Regular drug-eluting stents versus dedicated bifurcation drug-eluting BiOSS® stents for coronary bifurcation treatment: four-year results of randomized POLBOS I and POLBOS II clinical trials.

AIMS: The aim of this study was to analyze 4-year follow-up data of two clinical trials POLBOS I & II to compare regular DES (rDES) and dedicated bifurcation stents BiOSS®.

METHODS AND RESULTS: In POLBOS trials BiOSS® stents were compared with rDES in patients with stable CAD or NSTE-ACS (POLBOS I: paclitaxel eluting BiOSS® Expert vs rDES; POLBOS II: sirolimus eluting BiOSS® LIM vs rDES). 445 patients with 222 patients in BiOSS group and 223 patients in rDES group were analyzed. At 48-month there were no statistical differences in terms of MACE (rDES vs BiOSS: 18.8%vs19.8%,p=0.64), TLR (12.1%vs15.3%,p=0.34), MI (4.5%vs2.1%,p=0.72) or cardiac death (2.2%vs1.8%,p=0.81) between rDES and BiOSS groups. The chance for MACE decreased with female sex and with POT, whereas the chance for MACE increased with main vessel predilatation, NSTE-ACS, diabetes treated with insulin and true bifurcation.

CONCLUSIONS: The results suggest that bifurcation lesions with BiOSS stents might be treated as efficient and safe as with rDES.