Comparison of dedicated BIOSS bifurcation stents with regular drug-eluting stents for coronary artery bifurcated lesions: Pooled analysis from two randomized studies.

BACKGROUND Coronary bifurcation treatment poses a therapeutic challenge. The aim of this study was to analyze pooled data of two randomized clinical trials, POLBOS I and POLBOS II, to compare 1-year follow-up results and identify possible prognostic factors. METHODS In POLBOS trials dedicated bifurcation BiOSS® stents were compared with regular drug eluting stents (rDES) in patients with stable coronary artery disease (CAD) or non ST-segment elevation acute coronary syndrome (POLBOS I: paclitaxel eluting BiOSS® Expert vs. rDES; POLBOS II: sirolimus eluting BiOSS® LIM vs. rDES). Provisional T-stenting was the default strategy. Angiographic control was performed at 12 months. The primary endpoint was major adverse cardiovascular events (MACE) rate defined as the rate of cardiac death, myocardial infarction (MI) or target lesion revascularization (TLR). RESULTS 445 patients with 222 patients in the BiOSS group and 223 patients in the rDES group were analyzed. In 26.7% cases procedures were performed within distal left main, and true bifurcations which accounted for 81.6% of treated lesions. At 12 months the whole population exhibited no statistical differences in terms of MACE, TLR, MI or cardiac death between rDES and BiOSS groups. In multivariate analysis odds for MACE decreased with female sex (OR 0.433, 95% CI 0.178-0.942, p = 0.047) and with POT use (OR 0.208, 95% CI 0.097-0.419, p < 0.001), whereas the odds for MACE increased with main vessel predilatation (OR 2.191, 95% CI 1.042-5.066, p = 0.049) and diabetes mellitus treated with insulin (OR 2.779, 95% CI 1.1-6.593, p = 0.024). CONCLUSIONS Pooled data showed no significant difference between MACE and TLR rates for BiOSS® group vs rDES group.