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

Merinopoulos, Ioannis, Gunawardena, Tharusha, Corballis, Natasha, Uthayachandran, Bhalraam, Gilbert, Tim, Maart, Clint, Richardson, Paul, Ryding, Alisdair, Sarev, Toomas, Sawh, Chris, Sulfi, Sreekumar, Wickramarachchi, Upul, Wistow, Trevor, Mohamed, Mohamed O., Mamas, Mamas A., Vassiliou, Vassilios S. ORCID: and Eccleshall, Simon C. (2023) Paclitaxel drug coated balloon-only angioplasty for de novo coronary artery disease in elective clinical practice. Clinical Research in Cardiology, 112 (9). 1186–1193. ISSN 1861-0684

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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.

Item Type: Article
Additional Information: Funding information: This is an investigator-initiated study partially supported by the National Institute for Health Research Capability Fund from Norfolk and Norwich University Hospital and B Braun Ltd. Dr Corballis was an NIHR Academic Clinical Fellow.
Uncontrolled Keywords: de novo disease,drug-coated balloon,stable angina,cardiology and cardiovascular medicine ,/dk/atira/pure/subjectarea/asjc/2700/2705
Faculty \ School: Faculty of Medicine and Health Sciences > Norwich Medical School
UEA Research Groups: Faculty of Medicine and Health Sciences > Research Groups > Cardiovascular and Metabolic Health
Faculty of Science > Research Groups > Norwich Epidemiology Centre
Faculty of Medicine and Health Sciences > Research Groups > Norwich Epidemiology Centre
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Depositing User: LivePure Connector
Date Deposited: 09 Sep 2022 12:30
Last Modified: 11 Sep 2023 08:30
DOI: 10.1007/s00392-022-02106-y

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