Key result
DCB-based strategy shows similar 3-year MACE rates to DES-only for coronary chronic total occlusions.
Why the study?
Data on drug-coated balloons for de novo coronary chronic total occlusion are limited, motivating investigation of long-term outcomes of substituting drug-eluting stents with drug-coated balloons.
Does a less drug-eluting stent strategy using drug-coated balloons reduce major adverse cardiovascular events in patients with de novo coronary chronic total occlusion compared to a drug-eluting stent-only strategy?
Observational (n=591)
Yes
Does a less drug-eluting stent strategy using drug-coated balloons reduce major adverse cardiovascular events in patients with de novo coronary chronic total occlusion compared to a drug-eluting stent-only strategy?
Hazard Ratio: 0.932 (95% CI 0.532–1.633)
Absolute Event Rate: 11.8% vs 12%
p-value: p=0.805
A less drug-eluting stent strategy using drug-coated balloons for de novo coronary chronic total occlusion yields similar long-term clinical outcomes compared to a DES-only approach, offering a potential 'stent-less' therapy.
Background Data on drug-coated balloons (DCB) for de novo 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 de novo 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, p < 0.001). A total of 112 patients in the DCB group and 71 patients in the DES-only group (38.6% vs. 22.3%, p < 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, p < 0.001). There were no significant differences in restenosis occurrence between the two groups (20.5% vs. 19.7%, p > 0.999). The Kaplan–Meier estimates of MACE at 3-year (11.8% vs. 12.0%, log-rank p = 0.688) was similar between the groups. Conclusion Percutaneous coronary intervention with DCB is a potential “stent-less” therapy for de novo CTO lesions with satisfactory long-term clinical results compared to the DES-only approach.
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Wang et al. (2023) conducted an observational in De novo coronary chronic total occlusion (CTO) (n=591). Less drug-eluting stent strategy (drug-coated balloon alone or combined with DES) vs. Drug-eluting stent (DES)-only strategy was evaluated on Major adverse cardiovascular events (MACE) at 3 years (HR 0.932, 95% CI 0.532-1.633, p=0.805). A less drug-eluting stent strategy using drug-coated balloons resulted in a similar 3-year rate of major adverse cardiovascular events compared to a drug-eluting stent-only approach in patients with de novo coronary chronic total occlusion (HR 0.932).
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