News Release 

Randomization of provisional vs two-stent techniques in complex bifurcation lesions

Provisional stenting for complex coronary bifurcation stenosis: no longer the default procedure?

PCR

Aim: The present study aimed to assess the benefits of two-stent techniques for patients with DEFINITION criteria-defined complex coronary bifurcation lesions.

Methods and Results: In total, 653 patients with complex bifurcation lesions at 49 international centres were randomly assigned to undergo the systematic two-stent technique (two-stent group) or provisional stenting (provisional group). The primary endpoint was the 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). The safety endpoint was definite or probable stent thrombosis (ST).

At the 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 the 1-year after indexed procedures, the incidence of cardiac death was 2.5% in the provisional group, non-significant to 2.1% in the two-stent group ([HR]: 0.86, 95% CI: 0.31-2.37, p = 0.772).

Conclusion: For DEFINITION criteria-defined complex coronary bifurcation lesions, the systematic two-stent approach was associated with a significant improvement in clinical outcomes compared with the provisional stenting approach. Further study is urgently warranted to identify the mechanisms contributing to the increased rate of TVMI after provisional stenting

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Notes to editors

Key information

    o A PCR Press Release on Multicentre, Randomised Comparison of Two-Stent and Provisional Stenting Techniques in Patients with Complex Coronary Bifurcation Lesion by Shao-Liang Chen

    o Presentation during the #PCR e-Course - http://www.pcr-ecourse.com

    o Session on Main Arena Channel, Friday 26 June - 14:16 Paris time (UTC+2)

    o PCR e-Course: 25, 26, 27 June 2020

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