What is the difference between plain old balloon angioplasty (POBA) and drug-coated balloon angioplasty (DCBA) in patients with vascular disease?

Plain Old Balloon Angioplasty vs Drug-Coated Balloon Angioplasty

Drug-coated balloons (DCBs) deliver antiproliferative drugs (typically paclitaxel) directly to the vessel wall without leaving behind permanent metal or polymer, reducing restenosis rates compared to plain balloon angioplasty in specific clinical scenarios, but their use is highly context-dependent based on anatomic location and lesion type. 1

Mechanism of Action

• Plain old balloon angioplasty (POBA) mechanically dilates stenotic vessels through radial force, but provides no pharmacologic prevention of neointimal hyperplasia, leading to higher restenosis rates 2
• Drug-coated balloons use an inactive excipient to deliver a therapeutic dose of paclitaxel to the vessel wall during inflation, inhibiting smooth muscle cell proliferation and reducing restenosis without requiring a permanent implant 3, 4
• The antiproliferative effect occurs during the brief balloon inflation period (typically 30-60 seconds), with drug transfer to the vessel wall 5

Coronary Artery Applications

In-Stent Restenosis (Established Indication)

• The European Society of Cardiology provides Class I, Level A recommendation for DCBs specifically for in-stent restenosis 1
• DCBs are the guideline-endorsed treatment for ISR following both bare-metal stents and drug-eluting stents, as the existing stent scaffold prevents elastic recoil while the drug prevents further neointimal hyperplasia 1
• Network meta-analyses show DCBs avoid adding another layer of metal in previously failed stents, which is particularly important in recurrent ISR 2

De Novo Coronary Lesions (Not Recommended)

• The European Society of Cardiology explicitly does NOT recommend DCBs for de novo coronary lesions 1
• The American College of Cardiology and European Society of Cardiology prioritize drug-eluting stents over DCBs for de novo disease 1
• Without a scaffold to prevent elastic recoil, POBA and DCBs have inferior acute results in de novo lesions compared to stenting 2

Peripheral Arterial Disease Applications

Femoropopliteal Disease (Preferred Strategy)

• Drug-eluting treatment should be considered as first-choice strategy for femoropopliteal lesions 1
• Early European studies showed improved short-term patency rates with DCBs compared to POBA in femoropopliteal arteries 1
• For long femoropopliteal lesions (≥15cm), DCBs demonstrate significantly lower late lumen loss at 6 months (0.27mm vs 1.32mm, p<0.001), higher freedom from target lesion revascularization at 24 months (81.58% vs 43.18%, p<0.001), and higher primary patency (46.88% vs 15.00%, p=0.003) compared to POBA 6

Below-the-Knee Disease (No Benefit)

• DCBs have shown NO superiority over plain balloon angioplasty in below-the-knee disease 1
• In infra-popliteal lesions, drug-eluting balloons and bare metal stent implantation show no superiority over plain balloon angioplasty, though drug-eluting stents may be used for relatively short proximal lesions 2

Renal Artery Disease

• For atherosclerotic renal artery stenosis, stent placement has consistently proven superior to balloon angioplasty alone, with ostial lesions particularly unsuitable for POBA due to vascular recoil from confluent aortic plaque 2
• Balloon angioplasty with bailout stent placement is recommended for fibromuscular dysplasia lesions 2

Dialysis Access Applications

• The American Journal of Kidney Diseases states there is inadequate evidence to recommend drug-coated balloons versus standard high-pressure balloons for arteriovenous fistula/graft stenosis 1, 7
• Multiple randomized trials show DCBs improve patency rates in dialysis access, but guidelines have not yet endorsed them over high-pressure POBA (>20 atm) 7

Critical Safety Considerations

• The FDA issued a warning in January 2019 regarding possible increased long-term mortality with paclitaxel-coated devices in peripheral artery disease 1
• The FDA allows continued use but mandates discussion of risks/benefits with patients, including possible increased mortality risk, and requires continued surveillance for all paclitaxel-coated device use 1
• The incidence of major adverse events does not significantly differ between DCB and POBA in most studies 6

Technical Differences

• DCB angioplasty substantially differs from both POBA and drug-eluting stent angioplasty on several technical aspects 4
• Adequate lesion preparation is critical for DCB success—the vessel must be predilated to ensure proper drug transfer to the vessel wall 4
• DCBs require careful handling to avoid drug loss before deployment, unlike POBA which has no such constraint 5
• POBA can be performed with immediate high-pressure inflation, while DCBs require controlled inflation to optimize drug delivery 4

Common Pitfalls to Avoid

• Using DCBs for de novo coronary lesions contradicts current guideline recommendations 1
• Inadequate lesion preparation before DCB deployment reduces drug transfer and efficacy 4
• Ignoring the FDA mortality warning when using paclitaxel-coated devices in peripheral disease 1
• Expecting DCB benefit in below-the-knee disease where evidence shows no superiority over POBA 1