From the Guidelines
The 6-month patency rate of SFA lesions treated with drug-coated balloons is significantly higher compared to plain balloon angioplasty, with patency rates ranging from 80-90% for DCBs versus 50-60% for plain balloons. When considering the treatment of superficial femoral artery (SFA) lesions, the choice between plain balloon angioplasty (PBA) and drug-coated balloons (DCBs) is crucial for determining patency rates and overall patient outcomes.
Key Considerations
- The use of DCBs has been shown to significantly improve patency rates when compared to conventional balloon angioplasty, as demonstrated in multiple prospective randomized trials 1.
- DCBs coated with paclitaxel deliver antiproliferative medications directly to the vessel wall during angioplasty, inhibiting neointimal hyperplasia and reducing restenosis.
- Despite a warning from the FDA regarding possible increased long-term mortality rates associated with paclitaxel-coated balloons and paclitaxel-eluting stents, the FDA has allowed for their continued use with recommendations for surveillance and discussion of risks and benefits with patients 1.
Treatment Recommendations
- For optimal outcomes with DCBs, appropriate antiplatelet therapy is essential, typically including aspirin 81-325mg daily indefinitely and clopidogrel 75mg daily for at least 1 month post-procedure.
- The superior patency rates with DCBs translate to fewer repeat interventions and improved clinical outcomes for patients with peripheral arterial disease affecting the SFA, making them the preferred option despite their higher initial cost.
Clinical Implications
- The decision to use DCBs or plain balloons should be made on a case-by-case basis, taking into account the individual patient's risk factors, disease severity, and potential benefits and risks of each treatment option.
- Clinicians should discuss the potential risks and benefits of DCBs with patients, including the possible increased risk of long-term mortality, to ensure informed decision-making.
From the Research
6-Month Patency Rate of SFA Lesions Treated with Plain Balloon vs Drug Coated Balloon
- The 6-month patency rate of SFA lesions treated with plain balloon vs drug coated balloon is not directly reported in the provided studies.
- However, the study 2 reports a 6-month late-lumen loss rate, which is a related outcome measure.
- According to the study 2, the 6-month late-lumen loss rate was lower in the drug-coated balloon group (0.18 ± 0.81 mm) compared to the plain old balloon angioplasty (POBA) group (1.34 ± 0.94 mm, P < 0.001).
- Another study 3 reports the 2-year results of the MDT-2113 SFA Japan randomized trial, which compared the safety and efficacy of the IN.PACT Admiral drug-coated balloon (DCB) with uncoated percutaneous transluminal angioplasty (PTA) for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal artery.
- The study 3 found that patients treated with DCB exhibited superior 24-month primary patency compared to PTA (79.8% vs. 46.9%; log rank P < 0.001).
- The study 4 also compared the outcomes of drug-coated balloons (DCBs) with standard percutaneous transluminal angioplasty (PTA) for the treatment of symptomatic superficial femoral and popliteal peripheral artery disease, and found that DCB resulted in higher primary patency versus PTA (82.2% versus 52.4%; P < 0.001) at 12 months.
Comparison of Plain Balloon and Drug Coated Balloon
- The provided studies suggest that drug-coated balloons are superior to plain balloons in terms of patency rates and late-lumen loss rates for the treatment of SFA lesions.
- However, the 6-month patency rate is not directly reported in the provided studies, and the available data are limited to late-lumen loss rates and 12- or 24-month patency rates.
- Further research is needed to determine the 6-month patency rate of SFA lesions treated with plain balloon vs drug coated balloon.