Clin Res Cardiol. 2026 Jun 22. doi: 10.1007/s00392-026-02957-9. Online ahead of print.
ABSTRACT
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.
PMID:42329403 | DOI:10.1007/s00392-026-02957-9