Vassilios S Vassiliou1,2,3,4, Simon C Eccleshall5, Ioannis Merinopoulos5,6, Tharusha Gunawardena5,6, Upul Wickramarachchi5,6, Paul Richardson5, Clint Maart5, Sulfi Sreekumar5, Chris Sawh5, Trevor Wistow5, Toomas Sarev5, Alisdair Ryding5, Tim Gilbert5, Aris Perperoglou7. 1. Department of Cardiology, Norfolk and Norwich University Hospital, Norwich, UK. v.vassiliou@uea.ac.uk. 2. Norwich Medical School, University of East Anglia, Norwich, UK. v.vassiliou@uea.ac.uk. 3. Royal Brompton Hospital, London, UK. v.vassiliou@uea.ac.uk. 4. Norwich Medical School, University of East Anglia, 2.06 Bob Champion Research & Education Building, Norwich, NR4 7TJ, UK. v.vassiliou@uea.ac.uk. 5. Department of Cardiology, Norfolk and Norwich University Hospital, Norwich, UK. 6. Norwich Medical School, University of East Anglia, Norwich, UK. 7. School of Mathematics, Statistics and Physics, Newcastle University, Newcastle Upon, UK.
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.
OBJECTIVES: We aimed to investigate long-term survival of paclitaxelDCB 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 paclitaxelDCB 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 paclitaxelDCB 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.
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