Aortic & peripheral vascular disease
Safety and effectiveness of drug-coated devices in chronic limb-threatening ischaemia: a nationwide analysis
Authors' conclusion
In this national CLTI cohort, drug-coated devices were associated with reduced amputation and mortality. Data from this study suggest that DCBs may offer consistent benefit without increased costs.
Study context
- Population
- Medicare beneficiaries aged ≥66 years who underwent femoropopliteal revascularisation for CLTI between 2016 and 2023
- Participants
- 108,304 CLTI patients
- Exposure
- PBA±BMS vs drug-coated balloons (DCBs)±BMS vs drug-eluting stents (DES)
- PBA±BMSn = 52.5%reference
- DCB±BMSn = 30.7%
- DESn = 16.8%
Methodological detailsnationwide, Medicare beneficiaries, multivariable Cox and gamma regression models
- Nationwide
- Medicare beneficiaries
- Multivariable Cox and gamma regression models
Main finding
As reported in the abstract
Composite of:
- All-cause mortality
- Major amputation
Observational data: associations, not effects.
Further findings
| Outcome | PBA±BMS | DCB±BMS | DES | HR (95% CI) | |
|---|---|---|---|---|---|
| Composite of all-cause mortality or major amputation · 5 years — DCB±BMS vs PBA±BMS · lower risk | 75.69% | 71.19% | 71.71% | 0.92 (0.90–0.93) | |
| Composite of all-cause mortality or major amputation · 5 years — DES vs PBA±BMS · lower risk | 0.93 (0.92–0.95) | ||||
| Major amputation, mortality, MALE and reintervention (DCBs) · major amputation | 0.87 (0.84–0.91) | ||||
| Major amputation, mortality, MALE and reintervention (DCBs) · mortality | 0.93 (0.91–0.94) | ||||
| Major amputation, mortality, MALE and reintervention (DCBs) · MALE | 0.96 (0.94–0.98) | ||||
| Major amputation, mortality, MALE and reintervention (DCBs) · reintervention | 0.97 (0.96–0.99) | ||||
| 0.512Hazard ratio (log scale) |
| Outcome | PBA±BMS | DCB±BMS | DES | Estimate | |
|---|---|---|---|---|---|
| Proportion of BMS use | 10.1% | 3.1% | Not reported in the abstract | DES: not reported in the abstract |
Original publication
Safety and effectiveness of drug-coated devices in chronic limb-threatening ischaemia: a nationwide analysis. EuroIntervention. Published 2 March 2026. doi:10.
Summarised from the published abstract; every number is checked against it