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Comparison of 6-Month Outcomes of Endovascular vs Surgical Revascularization for Patients With Critical Limb Ischemia
Monil Majmundar1, Kunal N Patel2, Rajkumar Doshi3
1Department of Cardiovascular Medicine, University of Kansas Medical Center, Kansas City.
Insights
Endovascular revascularization (ER) for critical limb ischemia (CLI) showed similar mortality but a higher amputation risk versus surgical revascularization (SR). However, amputation risk was comparable in high-volume centers, with ER being safer overall.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Health Outcomes Research
Background:
- Critical limb ischemia (CLI) poses significant risks, with endovascular revascularization (ER) and surgical revascularization (SR) as primary treatment options.
- Previous studies on ER vs. SR for CLI have yielded mixed results, potentially due to the evolution of endovascular technologies.
Purpose of the Study:
- To compare the 6-month outcomes of ER versus SR in a large patient cohort with CLI.
- To evaluate the safety and efficacy of ER and SR strategies for CLI treatment.
Main Methods:
- Retrospective analysis of 66,277 patients with CLI undergoing ER or SR from 2016-2018 using the Nationwide Readmissions Database.
- Propensity score matching (1:1) was employed to minimize confounding factors between the ER and SR groups.
- Primary outcome was major amputation at 6 months; secondary outcomes included mortality and in-hospital safety composite.
Main Results:
- ER was associated with an 18% higher risk of major amputation compared to SR (9.9% vs. 8.4%), but this difference disappeared when procedures were performed in high-volume centers.
- Mortality rates were similar between ER and SR groups (4.7% vs. 4.4%).
- ER demonstrated a 17% lower risk of in-hospital safety composite outcomes (acute kidney injury, major bleeding, vascular complication) compared to SR.
Conclusions:
- While ER for CLI is associated with a higher risk of major amputation than SR, it offers comparable mortality and improved in-hospital safety.
- The increased risk of major amputation with ER is mitigated when procedures are conducted in high-volume centers.
- These findings suggest ER is a safer alternative to SR for CLI, particularly in experienced centers, despite a potential increase in amputation rates.
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 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.
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 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).
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.
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