ABSTRACT
Objective To invesgate the safety and efficacy of the second generation biodegradable polymer Cobalt-Chromium sirolimus-eluting stent (EXCEL2) stent in diabetic patients by a subgroup analysis of of the CREDITⅡand CREDIT Ⅲ trials. Methods All patients who were implanted with the EXCEL2 stent were enrolled in the CREDITⅡand CREDIT Ⅲ trials. The primary endpoint was target lesion failure at 24-month, defi ned as a composite of cardiac death, target vessel myocardial infarction (TV-MI) and target lesion revascularization(TLR). The secondary endpoint was endpoints including all-cause death, all myocardial infarction (MI) or any revascularization.Results A total of 828 patients were included from the patients who were implanted with the EXCEL2 stent in the CREDIT II and CREDIT Ⅲ trials. 24-month follow-up rate was 99.5%. There was no significant difference in the primary endpoint (P>0.05) and event rates of the secondary endpoints(P>0.05) between the diabetic and non-diabetic group, which included all-cause death[diabetics (2.5%)vs.non-diabetics(1.4%),P>0.05],myocardial infarction(MI)(7.5% vs.5.0%,P>0.05),all from of revascularization(5.0% vs.3.9%,P>0.05),and stent thrombosis(0.6% vs.0.4%,P>0.05).Conclusions EXCEL 2 stent met the objective performance goal on effcacy and safety, which can reduce make stent restenosis, target vessel revascularization ,with 160 diabetic cases among them, and stent thrombosis in diabetic patients.
ABSTRACT
Stent fracture (SF) has been implicated as a risk factor for in-stent restenosis, but its incidence and clinical characteristics are not well established. Therefore we investigated the conditions associated with stent fracture and its clinical presentation and outcome. Between 2004 and 2007, consecutive cases of SF were collected from the Seoul National University Hospital. Clinical characteristics and outcome of patients with fractured stents were compared with a ten-fold cohort of age and gender matched controls (n = 236). A total of 4,845 patients received percutaneous coronary intervention and 3,315 patients (68.4%) underwent angiographic follow-up. Twenty-eight fractured stents were observed in 24 patients. The incidence of SF was 0.89% for sirolimus-eluting stents (SES) and 0.09% for paclitaxel-eluting stents. Chronic kidney disease, stent implantation in the right coronary artery (RCA), and SES use were independent predictors of drug-eluting stent fracture by multivariate analysis. SF was significantly associated with binary restenosis (11.4% vs 41.7%, P < 0.001) and increased risk of target lesion revascularization (8.1% vs 33.3%, P = 0.001). Patients with SF but without significant restenosis showed excellent outcome despite only medical treatment. In conclusion, SF is associated with increased rates of restenosis and repeat revascularization. Significant risk factors include chronic kidney disease, RCA intervention, and SES use.
Subject(s)
Aged , Female , Humans , Male , Middle Aged , Age Factors , Cardiovascular Agents/administration & dosage , Cohort Studies , Coronary Angiography , Coronary Restenosis/diagnosis , Coronary Stenosis/diagnostic imaging , Drug-Eluting Stents , Paclitaxel/administration & dosage , Prosthesis Failure , Registries , Risk Factors , Sex Factors , Sirolimus/administration & dosageABSTRACT
Stent fracture (SF) has been implicated as a risk factor for in-stent restenosis, but its incidence and clinical characteristics are not well established. Therefore we investigated the conditions associated with stent fracture and its clinical presentation and outcome. Between 2004 and 2007, consecutive cases of SF were collected from the Seoul National University Hospital. Clinical characteristics and outcome of patients with fractured stents were compared with a ten-fold cohort of age and gender matched controls (n = 236). A total of 4,845 patients received percutaneous coronary intervention and 3,315 patients (68.4%) underwent angiographic follow-up. Twenty-eight fractured stents were observed in 24 patients. The incidence of SF was 0.89% for sirolimus-eluting stents (SES) and 0.09% for paclitaxel-eluting stents. Chronic kidney disease, stent implantation in the right coronary artery (RCA), and SES use were independent predictors of drug-eluting stent fracture by multivariate analysis. SF was significantly associated with binary restenosis (11.4% vs 41.7%, P < 0.001) and increased risk of target lesion revascularization (8.1% vs 33.3%, P = 0.001). Patients with SF but without significant restenosis showed excellent outcome despite only medical treatment. In conclusion, SF is associated with increased rates of restenosis and repeat revascularization. Significant risk factors include chronic kidney disease, RCA intervention, and SES use.