Key result
DCB-only angioplasty shows no difference in MACE versus DES after four years.
Why the study?
Data were limited regarding the safety and efficacy of drug-coated balloon-only angioplasty compared with second-generation drug-eluting stents for multivessel coronary disease.
Does paclitaxel drug-coated balloon-only angioplasty improve or maintain safety and efficacy compared to second-generation drug-eluting stents in patients undergoing multivessel angioplasty?
Does paclitaxel drug-coated balloon-only angioplasty improve or maintain safety and efficacy compared to second-generation drug-eluting stents in patients undergoing multivessel angioplasty?
A paclitaxel drug-coated balloon-only strategy demonstrated comparable long-term clinical outcomes to second-generation drug-eluting stents in patients undergoing multivessel coronary angioplasty.
Should not yet change DES-first practice in multivessel disease; leaves open need for RCTs to confirm equivalence.
Background: There are limited data about the use of drug-coated balloon (DCB)-only angioplasty for multivessel coronary disease. Objectives: The aim of this study was to assess the safety and efficacy of DCB-only angioplasty as compared with second-generation drug-eluting stents (DESs) in patients undergoing multivessel angioplasty. Methods: We compared major adverse cardiovascular events (MACEs) in all patients undergoing multivessel angioplasty in our institution from 1 January 2015 until 15 November 2019, with either the DCB-only or DES-only strategy. The primary endpoint of our study was a MACE, including cardiovascular mortality, acute coronary syndrome, target lesion revascularisation, stroke, or major bleeding. Data were analysed using Cox regression models, Kaplan–Meier estimator plots, and propensity score matching. Results: A total of 159 consecutive patients treated with DCB-only angioplasty and 222 consecutive patients treated with DES-only angioplasty were identified. The majority of the vessels treated were large vessels (>3 mm). After a median follow-up of 4 years, a total of 52 (33%) patients in the DCB and 73 (33%) patients in the DES group encountered a MACE (p = 0.97). The results did not change following propensity score matching. On multivariate Cox regression analysis in the propensity score-matched cohort, atrial fibrillation [HR = 2.37, CI: (1.22–4.61), p = 0.011] and diabetes [HR = 1.71, CI: (1.13–2.60), p = 0.011] were the only independent adverse predictors of MACE. Conclusions: DCB-only angioplasty appears to be safe and efficient when compared to DES for multivessel angioplasty in terms of MACEs after a follow-up of 4 years.
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Merinopoulos et al. (2025) studied this question. DCB-only angioplasty and DES showed no significant difference in major adverse cardiovascular events (33% in both groups) after 4 years of follow-up.
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