A randomized study demonstrates that a two-stent strategy is associated with a significant improvement in clinical outcomes at 1 year in comparison with provisional stenting for patients with complex coronary bifurcation lesions (CBLs).
These findings were presented Friday at the PCR e-Course 2020 by Shao-Liang Chen, MD, PhD, of Nanjing First Hospital, Nanjing Medical University, China, on behalf of the DEFINITION II trial investigators. Jun-Jie Zhang, MD, PhD, of Nanjing First Hospital and colleagues, including Chen, reported on the findings in a manuscript that was simultaneously published online in the European Heart Journal.
Stenting of CBLs is associated with suboptimal clinical results compared to non-CBLs. The European Society of Cardiology (ESC) 2018 guidelines state that a two-stent strategy may be preferable for complex CBLs; however, there is no universal definition of CBL complexity. The goal of this study was to assess the benefits of two-stent techniques for patients with DEFINITION (Definitions and Impact of Complex Bifurcation Lesions on Clinical Outcomes After Percutaneous Coronary Intervention Using Drug-Eluting Stents) criteria-defined complex CBLs.
A total of 653 patients with CBLs at 49 international centers were randomly assigned to undergo either a two-stent technique (two-stent group n = 328) or provisional stenting (provisional group n = 325). The primary endpoint was the composite of target lesion failure (TLF) at 1-year follow up, including cardiac death, target-vessel myocardial infarction (TVMI), and clinically driven target lesion revascularization (TLR). The safety endpoint was definite or probable stent thrombosis (ST).
At 1-year follow-up, TLF occurred in 37 (11.4%) and 20 (6.1%) patients in the provisional and two-stent groups, respectively (77.8%; DK crush; hazard ratio [HR], 0.52; 95% confidence interval [CI], 0.30–0.90; p = 0.019), largely driven by increased TVMI (7.1%, HR, 0.43; 95% CI, 0.20–0.90, p = 0.025) and clinically driven TLR (5.5%; HR, 0.43; 95% CI, 0.19–1.00, p = 0.049) in the provisional group. At 1 year after indexed procedures, the incidence of cardiac death was 2.5% in the provisional group, which nonsignificantly different to 2.1% in the two-stent group (HR, 0.86; 95% CI, 0.31–2.37; p = 0.772). ST was comparable between the two groups.
The investigators concluded that for DEFINITION criteria-defined complex CBLs, the systematic two-stent approach was associated with a significant improvement in clinical outcomes in comparison with the provisional stenting approach. Further study is urgently warranted to identify the mechanisms contributing to the increased rate of TVMI after provisional stenting.
The study is sponsored by Nanjing First Hospital, Nanjing Medical University.
PCR e-Course is the virtual meeting being held in place of the annual in-person EuroPCR congress, which was canceled because of the COVID-19 pandemic.