Rapamycin-eluting stents for the treatment of bifurcated coronary lesions:: A randomized comparison of a simple versus complex strategy

Background Rapamycin-eluting stents (RES) have been shown to reduce restenosis in many types of lesions. However, the ideal strategy for the treatment of coronary bifurcated lesions has not been established to date. This randomized study compares 2 strategies for the RES treatment of bifurcation lesions: a simple approach (stenting the main vessel and balloon dilatation for the side branch [SB]) versus a complex approach (stents for both vessels). Methods To compare both strategies, a randomized study was conducted in 91 patients with true coronary bifurcation lestions. All patients received an RES at the main vessel, covering the SB. Patients from group A (n = 47) were assigned to balloon dilation of the involved SB (simple strategy); patients in group B (n = 44) were randomized to receive a second stent at the SB origin (complex strategy). There were no differences between groups regarding baseline clinical and angiographic data. Results Major adverse cardiac events occurred in 3 patients from group A (2 non-Q-wave myocardial infarctions and 1 target lesion revascularization). Six-month angiographic reevaluation was obtained in 80 patients (88%). Restenosis of the main vessel was observed in 1 (2%) patient from group A and in 4 (10%) from group B. Restenosis of the SB appeared in 2 (5%) patients from group A and in 6 (15%) from group B. Conclusions Both strategies are effective in reducing the restenosis rate, with no differences in terms of clinical outcome. Elective SB stenting seems to provide no advantages over the simpler stent jail followed by SB balloon dilation.