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, < 0.00001, I = 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, = 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.
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| http://dx.doi.org/10.31083/j.rcm2512446 | DOI Listing |
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