Treatment Of Coronary Bifurcation Lesions Research Articles

CRT-133 Safety And Feasibility Of Everolimus-eluting Bioresorbable Vascular Scaffold In The Treatment Of Coronary Bifurcation Lesions

PCI treatment of coronary bifurcation lesions (CBL) is technically challenging. Bioresorbable vascular scaffold (BVS) provides temporary vessel scaffolding with drug-elution; restores normal vessel architecture and physiology upon resorption. There are limited data on the feasibility and safety of

A Randomized Trial of a Dedicated Bifurcation Stent Versus Provisional Stenting in the Treatment of Coronary Bifurcation Lesions

BackgroundBifurcation lesions are frequent among patients with symptomatic coronary disease treated by percutaneous coronary intervention. Current evidence recommends a conservative (provisional) approach when treating the side branch (SB). ObjectivesThe TRYTON (Prospective, Single Blind, Randomized Controlled Study to Evaluate the Safety & Effectiveness of the Tryton Side Branch Stent Used With DES in Treatment of de Novo Bifurcation Lesions in the Main Branch & Side Branch in Native Coronaries) bifurcation trial sought to compare treatment of de novo true bifurcation lesions using a dedicated bifurcation stent or SB balloon angioplasty. MethodsWe randomly assigned patients with true bifurcation lesions to a main vessel stent plus provisional stenting or the bifurcation stent. The primary endpoint (powered for noninferiority) was target vessel failure (TVF) (cardiac death, target vessel myocardial infarction, and target vessel revascularization). The secondary angiographic endpoint (powered for superiority) was in-segment percent diameter stenosis of the SB at 9 months. ResultsWe randomized 704 patients with bifurcation coronary lesions at 58 centers (30 from Europe and 28 from the United States). At 9 months, TVF was 17.4% in the bifurcation stent group compared with 12.8% in the provisional group (p = 0.11), mainly because of a higher periprocedural myocardial infarction rate (13.6% vs. 10.1%, p = 0.19). The TVF difference of +4.6% (2-sided 95% confidence interval: −1.0 to 10.3; upper limit of the 1-sided 95% confidence interval: 10.3) was not within the pre-specified noninferiority margin of 5.5% (p = 0.42 for noninferiority). The SB in-segment diameter stenosis among the angiographic cohort was lower in the bifurcation stent group compared with the provisional group (31.6% vs. 38.6%, p = 0.002 for superiority), with no difference in binary restenosis rates (diameter stenosis ≥50%) at 9 months follow-up (22.6% vs. 26.8%, p = 0.44). ConclusionsProvisional stenting should remain the preferred strategy for treatment of non–left main true coronary bifurcation lesions. (Prospective, Single Blind, Randomized Controlled Study to Evaluate the Safety & Effectiveness of the Tryton Side Branch Stent Used With DES in Treatment of de Novo Bifurcation Lesions in the Main Branch & Side Branch in Native Coronaries [TRYTON]; NCT01258972)

AXXESS™ Stent: Delivery Indications and Outcomes.

The successful treatment of coronary bifurcation lesions remains one of the challenges of interventional cardiology. The current consensus of the European Bifurcation Club based on published data advocates a provisional strategy, treating the main vessel (MV) with a single stent covering the side branch (SB), with bailout SB stenting as required. The success of this approach may be limited by failure to attain SB access after MV stenting but is preferred in most situations over routine SB plus MV stent techniques, which are associated with a significant increase in the rate of major adverse cardiac events. The AXXESS self-expanding biolimus-eluting stent has been developed as a solution to these challenges within the coronary circulation and maintains provisional MV stent approach but with added assurance of maintained SB access. It has a unique conical structure that is positioned spanning the carina, with scaffold extending into the carina of both the MV and SB. The purpose of this article is to describe the indication, implantation technique and outcome data supporting the use of the AXXESS stent in the treatment of coronary bifurcation lesions.

ASSA14-12-11 Modified mini-crush versus Cullotte techniques in bifurcation lesions of left anterior descending artery: clinical and angiographic long-term outcome after implantation of drug-eluting stents

Background The best option on the treatment of coronary bifurcation lesions is a subject of considerable debate. However, recent evidence suggests that bifurcation lesions might be treated by drug-eluting stent on both branches using the mini-crush (MMC) with a low rate of major adverse cardiac event and restenosis. This retrospective study sought to assess the clinical and angiographic long-term outcome after implanting drug-eluting stents in the bifurcation lesions of left anterior descending artery (LAD) with the Cullotte and MMC technique. Methods From April 2003 to January 2013, 445 patients were consecutively treated with either MMC (MMC group, n = 141) or Cullotte (Cullotte group, n = 304). The results of in-hospital and 12-month clinical follow-up were analysed. The indexes of in-hospital, angiographic restenosis at 12-months and major adverse cardiac events (MACE) including death, myocardial infarction or any target lesion revascularisation were evaluated. Results The mean 12-month angiographic follow-up was completed in 63 patients (44.7%) of MMC group and in 118 patients (38.8%) of Cullotte group. The MMC group compared with the Cullotte group had significantly shorter operative time and lower main or side branches restenosis (hazard ratio [HR]: 0.41, 95% confidence interval [CI]: 0.20 to 0.85; p = 0.016; and HR 0.52, 95% CI 0.27–0.99; P = 0 .047, respectively). So, the MMC group compared with the Cullotte group had significantly lower revascularisation (HR 0.57, 95% CI 0.31–0.97; p = 0.023). After a propensity score adjustment, 2-year cumulative major adverse cardiac events were similar between groups (p = 0.16). Conclusions The modified mini-crush technique with DES can be safely performed giving complete coverage of the ostium of side branches and optimising side branch access. Both techniques of bifurcation treatment met high procedural success with low complication rates and similar major adverse cardiac event long-term outcome. However, the MMC minimised the stent structs in main branch, yields a lower restenosis rate at main or side branches.

Impact of final kissing balloon inflation after simple stent implantation for the treatment of non-left main true coronary bifurcation lesions in patients with acute coronary syndrome

ObjectivesWe sought to evaluate the impact of final kissing balloon inflation (FKBI) after simple stent implantation for the treatment of non-left main true coronary bifurcation lesions in patients with acute coronary syndrome (ACS). BackgroundWhether FKBI should be mandatory after simple stent implantation for the treatment of coronary bifurcation lesion is controversial. Besides, ACS patients who have undergone bifurcation percutaneous coronary intervention with simple stent implantation may experience worse prognosis compared to stable angina pectoris patients. MethodsTwo hundred and fifty one eligible patients (67.7% male, mean age 61.7±10.4years) were enrolled. The study population was divided into two groups according to the performance of FKBI. The primary end points were major adverse cardiac event (MACE); target lesion revascularization (TLR), non-fatal myocardial infarction (MI) and cardiac death during the follow-up period. ResultsOver a mean follow-up period of 3.0±1.9years, there were 29 MACEs (10 TLR, 6 non-fatal MI, and 13 cardiac deaths), representing an event rate of 11.6%. Kaplan–Meier survival analysis revealed that FBKI group had favorable outcome compared to non-FKBI group with regard to hard events (p=0.010) as well as composite MACEs (p=0.008). In multivariable analysis, FKBI was a significant predictor of composite MACEs [hazard ratio 0.398 (95% confidence interval 0.190–0.836, p=0.015)] and hard events [hazard ratio 0.325 (95% confidence interval 0.130–0.811, p=0.016)]. ConclusionsIn terms of prognosis, performing FKBI after simple stent implantation for the treatment of non-left main true coronary bifurcation lesions may be mandatory in ACS patients.

A SYSTEMATIC REVIEW AND META-ANALYSIS OF TWO-STENT TECHNIQUES FOR THE TREATMENT OF CORONARY BIFURCATION LESIONS

Single stent in the main branch with provisional stent in the side branch is the preferred approach for treatment of coronary bifurcation lesions. However, utilizing two stents as the initial approach may be appropriate for large side branch involvement or for Medina classification 1,1,1 lesions. Several two-stent techniques are available, yet data comparing the efficacy of these techniques to guide clinical decision making is limited. We conducted a systemic review and meta-analysis of published studies to compare outcomes after Crush stenting, T-stenting and Simultaneous Kissing Stent (SKS) techniques. We conducted a comprehensive literature search and performed a systematic review and meta-analysis using random effects to compare clinical outcomes after crush stenting, T-stenting and simultaneous kissing stenting. The primary endpoint was major adverse cardiovascular events (MACE) defined as a composite of cardiac death, nonfatal myocardial infarction, or target lesion revascularization. Data are presented as odds ratio (OR) with 95% confidence intervals (95% CI). A p value of ≤0.05 defined statistical significance. Initial literature search identified 2799 articles and 86 publications were reviewed in detail. 7 studies that compared the two-stent bifurcation stenting techniques of interest were included in the analysis. Four trials compared Crush stenting and SKS in 269 patients and five studies compared Crush stenting and T-stenting in 534 patients. Compared with SKS, crush technique was associated with a significantly lower MACE rate (OR=0.47, 95%CI 0.23 to 0.97, p=0.04) (Figure 1). Compared with T-stenting, crush technique was associated with numerically, but not statistically lower MACE rate (OR=0.74, 95%CI 0.47 to 1.16, p=0.19). There is paucity of randomized controlled trials comparing two-stent techniques for treatment of coronary bifurcation lesions. The present meta-analysis suggests that Crush stenting may be a preferable approach compared to SKS and possibly T-stenting. However, the analysis is limited by small number of patients in observational studies. This underscores the need for an adequately powered randomized trial.

Coronary Bifurcations: Still the Touchstone of Drug-eluting Stents and Bioresorbable Vascular Scaffolds?

Coronary bifurcation lesions that involve significant side branches represent a particularly challenging subset of target lesions for percutaneous coronary interventions. Besides the necessity for the interventional cardiologist to often perform technically demanding interventions with more procedural steps, clinical outcome following percutaneous coronary intervention has usually been somewhat inferior. For more than two decades, coronary bifurcation lesions represent a serious touchstone for both interventional cardiologists and various types of stents and vascular scaffolds. The use of first-generation drug-eluting stents (DES) has reduced the incidence of restenosis following percutaneous coronary intervention of bifurcation lesions as compared to bare metal stents. In a first, small-sized study by Colombo et al, a numerically lower rate of angiographic restenosis was seen in bifurcated lesions treated with a single DES in the main vessel. In the meantime, pooled data of the Nordic Bifurcation and the British Bifurcation Coronary studies, both using first-generation Cypher DES (Cordis; Waaren, New Jersey, United States), have clearly demonstrated at 9-month follow-up that clinical outcome is superior following a simple approach with provisional Tstenting of the side branch vs a complex approach. In addition, the Nordic Bifurcation study has shown that long-term outcome (up to 5 years) following bifurcation stenting with a simple approach was at least as good as the outcome of a complex approach. The aforementioned studies were performed with the first-generation Cypher stent that had a closed-cell design. The results of several in vitro studies and bench tests suggest that DES with different stent materials and designs may act differently in the setting of bifurcation stenting. Moreover, the coatings of various DES types show significant dissimilarities in mechanical properties, which may be relevant during kissing balloon inflations that apply a significant shear stress to the coatings of DES. Consequently, the assessment of clinical outcome

Dedicated Tryton Side Branch Stents used in the treatment of coronary bifurcation lesions

IntroductionCoronary bifurcation lesions account for 15–20% of all percutaneous coronary interventions.Dedicated bifurcation stents have recently been introduced with the aim to simplify treatment and improve early and late outcomes following stenting of bifurcation lesions.The purpose of our study was to assess the safety and effectiveness of the Tryton dedicated side branch stent at a 6-month clinical and angiography follow-up. MethodsForty-two patients with bifurcation lesions were included in our study. The primary endpoint was a 6-month MACE and angiographic stent patency was also evaluated by MS-CT coronarography. ResultsTwenty-two patients (52.38%) were treated for acute coronary syndromes, 39 (92.85%) lesions were “true bifurcations”. The 6-month clinical follow-up was performed in all patients. The 6-month MACE rate (cardiac death, myocardial infarction and target lesion revascularization) was 9.52% (95% CI: 2.66–22.62%); of these one patient (2.38%; 95% CI: 0.06–12.57%) died due to cardiogenic shock caused by early stent thrombosis and three patients (7.14%; 95% CI: 1.50–19.48%) required repeated revascularization (TVR) due to in-stent restenosis, all of them in bare metal stents. Tryton stent implantation was successful in 100% lesions.6-Month MS-CT coronarography was performed in 39 (92.85%) patients. The implanted bifurcation Tryton stents were satisfactorily visualized in 97.43% of them and a satisfactory 6-month angiographic patency was demonstrated in 37 patients (88.1%). ConclusionThe usage of a dedicated bifurcation Tryton Side Branch Stent for PCI of the bifurcation lesions is technically feasible with satisfactory long-term results.

Coronary Artery Bifurcation Lesions: A Review of Contemporary Techniques in Percutaneous Coronary Intervention

Percutaneous intervention of coronary bifurcation lesions continues to challenge interventional cardiologists. Nonetheless, the past decade has seen an explosion in the development of clinical novel techniques and well-conducted trials validating the relative efficacy and safety of these techniques. For the most part, consensus has emerged regarding the preferred technique, that being provisional stenting of the side-branch (SB), based on the results of several randomised trials that, with the exception of one, have shown no benefit of a two-stent approach, utilising any one of several techniques, including the crush, culotte, or other modifications. Only the double-kiss (DK) crush appears to confer better clinical outcomes, possibly because of the superiority of the technique in optimising access to the SB. Trial data are still pending regarding the efficacy of two-stent techniques in patients with complex SB lesions and with large-calibre SBs. The use of second-generation drug-eluting stents is associated with better results compared to historical data. Preliminary data from studies utilising dedicated bifurcation stents similarly shows favourable results. Bifurcation stenting using bioresorbable vascular scaffolds is at an early stage, with prospective trial data needed to validate this technology for the use in this subset of patients. Modern imaging tools such as intravascular ultrasound and optical coherence tomography, as well as physiological assessment of SB lesions, are now utilised in decision-making regarding stent strategy, though trial data showing better outcomes with routine use of these tools are lacking.

Assessment of side branch predilation before a provisional T-stent strategy for bifurcation lesions. A randomized trial

A simple approach is the predominant strategy for the percutaneous coronary intervention of bifurcation lesions. Performing side branch (SB) predilation in this context is currently a matter of controversy. In this study, we assess the efficacy of SB predilatation before a provisional T-stent strategy for bifurcation lesions. Between February 2009 and November 2012, 372 patients with true bifurcation lesions were randomized to either predilation of the SB (n = 187) or no predilatation (n = 185) before main branch (MB) stent implantation and a subsequent SB provisional stent strategy. There were no significant differences between the patient groups regarding the baseline characteristics. After MB stent implantation, the TIMI flow of the SB was higher in the patients with SB predilation: TIMI flow 0 to 1; 2 (1%) versus 18 (10%), P < .001; and TIMI flow III; 179 (96%) versus 152 (82%), P < .001. Side branch stenting rates were 4% versus 3%, P = not significant. In addition, 60 patients (32%) from the SB predilation group presented SB residual stenosis by visual inspection <50%, and TIMI flow ≥III did not require any additional treatment. The failure rate of SB rewiring, the time of rewiring, the number of wires used, and the incidence of major events were similar in both groups of patients. Predilation of the SB resulted in improved TIMI flow after MB stenting and less indication to subsequently treat the SB. If rewiring of the SB is required, predilation did not hinder this maneuver.

Effect of force-induced mechanical stress at the coronary artery bifurcation stenting: Relation to in-stent restenosis

The deployment of metallic stents during percutaneous coronary intervention has become common in the treatment of coronary bifurcation lesions. However, restenosis occurs mostly at the bifurcation area even in present era of drug-eluting stents. To achieve adequate deployment, physicians may unintentionally apply force to the strut of the stents through balloon, guiding catheters, or other devices. This force may deform the struts and impose excessive mechanical stresses on the arterial vessels, resulting in detrimental outcomes. This study investigated the relationship between the distribution of stress in a stent and bifurcation angle using finite element analysis. The unintentionally applied force following stent implantation was measured using a force sensor that was made in the laboratory. Geometrical information on the coronary arteries of 11 subjects was extracted from contrast-enhanced computed tomography scan data. The numerical results reveal that the application of force by physicians generated significantly higher mechanical stresses in the arterial bifurcation than in the proximal and distal parts of the stent (post hoc P &amp;lt; 0.01). The maximal stress on the vessels was significantly higher at bifurcation angle &amp;lt;70° than at angle ≧70° (P &amp;lt; 0.05). The maximal stress on the vessels was negatively correlated with bifurcation angle (P &amp;lt; 0.01). Stresses at the bifurcation ostium may cause arterial wall injury and restenosis, especially at small bifurcation angles. These finding highlight the effect of force-induced mechanical stress at coronary artery bifurcation stenting, and potential mechanisms of in-stent restenosis, along with their relationship with bifurcation angle.

TCTAP A-152 Impact of Final Kissing Balloon Inflation After Simple Stent Implantation for the Treatment of Non-left Main True Coronary Bifurcation Lesions in Patients with Acute Coronary Syndrome

It is still a controversial issue that performing final kissing balloon inflation (FKBI) after simple stent implantation for the treatment of coronary bifurcation lesion is mandatory. Besides, acute coronary syndrome (ACS) patients who underwent bifurcation percutaneous coronary intervention with

Triple versus dual antiplatelet therapy after percutaneous coronary intervention for coronary bifurcation lesions: results from the COBIS (COronary BIfurcation Stent) II Registry

The efficacy and safety of adding cilostazol to aspirin plus clopidogrel (triple antiplatelet therapy, TAPT) have not been fully evaluated in complex percutaneous coronary intervention (PCI). We sought to investigate whether TAPT after PCI for bifurcation lesions improves long-term clinical outcomes. Consecutive patients undergoing PCI for bifurcation lesions were enrolled from 18 centers in Korea between 2003 and 2009. We compared target vessel failure (TVF), defined as a composite of cardiac death, myocardial infarction (MI), and target vessel revascularization (TVR), among 675 patients who received TAPT and 2081 who received dual antiplatelet therapy (DAPT: aspirin plus clopidogrel). Patients who received TAPT had more cardiovascular co-morbidities with regard to clinical, angiographic, and procedural characteristics. During the follow-up (median 36 months), 346 (12.6%) TVFs occurred. The incidence of TVF was significantly higher in the TAPT group, mainly driven by a higher TVR rate. In the TAPT group, however, the risk of TVF was not significantly different from the DAPT group after adjusting for the confounders of TVFs (adjusted hazard ratio [HR] 0.86, 95% confidence interval [CI] 0.53-1.39, p = 0.53). And also, there were no significant differences between the 2 groups in terms of the risks for death, cardiac death, MI, TVR, stent thrombosis, or cerebrovascular accident. These results were consistent after propensity score-matched analysis, and were also constant among the high-risk subgroups. TAPT after bifurcation PCI had no beneficial effect on the risk of long-term clinical outcomes in real-world clinical practice. Further studies are needed to confirm these findings.

Differential Prognostic Impact of Treatment Strategy Among Patients With Left Main Versus Non–Left Main Bifurcation Lesions Undergoing Percutaneous Coronary Intervention: Results From the COBIS (Coronary Bifurcation Stenting) Registry II

The authors sought to investigate whether the impact of treatment strategies on clinical outcomes differed between patients with left main (LM) bifurcation lesions and those with non-LM bifurcation lesions. Few studies have considered anatomic location when comparing 1- and 2-stent strategies for bifurcation lesions. We compared the prognostic impact of treatment strategies on clinical outcomes in 2,044 patients with non-LM bifurcation lesions and 853 with LM bifurcation lesions. The primary outcome was target lesion failure (TLF) defined as a composite of cardiac death, myocardial infarction (MI), and target lesion revascularization. The 2-stent strategy was used more frequently in the LM bifurcation group than in the non-LM bifurcation group (40.3% vs. 20.8%, p < 0.01). During a median follow-up of 36 months, the 2-stent strategy was not associated with a higher incidence of cardiac death (hazard ratio [HR]: 1.24; 95% confidence interval [CI]: 0.72 to 2.14; p= 0.44), cardiac death or MI (HR: 1.12; 95% CI: 0.58 to 2.19; p=0.73), or TLF (HR: 1.39; 95% CI: 0.99 to 1.94; p= 0.06) in the non-LM bifurcation group. In contrast, in patients with LM bifurcation lesions, the 2-stent strategy was associated with a higher incidence of cardiac death (HR: 2.43; 95% CI: 1.05 to 5.59; p= 0.04), cardiac death or MI (HR: 2.09; 95% CI: 1.08 to 4.04; p= 0.03), as well as TLF (HR: 2.38; 95% CI: 1.60 to 3.55; p < 0.01). Significant interactions were present between treatment strategies and bifurcation lesion locations for TLF (p= 0.01). The 1-stent strategy, if possible, should initially be considered the preferred approach for the treatment of coronary bifurcation lesions, especially LM bifurcation lesions. (Korean Coronary Bifurcation Stenting [COBIS] Registry II; NCT01642992).

CRT-131 Feasibility of the Use of the Tryton™ Dedicated Bifurcation Stent via the Transradial Route - A Single Centre Experience

The use of the Transradial access (TR) for the treatment of Coronary Bifurcation Lesions (CBL) with Percutaneous Coronary Intervention (PCI) can be limited where a two stent strategy is required as larger sheath and guide catheters are required to facilitate stent delivery. With the development of

CRT-165 Fractional Flow Reserve Versus Kissing Balloon Inflation in Coronary Bifurcations: A Meta-Analysis of Success Rates

Percutaneous coronary intervention of coronary bifurcation lesions (CBL) is technically difficult. The European Bifurcation Club recommends performing either fractional flow reserve (FFR) estimation of the side-branch or kissing balloon inflation (KBI) after the main vessel stenting when a

The utility of stent enhancement to guide percutaneous coronary intervention for bifurcation lesions

Percutaneous coronary intervention (PCI) of bifurcation lesions is complex and is technically very demanding. Coronary angiography is considered the gold standard method to guide PCI but has several limitations. The purpose of this study was to determine the utility of stent enhancement with StentBoost® (StB), a novel fluoroscopic imaging technique, and its potential role during bifurcation PCI. This prospective study included 97 patients who underwent bifurcation PCI (98 bifurcations), using StB. Bifurcation lesions were classified according to the modified Medina classification. StB was performed in all patients to obtain improved stent visualisation and to detect optimal release and deployment. Therefore, three groups were formed, according to the quality of image: optimal visualisation, suboptimal visualisation and poor visualisation. Most of the bifurcation disease involved the main vessel (99%) and in 80 patients (81.6%) there was side branch involvement. Most bifurcations had both main vessel and side branch lesions (Medina 1,1,1) (70 patients, 71.4%). StB image quality was good in 79.6% of the cases (optimal visualisation of the stent and guidewire), was suboptimal in 19.4%, and poor in 1% (overlapping of structures or devices). In three cases, StB enabled the identification of the guidewire and angioplasty balloon passing outside stent borders during rewiring of the side branch. Imaging techniques have a primary role during bifurcation PCI. StentBoost is a simple and quick method that offers several advantages, enabling improved stent visualisation, appropriate rewiring of the side branch, adequate stent expansion and optimal apposition of the struts to the wall.

The Tryton Side Branch Stent™ for the treatment of coronary bifurcation lesions

Coronary bifurcation lesions account for approximately 15% of all percutaneous coronary interventions (PCI) performed. Although clinical outcomes after PCI have been improved considerably, PCI of bifurcation lesions remains to be associated with adverse clinical events, when compared with non-bifurcation PCI. Therefore, several dedicated bifurcation devices have been developed to improve clinical outcomes. The Tryton Side Branch Stent™ is such device and is used in combination with a regular tubular balloon expandable stent in the main branch. Multiple single and multicenter registries and a patient pooled analysis including 900 patients have shown promising results regarding clinical outcomes after bifurcation PCI with Tryton. The pivotal Tryton IDE randomized trial is currently underway comparing the Tryton stent with side branch balloon angioplasty as side branch treatment in bifurcation lesions challenging the current dogma of provisional single stent strategy as treatment for coronary bifurcation lesions.

TCT-390 AXXESS TREatment for bifurcation coronary disease. A Multicentre rEgistry: first Italian experience. (Estreme-I Registry).

The percutaneous treatment of coronary bifurcation lesions with stent implantation is associated with increased adverse clinical events and inferior angiographic outcomes, when compared with mid-vessel lesions. The Axxess stent is a dedicated, self-expanding, drug-eluting (Biolimus A9) bifurcation

TCT-396 Use of ABSORB(tm) Bioresorbable vascular scaffold for treatment of Coronary Bifurcation lesions - "Real ABSORB Registry"

TCT-396 Use of ABSORB(tm) Bioresorbable vascular scaffold for treatment of Coronary Bifurcation lesions - "Real ABSORB Registry"