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. 2023 Sep;112(9):1186-1193.
doi: 10.1007/s00392-022-02106-y. Epub 2022 Sep 14.

Paclitaxel drug-coated balloon-only angioplasty for de novo coronary artery disease in elective clinical practice

Ioannis Merinopoulos  1   2 , Tharusha Gunawardena  1   2 , Natasha Corballis  1   2 , U Bhalraam  3 , Tim Gilbert  1 , Clint Maart  1 , Paul Richardson  1 , Alisdair Ryding  1 , Toomas Sarev  1 , Chris Sawh  1 , Sreekumar Sulfi  1 , Upul Wickramarachchi  1   2 , Trevor Wistow  1 , Mohamed O Mohamed  4 , Mamas A Mamas  4 , Vassilios S Vassiliou #  5   6 , Simon C Eccleshall #  1
Affiliations

Paclitaxel drug-coated balloon-only angioplasty for de novo coronary artery disease in elective clinical practice

Ioannis Merinopoulos et al. Clin Res Cardiol. 2023 Sep.

Abstract

Objective: We aimed to investigate the safety of drug-coated balloon (DCB)-only angioplasty compared to drug-eluting stent (DES), as part of routine clinical practice.

Background: The recent BASKETSMALL2 trial demonstrated the safety and efficacy of DCB angioplasty for de novo small vessel disease. Registry data have also demonstrated that DCB angioplasty is safe; however, most of these studies are limited due to long recruitment time and a small number of patients with DCB compared to DES. Therefore, it is unclear if DCB-only strategy is safe to incorporate in routine elective clinical practice.

Methods: We compared all-cause mortality and major cardiovascular endpoints (MACE), including unplanned target lesion revascularisation (TLR) of all patients treated with DCB or DES for first presentation of stable angina due to de novo coronary artery disease between 1st January 2015 and 15th November 2019. Data were analysed with Cox regression models and cumulative hazard plots.

Results: We present 1237 patients; 544 treated with DCB and 693 treated with DES for de novo, mainly large-vessel coronary artery disease. On multivariable Cox regression analysis, only age and frailty remained significant adverse predictors of all-cause mortality. Univariable, cumulative hazard plots showed no difference between DCB and DES for either all-cause mortality or any of the major cardiovascular endpoints, including unplanned TLR. The results remained unchanged following propensity score-matched analysis.

Conclusion: DCB-only angioplasty, for stable angina and predominantly large vessels, is safe compared to DES as part of routine clinical practice, in terms of all-cause mortality and MACE, including unplanned TLR.

Keywords: De novo disease; Drug-coated balloon; Stable angina.

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Conflict of interest statement

VSV received honoraria for speaking at conferences by Daiichi Sankyo and Novartis and a research grant from B Braun for investigator-initiated research. SCE received research grants for investigator-initiated research and lecture honoraria from B Braun. He also acts as a consultant for B Braun, Medtronic and MedAlliance. The other authors have nothing to declare.

Figures

Fig. 1
Fig. 1
Yearly usage of DCB and DES in patients with first presentation with stable angina and de novo disease
Fig. 2
Fig. 2
Consort diagram indicating how the final population included in this study was identified
Fig. 3
Fig. 3
Cumulative hazard plot of all-cause mortality for DCB versus 2nd-generation DES with numbers at risk shown below the graph. DCB drug-coated balloon, DES drug-eluting stent
Fig. 4
Fig. 4
Cumulative hazard plot of all-cause mortality in propensity score-matched cohort, for DCB vs 2nd-generation DES with numbers at risk shown at the bottom of the graph. DCB drug-coated balloon, DES drug-eluting stent
See this image and copyright information in PMC

References

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