言,共纳入2566例患者,其中500例(19%)接受LEB(糖尿病患者 = 355例,非糖尿病患者 = 145例),2066例(81%)接受PVI(糖尿病患者 = 1463例,非糖尿病患者 = 603例)。与非糖尿病患者相比,糖尿病患者更常为黑人(18%对14%),合并症更多,因组织缺损接受血运重建的频率更高(85%对58%)(所有P <.001)。在LEB组中,糖尿病患者与非糖尿病患者在1年主要通畅率(74%对71%;P =.52)、大截肢率(16%对12%;P =.39)或死亡率(10%对6%;P =.16)方面无显著差异。接受PVI的糖尿病患者与非糖尿病患者在1年主要通畅率(81%对79%;P =.36)、大截肢率(14%对11%;P =.09)或死亡率(6%对7%;P =.30)方面也无显著差异。对组间基线差异进行调整的多变量分析显示,LEB(风险比,1.55;95%置信区间,1.00 - 2.42;P =.05)和PVI(风险比,1.23;95%置信区间,0.97 - 1.56;P =.09)后,糖尿病组主要通畅率有更好的非显著趋势。风险调整后,LEB或PVI的糖尿病患者与非糖尿病患者在1年大截肢率或死亡率方面无显著差异(所有P≥.16)。
糖尿病患者和非糖尿病患者因膝部及以下动脉闭塞性疾病导致的严重肢体缺血,均可通过开放手术旁路或血管腔内介入治疗成功治疗。无论糖尿病状态如何,对于严重肢体缺血患者都应积极尝试保肢治疗。