Combined Paclitaxel-Eluting Balloon and Genous Cobalt-Chromium Alloy Stent Utilization in De Novo Coronary Stenoses (PEGASUS).

Abstract

OBJECTIVES: The aim of this study was to examine the angiographic result and its outcome predictors using the combination of paclitaxel-eluting balloon (PEB) and Genous stent. BACKGROUND: This approach to treat coronary stenoses is a logical strategy to strike a balance between minimizing restenosis and stent thrombosis. METHODS: From November 2010 to June 2012, 40 symptomatic patients with 44 de novo coronary lesions of diameter stenosis >/= 50% were treated with the combination of PEB and Genous stents. Angiographic and clinical follow-up were intended at 6 and 9 months, respectively. RESULTS: The mean age of patients was 61 +/- 11 years, with male predominance (83%). Diabetes mellitus and end-stage renal failure on peritoneal dialysis were found in 15 (38%) and 10 (25%) patients, respectively. Patients received dual antiplatelet therapy for 5.1 +/- 1.5 months post procedure. The size and length of PEB used was larger than the stents (3.13 +/- 0.46 mm and 28 +/- 9 mm vs. 2.98 +/- 0.36 mm and 23 +/- 7 mm). Restudy angiography was performed on 41 (95%) lesions in 37 (93%) patients at 5.9 +/- 1.7 months. Angiographic restenosis was seen in 5 (12%) lesions, and significantly associated with diabetes mellitus and dialysis dependency; the late lumen loss was 0.38 +/- 0.37 mm. At 9-month follow-up, no stent thrombosis was observed. CONCLUSIONS: The use of PEB combined with Genous stent is associated with a reasonably low restenosis and late lumen loss, whereas diabetes mellitus and renal failure with dialysis are poor predictors of angiographic restenosis.