Key result
Trial compares IVUS versus angiography guidance for DK crush stenting in complex bifurcation lesions.
Why the study?
Although DK crush stenting reduces clinical events in complex coronary bifurcation lesions and IVUS guidance improves DES implantation outcomes, whether IVUS-guided DK crush stenting improves clinical outcomes over angiography guidance in complex bifurcation lesions had never been studied in a randomized fashion.
RCT (n=556)
1:1 ratio
Yes
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Moving forward, the use of [intravascular imaging] guidance during coronary stenting should be as routine as is the use of cineangiography, a conclusion based on decades of evidence-based investigation. Thus, the question should no longer be ‘whether to use [intravascular imaging],’ but rather ‘which to use’ (IVUS or [optical coherence tomography]) and ‘how best to use.’”
“the benefits of IVUS-guided PCI at one year were achieved largely through achievement of IVUS-defined optimization targets rather than IVUS use alone.”
“We have to really explore this. I don’t want to be trapped by dogma and just say that I so firmly believe that it has to be the case [that IVUS is beneficial] when there are now new data that influence our perspective. I think we’re going to have to look really carefully at these, because it’s hard to disprove rigorously conducted science in a randomized controlled trial and say it can’t be. But I think we have to understand how. How can it be? And that will help us to unravel the story a little bit better and then inform the guidelines.”
IVUS guidance superiority in DK crush for complex bifurcations remains unproven; this trial leaves open optimal strategy.
BACKGROUND Double kissing (DK) crush approach for patients with coronary bifurcation lesions, particularly localized at distal left main or lesions with increased complexity, is associated with significant reduction in clinical events when compared with provisional stenting (PS). Recently, randomized clinical trial has demonstrated the net clinical benefits by intravascular ultrasound (IVUS)-guided implantation of drug-eluting stent (DES) in all-comers. However, the improvement in clinical outcome after DK crush treatment guided by IVUS over angiography-guidance for patients with complex bifurcation lesions have never been studied in a randomized fashion. TRIAL DESIGN DKCRUSH VIII study is a prospective, multicenter, randomized controlled trial designed to assess superiority of IVUS-guided versus angiography-guided DK crush stenting in patients with complex bifurcation lesions according to DEFINITION criteria. A total of 556 patients with complex bifurcation lesions will be randomly (1:1 of ratio) assigned to IVUS-guided or angiography-guided DK crush stenting group. The primary endpoint is the rate of 12-month target vessel failure (TVF), including cardiac death, target vessel myocardial infarction (TV-MI) or clinically driven target vessel revascularization (CD-TVR). The secondary endpoints consist of the individual component of primary endpoint, all-cause death, MI, and in-stent restenosis. The safety endpoint is the incidence of definite or probable stent thrombosis. An angiographic follow-up will be performed for all patients at 13 months and clinical follow-up will be continued annually until 3 years after the index procedure. CONCLUSION DKCRUSH VIII trial is the first study designed to evaluate the differences in efficacy and safety between IVUS-guided and angiography-guided DK crush stenting in patients with complex true bifurcation lesions. This study will also provide IVUS-derived criteria to define optimal DK crush stenting for bifurcation lesions at higher complexity.
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Ge et al. (2021) conducted an RCT in Complex coronary bifurcation lesions (n=556). Intravascular ultrasound (IVUS)-guided double kissing (DK) crush stenting vs. Angiography-guided DK crush stenting was evaluated on 12-month target vessel failure (TVF), including cardiac death, target vessel myocardial infarction (TV-MI) or clinically driven target vessel revascularization (CD-TVR). IVUS-guided DK crush stenting will be compared for superiority against angiography-guided DK crush stenting for 12-month target vessel failure in 556 patients with complex bifurcation lesions.
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