Multicentre, randomized comparison of two-stent and provisional stenting techniques in patients with complex coronary bifurcation lesions: the DEFINITION II trial

Abstract

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. 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%: double-kissing 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. Study registration http://www.clinicaltrials.com; Identifier: NCT02284750.

Effect of Paclitaxel-Coated Balloon Angioplasty on Side Branch Lesion and Cardiovascular Outcomes in Patients with De Novo True Coronary Bifurcation Lesions Undergoing Percutaneous Coronary Intervention

“…PCI for coronary bifurcation lesions was challenging. Compared with simple lesions, bifurcation lesions had more severe plaque burden and was more vulnerable to erosion and rupture [20]. Even if PCI procedure was gradually improving, displacement of crest and plaque, plaque rupture, and SB ostium elastic retraction still often occurred during PCI for bifurcation lesions [21].…”

Long‐term clinical outcomes in transradial versus transfemoral access for left main percutaneous coronary intervention

“…12 However, recent results from the DEFINITON II trial revealed significant advantages for the double-kissing crush technique, which has restarted the debate regarding the optimal treatment strategy. 13 In the DEFINITON II trial, TRA was used for greater than 78% of patients in the two-stent group (generally treated using the complex double-kissing crush technique) and the procedure was considered successful in more than 98% patients. 13 Furthermore, TRA was used for IVUS or OCT guidance in greater than 77% of cases in the DEFINITION trial (definitions and impact of complex bifurcation lesions on clinical outcomes after percutaneous coronary intervention using drug-eluting stents) 14 and in greater than 60% of cases in the ILUMIEN III: OPTIMIZE PCI trial (optical coherence tomography compared with intravascular ultrasound and with angiography to guide coronary stent implantation).…”

Outcomes at 1 Year of Non-Left Main Trunk Bifurcation Lesions Treated With a 2-Stent Strategy Using Newer-Generation Everolimus-Eluting Stents

“…It is also true that the efficacy of the 2-stent strategy has been demonstrated in cases of lesions >10 mm in length in the SB. 21,22 It may not be necessary to avoid the 2-stent strategy just because the lesion length of the SB is longer than usual. Indications for the 2-stent strategy should be judged on the basis of vessel diameter and lesion morphology.…”