This new device is a stainless steel platform of 120 µm thick with a sirolimus-eluting bio-absorbable polymer. It has two separate parts: a larger diameter proximal part and a smaller diameter distal part connected by two 1.2 mm structures. The objective of this study was to test (first in man) the device in bifurcations. We performed a prospective study of 60 patients with bifurcation lesions. The primary endpoint of the study were the major events (MACE) after one year. The secondary endpoint was the performance of the device, the angiographic parameters after 12 months and the safety.
21.7% of the population were patients with acute coronary syndrome and 38.3% of had diabetes, this being a high-risk population for a study of this nature. More than half of the patients (52%) had lesions that compromised the whole bifurcation (Medina 1,1,1). Late lumen loss at 12 months was 0.26 mm for the proximal vessel, 0.22 for the distal vessel and 0.09 mm for the side branch, with only 3 patients (6.4%) undergoing a lesion revascularization. All of them had focal restenosis of the device.
Conclusion: This device can be a quick and easy alternative for treating bifurcations with a single stent.
Robert J. Gil, MD.
2013-05-22
Original title: Dedicated bifurcation sirolimus-eluting stent BIOSS Lim registry: the first-in-man study.