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Background <p>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.</p> Aims <p>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.</p> Methods <p>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.</p> Results <p>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 (<i>n</i> = 660), nine evaluated CTOs (<i>n</i> = 870), six assessed calcified lesions (<i>n</i> = 455), and 12 included all-comer cohorts with complex lesions (<i>n</i> = 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.</p> Conclusions <p>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.</p> Graphical Abstract <p></p>

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Revascularization with drug-coated balloons alone in complex coronary artery disease: a systematic review

  • 期刊论文

  • 发表日期：

    2026年6月22日

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  • Michael Kunz,
  • Felix Götzinger,
  • Marnix Tjeerdsma,
  • Alana Korah,
  • Bernardo Cortese,
  • Tuomas T. Rissanen,
  • Bruno Scheller,
  • Andrew R. Chapman,
  • Felix Mahfoud,
  • Gregor Leibundgut,
  • Jasper Boeddinghaus

摘要

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.

Graphical Abstract