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

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.