What are the criteria for using drug-coated balloons (DCBs) in coronary arteries?

Criteria for Using Drug-Coated Balloons in Coronary Arteries

Drug-coated balloons (DCBs) are strongly recommended for the treatment of in-stent restenosis within bare-metal stents or drug-eluting stents as a Class I recommendation with Level A evidence. 1

Primary Indications for DCB Use

Established Indications (Class I)

• In-stent restenosis (ISR)
  • First-line treatment for both bare-metal stent (BMS) and drug-eluting stent (DES) restenosis 1
  • Provides effective antiproliferative drug delivery without adding another permanent metal layer

Strong Evidence-Based Indications

• Small vessel disease (vessels <2.5 mm in diameter)

  • DCBs show favorable outcomes in small vessels where stents have higher restenosis rates 2, 3
  • Particularly beneficial when DES implantation is technically challenging 4

• Bifurcation lesions (particularly side branches)

  • Allows treatment of side branches without compromising their anatomy 4, 3
  • Helps avoid the "stent jail" phenomenon in bifurcation treatment

• High bleeding risk patients

  • Shorter duration of dual antiplatelet therapy (DAPT) possible compared to DES 3, 5
  • Beneficial for patients with contraindications to prolonged DAPT as listed in guideline contraindications for DES 1

Technical Requirements for Successful DCB Use

Lesion Preparation

• Adequate lesion preparation is mandatory before DCB application 6, 3
  • Optimal balloon pre-dilatation to achieve <30% residual stenosis
  • Consider scoring/cutting balloons for calcified lesions
  • Ensure absence of significant dissection (flow-limiting) before DCB application

Procedural Technique

• Use a provisional approach where DCB is considered the default device 6
• Minimize balloon-to-artery ratio (0.8:1 to 1:1)
• Inflation time of 30-60 seconds for optimal drug transfer
• Minimize time between lesion preparation and DCB inflation (<2 minutes) to prevent thrombus formation

Contraindications and Limitations

Relative Contraindications

• Significant residual stenosis (>30%) after lesion preparation
• Flow-limiting dissections requiring stent implantation
• Heavy calcification without adequate lesion preparation
• Acute vessel closure or threatened closure
• Thrombus-containing lesions without adequate thrombus aspiration

Situations Where DES is Preferred Over DCB

• Primary treatment of in-DES restenosis (Class I, Level A recommendation favors DES over DCB) 1
• Long lesions with significant elastic recoil
• Ostial lesions requiring precise positioning

Special Considerations

Antiplatelet Therapy

• Shorter DAPT duration possible compared to DES (typically 1-3 months)
• Beneficial for patients with:
  • Expected poor compliance with prolonged DAPT
  • Increased bleeding risk
  • Need for non-elective surgery in the short term
  • Concomitant anticoagulation therapy 1

Device Selection

• Not all DCBs are equivalent - no "class effect" exists 3
• Consider DCBs with:
  • Proven efficacy in clinical trials
  • Homogeneous drug distribution
  • Appropriate drug-excipient combination

Emerging Applications

• Long diffuse coronary disease
• Chronic total occlusion (after successful recanalization)
• Patients with diabetes mellitus
• Acute coronary syndromes 3, 5

Practical Implementation

1. Assess lesion characteristics (vessel size, lesion length, calcification)
2. Determine patient risk factors (bleeding risk, DAPT compliance)
3. Perform optimal lesion preparation
4. Evaluate angiographic result after preparation
5. Apply DCB if residual stenosis <30% and no flow-limiting dissection
6. Consider "bailout" stenting if suboptimal result after preparation

Pitfalls to Avoid

• Inadequate lesion preparation leading to suboptimal drug delivery
• Delayed DCB delivery after lesion preparation (>2 minutes)
• Inappropriate sizing of DCB (oversizing can cause dissections)
• Insufficient inflation time (<30 seconds)
• Treating flow-limiting dissections with DCB instead of stenting

By following these criteria and technical considerations, DCBs can be effectively utilized in selected coronary lesions, providing a stent-free alternative that preserves vessel anatomy and potentially reduces long-term complications associated with permanent implants.