Treatment of coronary artery disease with bare metal stents followed by paclitaxel- coated balloon catheter versus paclitaxel-eluting stents- randomized trial

Purpose: The aim of the study is to compare single dose of Paclitaxel delivered from Paclitaxel-coated Balloon Catheter - SeQuent Please (DEB) after implantation of the cobalt chromium bare metal stent- Coroflex Blue (BMS) versus the slow release of Paclitaxel from the drug eluting stent - Coroflex Please (DES). Method: We included 202 patients with stable or unstable angina and coronary artery stenosis > 50% in native vessels from 2.5 to 3.5 mm in diameter. All patients were randomized 1:1 to either DES or BMS+ DEB (DEB) group. In-hospital, 30 day and 6 month clinical data were collected after the randomization and index procedure. Primary endpoint was: target lesion failure (TLF) defined as cardiac death, myocardial infraction (MI), repeat percutaneous coronary intervention (PCI) or coronary artery by-pass (CABG) related to the target vessel. Angiographic endpoints were late loss and binary restenosis measured in 9 month angiograpy control in 50% of patients. In stent thrombosis (ST) (definite according to ARC definition) was recorded as additional safety endpoint. Results: Stent placement of DES or BMS postdilated with DEB was successful in 202 patients (100 DES vs. 102 DEB) There was no patient lost to follow up. Before discharge the primary endpoint was met in 5 patients. (two in DES vs three in DEB group; p= ns). ST occurred in 4 patients (one in DES vs three in DEB; p=ns). During 30 days follow up, primary endpoint occurred in 7 patients (2 in DES vs. 5 in DEB; p=ns). ST was noted in 6 patients (1 in DES vs 5 in DEB; p=ns). In the 6 months follow-up, the primary endpoint occurred in 11 patients (3 in DES vs. 8 in DEB; p=ns). There were more statisticaly non-significant ST in DEB group (1in DES vs. 6 in DEB; p=0.1). Concusions: SeQuent Please (DEB) after implantation the cobalt chromium bare metal stent- Coroflex Blue (BMS) is comparable with Coroflex Please (DES) treatment, nevertheless stent thrombosis was more frequent (not statistically significant) in Coroflex Blue (BMS) plus SeQuent Please (DEB) group.