Comparative Outcomes of Catheter-Directed Thrombolysis and Open Surgical Revascularization in Early-Stage Acute Limb Ischemia: Real-World Evidence from a Retrospective Cohort Study
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Background: Acute limb ischemia (ALI) is a vascular emergency where timely revascularization is crucial for limb salvage and survival. While open surgical revascularization (OSR) has been the traditional standard, catheter-directed thrombolysis (CDT) has emerged as a minimally invasive alternative. Comparative real-world evidence in early-stage ALI (Rutherford I–IIa) remains limited. Methods: We conducted a retrospective single-center cohort study including 36 patients with ALI treated between 2019 and 2023 (OSR: n=24; CDT: n=12). Demographics, comorbidities, procedural details, and outcomes were analyzed. The primary endpoint was a composite of in-hospital mortality, primary patency, and secondary patency. Secondary endpoints included amputation, cerebrovascular events, renal function, and hospital stay. Effect sizes with 95% confidence intervals were reported alongside p-values to address type II error risk. Results: Baseline characteristics were comparable between groups. Both OSR and CDT significantly improved ankle-brachial index (0.64 ± 0.43 to 0.93 ± 0.33, p< 0.001) and postoperative arterial patency. At 12 months, primary patency was 66.7% (OSR) vs. 50.0% (CDT), and secondary patency was 79.2% vs. 75.0% (p>0.05). Major amputation (12.5% vs. 16.7%) and mortality (8.3% vs. 16.7%) rates did not differ significantly. Hospital stay was longer after OSR (7.29 ± 4.58 vs. 6.08 ± 8.75 days, p=0.038). Fibrinogen levels decreased significantly during CDT, but no major bleeding events occurred. Conclusion: Both OSR and CDT provide effective revascularization in early ALI, with comparable limb salvage and survival outcomes. CDT offers a minimally invasive alternative with acceptable safety when accompanied by careful monitoring, whereas OSR remains a reliable option with immediate reperfusion. Larger multicenter studies are needed to refine patient selection and optimize treatment algorithms.