Outcomes with Drug-coated balloons vs. Drug-eluting Stents in Small-Vessel Coronary Artery Disease

Abstract Background The use of drug-coated balloons (DCBs) in small-vessel coronary artery disease (SVD) remains controversial. Methods We performed a meta-analysis of all randomized controlled trials (RCTs) reporting the outcomes of DCB vs. DES in de-novo SVD. We included a total of 5 RCTs (1459 patients), with (DCB n = 734 and DES n = 725). Results Over a median follow-up duration of 6 months, DCB was associated with a smaller late lumen loss (LLL) compared with DES (mean difference − 0.12 mm (95% confidence interval (CI) [−0.21, −0.03 mm], p = 0.01). Over a median follow-up of 12 months, both modalities had a similar risk of major adverse cardiovascular events (MACE) (8.7% vs. 10.2%; odds ratio (OR): 0.94, 95% CI [0.49–1.79], p = 084), all-cause mortality (1.17% vs. 2.38%; OR: 0.53, 95% CI [0.16–1.75], p = 0.30), target lesion revascularization (TLR) (7.9% vs. 3.9%; OR: 1.26, 95% CI [0.51–3.14], p = 0.62), and target vessel revascularization (TVR) (8.2% vs. 7.8%; OR: 1.06, 95% CI [0.40–2.82], p = 0.91). DCBs were associated with a lower risk of myocardial infarction (MI) compared with DES (1.55% vs. 3.31%; OR: 0.48, 95% CI [0.23–1.00], p = 0.05, I2 = 0%). Conclusion PCI of SVD with DCBs is associated with a smaller LLL, a lower risk of MI, and a similar risk of MACE, death, TLR, and TVR compared with DES over one year. DCB appears as an attractive alternative to DES in patients with de-novo SVD, but long-term clinical data beyond are still needed.