Long-term outcomes of less drug-eluting stents by the use of drug-coated balloons in coronary chronic total occlusion intervention: A multicenter observational study.

BACKGROUND

Data on drug-coated balloons (DCB) for coronary chronic total occlusion (CTO) are limited. We aimed to investigate the long-term outcomes of substitution of drug-eluting stents (DES) by DCB.

METHODS

We compared the outcomes of less DES strategy (DCB alone or combined with DES) and DES-only strategy in treating coronary CTO in this prospective, observational, multicenter study. The primary endpoints were major adverse cardiovascular events (MACE), target vessel revascularization, myocardial infarction, and death during 3-year follow-up. The secondary endpoints were late lumen loss (LLL) and restenosis until 1-year after operation.

RESULTS

Of the 591 eligible patients consecutively enrolled between January 2015 and December 2019, 281 (290 lesions) were treated with DCB (DCB-only or combined with DES) and 310 (319 lesions) with DES only. In the DCB group, 147 (50.7%) lesions were treated using DCB-only, and the bailout stenting rate was relatively low (3.1%). The average stent length per lesion in the DCB group was significantly shorter compared with the DES-only group (21.5 ± 25.5 mm vs. 54.5 ± 26.0 mm,  < 0.001). A total of 112 patients in the DCB group and 71 patients in the DES-only group (38.6% vs. 22.3%, < 0.001) completed angiographic follow-up until 1-year, and LLL was much less in the DCB group (-0.08 ± 0.65 mm vs. 0.35 ± 0.62 mm,  < 0.001). There were no significant differences in restenosis occurrence between the two groups (20.5% vs. 19.7%,  > 0.999). The Kaplan-Meier estimates of MACE at 3-year (11.8% vs. 12.0%, log-rank  = 0.688) was similar between the groups.

CONCLUSION

Percutaneous coronary intervention with DCB is a potential "stent-less" therapy for CTO lesions with satisfactory long-term clinical results compared to the DES-only approach.