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


CONCLUSIONS
BIGUARD stent was safe and feasible in treatment of bifurcation lesions.
Chen
Shao-liang
SL
Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu 210006, China. chmengx@126.com
Zhang
Jun-jie
JJ
Ye
Fei
F
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D019917:Blood Vessel Prosthesis Implantation / Q000379:methods*; D023903:Coronary Restenosis / Q000517:prevention & control; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome