Drug-Coated Balloons in Cardiovascular Interventions

Established Indications

• The European Society of Cardiology provides Class I, Level A recommendation for drug-coated balloons specifically for in-stent restenosis, but explicitly does NOT recommend DCBs for de novo coronary lesions 1
• DCBs are the guideline-endorsed treatment for in-stent restenosis following both bare-metal stents and drug-eluting stents 1
• The mechanism works well in the contained environment of in-stent restenosis where the stent scaffold prevents elastic recoil 1

Peripheral Arterial Disease Applications

• Early European studies showed improved short-term patency rates with DCBs compared to plain balloon angioplasty in femoropopliteal arteries 2
• Drug-eluting treatment should be considered as first-choice strategy for femoropopliteal lesions 3
• DCBs have shown NO superiority over plain balloon angioplasty in below-the-knee disease 4

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 5
• The FDA allows continued use but recommends discussion of risks/benefits with patients, including possible increased mortality risk 5
• Continued surveillance is mandated for all paclitaxel-coated device use 5

Guideline Recommendations

• The American College of Cardiology and European Society of Cardiology prioritize drug-eluting stents over alternative strategies for de novo disease 1
• The European Society of Cardiology provides Class I, Level A recommendation for drug-coated balloons specifically for in-stent restenosis 1
• KDOQI guidelines state there is inadequate evidence to recommend drug-coated balloons versus standard high-pressure balloons for arteriovenous fistula/graft stenosis 6, 7

Drug-Coated Balloons vs Plain Old Balloon Angioplasty

Mechanism of Action and Coronary Artery Applications

• Plain old balloon angioplasty mechanically dilates stenotic vessels through radial force, but provides no pharmacologic prevention of neointimal hyperplasia, leading to higher restenosis rates, whereas 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, as shown in network meta-analyses that demonstrate DCBs avoid adding another layer of metal in previously failed stents 8
• Network meta-analyses show DCBs avoid adding another layer of metal in previously failed stents, which is particularly important in recurrent ISR, and without a scaffold to prevent elastic recoil, POBA and DCBs have inferior acute results in de novo lesions compared to stenting 8, 9

Peripheral Arterial Disease Applications

• 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, and balloon angioplasty with bailout stent placement is recommended for fibromuscular dysplasia lesions 10, 9
• 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 11

Guideline‑Endorsed Indications, Contraindications, and Safety Considerations for Drug‑Coated Balloons

1. Indications Supported by Evidence

• In‑stent restenosis (ISR) after bare‑metal or drug‑eluting stents – Drug‑coated balloons (DCBs) are endorsed by major cardiovascular societies as the preferred class I, level A therapy for ISR, avoiding the need for additional metal layers. 12
• Femoropopliteal peripheral arterial disease – Prospective randomized trials show that DCBs significantly improve vessel patency compared with plain balloon angioplasty, supporting their use as a first‑line strategy for femoropopliteal lesions. 12
• Arteriovenous fistula or graft stenosis in dialysis access – Paclitaxel‑coated DCBs have demonstrated markedly higher primary patency at 6 months (≈ 38 %–63 %) and at 12 months (≈ 23 %–44 %) versus conventional balloon angioplasty in multiple trials. 12
• KDOQI guidance on dialysis access – The Kidney Disease Outcomes Quality Initiative (KDOQI) states that current evidence is insufficient to recommend DCBs over standard high‑pressure balloons for AV fistula/graft stenosis. 13, 14, 15

2. Contraindications

• Absolute contraindication: Patients unable to tolerate or adhere to dual antiplatelet therapy (DAPT) should not receive DCBs in coronary applications. 16
• Relative contraindications:
  
  • Planned surgery that would require interruption of DAPT within the recommended timeframe. 16
  • High bleeding risk that would preclude safe antiplatelet therapy. 16

3. FDA Safety Warning

• The U.S. Food and Drug Administration (FDA) has issued a warning that paclitaxel‑coated balloons and stents used for peripheral artery disease may be associated with an increased risk of long‑term mortality compared with control devices. This warning applies to peripheral applications; coronary ISR data have not shown a similar mortality signal. 12

4. Procedural Recommendations

4.1 Balloon Inflation Pressure

• Lesion preparation should be performed with high‑pressure balloons (> 20 atm) before DCB deployment; the DCB itself is inflated at nominal or slightly above nominal pressure to ensure drug transfer without causing dissection. 12

4.2 Dual Antiplatelet Therapy (DAPT) After DCB Use

5. Evidence Gaps

• The optimal duration of balloon inflation time for maximizing primary patency remains undefined; current research identifies this as a gap rather than providing a concrete recommendation. 13, 14, 15
• Specific DAPT regimens for dialysis‑access DCB procedures lack guideline‑based definition and require further study. 13, 14, 15