Paclitaxel-coated balloon with bare-metal stenting in patients with chronic total occlusions in native coronary arteries.

ABSTRACT

OBJECTIVES: We sought to evaluate the efficacy and safety of paclitaxel-coated balloon plus bare-metal stenting (BMS) in chronic total occlusions (CTOs). BACKGROUND: Drug-eluting stent implantation after recanalization of CTOs is limited by the occurrence of restenosis and risk for late stent thromboses. METHODS: In this prospective, bicenter trial we treated 48 patients after successful chronic total occlusion (CTO) recanalization in a native coronary artery with paclitaxel-coated balloon plus BMS. Patients were matched according to stent length, reference diameter, and diabetes mellitus with 48 patients treated with Taxus stent implantation. Dual antiplatelet therapy was prescribed for 6 months. Angiographic (clinical) follow-up was obtained after 6 (12) months. Primary endpoint was in-stent late lumen loss. RESULTS: There was no difference in patient baseline characteristics or procedural results. Stent length was 59.7 ± 32.4 mm (16-151 mm) for paclitaxel-coated balloon plus BMS versus 56.2 ± 25.9 mm (16-132 mm) for Taxus stent. Late loss was statistically not different within the stent with 0.64 ± 0.69 mm versus 0.43 ± 0.64 mm (difference 0.20 mm, 95% confidence interval -0.07 to 0.47, P = 0.14) and at the occlusion site with 0.33 ± 0.69 mm versus 0.26 ± 0.70 mm, respectively. Restenosis rate was 27.7% compared with 20.8% (P = 0.44) and the combined clinical endpoint (cardiac death, myocardial infarction attributed to the target vessel, target lesion revascularization) was 14.6% versus 18.8% (P = 0.58), respectively. CONCLUSIONS: In conclusion, for patients with complex CTOs in native coronary arteries the use of paclitaxel-coated balloon after bare-metal stenting was associated with similar clinical results and a nonsignificantly higher in-stent late loss compared with a matched population with paclitaxel-eluting stent implantation.