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Novel side branch ostial stent (BIGUARDTTM): first-in-man study

CHEN Shao-liang ZHANG Jun-jie YE Fei

中华医学杂志(英文版)2009,Vol.122Issue(18):2092-2096,5.
中华医学杂志(英文版)2009,Vol.122Issue(18):2092-2096,5.DOI:10.3760/cma.j.issn.0366-6999.2009.18.003

Novel side branch ostial stent (BIGUARDTTM): first-in-man study

Novel side branch ostial stent (BIGUARDTTM): first-in-man study

CHEN Shao-liang 1ZHANG Jun-jie 1YE Fei2

作者信息

  • 1. Nanjing First Hospital,Nanjing Medical University
  • 2. Beijing Anzhen Hospital
  • 折叠

摘要

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.

关键词

coronary bifurcation lesions/ side branch/ intravascular

Key words

coronary bifurcation lesions/ side branch/ intravascular

引用本文复制引用

CHEN Shao-liang,ZHANG Jun-jie,YE Fei..Novel side branch ostial stent (BIGUARDTTM): first-in-man study[J].中华医学杂志(英文版),2009,122(18):2092-2096,5.

中华医学杂志(英文版)

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0366-6999

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