Purpose: Multiple randomized clinical trials have shown superiority of drug-eluting stents (DES) over bare-metal stents (BMS) for infrapopliteal disease. However, real-world data on DES utilization and outcomes in infrapopliteal chronic limb-threatening ischemia (CLTI) patients are unknown.
Materials and methods: We utilized the Nationwide Readmission Database (NRD) from 2016 to 2017 to extract patients undergoing infrapopliteal intervention with stents (BMS and DES) for CLTI using appropriate ICD-10 codes. Multilevel logistic regression with hospital ID as random effect was used to assess DES utilization. Primary outcome was the composite of target limb major amputation (TLmajA) and target limb revascularization (TLR). Multivariate Cox-proportional hazard regression was used to adjust for confounders.
Results: Our study included a total of 1817 patients. Of these patients, 1056 patients (58.1%) received DES; DES utilization was stable (relative change: +2.5%, p-trend: 0.867) between 2016 and 2017 and was higher in teaching hospitals (adjusted odds ratio [aOR] = 1.28, 95% CI = 1.03-1.61, p=0.029] and medium (aOR = 3.13, 95% CI = 2.17-4.55, p≤0.001) and large (aOR = 1.56, 95% CI = 1.14-2.17, p=0.005) bed-sized hospitals. Inter-class correlation was 0.44 suggesting ~44% variation in DES utilization between any 2 random hospitals; DES was associated with lower rate of the primary composite outcome (aHR = 0.75, 95% CI = 0.62-0.92, p=0.004) compared with BMS.
Conclusion: In patients undergoing infrapopliteal intervention for CLTI, DES demonstrated significant underutilization despite supportive evidence of their superiority compared with BMS; DES was associated with improvement in the primary composite outcome compared with BMS.
Keywords: angioplasty; chronic limb-threatening ischemia; drug-eluting stent; nationwide readmissions database.