Drug-Coated Balloons in Acute Coronary Syndrome
Drug-coated balloons (DCBs) are not currently recommended in major guidelines for routine use in acute coronary syndrome, as drug-eluting stents (DES) remain the standard of care for percutaneous coronary intervention in ACS patients. 1
Current Guideline Recommendations for ACS Revascularization
The established approach for ACS management prioritizes DES implantation during PCI:
- In single-vessel disease, PCI with stenting of the culprit lesion is the first-choice revascularization strategy. 1
- New-generation DES are specifically recommended over bare metal stents in patients undergoing PCI for ACS. 1
- Stent implantation mechanically stabilizes the disrupted plaque at the lesion site, with particular benefit in high-risk lesions characteristic of ACS. 1
The 2015 ESC Guidelines and 2014 AHA/ACC Guidelines make no mention of DCBs as a treatment option for ACS, reflecting the lack of guideline-level evidence supporting their use in this setting. 1
Emerging Research Evidence on DCBs in ACS
While guidelines do not endorse DCBs for ACS, recent trials have begun exploring this application:
BASKET-SMALL 2 Trial (Most Recent High-Quality Evidence)
The BASKET-SMALL 2 trial found no significant difference in major adverse cardiac events between DCB and DES at 1-year follow-up in ACS patients with small vessel disease (hazard ratio 0.50,95% CI 0.19-1.26). 2
Key findings from this 2022 randomized trial:
- Among 758 patients, 214 (28.2%) presented with ACS (including STEMI, NSTEMI, and unstable angina). 2
- At 3 years, there were similar major adverse cardiac event rates between DCB and DES groups with no significant interaction between clinical presentation and treatment effect (P=0.301). 2
- For cardiac death and nonfatal myocardial infarction, DCB showed lower rates in ACS patients at 1 year, though this interaction was not sustained at 3 years. 2
Additional Supporting Studies
A 2023 single-center retrospective study of 455 ACS patients found comparable MACE rates between DCB (12.0%) and DES (13.4%) at one year (P=0.73). 3
A 2022 study of ACS patients with vulnerable plaques demonstrated that DCB had smaller late luminal loss compared to DES, with similar safety profiles (MACE: 7.3% vs 8.8%, P>0.05). 4
Critical Limitations and Caveats
The major limitation is that all DCB evidence in ACS comes from small observational studies or subgroup analyses, not from large randomized trials specifically designed for ACS populations. 3, 2, 4
Most DCB experience has been gained in elective PCI settings (in-stent restenosis, small vessel disease, bifurcation lesions), not in the acute thrombotic environment of ACS. 5, 6
DCBs require adequate lesion preparation and may leave residual dissections without the scaffolding support that stents provide—particularly problematic in the unstable plaque morphology of ACS. 5, 6
Potential Future Role
DCBs may become relevant for specific ACS subgroups where stent-related complications are particularly concerning:
- Patients at high bleeding risk requiring shorter dual antiplatelet therapy duration 5, 3
- Small vessel disease where stent implantation carries higher restenosis risk 2
- Patients with diabetes mellitus, though this remains investigational 5
However, until large randomized controlled trials demonstrate non-inferiority or superiority to DES for mortality, myocardial infarction, and quality of life outcomes in ACS, DCBs should not replace DES as standard therapy. 1, 2
Clinical Bottom Line
Continue using DES as the standard revascularization approach for ACS patients undergoing PCI, as recommended by all major guidelines. 1 DCBs remain an investigational option that may be considered in highly selected cases (small vessels, high bleeding risk) within the context of clinical trials or when discussed with interventional cardiology experts, but they are not ready for routine clinical practice in ACS. 5, 2