Key result
Drug-coated balloons showed no significant difference in all-cause mortality compared to drug-eluting stents for de novo unprotected left main stem disease (HR 1.42; 95% CI 0.61-3.32; p=0.42).
Why the study?
Data are limited from studies investigating the treatment of de novo unprotected left main stem disease with drug-coated balloon angioplasty compared with second-generation drug-eluting stents.
Does paclitaxel drug-coated balloon angioplasty reduce mortality compared to second-generation drug-eluting stents in patients with de novo unprotected left main stem disease?
Cohort (n=148)
Does paclitaxel drug-coated balloon angioplasty reduce mortality compared to second-generation drug-eluting stents in patients with de novo unprotected left main stem disease?
Hazard Ratio: 1.42 (95% CI 0.61–3.32)
Absolute Event Rate: 19.5% vs 15.9%
p-value: p=0.42
Drug-coated balloon angioplasty appears to be a safe alternative to second-generation drug-eluting stents for de novo unprotected left main stem disease, with comparable mortality and revascularization outcomes at 33 months.
The objective of this study is to compare the outcomes of patients treated with drug-coated balloons (DCBs) or second-generation drug-eluting stents (DESs) for de novo unprotected left main stem (LMS) disease. Previous studies comparing the treatment of LMS disease suggest that the mortality for DES PCI is not worse than CABG. There are limited data from studies investigating the treatment of de novo LMS disease with DCB angioplasty. We compared the all-cause and cardiac mortality of patients treated with paclitaxel DCB to those with second-generation DES for de novo LMS disease from July 2014 to November 2019. Data were analysed using Kaplan–Meier analyses and propensity-matched analyses. A total of 148 patients were treated with either a DCB or DES strategy. There was no significant difference in all-cause mortality in the DCB group (19.5%) compared to the DES group (15.9%) (HR 1.42 [0.61–3.32], p = 0.42). Regarding cardiac mortality, 2 (4.9%) were recorded for the DCB group and 7 (6.5%) for the DES group (HR 1.21 [0.31–4.67], p = 0.786); for target vessel myocardial infarction, there were 0 (0%) for the DCB group and 7 (6.5%) for the DES group; and for target lesion revascularisation, there were 3 (7.3%) in the DCB group and 9 (8.3%) in the DES group (HR: 0.89 [0.24–3.30]). p = 0.86. These remained not significant after propensity score matching. We found no difference in the mortality outcomes with DCB angioplasty compared to second-generation DES, with a median follow-up of 33 months. DCB can therefore be regarded as a safe option in the treatment of LMS disease in suitable patients.
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Gunawardena et al. (2023) conducted a cohort in de novo unprotected left main stem (LMS) disease (n=148). Paclitaxel drug-coated balloon (DCB) vs. Second-generation drug-eluting stents (DES) was evaluated on all-cause mortality (HR 1.42, 95% CI 0.61-3.32, p=0.42). Drug-coated balloons showed no significant difference in all-cause mortality compared to drug-eluting stents for de novo unprotected left main stem disease (HR 1.42; 95% CI 0.61-3.32; p=0.42).
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