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.
Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu 210006, China. chmengx@126.com
Shao-liang
SL
Chen
Jun-jie
JJ
Zhang
Fei
F
Ye
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