In an adult with acute coronary syndrome who is a candidate for percutaneous coronary intervention, should a drug‑eluting balloon be used instead of a drug‑eluting stent?

Drug-Eluting Balloons in Acute Coronary Syndrome

Drug-eluting stents (DES), not drug-eluting balloons (DCB), remain the default and guideline-recommended treatment for acute coronary syndrome requiring percutaneous coronary intervention. New-generation DES are specifically endorsed as the standard of care across all major international guidelines for ACS patients 1.

Guideline-Based Standard of Care

Primary Recommendation for ACS

• New-generation DES are indicated (Class I, Level A) for percutaneous treatment of significant coronary lesions in ACS patients 1. This represents the highest level of recommendation based on multiple randomized trials demonstrating superior safety and efficacy.

• The European Society of Cardiology 2014 guidelines explicitly state that new-generation DES are "preferred over BMS as the default option" in ACS, with no particular safety concerns in this population 1.

• The 2016 ESC guidelines for non-ST-elevation ACS reaffirm that "new-generation DESs are recommended over BMSs" (Class I, Level A) in patients undergoing PCI 1.

Duration of Dual Antiplatelet Therapy

• DAPT should be maintained for 12 months following DES implantation in ACS patients, irrespective of stent type 1.

• This 12-month duration applies to all ACS presentations (STEMI, NSTEMI, unstable angina) and represents a Class I, Level A recommendation 1.

Drug-Coated Balloon Evidence in ACS

Limited Guideline Support

• DCB are NOT mentioned in any major guideline as a recommended strategy for de novo lesions in ACS 1.

• The only guideline reference to DCB notes they were tested for in-stent restenosis following bare-metal stent implantation, not for primary ACS treatment 1.

• One guideline explicitly states that "the combination of a drug-eluting balloon with cobalt chromium stent implantation was inferior to SES for de novo indications" in the PEPCAD III trial 1.

Research Evidence Shows Equipoise, Not Superiority

BASKET-SMALL 2 Trial (2022) - The highest quality randomized evidence:

• In 214 ACS patients (28% of 758 total patients), DCB showed no significant difference in major adverse cardiac events compared to DES at 1 year (hazard ratio 0.50,95% CI 0.19-1.26) 2.

• At 3-year follow-up, there were similar major adverse cardiac event rates with no significant interaction between clinical presentation and treatment (P=0.301) 2.

• While secondary endpoints suggested lower cardiac death and nonfatal MI at 1 year with DCB in ACS patients, this did not persist at 3 years 2.

Single-Center Observational Data:

• A 2016 retrospective study of 335 small vessel disease patients (77.9% presenting with ACS in the DCB group) showed comparable 1-year outcomes between DCB and DES (11.6% vs 11.7% MACE, P=1.000) 3.

• However, this was not a randomized trial and involved only small vessels (≤2.5 mm diameter) 3.

Clinical Algorithm for Decision-Making

When to Use DES (Standard Approach)

1. All ACS patients requiring PCI should receive new-generation DES as first-line therapy 1
2. This applies to:
   • STEMI patients undergoing primary PCI 1
   • NSTE-ACS patients with high-risk features 1
   • All vessel sizes and lesion complexities 1

Theoretical Scenarios Where DCB Might Be Considered (Off-Guideline)

Only consider DCB in ACS if ALL of the following apply:

• Small vessel disease (reference diameter ≤2.5 mm) 3, 2
• High bleeding risk requiring shortened DAPT duration 3, 4
• Patient has absolute contraindication to 12-month DAPT 1
• Experienced operator with DCB expertise available 5

Even in these scenarios, recognize this is NOT guideline-supported and represents experimental practice 1.

Critical Pitfalls to Avoid

Major Contraindications to DCB in ACS

• Never use DCB as routine first-line therapy in ACS - this directly contradicts Class I guideline recommendations for DES 1.

• Avoid DCB in large vessels - the PEPCAD III trial showed inferiority to DES in de novo lesions 1.

• Do not assume shorter DAPT is safer - while DCB theoretically allows shorter DAPT, the 12-month duration after ACS is driven by the thrombotic milieu of the acute event, not just the device 1.

Technical Considerations If DCB Used

• Adequate predilatation is mandatory for DCB efficacy - inadequate preparation leads to poor drug delivery 6, 4.

• Geographical mismatch (DCB not covering entire diseased segment) significantly increases failure rates 6.

• Bailout stenting must be immediately available - dissections requiring stenting occur in 10-30% of DCB cases 6.

Evidence Quality Assessment

Guideline evidence strongly favors DES:

• Multiple Class I, Level A recommendations across ESC and ACC/AHA guidelines 1
• Based on large randomized trials (SIRIUS, TAXUS, etc.) specifically including ACS patients 1

DCB evidence is insufficient:

• Only one randomized trial (BASKET-SMALL 2) with ACS subgroup analysis 2
• Remaining evidence consists of observational studies and registries 3, 4
• No guideline endorsement for de novo ACS lesions 1

The most recent and highest quality evidence (BASKET-SMALL 2,2022) shows non-inferiority but not superiority of DCB in small vessel ACS, and this has not changed guideline recommendations 2.