A Novel guide extension assisted stenting technique for coronary bifurcation lesions

A challenging technical scenario frequently encountered in a percutaneous coronary intervention of a coronary bifurcation lesion(CBL)is stent implantation of only the stenosed segment without compromising the other two normal segments in non-true bifurcation lesions.Another is precise stent implantation covering the side branch ostium without leaving excessive stent metal at the other two segments of a bifurcation lesion in complex true bifurcation lesions.The aim of this study was to describe a novel stenting technique for both non-true and true CBLs by using a guide extension catheter(GuideLiner).With the assistance of a guide extension catheter mounted on both the main and the side-branch guidewires and with its intubation down to the bifurcation carina,a stent can be implanted in the side branch segment or distal main segment of the bifurcation lesion appropriately without compromising the other two segments of the coronary bifurcation.Stent implantation is described in three bifurcation lesions in three cases and shown in detail with illustrative figures.The technique facilitates side-branch only stenting in side-branch mono-ostial(medina 0,0,1)CBL or only the distal main segment in distal mono-ostial(medina 0,1,0)CBL without compromising the other two remaining segments when using the onestent technique in non-true CBLs without leaving unnecessary excessive stent metal at the bifurcation site and when using a two-stent technique in complex true bifurcation lesions(tri-ostial or medina 1,1,1).Consequently,through optimizing stent deployment,the technique may have the potential to reduce the risk of subacute stent thrombosis and future in-stent restenosis.The most appropriate lesions suitable for the technique,and some other practical tips are also described.

Two-Stent Strategy for Bifurcation Lesions in Percutaneous Transluminal Coronary Angioplasty: Real-World Evidence

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.

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

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 reported.This 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 lesions.Methods:Between December 2014 and November 2015,a total of 222 consecutive patients with bifurcation lesions were enrolled in this study at ten Chinese centers.Patients 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 months.Secondary 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 lesions.The main analyses performed in this clinical trial included case shedding analysis,base-value equilibrium analysis,effectiveness analysis,and safety analysis.SAS version 9.4 was used for the statistical analyses.Results: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 BA.Late 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 between PEB and BA in the 9-month percentages of MACCEs(0.9%vs.3.7%,P=0.16)or non-fatal myocardial infarctions(0 vs.0.9%,P=0.49).There were no clinical events of target lesion revascularization,target vessel revascularization,target lesion failure,all-cause death,cardiac death or target lesion thrombosis in either group.Conclusions:In de novo non-left main coronary artery bifurcations treated with provisional T stenting,SB dilation with the PEB group demonstrated better angiographic results than treatment with regular BA at the 9-month follow-up in terms of reduced target lesion stenosis.Trial registration:ClinicalTrials.gov,NCT02325817;https://clinicaltrials.gov.

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

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.

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 （maxusTM） MS. SES-BDP （ExcelTM） 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.

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

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.

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

AIM To study the relationship of jailed polymer jacketed guide wires(PGW) with procedural myocardial infarction(PMI) after bifurcation coronary interventions.METHODS 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 PMI.RESULTS 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.

A Case Summary of the Application of a Drug-eluting Stent Combined with a Drug-Coated Balloon in Left Main Coronary Artery Disease

Objective:To evaluate the clinical efficacy of a drug-eluting stent(DES)combined with a drug-coated balloon(DCB)in the treatment of left main coronary artery bifurcation lesions.Methods:A retrospective analysis was conducted on the clinical data of eight patients with left main coronary artery bifurcation lesions treated with a DES combined with a DCB who were admitted to our hospital from July 2016 to July 2017.These eight patients all underwent DES treatment for their left main coronary artery and left anterior descending coronary artery lesions,and DCB treatment at the ostium of the left circumflex artery;six of the patients underwent surgical procedures under the guidance of intravascular ultrasonography.Immediate postoperative angiography was used to evaluate the patency of the diseased vessels,and the restenosis rate at the 6-month follow-up after the operation and the incidence of serious clinical events within 6 months were assessed as well.Results:The use of a DES combined with a DCB in the treatment of left main coronary artery bifurcation lesions had a low restenosis rate(left main coronary artery(8.4±5.3)%,left anterior descending coronary artery(18.2±5.0)%,left circumflex artery(30.5±16.5)%).No serious clinical events occurred in any patients.Conclusion:A DES combined with a DCB is a safe and effective interventional treatment for left main artery coro-nary bifurcation lesions.

Clinical and Angiographic Predictors of Major Side Branch Occlusion after Main Vessel Stenting in Coronary Bifurcation Lesions

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.

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

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.

Impact of Side Branch Lesion Length on Clinical Outcome after Coronary Stenting Techniques in Patients with Coronary Artery Bifurcation Disease:A Meta-Analysis

Objective:The optimal percutaneous coronary intervention(PCI)technique for bifurcation lesions remains controversial,especially considering the variability of the side branch(SB).A provisional stenting technique is currently recommended in most cases.This meta-analysis aimed to compare outcomes of different bifurcation PCI strategies,clarifying their scope of application.Methods:Randomized controlled trials comparing PCI strategies for coronary bifurcation lesions were systematically retrieved from PubMed,Cochrane,Web of Science,and EBSCO literature databases without limitations on published date or language.Major adverse cardiovascular events(MACEs)were stipulated as main outcomes.Secondary outcomes of interest were all-cause mortality,cardiovascular mortality,target lesion revascularization(TLR),target vessel revascularization,myocardial infarction(MI),and stent thrombosis.Both pooled analysis and sub-group analysis were performed.Results:Twenty-three randomized controlled trials with 6380 participants were included.Eighteen studies compared the provisional strategy with 2-stent approaches.No significant difference in MACEs(relative risk(RR),1.16;95%confidence interval(CI),0.90-1.48;I2=62%)was found between 1-stent and 2-stent techniques.However,when SB lesion length was used as the separation condition,the 2-stent strategy was associated with fewer MACEs(RR,1.87;95%CI,1.46-2.41;I2=70%),TLRs(RR,2.13;95%CI,1.50-3.02;I2=59%),and MIs(RR,2.17;95%CI,1.19-3.95;I2=52%)than the provisional strategy in those where SB lesions measured>10 mm long.Conclusions:In the current work,there was no significant difference between 1-stent and 2-stent techniques in terms of MACEs or secondary outcomes.However,2-stent approaches have clinical advantages over the provisional strategy in bifurcation when the SB lesion length is>10 mm due to fewer cases of TLR and MI.

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

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.

Interventions of side branches in the management of left ventricular dysfunction： a study based on the virtual dual chamber of the left ventricle

For interventional cardiologists, it is very challenging to do percutaneous coronary interventions （PCI） in lesions of ihe left main, bifilrcations or of chronic total occlusion types. However, it is more challenging to demonstrate an evidence based rationale supporting the indications of PCI in these lesions. In this article, new questions are raised on the benefits and the mechanism of benefits for PCI of bifilrcations revolving large side branches such as the diagonal （DIAG）,