What is the European expert consensus on the use of drug-coated balloons (DCB)?

European Expert Consensus on Drug-Coated Balloons (DCB)

Established Indications with Strong Consensus

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, 2

In-Stent Restenosis (Primary Indication)

• DCBs are the guideline-endorsed treatment for in-stent restenosis following both bare-metal stents and drug-eluting stents 1, 2, 3
• This represents the only Class I indication where DCBs have achieved consensus approval in European guidelines 2
• The mechanism works well in the contained environment of in-stent restenosis where the stent scaffold prevents elastic recoil 1

Small Vessel Disease (<3.0 mm)

• DCBs show favorable outcomes in small coronary vessels where drug-eluting stents have historically shown limited efficacy 4, 3, 5
• Recent randomized data demonstrate good efficacy and safety profiles specifically in vessels <3.0 mm diameter 3, 5
• This indication is gaining acceptance but remains secondary to the primary in-stent restenosis indication 5

Technical Principles Emphasized by European Experts

Lesion Preparation is Mandatory

• Adequate lesion preparation with conventional balloon angioplasty is essential before DCB application to facilitate drug delivery and assess dissection risk 6
• Complex lesions require additional imaging or functional measurements to determine if stenting will ultimately be needed 6
• The vessel must achieve an acceptable angiographic result without flow-limiting dissection before DCB-only strategy can be considered 6

Drug Delivery Mechanism

• DCBs deliver antiproliferative drugs (typically paclitaxel) into the vessel wall during a single balloon inflation using a lipophilic matrix 3
• The short contact time between balloon and vessel wall works effectively in contained environments but lacks structural support for de novo atherosclerotic lesions 1
• Without permanent scaffold, elastic recoil and dissection in de novo lesions lead to suboptimal acute results 1

Peripheral Arterial Disease Applications

Femoropopliteal Disease

• Early European studies showed improved short-term patency rates with DCBs compared to plain balloon angioplasty in femoropopliteal arteries 7
• Drug-eluting treatment should be considered as first-choice strategy for femoropopliteal lesions 8

Below-the-Knee Disease

• DCBs have shown NO superiority over plain balloon angioplasty in below-the-knee disease 7
• This represents an important limitation where the technology has not demonstrated benefit 7

Dialysis Access (Non-European but Relevant Context)

• KDOQI guidelines state there is inadequate evidence to recommend drug-coated balloons versus standard high-pressure balloons for arteriovenous fistula/graft stenosis 7
• However, paclitaxel-coated DCBs showed significantly improved patency in multiple trials for dialysis access 7

Critical Safety Consideration

The FDA issued a warning in January 2019 regarding possible increased long-term mortality with paclitaxel-coated devices in peripheral artery disease. 7

• This applies to both paclitaxel-coated balloons and paclitaxel-eluting stents 7
• The FDA allows continued use but recommends discussion of risks/benefits with patients, including possible increased mortality risk 7
• Continued surveillance is mandated for all paclitaxel-coated device use 7

Why DCBs Are NOT Recommended for De Novo Coronary Lesions

Definitive Evidence Against De Novo Use

• The randomized PEPCAD III study definitively showed that DCB combined with bare metal stent was inferior to sirolimus-eluting stents for de novo lesions 1
• Drug-eluting stents remain the default choice for nearly all de novo coronary lesions to prevent restenosis, myocardial infarction, and acute stent thrombosis 1
• Both American College of Cardiology and European Society of Cardiology prioritize drug-eluting stents over alternative strategies for de novo disease 1

Lack of Class Effect

• There is no "class effect" among different DCB devices - the interaction among balloon designs, drug doses, formulations, and release kinetics varies significantly 3
• This heterogeneity prevents broad generalizations about DCB efficacy across different manufacturers 3

Emerging Indications Under Investigation (Not Yet Consensus)

The following represent areas of ongoing research but lack guideline endorsement:

• Bifurcation lesions 3
• Large-vessel disease (≥3.0 mm) 3, 5
• High bleeding risk patients requiring short dual antiplatelet therapy 4, 3
• Acute coronary syndromes 3

Theoretical Advantages of "Leave Nothing Behind" Strategy

When DCBs work successfully, they offer:

• Reduced need for prolonged dual antiplatelet therapy, potentially reducing bleeding complications 6, 5
• No permanent foreign material, eliminating risk of very late stent failure 5
• Preservation of future bypass graft surgery options 5
• Potential for vascular restoration with plaque regression rather than neo-atherosclerosis 6

Common Pitfalls to Avoid

• Do not use DCBs for de novo coronary lesions outside clinical trials - this contradicts European guideline recommendations 1, 2
• Do not assume all DCB devices are equivalent - device-specific data must guide selection 3
• Do not skip adequate lesion preparation - inadequate predilatation leads to poor drug delivery and outcomes 6
• Do not use DCBs in below-the-knee peripheral disease expecting superiority over plain angioplasty 7
• Do not forget to discuss paclitaxel-related mortality concerns with patients when using DCBs in peripheral disease 7