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Revascularization with drug-coated balloons alone in complex coronary artery disease: a systematic review
Michael Kunz1,2, Felix Götzinger3,4, Marnix Tjeerdsma3,4
1Clinic of Cardiology, University Heart Center Basel, University Hospital Basel, University of Basel, Basel, Switzerland. m.kunz@usb.ch.
Insights
Drug-coated balloon (DCB) therapy offers a "leave-nothing-behind" option for coronary artery disease (CAD). While feasible for complex CAD, evidence is limited and of low quality, necessitating further research.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Devices
Background:
- Drug-coated balloon (DCB) therapy is an emerging alternative to traditional stent-based treatments for coronary artery disease (CAD).
- It is particularly considered for patients who may benefit from a "leave-nothing-behind" approach.
Purpose of the Study:
- To systematically review existing evidence on DCB-only therapy in complex coronary artery disease (CAD).
- To assess the potential clinical role of DCB-only therapy in managing complex CAD cases.
Main Methods:
- A systematic literature review was conducted across major databases (PubMed, CENTRAL, SCOPUS, ICTRP) up to March 2025.
- Studies included patients with complex CAD (bifurcation, calcified lesions, CTO, three-vessel, or left main disease) treated with DCB-only therapy.
- Risk of bias was assessed for all included studies.
Main Results:
- 34 studies met inclusion criteria, predominantly non-randomized, with most research originating from Asia.
- DCB-only therapy demonstrated acceptable outcomes in complex CAD patients.
- A significant limitation was the high risk of bias and lack of control groups in 47% of the studies.
Conclusions:
- DCB-only therapy appears feasible for select complex CAD patients.
- However, the current evidence base is limited, heterogeneous, and of low methodological quality.
- High-quality randomized controlled trials comparing DCB-only with drug-eluting stent (DES) strategies in complex CAD are essential.
Background:
Drug-coated balloon (DCB) therapy has emerged as an alternative to stent-based treatment in coronary artery disease (CAD), particularly in patients where a "leave-nothing-behind" approach may be advantageous.
Aims:
This systematic review aimed to evaluate the current evidence on DCB-only therapy in complex CAD and at assessing its potential role in clinical practice.
Methods:
We performed a systematic review searching PubMed, CENTRAL, SCOPUS, and ICTRP from inception to 24th March 2025 to identify studies investigating a DCB-only strategy in complex CAD, defined as bifurcation and calcified lesions, chronic total occlusions (CTO), three-vessel disease, or left main disease. The main inclusion criteria were (i) studies including patients with complex CAD and (ii) the use of DCB-only therapy as the main treatment strategy. Risk of bias was systematically assessed.
Results:
A total of 3120 records were identified. After duplicate removal, screening, and full-text review, 34 studies met our inclusion criteria (32 non-randomized, 2 randomized). Seven studies investigated bifurcation lesions (n = 660), nine evaluated CTOs (n = 870), six assessed calcified lesions (n = 455), and 12 included all-comer cohorts with complex lesions (n = 7079). Most studies were conducted in Asia. Overall, DCB-only therapy showed acceptable outcomes in patients with complex CAD. However, 47% (16/34) of studies lacked a control group and the overall risk of bias was high.
Conclusions:
DCB-only therapy may be feasible in selected patients with complex CAD, but current evidence remains scarce, heterogeneous, and of limited methodological quality. Randomized controlled trials comparing DCB-only with DES-based strategies in complex CAD are warranted.
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