Paclitaxel drug-coated balloon- (DCB) only angioplasty was not found to be associated with late mortality within 5 years compared with nonpaclitaxel second-generation drug-eluting stents (DES) in patients with de novo coronary artery disease, according to a study published in Clinical Research in Cardiology.
In the Safety of PAclitaxel dRug coaTed balloon only ANgioplaSty for de novo coronary artery disease (SPARTAN DCB) study, 1517 patients with de novo coronary artery disease were undergoing percutaneous coronary intervention (PCI) with DCB (n=429; average age, 66.9±10.2 years; 76.2% men) or DES (n=1088; average age, 66.8±10 years; 76.6% men) were enrolled. Patients who had previously undergone PCI or who had mixed DCB/DES PCIs following the index intervention were excluded.
Participants were followed up for an average of 31.6±16.3 months (interquartile range 16.8-45.3 months) in the DCB group and 44.4 ± 18.4 months (interquartile range 27.1-60 months) in the DES group. The incidence of chronic obstructive pulmonary disease was greater and more patients had a history of smoking in the DES vs DCB group, and the incidence of atrial fibrillation was greater in the DCB vs DES group.
Age, hypercholesterolemia, hypertension, peripheral vascular disease, prior myocardial infarction, heart failure, smoking, atrial fibrillation, decreasing estimated glomerular filtration rate (eGFR), and renal failure (ie, eGFR <45) were associated with worse survival in a univariate analysis. DCB intervention showed a nonsignificant trend toward better prognosis compared with DES (P =.08). Age, decreasing eGFR, and smoking were associated with worse prognosis in a multivariable analysis.
Study limitations include its retrospective nature, and nonrandomized and single center design.
“We have demonstrated that there is no evidence of increased late mortality associated with paclitaxel DCB compared to nonpaclitaxel second-generation DES for de novo coronary artery disease up to 5 years of follow-up,” the investigators commented. “In fact, there was actually a trend towards better survival with DCB, a finding consistent with the most recent meta-analysis.”
Merinopoulos I, Gunawardena T, Wickramarachchi U, et al. Long‑term safety of paclitaxel drug‑coated balloon‑only angioplasty for de novo coronary artery disease: The SPARTAN DCB study [published online September 2, 2020]. Clin Res Cardiol. doi: 10.1007/s00392-020-01734-6