Investigation of Factors for a Poor Prognosis in Rutherford 4 Patients Who Undergo Endovascular Treatment

Current classifications of chronic limb-threatening ischemia (CLTI) are insufficient to identify Rutherford (R) 4 patients with a poor prognosis. This study aimed to investigate the prognostic factors for patients with R4 CLTI who undergo endovascular treatment (EVT) using data from the Tokyo-taMA peripheral vascular intervention research COmraDE (TOMA-CODE) registry and to propose a risk-scoring system. We analyzed the data of 2,248 prospectively enrolled patients from the registry, divided into 3 groups: intermittent claudication (IC), n = 1,185; R4, n = 401; and R5-6, n = 662. We ascertained amputation-free survival (AFS) 1, 6, 12, 18, and 24 months post-EVT. The 2-year major AFS rates for IC, R4, and R5-6 were 0.944 (95% confidence interval [CI]: 0.921-0.960), 0.830 (0.753-0.885), and 0.576 (0.508-0.638), respectively. The final logistic regression model after addressing optimism included 5 factors: Non-ambulatory status, White blood cell count ≥ 10,000/μL, Revascularization for lesions in the infrapopliteal arteries, previous history of Cerebrovascular disease, and New York Heart Association class III-IV Heart failure (NoWRiCH score). We developed 3 risk-scoring models. When non-ambulatory status was assigned 2 points and the other factors were assigned 1 point each, the prognosis of R4 patients with ≥ 2 points was equivalent to that of R5-6 patients (R4/R5-6; 2-year survival rate, 95% CI: 0.423, 0.204-0.628, P < 0.001/0.576, 0.508-0.638, P < 0.001). The NoWRiCH score facilitates the identification of R4 patients with a poor prognosis.