OBJECTIVES: To compare the efficacy of sirolimus- and everolimus-eluting stents in patients with bifurcation lesions treated with provisional side-branch stenting. BACKGROUND: The efficacy of everolimus-eluting stents in bifurcation lesions has been poorly tested. METHODS:Patients with all types of Medina bifurcation lesions were randomly assigned to treatment with either a sirolimus- (n = 145) or everolimus-eluting stent (n = 148). We included patients with main vessel diameter over 2.5 mm and side branches over 2.25 mm. Patients with diffuse side-branch stenosis were excluded. RESULTS: There were no significant differences between patients from the sirolimus and everolimus groups in terms of age, risk factors, clinical status, location of the bifurcation lesions or angiographic variables. Immediate results and in-hospital outcome were also similar in both groups of patients. In-hospital death occurred in two patients, one from each group. Target lesion revascularization was required in nine patients: four patients (2.7%) from the sirolimus group and five patients (3.4%) from the everolimus group. Late cardiac mortality occurred in two patients from the sirolimus group and in one patient from the everolimus group. Major cardiac event rates at 1 year were similar in both groups: nine patients (6.2%) in the sirolimus group and nine patients (6.1%) from the everolimus group (p: ns). CONCLUSIONS: In patients with bifurcation lesions, no significant differences in clinical outcome at 1-year follow-up were observed between sirolimus- and everolimus-eluting stent groups.
RCT Entities:
OBJECTIVES: To compare the efficacy of sirolimus- and everolimus-eluting stents in patients with bifurcation lesions treated with provisional side-branch stenting. BACKGROUND: The efficacy of everolimus-eluting stents in bifurcation lesions has been poorly tested. METHODS:Patients with all types of Medina bifurcation lesions were randomly assigned to treatment with either a sirolimus- (n = 145) or everolimus-eluting stent (n = 148). We included patients with main vessel diameter over 2.5 mm and side branches over 2.25 mm. Patients with diffuse side-branch stenosis were excluded. RESULTS: There were no significant differences between patients from the sirolimus and everolimus groups in terms of age, risk factors, clinical status, location of the bifurcation lesions or angiographic variables. Immediate results and in-hospital outcome were also similar in both groups of patients. In-hospital death occurred in two patients, one from each group. Target lesion revascularization was required in nine patients: four patients (2.7%) from the sirolimus group and five patients (3.4%) from the everolimus group. Late cardiac mortality occurred in two patients from the sirolimus group and in one patient from the everolimus group. Major cardiac event rates at 1 year were similar in both groups: nine patients (6.2%) in the sirolimus group and nine patients (6.1%) from the everolimus group (p: ns). CONCLUSIONS: In patients with bifurcation lesions, no significant differences in clinical outcome at 1-year follow-up were observed between sirolimus- and everolimus-eluting stent groups.
Authors: K Gert van Houwelingen; Liefke C van der Heijden; Ming Kai Lam; Marlies M Kok; Marije M Löwik; J W Louwerenburg; Gerard C M Linssen; Maarten J IJzerman; Carine J M Doggen; Clemens von Birgelen Journal: Heart Vessels Date: 2016-01-08 Impact factor: 2.037