Abstract
BACKGROUND: Current guideline recommendations for the treatment of coronary in-stent restenosis (ISR) are primarily based on evidence from smaller, randomized trials comparing drug-coated balloons (DCBs) and second-generation drug-eluting stents (DES). PURPOSE: The purpose was to compare clinical outcomes between DCB and DES in routine clinical practice. METHODS: In this population-based cohort study, we identified 10,292 patients with ISR who underwent either DCB or DES intervention. After 1:1 propensity score matching, 3942 patients treated with either DCB or second-generation DES were included in the analysis. The composite primary end point was all-cause mortality or myocardial infarction (MI) at 1 year. Secondary end points included each component of the primary end point. The safety end point was defined by hospitalization due to bleeding events. RESULTS: At 1-year follow-up, the 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). 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 (HR, 0.83; 95% CI, 0.63-1.10). CONCLUSION: DCBs were associated with lower rates of the primary end point all-cause death or myocardial infarction, as well as secondary end points all-cause death and bleeding compared with second-generation DES. These findings suggest that DCBs may represent a safe and effective alternative to DES in selected patient populations.