scholarly journals 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

BMJ Open ◽  
2018 ◽  
Vol 8 (3) ◽  
pp. e020019 ◽  
Author(s):  
Jun-Jie Zhang ◽  
Xiao-Fei Gao ◽  
Ya-Ling Han ◽  
Jing Kan ◽  
Ling Tao ◽  
...  
Keyword(s):  
Informed Consent ◽  
Target Lesion ◽  
Target Vessel ◽  
Coronary Bifurcation ◽  
Coronary Bifurcation Lesions ◽  
Stent Restenosis ◽  
Institutional Review ◽  
Bifurcation Lesions ◽  
Provisional Stenting ◽  
Target Lesion Failure

IntroductionProvisional 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 analysisThis 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 disseminationThe 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 numberNCT02284750; Pre-results.

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

2020 ◽  
Vol 41 (27) ◽  
pp. 2523-2536 ◽  
Author(s):  
Jun-Jie Zhang ◽  
Fei Ye ◽  
Kai Xu ◽  
Jing Kan ◽  
Ling Tao ◽  
...  
Keyword(s):  
Cardiac Death ◽  
Target Lesion ◽  
Stent Group ◽  
Coronary Bifurcation ◽  
Coronary Bifurcation Lesions ◽  
Safety Endpoint ◽  
Bifurcation Lesions ◽  
Provisional Stenting ◽  
Target Lesion Failure

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.

Dedicated Bifurcation Stents Strategy

2009 ◽  
Vol 4 (1) ◽  
pp. 70
Author(s):  
Chen Shao-Liang ◽  
Imad Sheiban ◽  
◽  
Keyword(s):  
Interventional Cardiology ◽  
Daily Practice ◽  
Side Branch ◽  
Control Groups ◽  
Coronary Bifurcation ◽  
Percutaneous Approach ◽  
Coronary Bifurcation Lesions ◽  
Drug Eluting ◽  
Bifurcation Lesions ◽  
Provisional Stenting

Coronary bifurcation lesions represent an area of ongoing challenges in interventional cardiology, mainly due to the higher rate of residual stenosis and restenosis at the side branch ostium. Multiple two-stent bifurcation strategies, including T-stenting, V-stenting, simultaneuos kissing stenting, culotte stenting and classic crush techniques, have no advantages over one-stent techniques. This led to provisional stenting being considered as a mainstream approach, based on the results of numerous randomised trials. Dedicated bifurcation stents have been designed specifically to treat coronary bifurcations with the aim of addressing some of the shortcomings of the conventional percutaneous approach and facilitating the provisional approach. The development of more drug-eluting platforms and larger studies with control groups demonstrating their clinical applicability, efficacy and safety are required before these stents are widely incorporated into daily practice.

Side branch long lesion with main vessel vulnerable plaques by optical coherence tomography predict target-vessel myocardial infarction after provisional stenting in patients with coronary bifurcation

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
S.L Chen
Keyword(s):  
Side Branch ◽  
Lesion Group ◽  
Lesion Length ◽  
Coronary Bifurcation ◽  
Coronary Bifurcation Lesions ◽  
Vulnerable Plaques ◽  
Main Vessel ◽  
Bifurcation Lesions ◽  
Provisional Stenting ◽  
One Year

Abstract Background Provisional side branch (SB) stenting is correlated with target-vessel myocardial infarction (TVMI) in patients with coronary bifurcation lesions. However, the underlying mechanisms remain unknown. Objectives We aimed to determine the correlation of SB lesion length with vulnerable plaques using optical coherence tomography (OCT) and TVMI in patients with coronary bifurcation lesions treated by a provisional approach. Methods A total of 405 patients with 405 bifurcation lesions who underwent pre-PCI OCT imaging of both main vessel (MV) and SB was prospectively enrolled. Patients were defined as Long-SB lesion (SB lesion length ≥10 mm) and Short-SB lesion (SB lesion length <10 mm) groups according to quantitative coronary analysis and were also stratified by the presence of vulnerable plaques based on OCT findings. The primary endpoint was the occurrence of TVMI after provisional stenting at one-year follow-up. Results 178 (43.9%) patients had long SB lesions. Vulnerable plaques predominantly localized in the main vessel (MV) and more frequently in the Long-SB lesion group (42.7%) compared to 24.2% in the Short-SB lesion group (p<0.001). At one-year follow-up after provisional stenting, there were 31 (8.1%) TVMIs, with 11.8% in the Long-SB lesion group and 4.4% in the Short-SB lesion group (p=0.009), leading to significant difference in target lesion failure between two groups (15.2% vs. 6.6%, p=0.007). The rate of cardiac death, revascularization, and stent thrombosis was comparable between study groups. By multivariate regression analysis, long SB lesion length (p=0.011), presence of vulnerable plaques in the polygon of confluence (p=0.001), and true coronary bifurcation lesions (p=0.004) were three independent factors of TVMI. Conclusions Long-SB lesion length with MV vulnerable plaques predict increased TVMI after provisional stenting in patients with true coronary bifurcation lesions. Further study is warranted to identify the better stenting techniques for coronary bifurcation lesions with long lesion in the SB Kaplan-Meier survival curve Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): NSFC

P5752Which is the best stenting technique for coronary bifurcation lesions? Evidence from a network meta-analysis of randomized clinical trials

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
J Chiabrando ◽  
M Lombardi ◽  
G M Vescovo ◽  
G Biondi Zoccai ◽  
A Abbate ◽  
...  
Keyword(s):  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Cardiovascular Outcomes ◽  
Target Vessel ◽  
Coronary Bifurcation ◽  
Target Vessel Revascularization ◽  
Coronary Bifurcation Lesions ◽  
Increased Risk ◽  
Bifurcation Stenting ◽  
Bifurcation Lesions

Abstract Background Bifurcation lesions represent 20% of all coronary lesions treated by percutaneous coronary interventions (PCI). Although provisional technique with 1 stent in the main branch and balloon angioplasty of the side branch is considered the standard approach, the implantation of 2 stents is often being pursued with a wide variety of bifurcation stenting techniques. We thus conducted a systematic review and network meta-analysis of randomized clinical trials (RCTs) to compare clinical cardiovascular outcomes involving stenting techniques in coronary bifurcation lesions. Methods We searched on Pubmed, Google Scholar, Embase and Cochrane Library, up to October 2018 for published and unpublished RCTs that compared clinical cardiovascular outcomes in patients with bifurcation lesions treated with 7different techniques (crush [Cr]; culotte [Cu]; double kissing crush [DKCr], mini-crush [mCr], routine T-stenting [RTS], T-stenting and small protrusion [TAP], and provisional (1 stent technique)). We performed a frequentist fixed-effect network meta-analysis to estimate relative risks (RR) of major adverse cardiovascular events (“MACE”, typically defined as death, myocardial infarction and target vessel revascularization), target vessel revascularization (TVR), target lesion revascularization (TLR), and stent thrombosis (ST). Results We identified 14 studies, yielding data on 4285 patients. DKCr and mCr yielded significant reductions in MACE, TVR, and TLR when compared with the 1-stent technique (RR 0.31–0.55 [all P<0.01] and RR 0.42–0.45 [all P<0.02], respectively) and with the rest of the bifurcation techniques (RR 0.44–0.55 [all P<0.05] for DKCr and RR 0.37–0.45 [all P<0.05] for mCr). On the other hand, Cu and Cr were associated with an increased risk for ST compared to 1-stent technique (RR 3.25–4.27 [both P<0.05]) and to DKCr (RR 3.02–3.99 [both P<0.05]). We found no heterogeneity nor inconsistency between studies. Conclusions The various PCI bifurcation stenting techniques are associated with different cardiovascular outcomes, with double kissing crush and mini crush being more effective than others, including the 1-stent approach, whereas culotte and crush are associated with increased risk of stent thrombosis. Acknowledgement/Funding None

scholarly journals Randomized Comparison of FFR-Guided and Angiography-Guided Provisional Stenting of True Coronary Bifurcation Lesions

2015 ◽  
Vol 8 (4) ◽  
pp. 536-546 ◽  
Author(s):  
Shao-Liang Chen ◽  
Fei Ye ◽  
Jun-Jie Zhang ◽  
Tian Xu ◽  
Nai-Liang Tian ◽  
...  
Keyword(s):  
Coronary Bifurcation ◽  
Coronary Bifurcation Lesions ◽  
Bifurcation Lesions ◽  
Provisional Stenting
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