Mehaffey J Hunter, Hawkins Robert B, Fashandi Anna, Cherry Kenneth J, Kern John A, Kron Irving L, Upchurch Gilbert R, Robinson William P
Division of Vascular and Endovascular Surgery and Division of Thoracic and Cardiovascular Surgery, Department of Surgery, University of Virginia, Charlottesville, Va.
Division of Vascular and Endovascular Surgery and Division of Thoracic and Cardiovascular Surgery, Department of Surgery, University of Virginia, Charlottesville, Va.
J Vasc Surg. 2017 Oct;66(4):1109-1116.e1. doi: 10.1016/j.jvs.2017.04.036. Epub 2017 Jun 24.
Lower extremity bypass (LEB) has traditionally been the "gold standard" in the treatment of critical limb ischemia (CLI). Infrainguinal endovascular intervention (IEI) has become more commonly performed than LEB, but comparative outcomes are limited. We sought to compare rates of major adverse limb events (MALEs) and major adverse cardiovascular events (MACEs) after LEB and IEI in a propensity score-matched, national cohort of patients with CLI.
The National Surgical Quality Improvement Program (NSQIP) vascular targeted files (2011-2014) for LEB and IEI were merged. CLI patients were identified by ischemic rest pain or tissue loss. Patients were matched on a 1:1 basis for propensity to undergo LEB or IEI. Primary outcomes were 30-day MALEs and MACEs. Within the propensity-matched cohort, multivariate logistic regression was used to identify independent predictors of MALEs and MACEs.
A total of 13,294 LEBs and IEIs were identified, with 8066 cases performed for CLI. Propensity matching identified 3848 cases (1924 per group). There were no differences in preoperative variables between the propensity-matched LEB and IEI groups (all P > .05). At 30 days, rates of MALEs were significantly lower in the LEB group (9.2% LEB vs IEI 12.2%; P = .003). On multivariate logistic regression, bypass with single-segment saphenous vein vs IEI (odds ratio [OR], 0.7; 95% confidence interval [CI], 0.54-0.92; P = .01), bypass with alternative conduit (prosthetic, spliced vein, or composite) vs IEI (OR, 0.7; 95% CI, 0.56-0.98; P = .04), antiplatelet therapy (OR, 0.8; 95% CI, 0.58-1.00; P = .049), and statin therapy (OR, 0.8; 95% CI, 0.62-0.99; P = .04) were protective against MALEs, whereas infrageniculate intervention (OR, 1.4; 95% CI, 1.09-1.72; P = .01) and a history of prior bypass of the same arterial segment (OR, 1.8; 95% CI, 1.41-2.41; P <. 0001) were predictive. Rates of 30-day MACEs were not significantly different (4.9% LEB vs 3.7% IEI; P = .07) between the groups. Independent predictors of MACEs included age (OR, 1.02; 95% CI, 1.01-1.04; P = .01), steroid use (OR, 1.8; 95% CI, 1.08-2.99; P = .03), congestive heart failure (OR, 1.7; 95% CI, 1.00-1.96; P = .02), beta blocker use (OR, 1.6; 95% CI, 1.09-1.43; P = .01), dialysis (OR, 2.3; 95% CI, 1.55-3.45; P < .0001), totally dependent functional status (OR, 3.1; 95% CI, 1.25-7.58; P = .02), and suboptimal conduit for LEB compared with IEI (OR, 1.6; 95% CI, 1.08-2.36; P = .02).
Within this large, propensity-matched, national cohort, LEB predicted lower risk-adjusted 30-day MALE rate compared with IEI. Furthermore, there was no difference in 30-day MACE rate between the groups despite higher inherent risk with open surgical procedures. Therefore, this study supports the effectiveness and primacy of LEB for revascularization in CLI.
传统上,下肢旁路移植术(LEB)一直是治疗严重肢体缺血(CLI)的“金标准”。腹股沟下血管腔内介入治疗(IEI)的开展频率已超过LEB,但对比研究结果有限。我们旨在比较倾向评分匹配的全国CLI患者队列中,LEB和IEI术后的主要肢体不良事件(MALE)和主要心血管不良事件(MACE)发生率。
合并国家外科质量改进计划(NSQIP)2011 - 2014年LEB和IEI的血管靶向文件。通过静息性缺血性疼痛或组织缺失来识别CLI患者。患者根据接受LEB或IEI的倾向进行1:1匹配。主要结局为30天的MALE和MACE。在倾向匹配队列中,采用多因素logistic回归确定MALE和MACE的独立预测因素。
共识别出13294例LEB和IEI手术,其中8066例为CLI患者。倾向匹配后确定3848例(每组1924例)。倾向匹配的LEB组和IEI组术前变量无差异(所有P>.05)。30天时,LEB组的MALE发生率显著低于IEI组(LEB为9.2%,IEI为12.2%;P =.003)。多因素logistic回归显示,单段大隐静脉旁路移植术与IEI相比(比值比[OR],0.7;95%置信区间[CI],0.54 - 0.92;P =.01),使用替代管道(人工血管、拼接静脉或复合管道)的旁路移植术与IEI相比(OR,0.7;95% CI,0.56 - 0.98;P =.04),抗血小板治疗(OR,0.8;95% CI,0.58 - 1.00;P =.049),以及他汀类药物治疗(OR,0.8;95% CI,0.62 - 0.99;P =.04)对MALE有保护作用,而膝下介入治疗(OR,1.4;95% CI,1.09 - 1.72;P =.01)和同一动脉段既往有旁路移植史(OR,1.8;95% CI,1.41 - 2.41;P <.0001)具有预测性。两组30天MACE发生率无显著差异(LEB为4.9%,IEI为3.7%;P =.07)。MACE的独立预测因素包括年龄(OR,1.02;95% CI,1.01 - 1.04;P =.01),使用类固醇(OR,1.8;95% CI,1.08 - 2.99;P =.03),充血性心力衰竭(OR,1.7;95% CI,1.00 - 1.96;P =.02),使用β受体阻滞剂(OR,1.6;95% CI,1.09 - 1.43;P =.01),透析(OR,2.3;95% CI,1.55 - 3.45;P <.0001),完全依赖的功能状态(OR,3.1;95% CI,1.25 - 7.58;P =.02),以及与IEI相比LEB的管道不理想(OR,1.6;95% CI,1.08 - 2.36;P =.02)。
在这个大型的、倾向评分匹配的全国队列中,与IEI相比,LEB预测的30天MALE风险调整率更低。此外,尽管开放手术固有风险更高,但两组30天MACE发生率无差异。因此,本研究支持LEB在CLI血管重建中的有效性和首要地位。