Purpose: Evaluate long-term outcomes of patients with critical limb ischemia and long-segment ( >38mm) infrapopliteal lesions treated with everolimus-eluting coronary stents (EES) with prior failed angioplasty (PTA).
Materials and Methods: We reviewed clinical and target lesion information in patients with long-segment lesions treated with EES after failed PTA between 01/2009 – 09/2018. The primary endpoint was 2-year major amputation free survival; secondary endpoints included freedom from 30-day major adverse event (MAE) and overall survival at 24-months. To evaluate the primary and secondary endpoints, Kaplan-Meier analyses was performed. The log-rank test was used to compare differences between Rutherford groups (Rutherford 4 and 5 compared to Rutherford 6) for each endpoint.
Results: Sixty-three patients (age 73.6±11.2, 24 female 39 male), with sixty-five treated limbs met inclusion criteria. Thirty-seven Rutherford 4 or 5 limbs were included, and 28 Rutherford 6 limbs were included. Mean lesion length was 102.4±53.0mm [44.0-380mm]. The mean number of stents used was 2.8; range [2-10 stents]. During the two-years post-procedure, 40 patients were censored: there were 12 deaths, 9 major amputations, and 19 patients were lost to two-year follow-up. Two-year freedom from major amputation for Rutherford 4 and 5 patients was 84.8% compared to 44.5% for patients in the Rutherford 6 group (p=0.002; Hazards Ratio: 3.9, confidence interval [1.6-9.4]). The overall amputation free survival at two-years was 66.2% and the overall two-year survival was 78.3%. There were 5 MAE within 30-days (4 deaths and 1 major amputation).
Conclusion: In patients with critical limb ischemia, placement of multiple EES in long-segment infrapopliteal lesions with prior failed PTA is a durable treatment option with two year amputation free survival of 66.6%. Patients with Rutherford 4 and 5 critical limb ischemia have markedly better outcomes compared to patients with Rutherford 6 limb ischemia.