ArticleClinical research in cardiology : official journal of the German Cardiac Society2026
Revascularization with drug-coated balloons alone in complex coronary artery disease: a systematic review.
Article in Clinical research in cardiology : official journal of the German Cardiac Society, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundDrug-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.
aimsThis systematic review aimed to evaluate the current evidence on DCB-only therapy in complex CAD and at assessing its potential role in clinical practice.
methodsWe 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.
resultsA 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.
conclusionsDCB-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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