From the Guidelines
Drug-coated balloon (DCB) therapy is recommended as the first choice for femoro-popliteal lesion revascularization, especially in surgical high-risk patients, due to its improved long-term patency and safety profile, as supported by the most recent guidelines 1.
Key Considerations
- DCB therapy has been shown to provide superior patency rates compared to plain balloon angioplasty, with primary patency rates of 65-85% at 12 months.
- The MACE (Major Adverse Cardiovascular Events) rates with DCBs are generally low, typically under 10% at one year.
- Proper lesion preparation is essential, including adequate pre-dilation and ensuring appropriate balloon sizing (1:1 ratio to vessel diameter).
- Inflation time should be 2-3 minutes to maximize drug transfer.
- Post-procedure, patients should receive dual antiplatelet therapy with aspirin (75-100mg daily, indefinitely) and clopidogrel (75mg daily for at least 1 month).
Specific Recommendations
- For short lesions (<25 cm), an endovascular-first strategy is recommended, with DCB therapy being a viable option 1.
- For long lesions (>25 cm), bypass surgery is indicated when an autologous vein is available and life expectancy is > 2 years, but endovascular therapy may be considered in patients unfit for surgery 1.
Limitations and Future Directions
- The efficacy of DCBs may be limited in heavily calcified lesions, chronic total occlusions, or in-stent restenosis cases, where additional strategies might be needed.
- Further research is needed to fully understand the long-term benefits and risks of DCB therapy in different patient populations and lesion types.
From the Research
Overview of DCB Revascularization
- DCB revascularization is a treatment approach for femoropopliteal arterial disease, which involves the use of drug-coated balloons to reduce restenosis rates 2.
- The evidence suggests that DCB revascularization is associated with improved outcomes compared to plain old balloon angioplasty (POBA), including reduced target lesion revascularization and improved primary patency 2, 3, 4, 5.
Comparison of DCB and DES
- Studies have compared the effectiveness of DCB revascularization with drug-eluting stents (DES) for femoropopliteal lesions, with mixed results 3, 5.
- One study found that DCB revascularization was not superior to DES in the treatment of complex femoropopliteal lesions, with similar rates of restenosis and clinically driven target lesion revascularization 3.
- Another study found that DES and DCB revascularization had comparable effectiveness and safety at 12 months, but a trend in favor of DES was observed up to 36 months 5.
Predictors of Restenosis
- Predictors of restenosis after DCB revascularization include diabetes, heavily calcified lesions, and popliteal lesions 2.
- The use of standard-dose DCBs (3 μg/mm2) was found to be more effective than low-dose DCBs (2 μg/mm2) in reducing binary restenosis 2.
Safety and Efficacy
- DCB revascularization has been found to be safe and effective in delaying restenosis in long, complex lesions and restenosis of the femoropopliteal tract 4.
- The major amputation rate was found to be low (2.1% at 2 years) in a study of DCB revascularization for complex femoropopliteal lesions 4.
Emerging Applications
- DCB revascularization is being explored as a treatment option for de novo stenosis in large vessel coronary artery disease, with promising results from observational and randomized studies 6.