First-in-human feasibility and safety study of a true bifurcated stent for the treatment of bifurcation coronary artery lesions (DBS stent): six month angiographic results and five year clinical follow-up.

Aims: To evaluate the safety and long-term efficacy of a true dedicated bifurcation bare metal stent (DBS) for the treatment of bifurcation coronary artery lesions.

Methods And Results: Thirty-four patients were enrolled in this prospective multicentre study. The majority of culprit lesions were located on the left anterior descending artery/diagonal bifurcation (n=19) followed by the distal protected left main (n=7), the left circumflex artery/obtuse marginal (n=4) and the distal right coronary artery/posterior descending artery (n=4). Successful delivery of the DBS stent at the bifurcation site was achieved in 32 patients (94%). Angiographic follow-up at six months was complete in 29 patients (91%). Clinical follow-up was achieved at five years in all DBS patients. There were no cardiac deaths or stent thrombosis. At six months, the MACE rate was 6/32 (19%) and the total binary restenosis rate was 10/29 (34%). MACE at 5 years consisted only in target vessel revascularisation and occurred in eight patients (25%).

Conclusions: The DBS bare metal true bifurcated stent can be delivered successfully and safely in selected bifurcated lesions and has demonstrated long-term efficacy in most patients.