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October 29, 2017

DKCRUSH-V Evaluates Double-Kissing Crush Two-Stent Technique in Left Main Bifurcation Lesions

October 30, 2017—Results from the large-scale randomized DKCRUSH-V trial examining the double-kissing (DK) crush two-stent technique compared with provisional stenting (PS) in the treatment of true distal bifurcation lesions of the left main (LM) artery, found that the DK crush technique was associated with a lower rate of target lesion failure at 1 year. The findings were reported at TCT 2017, the 29th annual Transcatheter Cardiovascular Therapeutics scientific symposium being held October 30 to November 2 in Denver, Colorado. The study was simultaneously published by Shao-Liang Chen, MD, et al in the Journal of the American College of Cardiology.

As noted in the TCT announcement, previous studies have shown that the DK crush two-stent technique improved clinical outcomes in LM bifurcations compared to culotte stenting as well as in non-LM bifurcations compared to PS. The DK crush technique has never been compared to PS in LM bifurcation lesions in a random fashion.

The DKCRUSH-V trial randomized 482 patients from 26 centers in five countries (China, Indonesia, Thailand, Italy, and the United States) with true distal LM bifurcation lesions (Medina 1,1,1 or 0,1,1) to either DK crush stenting (n = 240) or PS (n = 242). The primary endpoint was the 1-year composite rate of target lesion failure (TLF; cardiac death, target vessel myocardial infarction [TVMI], or clinically driven target lesion revascularization [TLR]). Routine 13-month angiographic follow-up was scheduled after the primary endpoint was determined. The technique was successful in 100% of the DK group and 97.1% of the PS group.

The study found that TLF within 1 year occurred in 12 patients (5%) assigned to DK crush and in 26 patients (10.7%) assigned to PS (hazard ratio, 0.42; 95% confidence interval, 0.21-0.85; P = .02). Compared to PS, DK crush also resulted in lower rates of TVMI (0.4% vs 2.9%; P = .03) and definite or probable stent thrombosis (0.4% vs 3.3%; P = .02).

Clinically driven TLR (3.8% vs 7.9%; P = .06) and angiographic restenosis within the LM complex (7.1% vs 14.6%; P = .1) tended to be more frequent with PS compared to DK crush. There was no significant difference in cardiac death between the groups.

Dr. Chen commented in the TCT announcement, “In this trial, PCI of true distal LM bifurcation lesions using a planned DK crush two-stent strategy resulted in a lower rate of TLF at 1 year compared to provisional stenting. These results indicate that double-kissing crush may be a better option for these patients.” Dr. Chen is Director of Cardiology and Cath Lab at Nanjing First Hospital, Vice President of Nanjing First Hospital, Nanjing Medical University, and Professor of Internal Medicine and Cardiology at Nanjing Medical University in Nanjing, China.

The DKCRUSH-V trial was funded by a grant from the National Science Foundation of China and jointly supported by Nanjing Municipal Medical Development Project, Microport, Abbott Vascular, and Medtronic.

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October 30, 2017

FDA Approves Expansion of CeloNova's COBRA REDUCE Trial

October 30, 2017

FDA Approves Expansion of CeloNova's COBRA REDUCE Trial


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