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

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: Shao-Liang Chen, Fei Ye, Jun-Jie Zhang, Tian Xu, Nai-Liang Tian, Zhi-Zhong Liu, Song Lin, Shou-Jie Shan, Zhen Ge, Wei You, Yue-Qiang Liu, Xue-Song Qian, Feng Li, Song Yang, Tak W Kwan, Bo Xu, Gregg W Stone
• Journal: JACC. Cardiovascular interventions (JACC Cardiovasc Interv) Vol. 8 Issue 4 Pg. 536-46 (Apr 20 2015) ISSN: 1876-7605 [Electronic] United States
• PMID: 25819187 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Topics

• Age Factors
• Aged
• Angioplasty, Balloon, Coronary (methods, mortality)
• Coronary Angiography (methods)
• Coronary Restenosis (diagnostic imaging, mortality)
• Coronary Stenosis (diagnostic imaging, mortality, therapy)
• Coronary Vessels (diagnostic imaging)
• Drug-Eluting Stents
• Female
• Follow-Up Studies
• Fractional Flow Reserve, Myocardial
• Humans
• Kaplan-Meier Estimate
• Male
• Middle Aged
• Proportional Hazards Models
• Risk Assessment
• Severity of Illness Index
• Sex Factors
• Statistics, Nonparametric
• Survival Rate
• Time Factors
• Treatment Outcome