Abstract Body (Do not enter title and authors here): Background: The evidence comparing drug-coated balloons (DCBs) and second-generation drug-eluting stents (DES) for the treatment of coronary in-stent restenosis (ISR) is primarily derived from small-scale, randomized trials.
Purpose: To compare clinical outcomes between DCB and second generation DES in clinical practice between 2012 and 2021.
Methods: We identified 10,292 patients with ISR who underwent either DCB or DES intervention. After 1:1 propensity score matching, 3,942 patients treated with either DCB or second-generation DES were included in the analysis. The composite primary outcome was all-cause mortality or myocardial infarction (MI) at 1 year. Secondary outcomes included each component of the primary outcome and hospitalization for bleeding.
Results: At 1-year follow-up, the composite primary outcome occurred in 10.4% (n=206) of the DCB group versus 12.9% (n=254) of the DES group (HR 0.77; 95% CI, 0.64–0.93). A sensitivity analysis restricted to single-vessel PCI confirmed these findings (HR 0.78; 95% CI, 0.65–0.95). Among secondary outcomes, all-cause mortality was lower in the DCB group (6.3%, n=125) compared to the DES group (8.1%, n=160; HR 0.75, 95% CI 0.59–0.94), as was hospitalization for bleeding (2.5%, n=50 vs. 4.2%, n=82; HR 0.65, 95% CI 0.45–0.96). Rates of MI were similar between groups.
Conclusion: In this real-world analysis, the use of DCBs for the treatment of ISR was associated with comparable or lower rates of all-cause death, myocardial infarction, and bleeding at 1 year, compared with second-generation DES. These findings suggest that DCBs may represent a safe and effective alternative to DES in selected patients.