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Novel side branch ostial stent (BIGUARD^TM): first-in-man study
作者姓名:CHEN Shao-liang  ZHANG Jun-jie  YE Fei
作者单位:[1]Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu 210006, China [2]Department of Cardiology, Beijing Anzhen Hospital, Beijing 100046, China
摘    要:Background Stenting a bifurcation lesion is technically challenging. No study has reported the clinical outcome of a dedicated bifurcation stent in China. We aimed to analyze the safety and clinical outcome of a novel side branch ostial stent (BIGUARDTM) stent in treating coronary bifurcation lesions. Methods Forty-seven patients were enrolled in this first-in-man study, with 61.7% true bifurcation lesions (0,1,1 and 1,1,1) and 26.7% diabetes. A two-stent technique was used in 27.6% of the patients, and 64.7% of patients crossed from the one-stent technique to the two-stent arm. Clinical and angiographic follow-up data at 12 months were available in all the 47 patients and in 43 patients (91.9%), respectively. The study endpoint was the occurrence of major adverse cardiac events (MACE) at 12 months. Results Only one patient had a non-ST segment elevation myocardial infarction, which led to 2% of the in-hospital composite MACE. Notably, the target lesion revascularization at 12 months was 8.6%, with a 10.6% composite MACE at 12 months. Neither cardiac death nor stent thrombosis was seen during the follow-up. By quantitative coronary analysis, the restenosis rate at the main vessel and ostium of the side branch was 9.4% and 2.1%, respectively. Four of 12 patients (33.3%) treated with one-stent and kissing balloon inflation had restenosis in the main vessel. Conclusion BIGUARDTM stent was safe and feasible in treatment of bifurcation lesions.

关 键 词:支架技术  血管造影  商标  MACE  冠状动脉  复合材料  心肌梗死  血栓形成

Novel side branch ostial stent (BIGUARDTM): first-in-man study
CHEN Shao-liang,ZHANG Jun-jie,YE Fei.Novel side branch ostial stent (BIGUARDTM): first-in-man study[J].Chinese Medical Journal,2009,122(18):2092-2096.
Authors:《Chinese Medical Journal》
Abstract:

Background  Stenting a bifurcation lesion is technically challenging. No study has reported the clinical outcome of a dedicated bifurcation stent in China. We aimed to analyze the safety and clinical outcome of a novel side branch ostial stent (BIGUARDTM) stent in treating coronary bifurcation lesions.
Methods  Forty-seven patients were enrolled in this first-in-man study, with 61.7% true bifurcation lesions (0,1,1 and 1,1,1) and 26.7% diabetes. A two-stent technique was used in 27.6% of the patients, and 64.7% of patients crossed from the one-stent technique to the two-stent arm. Clinical and angiographic follow-up data at 12 months were available in all the 47 patients and in 43 patients (91.9%), respectively. The study endpoint was the occurrence of major adverse cardiac events (MACE) at 12 months.
Results  Only one patient had a non-ST segment elevation myocardial infarction, which led to 2% of the in-hospital composite MACE. Notably, the target lesion revascularization at 12 months was 8.6%, with a 10.6% composite MACE at 12 months. Neither cardiac death nor stent thrombosis was seen during the follow-up. By quantitative coronary analysis, the restenosis rate at the main vessel and ostium of the side branch was 9.4% and 2.1%, respectively. Four of 12 patients (33.3%) treated with one-stent and kissing balloon inflation had restenosis in the main vessel.
Conclusion  BIGUARDTM stent was safe and feasible in treatment of bifurcation lesions.

Keywords:coronary bifurcation lesions  side branch  intravascular
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