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

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.

Treatment effects of systematic two-stent and provisional stenting techniques in patients with complex coronary bifurcation lesions: rationale and design of a prospective, randomised and multicentre DEFINITION II trial.

INTRODUCTION: Provisional stenting (PS) for simple coronary bifurcation lesions is the mainstay of treatment. A systematic two-stent approach is widely used for complex bifurcation lesions (CBLs). However, a randomised comparison of PS and two-stent techniques for CBLs has never been studied. Accordingly, the present study is designed to elucidate the benefits of two-stent treatment over PS in patients with CBLs. METHODS AND ANALYSIS: This DEFINITION II study is a prospective, multinational, randomised, endpoint-driven trial to compare the benefits of the two-stent technique with PS for CBLs. A total of 660 patients with CBLs will be randomised in a 1:1 fashion to receive either PS or the two-stent technique. The primary endpoint is the rate of 12-month target lesion failure defined as the composite of cardiac death, target vessel myocardial infarction (MI) and clinically driven target lesion revascularisation. The major secondary endpoints include all causes of death, MI, target vessel revascularisation, in-stent restenosis, stroke and each individual component of the primary endpoints. The safety endpoint is the occurrence of definite or probable stent thrombosis. ETHICS AND DISSEMINATION: The study protocol and informed consent have been approved by the Institutional Review Board of Nanjing First Hospital, and accepted by each participating centre. Written informed consent was obtained from all enrolled patients. Findings of the study will be published in a peer-reviewed journal and disseminated at conferences. TRIAL REGISTRATION NUMBER: NCT02284750; Pre-results.

Comparison of paclitaxal vs. sirolimus eluting stents with bio-degradable polymer for the treatment of coronary bifurcation lesions: subgroup analysis from DKCRUSH-I and DKCRUSH-II studies.

BACKGROUND: The difference in clinical outcome between paclitaxal-eluting stents (PES) and sirolimus-eluting stents with bio-degradable polymer (SES-BDP) for bifurcation lesions remains unclear. The present study aimed to investigate the one-year clinical outcome after DK crush stenting using PES (Taxus(TM)) vs. SES-BDP (Excel(TM)) from our database. METHODS: A total of 275 patients (90 from the DKCRUSH-I and 185 from the DKCRUSH-II study) were studied. The primary endpoint was the occurrence of major adverse cardiac events (MACE) at 12 months; including cardiac death, myocardial infarction (MI), or target vessel revascularization (TVR). The rate of binary restenosis and stent thrombosis served as secondary endpoints. RESULTS: At follow-up, minimal luminal diameter (MLD) in the Taxus group was (2.11 ± 0.66) mm, with resultant increased target lesion revascularization (TLR) 12.2% and TVR 14.4%, significantly different from the Excel group; (2.47 ± 0.56) mm, P < 0.001, 3.2%, P = 0.006, 4.9%, P = 0.019, respectively. As a result there was a significant difference in MACE between the Taxus (20.0%) and Excel (10.3%, P = 0.038) groups. Overall stent thrombosis was monitored in 11 patients (4.0%), with five in the Excel group (2.7%) and six in the Taxus group (6.7%). All stent thrombosis in the Excel group was classified as early, and all were defined as late in the Taxus group. CONCLUSION: The Excel stent had lower rate of stent thrombosis, TLR, TVR, and composite MACE at 12-month after an indexed stenting procedure, compared to the Taxus stent.

Clinical outcomes of percutaneous coronary intervention for chronic total occlusion lesions in remote hospitals without on-site surgical support.

BACKGROUND: The safety of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) lesions in remote hospitals without surgical facilities remains unknown. This study aimed to evaluate three-year outcomes after CTO for PCI in ten centers around China where no on-site coronary artery bypass grafting (CABG) support was available. METHODS: A total of 152 patients from 10 Chinese hospitals without on-site surgical facilities were prospectively studied. Intra-procedural and in-hospital events were assessed. Angiographic follow-up was indexed eight months after the initial procedure. Clinical follow-up was extended to three years. The primary outcome was the rate of major adverse cardiac events (MACE), defined as cardiac death, myocardial infarction and target-vessel revascularization (TVR). RESULTS: The incidence of CTO was 7.9% in patients who underwent PCI. Successful recanalization was achieved in 132 patients (86.8%). Compared with patients in the PCI success group, patients with PCI procedural failure had longer lesion lengths ((42.32 +/- 22.08) mm vs (27.61 +/- 22.85) mm, P = 0.023), a higher rate of perforation (25.0% vs 0, P = 0.014), and a greater need for pericardial puncture. There were significant differences in MACE in-hospital and at one year and three years between the failure (10.0%, 30.0% and 35.0%) and the success (3.0%, 12.1% and 14.4%) groups (P = 0.037, 0.034 and 0.040, respectively). These led to a significant decrease in the MACE-free survival rate at one and three years in the failure group, compared with the success group (P = 0.031 and 0.023, respectively). Stump was the only predictor of recanalization success (HR 0.158, 95% CI 0.041-0.612, P = 0.008), whereas procedural failure (OR 13.023, 95% CI 6.67-13.69, P = 0.002), incomplete revascularization (OR 9.71, 95% CI 2.93-5.59, P = 0.005), and total stent length (OR 6.02, 95% CI 1.55-11.93, P = 0.027) were three independent predictors of MACE. CONCLUSIONS: PCI for CTO was unsafe in remote hospitals without CABG facilities. Paying attention to coronary perforation is important for successful procedures.