A RANDOMIZED COMPARISON OF SIROLIMUS- VERSUS PACLITAXEL-ELUTING STENT FOR TREATMENT OF BIFURCATION LESIONS BY SINGLE STENT AND KISSING BALLOONING: RESULTS OF SINGLE KISS TRIAL

Abstract

article Background: In the treatment of bifurcation lesions, routine stenting of both branches has thus far failed to demonstrate a clear clinical advantage over a provisional one-stent strategy. On the other hand, large scale data evaluating different stent types for clinical outcomes after one-stent treatment with final kissing infla- tion (FKI) of bifurcation lesions is also limited. This prospective study evaluated the clinical and angiographic outcomes of paclitaxel-eluting stents (PES) vs. sirolimus-eluting stents (SES) in single crossover main branch stenting followed by FKI in patients with bifurcation lesions. Methods: We randomized 800 patients with single bifurcation lesions to PES (n=400) and SES (n=400) groups. Results: Crossover rates to the two-stent strategy were low in both groups (PES 1.5%, SES 2.8%; p=0.23). At 1 year, there was no significant difference in the primary endpoint of this study, target lesion revasculariza- tion rate (PES 3.8%, SES 3.2%, hazard ratio 0.83; 95% confidence interval 0.39 to 1.76; p=0.62). Stent throm- bosis occurred in only 1 case in the SES group after 282 days. At 9 months, a total of 593 patients underwent quantitative coronary measurement. The main branch restenosis rate in the PES group was significantly