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

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 (BIGUARD) 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:BIGUARD stent was safe and feasible in treatment of bifurcation lesions.

journal_name

Chin Med J (Engl)

journal_title

Chinese medical journal

authors

Chen SL,Zhang JJ,Ye F

subject

Has Abstract

pub_date

2009-09-20 00:00:00

pages

2092-6

issue

18

eissn

0366-6999

issn

2542-5641

journal_volume

122

pub_type

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