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

Merinopoulos, Ioannis; Gunawardena, Tharusha; Corballis, Natasha; Bhalraam, U; Gilbert, Tim; Maart, Clint; Richardson, Paul; Ryding, Alisdair; Sarev, Toomas; Sawh, Chris; Sulfi, Sreekumar; Wickramarachchi, Upul; Wistow, Trevor; Mohamed, Mohamed O.; Mamas, Mamas; Vassiliou, Vassilios S.; Eccleshall, Simon C.

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Authors

Ioannis Merinopoulos

Tharusha Gunawardena

Natasha Corballis

U Bhalraam

Tim Gilbert

Clint Maart

Paul Richardson

Alisdair Ryding

Toomas Sarev

Chris Sawh

Sreekumar Sulfi

Upul Wickramarachchi

Trevor Wistow

Mohamed O. Mohamed

Vassilios S. Vassiliou

Simon C. Eccleshall



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. Graphic abstract:

Journal Article Type Article
Acceptance Date Sep 6, 2022
Online Publication Date Sep 14, 2022
Publication Date Sep 1, 2023
Publicly Available Date May 30, 2023
Journal Clinical Research in Cardiology
Print ISSN 1861-0684
Publisher Springer Verlag
Volume 112
Issue 9
Pages 1186-1193
DOI https://doi.org/10.1007/s00392-022-02106-y
Keywords Drug-coated balloon, De novo disease, Stable angina
Publisher URL https://link.springer.com/article/10.1007/s00392-022-02106-y

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