Which patients or lesion types are appropriate for drug‑coated balloons (DCBs) such as paclitaxel‑coated balloons, what are the contraindications, recommended inflation duration and pressure, and the post‑procedure dual antiplatelet therapy (DAPT) regimen?

Drug-Coated Balloons: Indications, Contraindications, and Management

Drug-coated balloons (DCBs) are guideline-endorsed for in-stent restenosis following both bare-metal and drug-eluting stents, but are NOT recommended for de novo coronary lesions; in peripheral arterial disease, DCBs should be considered first-line for femoropopliteal lesions but show no benefit in below-the-knee disease, and all paclitaxel-coated devices carry an FDA warning regarding possible increased long-term mortality. 1, 2, 3

Appropriate Patient and Lesion Types

Coronary Artery Disease

In-stent restenosis (ISR):

• DCBs are the Class I, Level A guideline recommendation for treating ISR after both bare-metal stents and drug-eluting stents. 1 The mechanism works optimally in the contained environment of ISR where the existing stent scaffold prevents elastic recoil. 1
• Network meta-analyses demonstrate that DCBs avoid adding another layer of metal in previously failed stents, which is particularly important in recurrent ISR. 1
• DCBs are a reasonable alternative when additional stent layers are undesirable. 2

De novo coronary lesions:

• The European Society of Cardiology explicitly does NOT recommend DCBs for de novo coronary lesions (no Class I recommendation). 1 Without a scaffold to prevent elastic recoil, DCBs have inferior acute results compared to stenting in de novo disease. 1
• The American College of Cardiology and European Society of Cardiology prioritize drug-eluting stents over alternative strategies for de novo disease. 1

Peripheral Arterial Disease

Femoropopliteal lesions:

• 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 plain balloon angioplasty. 1
• Multiple prospective randomized trials demonstrated significantly improved patency when compared to conventional balloon angioplasty. 3, 2

Below-the-knee disease:

• DCBs have shown NO superiority over plain balloon angioplasty in below-the-knee disease. 1 Drug-eluting balloons and bare metal stent implantation show no benefit over plain balloon angioplasty in infra-popliteal lesions. 1

Dialysis Access Maintenance

Arteriovenous fistula/graft stenosis:

• DCBs coated with paclitaxel have demonstrated significantly improved patency rates compared to conventional balloon angioplasty in multiple prospective randomized trials. 3, 2
• Clinical success rates show cumulative patency at 6-month (primary) of 38% to 63% and 12-month (primary) of 23% to 44%. 3
• However, KDOQI guidelines state there is inadequate evidence to recommend drug-coated balloons versus standard high-pressure balloons for arteriovenous fistula/graft stenosis. 1, 3 More research is needed in this area. 3

Contraindications

Absolute Contraindications

• Inability to tolerate or comply with dual antiplatelet therapy (DAPT). 3 Patients who cannot take DAPT should not receive DCB treatment in coronary applications.
• De novo coronary lesions where guideline-directed therapy calls for drug-eluting stents. 1

Relative Contraindications

• Anticipated surgery requiring discontinuation of DAPT within the recommended timeframe. 3 For coronary applications, this creates significant risk.
• High risk of bleeding that would preclude appropriate antiplatelet therapy. 3
• Below-the-knee peripheral arterial disease where DCBs show no benefit over conventional angioplasty. 1

Critical FDA Safety Warning

On January 17,2019, the FDA issued a warning letter about a possible increase in long-term mortality rates among patients with peripheral artery disease treated with paclitaxel-coated balloons and paclitaxel-eluting stents when compared to patients treated with control devices. 3, 1, 2

• The FDA allows continued use but mandates discussion of risks and benefits with patients, including possible increased mortality risk. 3, 1, 2
• Continued surveillance is required for all paclitaxel-coated device use. 1
• This warning applies to peripheral applications; coronary ISR data did not show similar mortality signals. 3

Recommended Inflation Duration and Pressure

Inflation Duration

The optimal duration of balloon inflation time during angioplasty to improve intervention primary patency remains an area requiring more evidence. 3 Current guidelines identify this as a research gap rather than providing specific recommendations.

Practical approach based on device characteristics:

• Most DCB protocols use 60-120 seconds of inflation time to allow adequate drug transfer to the vessel wall. 4, 5
• Adequate lesion preparation before DCB inflation is critical—the vessel must be optimally dilated with conventional or high-pressure balloons first. 4, 5, 6
• A single prolonged inflation is the standard technique to deliver antiproliferative drugs to local arterial tissue. 5

Inflation Pressure

• Use nominal pressure or slightly above to ensure adequate vessel wall contact without causing dissection. 4, 5
• High-pressure balloons (>20 atm) should be used for lesion preparation before DCB application, not for the DCB itself. 3
• The goal is drug delivery, not aggressive mechanical dilation—that should already be accomplished during preparation. 4, 5

Post-Procedure Dual Antiplatelet Therapy (DAPT) Regimen

Coronary Applications (In-Stent Restenosis)

Standard DAPT duration:

• For acute coronary syndrome patients: 12 months of aspirin (75-100 mg daily) plus a P2Y12 inhibitor (ticagrelor, prasugrel, or clopidogrel). 7 This applies regardless of whether DCB or drug-eluting stent was used for ISR treatment.
• For stable coronary artery disease: 6 months of DAPT is the default duration. 7
• After completing DAPT, continue aspirin 75-100 mg daily indefinitely. 7

P2Y12 inhibitor selection:

• In ACS, ticagrelor (180 mg loading, 90 mg twice daily) is preferred over clopidogrel. 7
• Prasugrel (60 mg loading, 10 mg daily) is acceptable in ACS patients without prior stroke/TIA. 7
• For stable CAD, clopidogrel 75 mg daily is the default. 7

Modified duration for high bleeding risk:

• High bleeding-risk ACS patients may shorten DAPT to 6 months. 7
• High bleeding-risk stable CAD patients may shorten DAPT to 3 months. 7
• Absolute minimum is 1 month of DAPT for any coronary intervention. 7

Peripheral Arterial Disease Applications

For PAD revascularization with DCB:

• The American College of Cardiology recommends DAPT for 2-6 months after DCB procedure for PAD revascularization, based on 2024 ACC/AHA guidelines. 2
• This is shorter than coronary applications because peripheral vessels have different thrombotic risk profiles.

Dialysis Access Applications

For arteriovenous fistula/graft treatment:

• Standard antiplatelet therapy recommendations for dialysis access procedures apply. 3
• Specific DAPT duration for DCB use in dialysis access is not well-established in guidelines. 3

Bleeding Mitigation Strategies

• Prescribe a proton-pump inhibitor (PPI) to all patients on DAPT to reduce gastrointestinal bleeding risk. 7
• Maintain low-dose aspirin (75-100 mg daily); higher doses provide no additional benefit and increase bleeding. 7
• Use radial artery access for coronary procedures whenever feasible to reduce access-site bleeding. 7

Common Pitfalls and How to Avoid Them

Inadequate lesion preparation:

• The most common error is applying DCB without optimal pre-dilation. 4, 5 Always achieve adequate vessel dilation with conventional or high-pressure balloons before DCB application—residual stenosis >30% predicts DCB failure. 4, 5

Using DCB for inappropriate indications:

• Do not use DCB for de novo coronary lesions where drug-eluting stents are guideline-recommended. 1 The lack of scaffold support leads to inferior outcomes.
• Do not use DCB for below-the-knee PAD where no benefit has been demonstrated. 1

Premature DAPT discontinuation:

• Never stop both aspirin and P2Y12 inhibitor simultaneously except in life-threatening bleeding. 7 If DAPT must be shortened, stop the P2Y12 inhibitor first while maintaining aspirin to avoid catastrophic stent thrombosis (mortality 20-40%). 7

Failing to discuss FDA mortality warning:

• For peripheral applications, document discussion of the FDA warning about possible increased long-term mortality with paclitaxel-coated devices. 3, 1, 2 This is a medicolegal requirement.

Inadequate follow-up:

• Mandatory reassessment at 6 months and 12 months is required for all patients on DAPT. 7 Failure to actively decide whether to continue or stop DAPT at 12 months is considered a critical error. 7