title: 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.
abstract: 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.
authors.affiliation: Department of Cardiology, Toyohashi Heart Center, 21-1 Gobutori, Oyamacho, Toyohashi, 441-8530, Aichi, Japan. yuya0728@m3.kcn.ne.jp
authors.forename: Kenya
authors.initials: K
authors.lastname: Nasu
authors.forename: Yuji
authors.initials: Y
authors.lastname: Oikawa
authors.forename: Ryohei
authors.initials: R
authors.lastname: Yoshikawa
authors.forename: Makoto
authors.initials: M
authors.lastname: Kadotani
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Takeda
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Ota
authors.forename: Haruo
authors.initials: H
authors.lastname: Kamiya
authors.forename: Mitsuru
authors.initials: M
authors.lastname: Muto
authors.forename: Atsunori
authors.initials: A
authors.lastname: Okamura
authors.forename: Masaru
authors.initials: M
authors.lastname: Yamaki
authors.forename: Shinichi
authors.initials: S
authors.lastname: Usui
authors.forename: Satoru
authors.initials: S
authors.lastname: Tohara
authors.forename: Jun
authors.initials: J
authors.lastname: Yamashita
authors.forename: Masatoshi
authors.initials: M
authors.lastname: Suzuki
authors.forename: Ren
authors.initials: R
authors.lastname: Kawaguchi
authors.forename: Kenji
authors.initials: K
authors.lastname: Kawajiri
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Nakatsu
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Uchida
authors.forename: Yoshifumi
authors.initials: Y
authors.lastname: Kashima
authors.forename: Nozomu
authors.initials: N
authors.lastname: Kawashima
authors.forename: Takefumi
authors.initials: T
authors.lastname: Ozaki
authors.forename: Takayuki
authors.initials: T
authors.lastname: Ogawa
authors.forename: Tadanori
authors.initials: T
authors.lastname: Aizawa
authors.forename: Takahiko
authors.initials: T
authors.lastname: Suzuki
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation / Q000379:methods*; D018592:Cross-Over Studies; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000175:diagnosis / Q000453:epidemiology* / Q000628:therapy*; D017239:Paclitaxel / Q000008:administration & dosage*; D020123:Sirolimus / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D017239:Paclitaxel; D020123:Sirolimus