Cost-effectiveness analysis of infrapopliteal drug-eluting stents
Konstantinos Katsanos1, Dimitris Karnabatidis, Athanasios Diamantopoulos
1Department of Interventional Radiology, School of Medicine, Patras University Hospital, 26504, Rion, Greece. katsanos@med.upatras.gr
Insights
Drug-eluting stents for critical limb ischemia (CLI) offer improved survival. Both bail-out and primary stenting strategies show favorable cost-effectiveness, with single-digit numbers needed to treat for better outcomes.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Health Economics
Background:
- Cost-utility data for below-the-knee drug-eluting stent placement are lacking.
- Critical Limb Ischemia (CLI) treatment effectiveness and cost require evaluation.
Purpose of the Study:
- To determine the cost-effectiveness of infrapopliteal drug-eluting stents for CLI.
- To compare two strategies: Bail-out Sirolimus-eluting stents (SES) and Primary Everolimus-eluting stents (EES).
Main Methods:
- Reconstruction of event-free survival outcomes (death, amputation, repeat procedures).
- Analysis of Bail-out SES versus bare metal stents and primary EES versus balloon angioplasty.
- Calculation of Number-Needed-to-Treat (NNT) and Incremental Cost-Effectiveness Ratios (ICERs) over 3 years.
Main Results:
- Both Bail-out SES and primary EES significantly improved event-free survival (HR 0.68 and 0.53, respectively).
- Bail-out SES yielded a survival gain of 0.89 years with NNT 4.6 and ICER €6,518.
- Primary EES yielded a survival gain of 0.91 years with NNT 2.7 and ICER €11,581.
- Longer lesion length (>10 cm) and higher DES cost (>€1000) reduced economic favorability.
Conclusions:
- Both bail-out SES and primary EES strategies for infrapopliteal arteries in CLI are cost-effective.
- Both approaches demonstrate single-digit NNT and relatively low ICERs, supporting their use in CLI treatment.
Introduction:
There are no cost-utility data about below-the-knee placement of drug-eluting stents. The authors determined the cost-effectiveness of infrapopliteal drug-eluting stents for critical limb ischemia (CLI) treatment.
Methods:
The event-free individual survival outcomes defined by the absence of any major events, including death, major amputation, and target limb repeat procedures, were reconstructed on the basis of two published infrapopliteal series. The first included spot Bail-out use of Sirolimus-eluting stents versus bare metal stents after suboptimal balloon angioplasty (Bail-out SES).The second was full-lesion Primary Everolimus-eluting stenting versus plain balloon angioplasty and bail-out bare metal stenting as necessary (primary EES). The number-needed-to-treat (NNT) to avoid one major event and incremental cost-effectiveness ratios (ICERs) were calculated for a 3-year postprocedural period for both strategies.
Results:
Overall event-free survival was significantly improved in both strategies (hazard ratio (HR) [confidence interval (CI)]: 0.68 [0.41-1.12] in Bail-out SES and HR [CI]: 0.53 [0.29-0.99] in Primary EES). Event-free survival gain per patient was 0.89 (range, 0.11-3.0) years in Bail-out SES with an NNT of 4.6 (CI: 2.5-25.6) and a corresponding ICER of 6,518
Conclusions:
Both strategies of bail-out SES and primary EES placement in the infrapopliteal arteries for CLI treatment exhibit single-digit NNT and relatively low corresponding ICERs.

