Treatment of bifurcation lesions using dedicated bifurcation stents versus classic bare-metal stents. Randomized, controlled trial with 12-month angiographic follow up.

BACKGROUND: The aim of this study was to compare the use of classic bare- metal stents with dedicated bifurcation bare-metal stents in patients who were not eligible for drug-eluting stents (DES) implantation. METHODS: Sixty patients with bifurcation stenosis were randomly assigned to received either a dedicated bifurcation or a bare-metal stent (n = 30) or classic bare-metal stent (n = 30) with stenting of the parent vessel and angioplasty/or provisional stenting of the side branch. Fifty-nine patients underwent 12-month clinical and angiographic follow up unless this was performed earlier due to symptoms. Dual antiplatelet treatment was administered for 1 month. Acute success as well as the long-term clinical and angiographic outcome have been assessed in both groups. RESULTS: Baseline demographic, angiographic and procedure-related characteristics were well balanced in both groups. The use of dedicated stents was associated either with reduced procedure or fluoroscopy time (34 +/- 9 minutes vs. 46 +/- 20 minutes; p = 0.004 and 9 +/- 6 minutes vs. 15 +/- 9 minutes; p = 0.003, respectively) and lesser contrast volume (168 +/- 86 milliliters vs. 199 +/- 103 ml; p = 0.02). At the 12-month follow up, no statistically significant difference was found between both groups regarding major adverse cardiovascular events (MACE) (13.7 vs. 13.3%; p = 0.9). CONCLUSIONS: In our study we failed to demonstrate the superiority of a dedicated stent versus classic a bare-metal stent for the treatment of bifurcation lesions regarding MACE in patients who were not eligible for DES implantation. However, the use of dedicated stents may be preferable due to reduced procedure and fluoroscopy time and lesser contrast volume.