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).

Keywords: coronary bifurcation lesions; fractional flow reserve; major adverse cardiac events; revascularization; stent thrombosis.