Long-term s afety of pa clitaxel d r ug-coa t ed balloon-only an gioplasty for de novo coronary artery disease: the SPAR
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ORIGINAL PAPER
Long‑term safety of paclitaxel drug‑coated balloon‑only angioplasty for de novo coronary artery disease: the SPARTAN DCB study Ioannis Merinopoulos1,2 · Tharusha Gunawardena1,2 · Upul Wickramarachchi1,2 · Paul Richardson1 · Clint Maart1 · Sulfi Sreekumar1 · Chris Sawh1 · Trevor Wistow1 · Toomas Sarev1 · Alisdair Ryding1 · Tim Gilbert1 · Aris Perperoglou3 · Vassilios S. Vassiliou1,2,4,5 · Simon C. Eccleshall1 Received: 12 June 2020 / Accepted: 17 August 2020 © The Author(s) 2020
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 secondgeneration 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
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