TY - JOUR
T1 - Comparison of 6-Month Outcomes of Endovascular vs Surgical Revascularization for Patients with Critical Limb Ischemia
AU - Majmundar, Monil
AU - Patel, Kunal N.
AU - Doshi, Rajkumar
AU - Anantha-Narayanan, Mahesh
AU - Kumar, Ashish
AU - Reed, Grant W.
AU - Puri, Rishi
AU - Kapadia, Samir R.
AU - Jaradat, Ziad A.
AU - Bhatt, Deepak L.
AU - Kalra, Ankur
N1 - Publisher Copyright:
© 1947 American Society of Mechanical Engineers (ASME). All rights reserved.
PY - 2022/8/19
Y1 - 2022/8/19
N2 - Importance: 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. Objective: 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 66277 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. Exposures: Endovascular or surgical revascularization. Main Outcomes and Measures: 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. Results: A total of 66277 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 54546 patients (82.3%) underwent ER and 11731 (17.7%) underwent SR. After propensity score matching, 11106 matched pairs were found. Endovascular revascularization was associated with an 18% higher risk of major amputation compared with SR (997 of 10090 [9.9%] vs 869 of 10318 [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 11106 [4.7%] vs 490 of 11106 [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 11106 [23.3%] vs 2979 of 11106 [26.8%]; odds ratio, 0.83; 95% CI, 0.78-0.88; P <.001). Conclusions and Relevance: 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.
AB - Importance: 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. Objective: 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 66277 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. Exposures: Endovascular or surgical revascularization. Main Outcomes and Measures: 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. Results: A total of 66277 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 54546 patients (82.3%) underwent ER and 11731 (17.7%) underwent SR. After propensity score matching, 11106 matched pairs were found. Endovascular revascularization was associated with an 18% higher risk of major amputation compared with SR (997 of 10090 [9.9%] vs 869 of 10318 [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 11106 [4.7%] vs 490 of 11106 [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 11106 [23.3%] vs 2979 of 11106 [26.8%]; odds ratio, 0.83; 95% CI, 0.78-0.88; P <.001). Conclusions and Relevance: 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.
UR - http://www.scopus.com/inward/record.url?scp=85137008274&partnerID=8YFLogxK
U2 - 10.1001/jamanetworkopen.2022.27746
DO - 10.1001/jamanetworkopen.2022.27746
M3 - Article
C2 - 35984655
AN - SCOPUS:85137008274
SN - 2574-3805
VL - 5
SP - E2227746
JO - JAMA network open
JF - JAMA network open
IS - 8
ER -