Shao-Liang Chen1, Fei Ye2, Jun-Jie Zhang2, Tian Xu3, Nai-Liang Tian3, Zhi-Zhong Liu3, Song Lin4, Shou-Jie Shan2, Zhen Ge2, Wei You3, Yue-Qiang Liu4, Xue-Song Qian5, Feng Li6, Song Yang7, Tak W Kwan8, Bo Xu9, Gregg W Stone10. 1. 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. 2. Nanjing First Hospital, Nanjing Medical University, Nanjing, China. 3. Nanjing Heart Center, Nanjing, China. 4. Jintan Municipal People's Hospital, Jintan, China. 5. Zhangjiagang People's Hospital, Zhangjiagang, China. 6. Huainan Oriental General Hospital, Huainan, China. 7. Yixin People's Hospital, Yixin, China. 8. Beth Israel Hospital, New York, New York. 9. Beijing Fuwai Cardiovascular Hospital, Beijing, China. 10. Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York. Electronic address: gstone@crf.org.
Abstract
OBJECTIVES: 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 0,1,1coronary 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).
RCT Entities:
OBJECTIVES: 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: Allison B Hall; Ivan Chavez; Santiago Garcia; Mario Gössl; Anil Poulose; Paul Sorajja; Yale Wang; Yves Louvard; Yiannis S Chatzizisis; Subhash Banerjee; Iosif Xenogiannis; M Nicholas Burke; Emmanouil S Brilakis Journal: EuroIntervention Date: 2021-07-20 Impact factor: 6.534
Authors: Claudio Chiastra; Francesco Iannaccone; Maik J Grundeken; Frank J H Gijsen; Patrick Segers; Matthieu De Beule; Patrick W Serruys; Joanna J Wykrzykowska; Antonius F W van der Steen; Jolanda J Wentzel Journal: Biomed Eng Online Date: 2016-08-05 Impact factor: 2.819