Coronary Bifurcation Lesions Treated With Simple Approach (from the Cordoba & Las Palmas [CORPAL] Kiss Trial)

The present report compared the incidence of 1-year clinical events in patients with bifurcation lesions that had been treated with a simple approach who were randomized to either a simultaneous final kissing balloon (KB) or an isolated side-branch (SB) balloon post-dilation. From February 2007 to December 2008, 293 patients with all types of Medina bifurcation lesions were enrolled in a prospective study. All patients underwent implantation of a sirolimus- or everolimus-eluting stent across the bifurcation and provisional SB stenting. Patients with no SB ostial compromise or those needing a second stent were excluded from the present study (n = 49). The eligible patients were randomly assigned to treatment with final KB inflation (n = 124, KB group) or isolated balloon after dilation (n = 120, non-KB group). No significant differences were found between the patients from the KB and non-KB groups in terms of age, risk factors, clinical status, or location of the bifurcation lesions. The angiographic data and immediate results were also similar in both groups. Four patients experienced a non–Q-wave acute myocardial infarction in the hospital: three (2%) from the KB group and one (1%) from the non-KB group. Two in-hospital deaths occurred in the non-KB group. Target lesion revascularization was required in 7 patients (3%): 5 from the KB group and 2 from the non-KB group. Late mortality occurred in 3 patients from the KB group and 2 patients from the non-KB group. The incidence of major events at 1 year (death, target lesion revascularization, or acute myocardial infarction) was similar in both groups: 11 (9%) from the KB group and 7 (6%) from the non-KB group (p = NS). In conclusion, no differences in the clinical outcome at 1 year of follow-up were observed between the patients with bifurcation lesions treated with a simple approach and either a simultaneous final KB or an isolated SB balloon post-dilation.