Drug-Coated Balloons versus Drug-Eluting Stents for the Treatment of De Novo Coronary Artery Disease: A Meta-Analysis of Randomized Controlled Trials.

Background: Because of the limitations in new-generation drug-eluting stents (DES), treatments advocating for non-stents with a drug-coated balloon (DCB) is now of great interest. Here, we conducted a meta-analysis to testify whether a DCB was more effective and safer than a DES in treating de novo coronary artery disease (CAD).

Methods: We searched PubMed, Embase, Cochrane Library, and Web of Science to obtain high-quality trials comparing DCB with DES for the treatment of de novo CAD. The primary endpoint was target lesion revascularization (TLR), and the secondary endpoints were in-lesion late lumen loss (LLL), all-cause death, myocardial infarction and binary restenosis.

Results: We enrolled 1661 patients from seven randomized clinical trials. Compared with the DES group, the MD (mean difference) of in-lesion LLL was significantly lower in the DCB group (MD -0.19, 95% CI -0.23 to -0.16, p < 0.00001, I² = 0%). The DCB group showed superiority in small vessel disease (SVD) in in-lesion LLL (MD -0.21, 95% CI -0.34 to -0.08, p = 0.001).

Conclusions: The DCB group exhibited a lower in-lesion LLL compared to the DES group, and DCB was not inferior to DES in other endpoints, including in the SVD subgroup. Hence, to our knowledge, DCB is non-inferior to DES for de novo CVD and SVD. DCB in patients with CVD needs further large and long-term clinical trials to demonstrate its long-term efficacy.

The prospero registration: CRD42021268965, https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=268965.