Long-term safety of paclitaxel drug-coated balloon-only angioplasty for de novo coronary artery disease: the SPARTAN DCB study

Merinopoulos, Ioannis, Gunawardena, Tharusha, Wickramarachchi, Upul, Richardson, Paul, Maart, Clint, Sreekumar, Sulfi, Sawh, Chris, Wistow, Trevor, Sarev, Toomas, Ryding, Alisdair, Gilbert, Tim, Perperoglou, Aris, Vassiliou, Vassilios S. and Eccleshall, Simon C. (2021) Long-term safety of paclitaxel drug-coated balloon-only angioplasty for de novo coronary artery disease: the SPARTAN DCB study. Clinical Research in Cardiology, 110 (2). pp. 220-227. ISSN 1861-0684

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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.

Item Type: Article
Uncontrolled Keywords: drug-coated balloon,mortality,stable angina,cardiology and cardiovascular medicine ,/dk/atira/pure/subjectarea/asjc/2700/2705
Faculty \ School: Faculty of Medicine and Health Sciences > Norwich Medical School
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Depositing User: LivePure Connector
Date Deposited: 26 Nov 2020 00:48
Last Modified: 13 Aug 2021 00:13
URI: https://ueaeprints.uea.ac.uk/id/eprint/77812
DOI: 10.1007/s00392-020-01734-6

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