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A randomized comparison of sirolimus- vs. paclitaxel-eluting stents for treatment of bifurcation lesions by single stent and kissing balloon: Results of the SINGLE KISS trial

2011; Elsevier BV; Volume: 166; Issue: 1 Linguagem: Inglês

10.1016/j.ijcard.2011.10.101

1874-1754

Kenya Nasu, Yuji Oikawa, Ryohei Yoshikawa, Makoto Kadotani, Yoshihiro Takeda, Hiroshi Ota, Haruo Kamiya, Mitsuru Muto, Atsunori Okamura, Masaru Yamaki, Shinichi Usui, Satoru Tohara, Jun Yamashita, Masatoshi Suzuki, Ren Kawaguchi, Kenji Kawajiri, Yusuke Nakatsu, Yasuhiro Uchida, Yoshifumi Kashima, Nozomu Kawashima, Takefumi Ozaki, Takayuki Ogawa, Tadanori Aizawa, Takahiko Suzuki,

Cardiac Imaging and Diagnostics

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 inflation (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 revascularization rate (PES 3.8%, SES 3.2%, hazard ratio 0.83; 95% confidence interval 0.39 to 1.76; p=0.62). Stent thrombosis 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 higher than that of the SES group (PES 12.2%, SES 5.5%; p=0.004), however both groups exhibited similar high side branch restenosis rates (PES 17.2%, SES 19.3%; p=0.6). Conclusions In patients with bifurcation lesions, a single stent strategy using PES and SES with FKI indicated similar 1 year clinical outcomes and safety profiles.