Department of Cardiovascular Medicine, University of Kansas Medical Center, Kansas City.
Department of Internal Medicine, St Peter's University Hospital, New Brunswick, New Jersey.
JAMA Netw Open. 2022 Aug 1;5(8):e2227746. doi: 10.1001/jamanetworkopen.2022.27746.
The Bypass Versus Angioplasty for Severe Ischemia of the Leg randomized controlled trial showed comparable outcomes between endovascular revascularization (ER) and surgical revascularization (SR) for patients with critical limb ischemia (CLI). However, several observational studies showed mixed results. Most of these studies were conducted before advanced endovascular technologies were available.
To compare ER and SR treatment strategies for 6-month outcomes among patients with CLI.
DESIGN, SETTING, AND PARTICIPANTS: This retrospective, population-based cohort study used the Nationwide Readmissions Database to identify 66 277 patients with CLI who underwent ER or SR from January 1, 2016, to December 31, 2018. Data analyses were conducted from January 1, 2022, to February 8, 2022. A propensity score with 1:1 matching was applied. Patients with CLI who underwent ER or SR were identified, and those with missing information on the length of stay and/or younger than 18 years were excluded.
Endovascular or surgical revascularization.
The primary outcome was a major amputation at 6 months. Significant secondary outcomes were in-hospital and 6-month mortality and an in-hospital safety composite of acute kidney injury, major bleeding, and vascular complication. Subgroup analysis was conducted for major amputation in high-volume centers.
A total of 66 277 patients were identified between 2016 and 2018 who underwent ER or SR for CLI. The Nationwide Readmissions Database does not provide racial and ethnic categories. The mean (SD) age of the cohort was 69.3 (12) years, and 62.5% of patients were male. A total of 54 546 patients (82.3%) underwent ER and 11 731 (17.7%) underwent SR. After propensity score matching, 11 106 matched pairs were found. Endovascular revascularization was associated with an 18% higher risk of major amputation compared with SR (997 of 10 090 [9.9%] vs 869 of 10 318 [8.4%]; hazard ratio, 1.18; 95% CI, 1.08-1.29; P = .001). However, no difference was observed in major amputation risk when both procedures were performed in high-volume centers. Endovascular revascularization and SR had similar mortality rates (517 of 11 106 [4.7%] vs 490 of 11 106 [4.4%]; hazard ratio, 1.06; 95% CI, 0.93-1.20; P = .39). However, the ER group had a 17% lower risk of in-hospital safety outcomes compared with the SR group (2584 of 11 106 [23.3%] vs 2979 of 11 106 [26.8%]; odds ratio, 0.83; 95% CI, 0.78-0.88; P < .001).
The results of this study suggest that ER was safer, without any difference in mortality, but ER was associated with an increased risk of major amputation compared with SR. However, the risk of major amputation was similar when both procedures were performed at high-volume centers.
Bypass Versus Angioplasty for Severe Ischemia of the Leg 随机对照试验表明，对于患有严重肢体缺血（CLI）的患者，血管内血运重建（ER）和手术血运重建（SR）的结果相当。然而，几项观察性研究结果不一。这些研究大多是在先进的血管内技术出现之前进行的。
比较 CLI 患者 6 个月时 ER 和 SR 治疗策略的结果。
设计、地点和参与者：这项回顾性、基于人群的队列研究使用全国再入院数据库，确定了 2016 年 1 月 1 日至 2018 年 12 月 31 日期间接受 ER 或 SR 的 66277 例 CLI 患者。数据分析于 2022 年 1 月 1 日至 2022 年 2 月 8 日进行。采用 1:1 匹配的倾向评分。确定了接受 ER 或 SR 的 CLI 患者，并排除了住院时间和/或年龄小于 18 岁的患者。
血管内或手术血运重建。
主要结局是 6 个月时的主要截肢。显著的次要结局包括院内和 6 个月死亡率以及急性肾损伤、大出血和血管并发症的院内安全性综合指标。进行了高容量中心的主要截肢亚组分析。
在 2016 年至 2018 年间，全国再入院数据库确定了 66277 例接受 ER 或 SR 治疗 CLI 的患者。该数据库未提供种族和民族类别。队列的平均（SD）年龄为 69.3（12）岁，62.5%的患者为男性。共有 54546 例（82.3%）患者接受 ER 治疗，11731 例（17.7%）患者接受 SR 治疗。在进行倾向评分匹配后，发现 11106 对匹配。与 SR 相比，ER 发生主要截肢的风险高 18%（10090 例中的 997 例[9.9%] vs 10318 例中的 869 例[8.4%]；风险比，1.18；95%CI，1.08-1.29；P = .001）。然而，当两种手术都在高容量中心进行时，主要截肢风险无差异。ER 和 SR 的死亡率相似（11106 例中的 517 例[4.7%] vs 11106 例中的 490 例[4.4%]；风险比，1.06；95%CI，0.93-1.20；P = .39）。然而，与 SR 组相比，ER 组的院内安全性结局风险低 17%（11106 例中的 2584 例[23.3%] vs 11106 例中的 2979 例[26.8%]；优势比，0.83；95%CI，0.78-0.88；P < .001）。
这项研究的结果表明，ER 更安全，死亡率无差异，但与 SR 相比，ER 发生主要截肢的风险更高。然而，当两种手术都在高容量中心进行时，主要截肢的风险相似。
