Underutilization of Drug-Eluting Stents in Infrapopliteal Intervention for Chronic Limb-Threatening Ischemia
Zachary Zuzek1, Shilpkumar Arora1, Irfan Helmy1
1Harrington Heart and Vascular Institute, Case Western Reserve University School of Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA.
Insights
Drug-eluting stents (DES) show better outcomes than bare-metal stents (BMS) for infrapopliteal chronic limb-threatening ischemia (CLTI). Despite evidence, DES are underutilized in real-world CLTI patients, but they are associated with improved limb outcomes.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Health Services Research
Background:
- Randomized trials indicate drug-eluting stents (DES) outperform bare-metal stents (BMS) for infrapopliteal disease.
- Real-world data on DES use and outcomes in chronic limb-threatening ischemia (CLTI) patients are limited.
Purpose of the Study:
- To evaluate drug-eluting stent (DES) utilization and outcomes in patients with infrapopliteal chronic limb-threatening ischemia (CLTI).
- To compare real-world outcomes of DES versus bare-metal stents (BMS) in this patient population.
Main Methods:
- Analysis of the Nationwide Readmission Database (NRD) from 2016-2017.
- Inclusion of patients undergoing infrapopliteal intervention for CLTI using ICD-10 codes.
- Multilevel logistic regression and Cox-proportional hazard regression were used to assess DES utilization and outcomes, adjusting for confounders.
Main Results:
- 1817 patients were included; 58.1% received DES.
- DES utilization was stable between 2016-2017 and higher in teaching and larger hospitals.
- DES use was associated with a significantly lower rate of major amputation or revascularization compared to BMS (aHR=0.75).
Conclusions:
- Drug-eluting stents (DES) are underutilized in real-world infrapopliteal interventions for CLTI, despite evidence of superiority.
- DES use is associated with improved limb salvage outcomes compared to bare-metal stents (BMS) in CLTI patients.
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.
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