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.
OBJECTIVE
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.


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.
Dibie
Alain
A
Institut Mutualiste Montsouris, Paris, France.
Chevalier
Bernard
B
Guyon
Philippe
P
Fajadet
Jean
J
Lefèvre
Thierry
T
Slama
Michel S
MS
Royer
Thierry
T
Glatt
Bernard
B
Philippe
François
F
Laborde
François
F
Larrazet
Fabrice
F