Novel side branch ostial stent （BIGUARD^TM）： first-in-man study

作     者：CHEN Shao-liang ZHANG Jun-jie YE Fei 

作者机构：Department of Cardiology Nanjing First Hospital Nanjing Medical University Nanjing Jiangsu 210006 China Department of Cardiology Beijing Anzhen Hospital Beijing 100046 China 

出 版 物：《Chinese Medical Journal》 (中华医学杂志（英文版）)

年 卷 期：2009年第122卷第18期

页      面：2092-2096页

核心收录：

学科分类：0710[理学-生物学] 081406[工学-桥梁与隧道工程] 1002[医学-临床医学] 07[理学] 08[工学] 0814[工学-土木工程] 071002[理学-动物学] 082301[工学-道路与铁道工程] 0823[工学-交通运输工程] 

主　　题：coronary bifurcation lesions side branch intravascular 

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.