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

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

doi:10.1007/s00392-022-02106-y

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

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

Research output: Contribution to journal › Article › peer-review

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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.

Original language	English
Pages (from-to)	1186–1193
Number of pages	8
Journal	Clinical Research in Cardiology
Volume	112
Issue number	9
Early online date	14 Sep 2022
DOIs	https://doi.org/10.1007/s00392-022-02106-y
Publication status	Published - Sep 2023

Keywords

De novo disease
Drug-coated balloon
Stable angina

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DCB angioplasty in elective patients resubmisionAccepted author manuscript, 520 KBLicence: CC BY

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Merinopoulos, I., Gunawardena, T., Corballis, N., Uthayachandran, B., Gilbert, T., Maart, C., Richardson, P., Ryding, A., Sarev, T., Sawh, C., Sulfi, S., Wickramarachchi, U., Wistow, T., Mohamed, M. O., Mamas, M. A., Vassiliou, V. S., & Eccleshall, S. 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. https://doi.org/10.1007/s00392-022-02106-y

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. ; Eccleshall, Simon C. / Paclitaxel drug coated balloon-only angioplasty for de novo coronary artery disease in elective clinical practice. In: Clinical Research in Cardiology. 2023 ; Vol. 112, No. 9. pp. 1186–1193.

@article{0d9ea2ee357d46eba60695115ccf2e8f,

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

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",

author = "Ioannis Merinopoulos and Tharusha Gunawardena and Natasha Corballis and Bhalraam Uthayachandran and Tim Gilbert and Clint Maart and Paul Richardson and Alisdair Ryding and Toomas Sarev and Chris Sawh and Sreekumar Sulfi and Upul Wickramarachchi and Trevor Wistow and Mohamed, {Mohamed O.} and Mamas, {Mamas A.} and Vassiliou, {Vassilios S.} and Eccleshall, {Simon C.}",

note = "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.",

year = "2023",

month = sep,

doi = "10.1007/s00392-022-02106-y",

language = "English",

volume = "112",

pages = "1186–1193",

journal = "Clinical Research in Cardiology",

issn = "1861-0684",

publisher = "Springer",

number = "9",

}

Merinopoulos, I, Gunawardena, T , Corballis, N, Uthayachandran, B, Gilbert, T, Maart, C, Richardson, P, Ryding, A, Sarev, T, Sawh, C, Sulfi, S, Wickramarachchi, U, Wistow, T, Mohamed, MO, Mamas, MA, Vassiliou, VS & Eccleshall, SC 2023, 'Paclitaxel drug coated balloon-only angioplasty for de novo coronary artery disease in elective clinical practice', Clinical Research in Cardiology, vol. 112, no. 9, pp. 1186–1193. https://doi.org/10.1007/s00392-022-02106-y

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.; Eccleshall, Simon C.

In: Clinical Research in Cardiology, Vol. 112, No. 9, 09.2023, p. 1186–1193.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Paclitaxel drug coated balloon-only angioplasty for de novo coronary artery disease in elective clinical practice

AU - Merinopoulos, Ioannis

AU - Gunawardena, Tharusha

AU - Corballis, Natasha

AU - Uthayachandran, Bhalraam

AU - Gilbert, Tim

AU - Maart, Clint

AU - Richardson, Paul

AU - Ryding, Alisdair

AU - Sarev, Toomas

AU - Sawh, Chris

AU - Sulfi, Sreekumar

AU - Wickramarachchi, Upul

AU - Wistow, Trevor

AU - Mohamed, Mohamed O.

AU - Mamas, Mamas A.

AU - Vassiliou, Vassilios S.

AU - Eccleshall, Simon C.

N1 - 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.

PY - 2023/9

Y1 - 2023/9

N2 - 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.

AB - 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.

KW - De novo disease

KW - Drug-coated balloon

KW - Stable angina

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U2 - 10.1007/s00392-022-02106-y

DO - 10.1007/s00392-022-02106-y

M3 - Article

VL - 112

SP - 1186

EP - 1193

JO - Clinical Research in Cardiology

JF - Clinical Research in Cardiology

SN - 1861-0684

IS - 9

ER -

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

Abstract

Keywords

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