Multicentre, randomized comparison of two-stent and provisional stenting techniques in patients with complex coronary bifurcation lesions: the DEFINITION II trial
Key result
Systematic two-stent technique cuts 1-year target lesion failure ~48% vs. provisional stenting.
- HR 0.52
- 95% CI 0.30-0.90
- P=0.019
- n=653
Why the study?
The benefits of two-stent techniques for patients with DEFINITION criteria-defined complex coronary bifurcation lesions were unclear.
Does a systematic two-stent technique reduce target lesion failure in patients with complex coronary bifurcation lesions compared to provisional stenting?
Population
653 patients with complex coronary bifurcation lesions at 49 international centres
Comparison
Systematic two-stent technique vs provisional stenting
Design
Multicentre randomized trial
Follow-up
1 year
Authors
Discussion
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Member takes
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“A systematic two-stent approach is associated with a lower rate of one-year target lesion failure for patients with complex coronary bifurcation lesions, compared to the provisional approach. The underlying mechanisms for increased target vessel myocardial infarction after provisional stenting are unclear and further study is warranted.”
“another success for this DK crush technique everyone is talking about recently”
“The underlying mechanisms for the increased target vessel MI rate after the provisional stenting technique are unclear, and further study is urgently warranted.”
Implication
In patients with complex coronary bifurcation lesions, a systematic two-stent approach significantly reduces target lesion failure at 1 year compared to provisional stenting.
Key Points
- To evaluate the safety and clinical efficacy of a systematic two-stent technique compared to provisional stenting in patients with complex coronary bifurcation lesions.
- Conducted a multicenter randomized trial across 49 international centers including 653 patients with DEFINITION criteria-defined complex coronary bifurcation lesions randomly assigned to systematic two-stent or provisional stenting (NCT02284750).
- Assessed the primary composite endpoint of target lesion failure (cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization) alongside stent thrombosis at 1-year follow-up.
- Target lesion failure at 1 year occurred in 6.1% (20 patients) in the two-stent group versus 11.4% (37 patients) in the provisional group (HR 0.52, 95% CI 0.30–0.90; P = 0.019).
- The primary outcome was driven by higher rates in the provisional group of target vessel myocardial infarction (7.1%; HR 0.43, 95% CI 0.20–0.90; P = 0.025) and clinically driven target lesion revascularization (5.5%; HR 0.43, 95% CI 0.19–1.00; P = 0.049).
- Cardiac death occurred in 2.1% of the two-stent group and 2.5% of the provisional group, showing no statistically significant difference (HR 0.86, 95% CI 0.31–2.37; P = 0.772).
Study Design
Type
RCT (n=653)
Randomization
randomized
Multicenter
Yes
Structured PICO
Does a systematic two-stent technique reduce target lesion failure in patients with complex coronary bifurcation lesions compared to provisional stenting?
P
Population
653 patients with DEFINITION criteria-defined complex coronary bifurcation lesions across 49 international centers, followed for 1 year.
I
Intervention
Systematic two-stent technique (77.8% double-kissing crush)
C
Comparator
Provisional stenting
O
Outcome
Composite of target lesion failure (TLF) at the 1-year follow-up, including cardiac death, target vessel myocardial infarction (TVMI), and clinically driven target lesion revascularization (TLR)composite
Main Result
Hazard Ratio: 0.52 (95% CI 0.3–0.9)
Absolute Event Rate: 6.1% vs 11.4%
p-value: p=0.019
In patients with complex coronary bifurcation lesions, a systematic two-stent approach significantly reduces target lesion failure at 1 year compared to provisional stenting.
Cite This Study
Zhang et al. (2020) conducted an RCT in complex coronary bifurcation lesions (n=653). Systematic two-stent technique vs. Provisional stenting was evaluated on Composite of target lesion failure (TLF), including cardiac death, target vessel myocardial infarction (TVMI), and clinically driven target lesion revascularization (TLR) (HR 0.52, 95% CI 0.30-0.90, p=0.019). The systematic two-stent technique significantly reduced target lesion failure at 1 year compared with provisional stenting (6.1% vs 11.4%; HR 0.52; 95% CI 0.30-0.90; P=0.019).