Drug-eluting stents for the treatment of bifurcation lesions: a randomized comparison between paclitaxel and sirolimus stents.

Background: Drug-eluting stents have been shown to reduce restenosis in many types of lesions. The purpose of this article is to assess the efficacy of sirolimus- and paclitaxel-eluting stents in patients with bifurcation lesions.
Methods: Between June 2003 and October 2004, 205 patients were enrolled in a prospective randomized trial; 103 patients were assigned to sirolimus stents and 102 patients to paclitaxel stents. All patients were treated by provisional T-stenting.
Results: There were no differences between groups in terms of age, risk factors, clinical condition, location of the bifurcation lesion, or other technical factors. Angiographic data and immediate results were also similar in both groups. Three patients developed inhospital non-Q-wave acute myocardial infarction (2 from the sirolimus group and 1 from the paclitaxel group). Follow-up angiography was obtained in 109 patients (53%). In the sirolimus group, 5 patients developed restenosis (9%): 1 at the main vessel, 2 at the side branch, and 2 in both branches. In contrast, 16 patients from the paclitaxel group had restenosis (29%): 6 at the main vessel, 5 at the side branch, and 5 in both branches. Target lesion revascularization at 24 +/- 5 months post stenting occurred in 4 patients from the sirolimus group (4%) and in 13 from the paclitaxel group (13%) (P < .05). Late loss at the main vessel in the sirolimus group patients was 0.31 +/- 0.59 versus 0.60 +/- 0.77 mm in patients from the paclitaxel group (P < .05).
Conclusions: Patients with bifurcation lesions treated by sirolimus showed significantly lower rates of late loss, restenosis and target lesion revascularization than patients treated with paclitaxel-eluting stents.