When to use drug-coated balloon (DCB) versus primary stenting in superficial femoral artery (SFA) angioplasty?

From the Guidelines

Drug-coated balloons (DCBs) should be used as the first-line therapy for superficial femoral artery (SFA) lesions that are short to moderate in length, have minimal calcification, and don't involve critical flow-limiting dissections, due to their ability to deliver anti-proliferative medication directly to the vessel wall without leaving a permanent implant, as supported by the most recent guidelines 1.

Key Considerations

• Lesion length and complexity: DCBs are preferred for shorter lesions (<15 cm), while primary stenting is more suitable for longer lesions (>15 cm) or those with significant calcification 1.
• Patient comorbidities and risk of restenosis: The decision between DCBs and primary stenting should take into account the patient's overall health and the risk of restenosis, with DCBs offering the advantage of "leaving nothing behind" while providing anti-restenotic benefits 1.
• Hybrid approach: A provisional stenting approach, starting with DCB and placing stents only when necessary, is often a practical strategy for many SFA interventions, as it allows for the benefits of both DCBs and stents to be utilized 1.

Benefits and Risks

• DCBs: offer the advantage of preserving future treatment options, providing anti-restenotic benefits, and minimizing the risk of in-stent restenosis and stent fracture 1.
• Primary stenting: provides better immediate luminal gain and scaffolding for complex lesions, but carries risks of fracture, in-stent restenosis, and limiting future revascularization options 1.

Clinical Decision-Making

• The choice between DCBs and primary stenting should be based on a thorough evaluation of the patient's individual characteristics, lesion complexity, and the potential benefits and risks of each approach, with the goal of optimizing outcomes and minimizing morbidity, mortality, and impact on quality of life 1.

From the Research

Decision Making for DCB vs Primary Stenting in SFA Angioplasty

When deciding between drug-coated balloon (DCB) and primary stenting in superficial femoral artery (SFA) angioplasty, several factors should be considered:

• The type and length of the lesion
• The presence of in-stent restenosis (ISR)
• The patient's overall health and risk factors

Evidence for DCB Use

Studies have shown that DCBs are effective in reducing restenosis and target lesion revascularization (TLR) in SFA disease:

• A study published in 2018 2 found that DCBs can safely treat SFA ISR with a reduction in recurrent restenosis and TLR at least at 1 year after plain old balloon angioplasty (POBA)
• The IN.PACT SFA Trial 3 demonstrated that DCB resulted in higher primary patency versus percutaneous transluminal angioplasty (PTA) (82.2% versus 52.4%; P<0.001) for the treatment of symptomatic superficial femoral and popliteal artery disease
• A meta-analysis of 45 randomized trials 4 found that the use of DCB significantly reduced the rate of TLR, with larger benefits observed in patients with peripheral artery disease (PAD) and respect to balloon-only angioplasty

Evidence for Primary Stenting Use

Primary stenting is also a viable option for SFA disease:

• The RAPID Trial 5 investigated the added value of DCB in a primary stenting strategy for intermediate and long segment SFA lesions, but found no significant difference in primary patency between the Supera + DCB group and the Supera group
• A study published in 2022 6 reported 12-month primary patency rates for various endovascular devices, including drug-eluting stents, DCBs, covered stents, and nitinol self-expanding stents, but noted that the increased variation in inclusion criteria and lesion complexity between studies does not allow for direct comparison between devices

Considerations for Device Selection

The choice between DCB and primary stenting should be based on individual patient characteristics and lesion specifics:

• DCBs may be preferred for patients with ISR or shorter lesions
• Primary stenting may be preferred for patients with longer lesions or more complex disease
• Further research is needed to determine the optimal device selection for specific patient populations and lesion types 6