A systematic review and meta-analysis of the use of drug-coated balloon angioplasty for treatment of both de novo and in-stent coronary chronic total occlusions.

Background: Modern contemporary percutaneous coronary intervention (PCI) techniques with drug-eluting stents (DES) have high procedural success rates in chronic total occlusion (CTO) but with a high prevalence of repeat revascularization. The use of drug-coated balloons (DCBs) in CTO is an alternative treatment strategy. The evidence for DCBs in CTO is, therefore, of interest, and we provide a structured and comprehensive review of the evidence available in terms of the use of DCBs in CTO, including de novo and in-stent (IS) CTO lesions.

Objectives: We conducted a systematic review and meta-analysis on the use of DCBs in the management of coronary CTO.

Methods: Electronic databases (PubMed, Embase and Ovid) were systematically searched from inception to April 2024 for DCB CTO studies. A meta-analysis was undertaken using a random-effects inverse-variance method due to heterogeneity. The primary outcome is target lesion revascularization (TLR). Secondary outcomes are major adverse cardiac events (MACE) as a composite of target lesion revascularization (TLR), cardiac death (CD), and any myocardial infarction (MI) including procedural and non-procedural MI, target vessel revascularization (TVR), angiographic outcomes such as late lumen loss (LLL), binary restenosis, and reocclusion.

Results: A total of 10 studies consisting of 1,695 patients were systematically reviewed. This showed that late luminal changes in terms of lumen gain and minimal lumen loss were consistently seen in CTO cohorts 7-12 months after DCB treatment. Five studies were included for meta-analysis with 1,474 patients. There were no significant differences in TLR between treatment strategies such as DCB, DES, and hybrid (DES + DCB) in both de novo and IS-CTO populations as follows: DCB vs DES [OR, 0.71; 95% CI 0.49-1.02], DCB vs DES in IS-CTO [OR, 0.78; 95% CI 0.45-1.34], DCB vs Hybrid [OR, 0.96; 95% CI 0.39-1.43], and hybrid vs DES [OR, 0.76; 95% CI 0.15-3.84]. Similar findings were seen with the MACE outcome. A sensitivity analysis showed no difference between the above-mentioned groups in terms of MI, CD, and TVR.

Conclusion: The limited initial evidence on DCB in coronary CTO-PCI suggests a safe and effective alternative treatment strategy and suggests RCTs are, therefore, required.