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A drug-eluting Balloon for the trEatment of coronary bifurcation lesions in the side branch:a prospective multicenter ranDomized (BEYOND)clinical trial in China

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Chinese Medical Journal 2020年第8期133卷 899-908页

作者： Quan-Min Jing Xin Zhao Ya-Ling Han Ling-Ling Gao Yang Zheng Zhan-Quan Li Ping Yang Hong-Liang Cong Chuan-Yu Gao Tie-Min Jiang Hui Li Jun-Xia Li Dong-Mei Wang Geng Wang Zhan-Chun Cong Zhong Zhang Department of Cardiology General Hospital of Northern Theater CommandShenyangLiaoning 110016China Peking University Clinical Research Institute Beijing 100191China Department of Cardiology The First Bethune Hospital of Jilin UniversityChangchunJilin 130021China Department of Cardiology The People’s Hospital of Liaoning ProvinceShenyangLiaoning 110016China Department of Cardiology China-Japan Union Hospital of Jilin UniversityChangchunJilin 130033China Department of Cardiology Tianjin Chest HospitalTianjin 300051China Department of Cardiology Henan Provincial People’s HospitalZhengzhouHenan 450008China Department of Cardiology Affiliated Hospital of Logistics University of People’s Armed Police ForceTianjin 300163China Department of Cardiology Daqing Oilfield General HospitalDaqingHeilongjiang 163001China Department of Cardiology The Seventh Medical Center of People’s Liberation Army General HospitalBeijing 100125China Department of Cardiology Bethune International Peace HospitalShijiazhuangHebei 050082China Department of Cardiology The 306th Hospital of People’s Liberation ArmyBeijing 100101China

Background:Treatment of coronary bifurcation lesions remains challenging;a simple strategy has been preferred as of late,but the disadvantage is ostium stenosis or even occlusion of the side branch(SB).Only a few single-center studies investigating the combination of a drug-eluting stent in the main branch followed by a drug-eluting balloon in the SB have been *** prospective,multicenter,randomized study aimed to investigate the safety and efficacy of a paclitaxel-eluting balloon(PEB)compared with regular balloon angioplasty(BA)in the treatment of non-left main coronary artery bifurcation ***:Between December 2014 and November 2015,a total of 222 consecutive patients with bifurcation lesions were enrolled in this study at ten Chinese *** were randomly allocated at a 1:1 ratio to a PEB group(n=113)and a BA group(n=109).The primary efficacy endpoint was angiographic target lesion stenosis at 9 *** efficacy and safety endpoints included target lesion revascularization,target vessel revascularization,target lesion failure,major adverse cardiac and cerebral events(MACCEs),all-cause death,cardiac death,non-fatal myocardial infarction,and thrombosis in target *** main analyses performed in this clinical trial included case shedding analysis,base-value equilibrium analysis,effectiveness analysis,and safety *** version 9.4 was used for the statistical ***:At the 9-month angiographic follow-up,the difference in the primary efficacy endpoint of target lesion stenosis between the PEB(28.7%±18.7%)and BA groups(40.0%±19.0%)was-11.3%(95%confidence interval:-16.3%to-6.3%,Psuperiority<0.0001)in the intention-to-treat analysis,and similar results were recorded in the per-protocol analysis,demonstrating the superiority of PEB to *** lumen loss was significantly lower in the PEB group than in the BA group(-0.06±0.32 vs.0.18±0.34 mm,P<0.0001).For intention-to-treat,there were no significant differences bet

关键词： coronary bifurcation lesions Drug-eluting balloon Target lesion stenosis Late lumen loss

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Clinical and Angiographic Predictors of Major Side Branch Occlusion after Main Vessel Stenting in coronary bifurcation lesions

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Chinese Medical Journal 2015年第11期128卷 1471-1478页

作者： Dong Zhang Bo Xu Dong Yin Yi-Ping Li Yuan He Shi-Jie You Shu-Bin Qiao Yong-Jian Wu Hong-Bing Yan Yue-Jin Yang Run-Lin Gao Ke-Fei Dou Department of Cardiology State Key Laboratory of Cardiovascular Disease Cardiovascular Institute Fuwai Hospital and National Center for Cardiovascular Diseases Chinese Academy of Medical Sciences and Peking Union Medical College Beijing 100037 China

Background： Major side branch （SB） occlusion is one of the most serious complications during percutaneous coronary intervention （PCI） for bifurcation lesions. We aimed to characterize the incidence and predictors of major SB occlusion during coronary bifurcation intervention. Methods： We selected consecutive patients undergoing PCI （using one stent or provisional two stent strategy） for bifurcation lesions with major SB. All clinical characteristics, coronary angiography findings, PCI procedural factors and quantitative coronary angiographic analysis data were collected. Multivariate logistic regression analysis was performed to identify independent predictors of SB occlusion. SB occlusion after main vessel （MV） stenting was defined as no blood flow or any thrombolysis in myocardial infarction （TIMI） flow grade decrease in SB after MV stenting. Results： Among all 652 bifurcation lesions, 32 （4.91%） SBs occluded. No blood flow occurred in 18 lesions and TIMI flow grade decreasing occurred in 14 lesions. In multivariate analysis, diameter ratio between MV/SB （odds ratio [OR]： 7.71,95% confidence interval [C/]： 1.53-38.85, P = 0.01）, bifurcation angle （OR： 1.03, 95% CI： 1.02-1.05, P 〈 0.01）, diameter stenosis of SB before MV stenting （OR： 1.05, 95% CI： 1.03-1.07, P〈 0.01）, TIMI flow grade of SB before MV stenting （OR： 3.59, 95% CI： 1.48-8.72, P〈 0.01） and left ventricular eject fraction （LVEF）（OR： 1.06, 95% Cl： 1.02-1.11, P 〈 0.01） were independent predictors of SB occlusion. Conclusions： Among clinical and angiographic findings, diameter ratio between MV/SB, bifurcation angle, diameter stenosis of SB before MV stenting, TIMI flow grade of SB before MV stenting and LVEF were predictive of major SB occlusion after MV stenting.

关键词： coronary bifurcation lesions Major Side Branch Occlusion Percutaneous coronary Intervention

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Double kissing crush technique for treatment of true coronary bifurcation lesions： two-year clinical outcomes from DKCRUSH-1 study

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Chinese Medical Journal 2009年第6期122卷 736-740页

作者： ZHANG Jun-jie CHEN Shao-liang YE Fei LIU Zhi-zhong ZHU Zhong-sheng TIAN Nai-liang LIN Song SHAN Shou-jie Department of Cardiology Nanjing First Hosptial of Nanjing Medical University Nanjing Jiangsu 210006 China

Standards for treating bifurcation lesions are crucial due to poor outcomes by percutaneous implantation of either bare metal stents or drug-eluting stents, even with several modified double-stent techniques including ＂T＂, ＂V＂, ＂Y＂, ＂culotte＂ and ＂simultaneous kissing stents （SKS）＂. Understanding the drawbacks in classical crush techniques, we proposed a novel double kissing （DK） crush technique being testified in our previous serial studies]＇2 The results from these randomized and pilot studies are describing a fantastic story---DK crush technique, by final kissing balloon inflation （FKBI） in 100% of lesions and high quality of kissing as assessed by both angiography and intravascular ultrasound, significantly improved the clinical outcome at a relative short-term follow-up. However, whether the advantage of the DK crush technique was sustained or not at a long-term remains unclear. The present study aimed to extend clinical follow-up and verify the differences between DK and classic crush techniques.

关键词： coronary bifurcation lesions DK crush final kissing balloon inflation

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Final kissing balloon dilatation in patients with coronary bifurcation lesions treated with 1-stent technique using drug-eluting stent:A meta-analysis of four clinical studies

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South China Journal of Cardiology 2013年第1期14卷 59-67页

作者：延荣强高立建陈纪林 State Key Laboratory of Cardiovascular Disease Fuwai HospitalNational Center for Cardiovascular DiseasesChinese Academy of Medical Sciences and Peking Union Medical College

The effects of final kissing balloon dilatation （FKBD） have not been systemically evaluated in patients with coronary bifurcation lesions treated with 1-stent strategy. A meta-analysis was performed to in- tegrate the results of independent studies to provide a more precise estimate of the treatment effect. Methods A systematic literature search was carried out for all the relevant articles up till March 2012. Only studies with adequate data reporting major adverse cardiac events （MACE） and target lesion revascularization （TLR）, and follow-up of at least 6 months were included. The endpoints analyzed in this meta-analysis were stent throm- bosis （ST）, all-cause death, myocardial infarction （MI）, MACE and TLR. Result Four studies were found to be eligible for inclusion in the meta-analysis. There were also no significant differences with the occurrence of MI （1.7% vs. 1.5%, OR 1.14, 95% CI 0.38 to 3.44, P = 0.81）, all-cause death （1.1% vs. 1.1%, P = 0.84, OR 0.91, 95% CI 0.35 to 2.35） and stent thrombosis （0.9% vs. 0.8%, OR 1.03, 95% CI 0.35 to 3.09, P = 0.95） in patients with FKBD or No FKBD. However, FKBD was associated with a higher risk of MACE （8.0% vs. 5.3%, OR 1.56, 95% CI, 1.02-2.39, P = 0.04）, primarily as a result of an increased risk of TLR （6.4% vs. 3.4%, OR 2.12, 95% CI 1.30 to 3.48 P = 0.003）. Conclusions In patients with coronary bifurca- tion lesions treated with 1-stent technique, FKBD may be associated with adverse outcomes mainly because of a higher rate of TLR.

关键词： final kissing balloon dilatation coronary bifurcation lesions drug-eluting stents

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Two-Stent Strategy for bifurcation lesions in Percutaneous Transluminal coronary Angioplasty: Real-World Evidence

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World Journal of Cardiovascular Diseases 2024年第3期14卷 140-156页

作者： Dilip Kumar Amit Malviya Animesh Mishra Rabin Chakraborty Sanjeev S. Mukherjee Soumya Patra Arindam Pande Rana Rathor Roy Debopriyo Mondal Ashesh Halder Sumit Shanker Medica Superspecialty Hospital 127 Eastern Metropolitan Bypass Nitai Nagar Mukundapur Kolkata West Bengal India North Eastern Indira Gandhi Regional Institute of Health & Medical Sciences (NEIGRIHMS) Mawdiangdiang Shillong Meghalaya India

Background: bifurcation lesions pose a high risk for adverse events after percutaneous coronary intervention (PCI). Evidence supporting the benefits of the two-stent strategy (2SS) for treating coronary bifurcation lesions in India is limited. This study aimed to evaluate the clinical outcomes of various 2SSs for percutaneous transluminal coronary angioplasty for bifurcation lesions in India. Materials and Methods: This retrospective, observational, multicentric, real-world study included 64 patients over 8 years. Data on demographics, medical history, PCI procedures, and outcomes were recorded. Descriptive statistics were computed using the SPSS software. Results: Patients (n = 64) had an average age of 65.3 ± 11.1 years, with 78.1% males. Acute coronary syndrome was reported in 18.8%, chronic stable angina in 40.6%, and unstable angina in 34.4% of participants. Two-vessel disease was observed in 98.4% of patients, and 99.4% had true bifurcation lesions. The commonly involved vessels were the left anterior descending artery (50%), left circumflex coronary artery (34.4%), and first diagonal artery (43.8%). Mean percent diameter stenosis was 87.2% ± 10.1%. The mean number of stents used was 2.00 ± 0.34. The 2SS techniques included the T and small protrusion (TAP) (39.1%), double kissing (DK) crush (18.8%), and the culotte techniques (14.1%). Procedural and angiographic success rate was 92.18%. Major adverse cardiovascular events at 1-year follow-up occurred in 7.8% of cases. Conclusion: The 2SS for bifurcation lesions showed favorable in-hospital and follow-up outcomes. Findings can serve as a resource for bifurcation angioplasty in India. Larger real-world studies with robust methodology are needed to validate these results.

关键词： bifurcation Stenting coronary bifurcation lesions Percutaneous

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coronary bifurcation angle from 3-D predicts clinical outcomes after stenting bifurcation lesions

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Chinese Medical Journal 2012年第12期125卷 2083-2088页

作者： CHEN Shao-liang Teguh Santoso ZHANG Jun-jie YE Fei XU Ya-wei FU Qiang KAN Jing Chitprapai Paiboon ZHOU Yong DING Shi-qing Tak W Kwan Department of Cardiology Nanjing First Hospital NanjingMedical University Nanjing Jiangsu 210006 China Department of Cardiology Medistra Hospital University ofIndonesia Medical School Jakarta Indonesia Department of Cardiology Shanghai 10th People＇s HospitalShanghai 200072 China Department of Cardiology Xuzhou Central Hospital XuzhouJiangsu 221009 China Department of Cardiology Bangkok General Hospital BangkokThailand Department of Cardiology Zhangjiagang People＇s HospitalZhangjiagang Jiangsu 215600 China Department of Cardiology Huainan Xinhua Hospital HuainanAnhui 232038 China Department of Cardiology Beth Israel Hospital NewYork USA

Background The predictive value of bifurcation angle （BA） for worse events after stenting bifurcation lesions remains to be unknown. The present study was to investigate the dynamic change of BA and clinical relevance for patients with coronary bifurcation lesions treated by drug-eluting stent （DES）. Methods BA was calculated by 3-D quantitative coronary analysis from 347 patients in DKCRUSH-II study. Primary endpoint was the occurrence of composite major adverse cardiac events （MACE） at 12-month, including cardiac death, myocardial infarction （MI） and target vessel revascularization （TVR）. Secondary end points were the rate of binary restenosis and stent thrombosis at 12-month. Results Stenting was associated with the reduction of distal BA. The cut-off value of distal BA for predicting MACE was 60°. Distal BA in 〈60° group had less reduction after stenting （（-1.96＋13.58）°vs. （-12.12±23.58）°, P 〈0.001）; two-stent technique was associated with significant reduction of distal BA （△（-4.05±14.20）°）, compared to single stent group （4＋1.55±11.73, P=0.003）; the target lesion revascularization （TLR）, TVR and MACE rate was higher in one-stent group （16.5%, 19.0% and 21.5%）, compared to two-stent group （3.8%, P=0.002; 7.5%, P=0.016; and 9.8%, P=0.024）, respectively. Among patients in ≥60° group, there were no significant differences in distal BA, stent thrombosis （ST）, MI, MACE, death, TLR, TVR between one- and two-stent groups; after stenting procedure, there was only slight change of distal BA in left anterior descending （LAD）-Ieft circumflex （LCX） subgroup （from （88.54±21.33）° at baseline to （82.44±31.72）° post-stenting）, compared to either LAD-diagonal branch （Di）, or LCX-obtuse marginal branch （OM）, or IRCA distal （RCAd）（all P 〈0.001 ）. Conclusion Two-stent technique was associated with significant reduction of distal BA. DK crush stenting had reduced rate of MACE in patients in 〈60° group, compared to one-stent technique.

关键词： coronary bifurcation lesions bifurcation angle major adverse cardiac events ROC curve

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Novel side branch ostial stent （BIGUARD^TM）： first-in-man study

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Chinese Medical Journal 2009年第18期122卷 2092-2096页

作者： CHEN Shao-liang ZHANG Jun-jie YE Fei Department of Cardiology Nanjing First Hospital Nanjing Medical University Nanjing Jiangsu 210006 China Department of Cardiology Beijing Anzhen Hospital Beijing 100046 China

Background Stenting a bifurcation lesion is technically challenging. No study has reported the clinical outcome of a dedicated bifurcation stent in China. We aimed to analyze the safety and clinical outcome of a novel side branch ostial stent （BIGUARDTM） stent in treating coronary bifurcation lesions. Methods Forty-seven patients were enrolled in this first-in-man study, with 61.7% true bifurcation lesions （0,1,1 and 1,1,1） and 26.7% diabetes. A two-stent technique was used in 27.6% of the patients, and 64.7% of patients crossed from the one-stent technique to the two-stent arm. Clinical and angiographic follow-up data at 12 months were available in all the 47 patients and in 43 patients （91.9%）, respectively. The study endpoint was the occurrence of major adverse cardiac events （MACE） at 12 months. Results Only one patient had a non-ST segment elevation myocardial infarction, which led to 2% of the in-hospital composite MACE. Notably, the target lesion revascularization at 12 months was 8.6%, with a 10.6% composite MACE at 12 months. Neither cardiac death nor stent thrombosis was seen during the follow-up. By quantitative coronary analysis, the restenosis rate at the main vessel and ostium of the side branch was 9.4% and 2.1%, respectively. Four of 12 patients （33.3%） treated with one-stent and kissing balloon inflation had restenosis in the main vessel. Conclusion BIGUARDTM stent was safe and feasible in treatment of bifurcation lesions.

关键词： coronary bifurcation lesions side branch intravascular

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Jailing polymer jacketed guide-wires during bifurcation coronary interventions is associated with procedural myocardial infarction

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World Journal of Cardiology 2017年第5期9卷 442-447页

作者： Arka Chatterjee Jeremy S White Taimoor Hashim Massoud A Leesar Division of Cardiovascular Disease University of Alabama at Birmingham Department of Internal Medicine University of Alabama at Birmingham

AIM To study the relationship of jailed polymer jacketed guide wires(PGW) with procedural myocardial infarction(PMI) after bifurcation coronary *** Consecutive bifurcation interventions performed from January 2010 to October 2014 were included in the study. Chart review was performed to obtain demographic, clinical and procedural data. PMI was defined as Creatine Kinase MB > 3 × upper reference limit of normal. Multivariate logistic regression was used to ascertain relationship of PGW use with *** Two hundred and ninety-three patients(age 63.5 ± 12.3 years; 33.8% diabetic) were included in the study. Eighty point two percent(n = 235) were true bifurcation lesions use of PGW was associated with PMI on univariate analysis(OR = 4.1; P = 0.002). This association remained significant after adjusting for other possible risk factors(OR = 3.5; P = 0.02).CONCLUSION Our results suggest that PGW use for side branch protection may be associated with PMI. Randomized studies are needed to validate these findings.

关键词： coronary bifurcation lesions Percutaneous coronary intervention Procedural myocardial infarction Jailed guidewire Polymer shearing

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