Long-termsafety ofpaclitaxel drug-coated balloon-onlyangioplasty for de novo coronary artery disease: the SPARTAN DCB study
File(s)
Author(s)
Type
Journal Article
Abstract
Objectives
We aimed to investigate long-term survival of paclitaxel DCB for percutaneous coronary intervention (PCI).
Background
Safety concerns have been raised over the use of paclitaxel devices for peripheral artery disease recently, following a meta-analysis suggesting increased late mortality. With regard to drug-coated balloon (DCB) angioplasty for coronary artery intervention however, there is limited data to date regarding possible late mortality relating to paclitaxel.
Methods
We compared all-cause mortality of patients treated with paclitaxel DCB to those with non-paclitaxel second-generation drug-eluting stents (DES) for stable, de novo coronary artery disease from 1st January 2011 till 31st December 2018. To have homogenous groups allowing data on safety to be interpreted accurately, we excluded patients with previous PCI and patients treated with a combination of both DCB and DES in subsequent PCIs. Data were analysed with Kaplan–Meier curves and Cox regression statistical models.
Results
We present 1517 patients; 429 treated with paclitaxel DCB and 1088 treated with DES. On univariate analysis, age, hypercholesterolaemia, hypertension, peripheral vascular disease, prior myocardial infarction, heart failure, smoking, atrial fibrillation, decreasing estimated glomerular filtration rate (eGFR) [and renal failure (eGFR < 45)] were associated with worse survival. DCB intervention showed a non-significant trend towards better prognosis compared to DES (p = 0.08). On multivariable analysis age, decreasing eGFR and smoking associated with worse prognosis.
Conclusion
We found no evidence of late mortality associated with DCB angioplasty compared with non-paclitaxel second-generation DES in up to 5 years follow-up. DCB is a safe option for the treatment of de novo coronary artery disease.
We aimed to investigate long-term survival of paclitaxel DCB for percutaneous coronary intervention (PCI).
Background
Safety concerns have been raised over the use of paclitaxel devices for peripheral artery disease recently, following a meta-analysis suggesting increased late mortality. With regard to drug-coated balloon (DCB) angioplasty for coronary artery intervention however, there is limited data to date regarding possible late mortality relating to paclitaxel.
Methods
We compared all-cause mortality of patients treated with paclitaxel DCB to those with non-paclitaxel second-generation drug-eluting stents (DES) for stable, de novo coronary artery disease from 1st January 2011 till 31st December 2018. To have homogenous groups allowing data on safety to be interpreted accurately, we excluded patients with previous PCI and patients treated with a combination of both DCB and DES in subsequent PCIs. Data were analysed with Kaplan–Meier curves and Cox regression statistical models.
Results
We present 1517 patients; 429 treated with paclitaxel DCB and 1088 treated with DES. On univariate analysis, age, hypercholesterolaemia, hypertension, peripheral vascular disease, prior myocardial infarction, heart failure, smoking, atrial fibrillation, decreasing estimated glomerular filtration rate (eGFR) [and renal failure (eGFR < 45)] were associated with worse survival. DCB intervention showed a non-significant trend towards better prognosis compared to DES (p = 0.08). On multivariable analysis age, decreasing eGFR and smoking associated with worse prognosis.
Conclusion
We found no evidence of late mortality associated with DCB angioplasty compared with non-paclitaxel second-generation DES in up to 5 years follow-up. DCB is a safe option for the treatment of de novo coronary artery disease.
Date Issued
2020-09-02
Date Acceptance
2020-08-17
Citation
Clinical Research in Cardiology, 2020, 110 (2), pp.220-227
ISSN
0300-5860
Publisher
Springer Verlag
Start Page
220
End Page
227
Journal / Book Title
Clinical Research in Cardiology
Volume
110
Issue
2
Copyright Statement
© The Author(s) 2020. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
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Identifier
http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000565473800001&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
Subjects
Science & Technology
Life Sciences & Biomedicine
Cardiac & Cardiovascular Systems
Cardiovascular System & Cardiology
Stable angina
Mortality
Drug-coated balloon
Publication Status
Published
Date Publish Online
2020-09-02