title: Randomized Comparison of FFR-Guided and Angiography-Guided Provisional Stenting of True Coronary Bifurcation Lesions: The DKCRUSH-VI Trial (Double Kissing Crush Versus Provisional Stenting Technique for Treatment of Coronary Bifurcation Lesions VI).
abstract: OBJECTIVE
  This study sought to compare the outcomes of fractional flow reserve (FFR)-guided and angiography (Angio)-guided provisional side-branch (SB) stenting for true coronary bifurcation lesions.
  
  
  BACKGROUND
  Angio-guided provisional SB stenting after stenting of the main vessel provides favorable outcomes for the majority of coronary bifurcation lesions. Whether an FFR-guided provisional stenting approach is superior has not been studied.
  
  
  METHODS
  A total of 320 patients with single Medina 1,1,1 and 0,1,1 coronary bifurcation lesions undergoing stenting with a provisional SB approach were randomly assigned 1:1 to Angio-guided and FFR-guided groups. SB stenting was performed for Thrombolysis In Myocardial Infarction flow grade<3, ostial SB stenosis>70%, or greater than type A dissection after main vessel stenting in the Angio-guided group and for SB-FFR<0.80 in the FFR-guided group. The primary endpoint was the 1-year composite rate of major adverse cardiac events (cardiac death, myocardial infarction, and clinically driven target vessel revascularization).
  
  
  RESULTS
  Comparing the Angio-guided and FFR-guided groups, treatment of the SB (balloon or stenting) was performed in 63.1% and 56.3% of lesions respectively (p=0.07); stenting of the SB was attempted in 38.1% and 25.9%, respectively (p=0.01); and, when attempted, stenting was successful in 83.6% and 73.3% of SBs, respectively (p=0.01). The 1-year composite major adverse cardiac event rate was 18.1% in both groups (hazard ratio: 0.91, 95% confidence interval: 0.48 to 1.88; p=1.00). The 1-year target vessel revascularization and stent thrombosis rates were 6.9% and 5.6% (p=0.82) and 1.3% and 0.6% (p=0.56) in the Angio-guided and FFR-guided groups, respectively.
  
  
  CONCLUSIONS
  In this multicenter, randomized trial, angiographic and FFR guidance of provisional SB stenting of true coronary bifurcation lesions provided similar 1-year clinical outcomes. (Randomized Study on DK Crush Technique Versus Provisional Stenting Technique for Coronary Artery Bifurcation Lesions; ChiCTR-TRC-07000015).
authors.affiliation: Nanjing First Hospital, Nanjing Medical University, Nanjing, China; Collaborative Innovation Center for Cardiovascular Disease Translational Medicine and Clinical Medical Research Center of Jiangsu Province, China. Electronic address: chmengx@126.com.
authors.forename: Shao-Liang
authors.initials: SL
authors.lastname: Chen
authors.affiliation: Nanjing First Hospital, Nanjing Medical University, Nanjing, China.
authors.forename: Fei
authors.initials: F
authors.lastname: Ye
authors.affiliation: Nanjing First Hospital, Nanjing Medical University, Nanjing, China.
authors.forename: Jun-Jie
authors.initials: JJ
authors.lastname: Zhang
authors.affiliation: Nanjing Heart Center, Nanjing, China.
authors.forename: Tian
authors.initials: T
authors.lastname: Xu
authors.affiliation: Nanjing Heart Center, Nanjing, China.
authors.forename: Nai-Liang
authors.initials: NL
authors.lastname: Tian
authors.affiliation: Nanjing Heart Center, Nanjing, China.
authors.forename: Zhi-Zhong
authors.initials: ZZ
authors.lastname: Liu
authors.affiliation: Jintan Municipal People's Hospital, Jintan, China.
authors.forename: Song
authors.initials: S
authors.lastname: Lin
authors.affiliation: Nanjing First Hospital, Nanjing Medical University, Nanjing, China.
authors.forename: Shou-Jie
authors.initials: SJ
authors.lastname: Shan
authors.affiliation: Nanjing First Hospital, Nanjing Medical University, Nanjing, China.
authors.forename: Zhen
authors.initials: Z
authors.lastname: Ge
authors.affiliation: Nanjing Heart Center, Nanjing, China.
authors.forename: Wei
authors.initials: W
authors.lastname: You
authors.affiliation: Jintan Municipal People's Hospital, Jintan, China.
authors.forename: Yue-Qiang
authors.initials: YQ
authors.lastname: Liu
authors.affiliation: Zhangjiagang People's Hospital, Zhangjiagang, China.
authors.forename: Xue-Song
authors.initials: XS
authors.lastname: Qian
authors.affiliation: Huainan Oriental General Hospital, Huainan, China.
authors.forename: Feng
authors.initials: F
authors.lastname: Li
authors.affiliation: Yixin People's Hospital, Yixin, China.
authors.forename: Song
authors.initials: S
authors.lastname: Yang
authors.affiliation: Beth Israel Hospital, New York, New York.
authors.forename: Tak W
authors.initials: TW
authors.lastname: Kwan
authors.affiliation: Beijing Fuwai Cardiovascular Hospital, Beijing, China.
authors.forename: Bo
authors.initials: B
authors.lastname: Xu
authors.affiliation: Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York. Electronic address: gstone@crf.org.
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
mesh_terms: D000367:Age Factors; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods* / Q000401:mortality; D017023:Coronary Angiography / Q000379:methods*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000401:mortality; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000401:mortality* / Q000628:therapy*; D003331:Coronary Vessels / Q000000981:diagnostic imaging; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D053805:Fractional Flow Reserve, Myocardial; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D018570:Risk Assessment; D012720:Severity of Illness Index; D012737:Sex Factors; D018709:Statistics, Nonparametric; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome
keywords: coronary bifurcation lesions; fractional flow reserve; major adverse cardiac events; revascularization; stent thrombosis