Xience side branch access stent for treatment of bifurcation coronary disease: a review of preclinical data

The Xience Side Branch Access (SBA) stent is an everolimus‐eluting stent designed specifically for branching coronary geometry, providing wire access into the side branch (SB) regardless of the planned treatment strategy. The stent is delivered via a low‐profile, dual‐lumen, and single‐tip catheter. A single inflation deploys the stent in the main branch (MB) and opens a portal into the SB. It is through this portal opening, allowing wire access into the SB, that this device differentiates itself from certain other dedicated bifurcation devices currently in various stages of development and testing. The Xience SBA stent was compared with a standard Multi‐Link Vision® stent using a provisional T‐stenting strategy in an ovine beating heart model. The Xience SBA stent tended to be deployed with less mean contrast usage (21.05 vs. 43.23 mL; P = 0.09), shorter fluoroscopy time (2.55 vs. 4.52 minute; P = 0.12), and lower rates of guidewire entanglement (16% vs. 100%) compared with the workhorse stent. As a result, the total procedure time with the Xience SBA stent was significantly shorter than that with the standard stent (5.46 vs. 8.65 minute; P = 0.01). The Xience SBA stent was also evaluated by four recently trained interventionalists who had no previous experience with the device. Using a perfused synthetic heart model, SB access time was reduced by 54%, average fluoroscopy time was reduced by 46%, and average contrast usage was lowered by 39% with the Xience SBA compared with the standard stent. Initial experience in the ovine model suggests that the Xience SBA stent is also amenable for use in distal left main coronary artery disease, regardless of whether it is deployed in the left ascending coronary artery or left circumflex artery and the portal opened in the opposing vessel. On the basis of these experimental results, the Xience SBA stent is an easy to use and versatile device for the purpose of SB access and potentially for the treatment of bifurcation coronary artery lesions. (J Interven Cardiol 2012;25:337–343)     

Long‐term risk of clinical events from stenting side branches of coronary bifurcation lesions with drug‐eluting and bare‐metal stents: An observational meta‐analysis

Objectives : To compare the long‐term risks of coronary bifurcation lesions treated with side‐branch stenting using drug‐eluting versus bare‐metal stents. Background : Side‐branch stenting is an off‐label practice, but when needed, the incidence of late adverse events may differ between drug‐eluting and bare‐metal stents. Methods : We systematically searched PubMed, and the National Institutes of Health and Cochrane Registries for studies of coronary bifurcation stenting reporting clinical outcomes over at least 5 months. Data were extracted and cross checked independently by two investigators for inclusion in an observational meta‐analysis. Clinical outcomes included major adverse clinical events (MACE), death, myocardial infarction, target vessel revascularization (TVR), and definite stent thrombosis. We used random‐effects models and meta‐regression in 6,825 subjects from 42 studies. Results : Most (79%) of the heterogeneity in MACE between treatment groups was explained by differences in stent type, side‐branch stenting, and length of follow‐up. Compared with drug‐eluting stents without side‐branch stenting, drug‐eluting stents with side‐branch stenting had a 3% higher incidence of myocardial infarction [95% confidence interval (CI) = 0.3%, 5%, P < 0.05], but no significant increase in MACE, death, TVR, or stent thrombosis. Bare‐metal stenting without side‐branch stenting had 10% (95% CI = 3%, 16%, P < 0.01) higher MACE, and 10% (95% CI = 4%, 17%, P < 0.01) higher TVR, whereas bare‐metal side‐branch stenting had 31% (95% CI = 23%, 39%, P < 0.001) higher MACE, and 19% (95% CI = 10%, 28%, P < 0.001) higher TVR. Conclusions : Side‐branch stenting has a much smaller impact on long‐term MACE with drug‐eluting stents compared with bare‐metal stents. Although this study does not support routine side‐branch stenting, when side‐branch stenting is required, drug‐eluting stents are associated with less adverse outcomes.© 2011 Wiley‐Liss, Inc.     

Comparison of zotarolimus‐ versus everolimus‐eluting stents in the treatment of coronary bifurcation lesions

Objectives : To compare zotarolimus‐eluting stent (Endeavor Sprint®; ZES‐S) and the everolimus‐eluting stent (Xience V®; EES) in the treatment of coronary bifurcation lesions Background : Both these stents have demonstrated good outcomes in the treatment of coronary lesions. However, the outcomes with respect to treatment of bifurcation lesions have yet to be conclusively demonstrated. Methods : In this single centered, nonrandomized, open label study, we treated, between August 2006 and December 2008, 110 bifurcations with ZES‐S and, in a second stage of the study, 129 bifurcations with EES. The primary end point was to compare the rate of major adverse cardiac events (MACE) (death, myocardial infarction, and new target lesion revascularization) in‐hospital and at 12 months of follow‐up. Provisional T stenting was the strategy used in the majority of cases. Angiographic follow‐up was performed only in patients who presented signs or symptoms suggestive of angina or ischemia. Results : There were no significant differences in in‐hospital MACE between the groups (ZES‐S: 8.1%; EES: 6.2%; P = 0.5). At 12 months, the ZES‐S group had significantly more MACE than the EES group (23.1% vs. 4.5%; P < 0.001) and an elevated index of new revascularization of the bifurcation (17.5% vs. 3.2%; P < 0.001). There were no significant differences in mortality (four patients in ZES‐S vs. one in EES; P = 0.14). Conclusion : The treatment of coronary bifurcation lesions using everolimus‐eluting stents results in better outcomes at 12 months of follow‐up than zotarolimus‐eluting stents. © 2011 Wiley Periodicals, Inc.     

Two‐year outcomes after deployment of XIENCE V everolimus‐eluting stents in patients undergoing percutaneous coronary intervention of bifurcation lesions: A report from the SPIRIT V single arm study

The aim of this analysis was to analyze outcomes of patients undergoing Xience V EES treatment of bifurcation lesions, a subset in which treatment is particularly challenging. The SPIRIT V Study provided an evaluation of the Xience V everolimus eluting stent (EES) performance in complex patient and lesion population. The SPIRIT V Single Arm Study enrolled 2700 patients with de novo coronary artery lesions suitable to be optimally treated with a maximum of four planned Xience V EES. Lesion evaluation was by visual assessment. The outcomes of the 492 patients undergoing Xience V EES stenting of ≥1 bifurcation lesion were compared to those with no bifurcation lesion treated. Compared to those without bifurcation treatment, patients with bifurcation treatment were more likely to have multi‐vessel disease (49% vs 40%), left main treatment (3.1% vs 0.9%), more lesions treated (1.5 vs 1.3), calcification (36.4% vs 27.5%), and ostial (17.1% vs 8.2%) and angulated lesions (29.3% vs 21.1%), all P < 0.001. The 30‐day composite rate of death, myocardial infarction (MI), target vessel revascularization (TVR) was 4.3% in patients with bifurcation PCI and 2.2% in those with non‐bifurcation PCI (P = 0.017). At 2 years, this composite event rate was 11.3% and 10.0% in these two groups, respectively (P = 0.403). Rates of cardiac death, MI, target lesion revascularization (TLR), TVR, and ARC defined definite or probable stent thrombosis (0.4% vs 0.9%, P = 0.402) were not significantly different between the two groups. Despite greater patient and lesion complexity, treatment of patients with bifurcation lesions using the Xience V EES in the SPIRIT V prospective Single Arm Study was safe and effective, with low overall event rates that were similar to those without bifurcation lesion treatment. © 2013 Wiley Periodicals, Inc.     

Strategies for drug‐eluting stent treatment of bifurcation coronary artery disease in the United States: Insights from the e‐Cypher S.T.L.L.R.Trial

Objectives: Our goal is to report the first large multicenter data for percutaneous coronary intervention (PCI) of bifurcation disease with drug‐eluting stents (DES) in the United States. Background: Bifurcation PCI remains a challenge to this date. There are limited data on outcomes of patients treated with bifurcation DES implantation, particularly in the United States. Methods: There were 161 patients with bifurcation disease [side branch (SB) ≥2‐mm] treated with ≥1 sirolimus‐eluting stents at 41 centers participating in the Stent deployment Techniques on cLinicaL outcomes of patients treated with the cypheR?stent (STLLR) trial. There was no protocol mandated strategy for bifurcation PCI. One‐year outcome data were collected. Angiographic and clinical data were adjudicated independently. Results: There were 147 patients (91.3%) treated with single stent strategy. Only 14 (8.7%) patients received sirolimus‐eluting stents implantation in both branches. Among patients with single stent strategy, double wire strategy (DW) was selected in 27 (18.4%) patients whereas single wire strategy (SW) was selected in 120 (81.6%) patients. There were 48 (32.7%) Medina 1,1,1 bifurcations treated with SW (n = 34; 70.8%) and DW (n = 14; 29.2%). There were 26 procedures started with SW which had SB dilatation during the procedure, one as a bailout (TIMI‐1 grade flow in the SB). Overall 1‐year death, myocardial infarction, and target lesion revascularization occurred in 2.4, 4.0, and 5.6%, respectively. There was no significant difference in clinical outcomes between SW and DW. SB dilatation was associated with a high rate of stent thrombosis (8.6%). Conclusions: Main branch stenting without SB protection is the most common approach utilized in the STLLR study, which may reflect contemporary DES bifurcation strategies in the Unite States. This strategy was associated with an acceptable low incidence of adverse outcomes at 1‐year. © 2009 Wiley‐Liss, Inc.     

The Acute Changes of Fractional Flow Reserve in DK (Double Kissing), Crush,and 1‐Stent Technique for True Bifurcation Lesions

Background: While many studies confirmed the importance of fractional flow reserve (FFR) in guiding complex percutaneous coronary interventions (PCI), data regarding the significance of FFR for bifurcation lesions are still lacking. Methods: Between October 2008 and October 2009, 51 patients with true bifurcation lesions were consecutively enrolled and randomized into double kissing (DK) crush (n = 25), and provisional 1‐stent (n = 26) groups. FFR measurements at baseline and hyperemia were measured at pre‐PCI, post‐PCI, and at 8‐month follow‐up. Results: Clinical follow‐ups were available in 100% of patients while only 33% of patients underwent angiographic follow‐up. Baseline clinical and angiographic characteristics were matched between the 2 groups. Pre‐PCI FFR of the main branch (MB) in the DK group was 0.76 ± 0.15, which was significantly lower than in the provisional 1‐stent group (0.83 ± 0.10, P = 0.029). This difference disappeared after the PCI procedure (0.92 ± 0.04 vs. 0.92 ± 0.05, P = 0.58). There were no significant differences in terms of baseline, angiographic, procedural indexes, and FFR of side branch (SB) between the 2 treatment arms. However, immediately after PCI, the patient with DK crush had higher FFR in the SB as compared to the provisional 1‐stent group (0.94 ± 0.03 vs. 0.90 ± 0.08, P = 0.028, respectively) and also they had lower diameter stenosis (8.59 ± 6.41% vs. 15.62 ± 11.69%, P = 0.015, respectively). Conclusion: In the acute phase, immediately after PCI for bifurcation lesion, DK crush stenting was associated with higher FFR and lower residual diameter stenosis in the SB, as compared with the provisional 1‐stent group. (J Interven Cardiol 2010;23:341–345)     

The Carina Angle—New Geometrical Parameter Associated with Periprocedural Side Branch Compromise and the Long‐Term Results in Coronary Bifurcation Lesions with Main Vessel Stenting Only

Background: The two main problems unresolved in coronary bifurcation stenting are periprocedural side branch compromise and higher restenosis at long term. The purpose of this study is to reveal the link between periprocedural side branch compromise and long‐term results after main vessel stenting only in coronary bifurcations. Methods: Eighty‐four patients formed the study population. The inclusion criteria were good‐quality angiograms, with maximal between‐branch angle opening, no overlap, permitting accurate angiographic analysis. Carina angle (α)—the distal angle between main vessel (MV) before bifurcation and side branch (SB)—was measured pre‐ and poststenting. Clinical follow‐up 9–12 months was obtained with coronary angiography if needed. Results: The patient population was high‐risk with 33% diabetics and 84% two‐ and three‐vessel disease. Ninety‐five stents were implanted in 92 lesions, with three T‐stenting cases. Drug‐eluting stents were implanted in 54%. Kissing‐balloon (KBI) or sequential inflation was performed in 35%. SB functional closure occurred in 17.4%, with independent predictors α < 40° and diameter ratio MB/SB >1.22. After 12±4 months there were five myocardial infarctions (6%) and 13 (15%) target lesion revascularization procedures. Independent predictors of major cardiovascular events were carina angle <40°, MB lesion length >8 mm, negative change of between‐branch angle, DES usage, and KBI. Conclusions: Smaller carina angle with straightening of MV—main branch from stent implantation in coronary bifurcations predicted higher SB compromise, restenosis, and MACE rates during follow‐up of 1 year.     

Drug eluting stenting in bifurcation coronary lesions long-term results applying a systematic treatment strategy

Objectives : To explore the long‐term results following implantation of drug‐eluting stents (DES) in bifurcation lesions according to contemporary “real world” practice. Background : Limited information is available on the long‐term outcomes of patients with bifurcation lesions who are treated using DES. A systematic approach for bifurcation lesion management was applied, using either a “provisional” single stent technique or a dedicated two stents strategy according to the side‐branch diameter and severity of its ostial stenosis. Methods : Four hundred one consecutive patients underwent bifurcation percutaneous coronary intervention (PCI) using DES and were included in our prospective registry. All adverse events were recorded up to 2 years and distinguished according to the planned PCI strategy (e.g., one versus two stents technique). Results : A planned two stents strategy was used in 141 patients (35% of patients). In 260 patients (65%), the planned treatment involved stenting of the main branch only with “provisional” stenting of the side‐branch according to procedural course. Thus, 24 patients (9.2%) needed additional stenting at the side‐branch to complete the PCI. Cumulative major adverse cardiac event rate at 1 and 2 years was similar for both groups (11.4% vs. 14.8% at 1 year and 19.4% vs. 25.7% at 2 years for the single vs. two stents groups, accordingly, P = NS for both). Likewise, there was no difference in mortality, cardiac mortality, myocardial infarction, need for target lesions or target vessel revascularization, or definite stent thrombosis rate between the two groups at 6, 12, and 2 years follow‐up. The rate of angiographically confirmed (i.e., definite) stent thrombosis did not differ between the two groups during follow‐up. Conclusions : Our study revealed favorable long‐term clinical results following DES implantation using a systematic, rather simplified approach towards bifurcation stenting and using either a single or double stenting technique. © 2011 Wiley Periodicals, Inc.     

A modified balloon crush approach improves side branch access and side branch stent apposition during crush stenting of coronary bifurcation lesions.

OBJECTIVES: Despite the advent of drug eluting stents and newer interventional techniques designed to treat the main vessel and side branch in bifurcation stenoses, optimal treatment of the side branch remains problematic. We aimed to assess the feasibility of a modified balloon crush technique for percutaneous treatment of coronary bifurcation stenoses. BACKGROUND: Use of the crush technique in bifurcation stenoses remains limited by access to the side branch after main vessel stent deployment, as well as limitations of side branch stent deployment. The modified balloon crush technique aims to improve side branch access and stent apposition. METHODS: The modified balloon crush is similar to the previously described balloon crush technique. Following side branch stent deployment, a balloon positioned in the main vessel is deployed to crush the proximal side branch stent. A guide wire is then placed into the side branch with a subsequent high-pressure balloon inflation at the side branch ostium. This opens the stent struts at the ostium of the side branch, facilitating future passage of the guide wire following main vessel stent deployment, prior to kissing balloon inflation. RESULTS: We performed this modification of the crush technique safely in 10 patients. We were successful in obtaining side branch access in nine of ten patients following initial main vessel stent deployment. In the only failure, there was a 90 degrees angle between the main vessel and side branch. CONCLUSIONS: The modified balloon crush technique can be safely performed, while optimizing side branch access and side branch stent apposition.     

In‐hospital and nine‐month outcomes among patients with coronary lesions involving a side branch and treated with bare metal stents

Background : The optimal management of coronary lesions involving side branches is not known. New devices are being developed for dedicated bifurcation stenting or improved side branch access or protection. Several of these devices are bare‐metal stent (BMS) platforms. The risk of side branch compromise and outcome after standard BMS is not known. Methods : We evaluated the frequency of side branch involvement and the rate of side branch compromise in a retrospective analysis of 1,440 patients from three pooled historical BMS clinical trials. The impact of side branch compromise on in‐hospital and nine‐month clinical outcomes was assessed. Results : Side branches >2 mm in diameter were present within the stented segment in 39% of treated lesions. Compromise of a side branch occurred in 27% of 1,440 lesions, including 22% of side branches that were not diseased prior to stenting. Compromise was associated with increased in‐hospital MI (13.5% vs. 7.6%, P = 0.001), a trend for increased nine‐month clinically driven target vessel revascularization (TVR, 17.4% vs. 13.2%, P = 0.058), and increased nine‐month target vessel failure (composite of cardiac death, target vessel MI or TVR, 29.7% vs. 20.2%, P < 0.001). Conclusion : At least moderate‐sized side branches are involved frequently in lesions enrolled in routine clinical trials. Unexpected compromise of these side branches is common and is associated with increased in‐hospital and nine‐month adverse outcomes. © 2010 Wiley‐Liss, Inc.     

Another tool for the fork‐in‐the‐road toolbox

• A provisional stent strategy for bifurcation disease is a good rule of thumb.
• The Tryton bifurcation stent is an additional potential useful tool for use in complex coronary disease.
• If and when this device has a drug‐eluting side branch, its true role may be clearer.

     

Drug‐eluting stents in bifurcation lesions: To stent one branch or both?

OBJECTIVES: The objective of this study was to compare two techniques to treat bifurcation lesions: a single drug-eluting stent (DES) implanted in the main branch combined with balloon dilatation for the side branch vs. stenting of both branches (double stent). BACKGROUND: Percutaneous coronary intervention in coronary bifurcation lesions remains challenging. Although DES reduce restenosis in lesions, the double stent procedure has not shown clear advantages over a single stent with balloon dilation. METHODS: Fifty-three symptomatic patients with true bifurcation lesions were treated using either the double stent technique (n = 25) or one stent in the parent vessel plus balloon angioplasty of the side branch (n = 28). Procedural results and major adverse cardiac event rates (MACE: cardiac death, myocardial infarction, target vessel revascularization (TVR)) were compared. RESULTS: Angiographic procedural success (residual stenosis <30% in both branches) was 75% in the single stent group and 100% in the double stent group (P = 0.01). All differences were due to residual stenosis of the side branch. Clinical follow-up (6-18 months) was available for all patients; 90.5% of patients had a coronary angiography or nuclear stress test. Three patients (11%) in the single stent group and two (8%) in the double stent group had ischemia-driven TVR (P = NS). Asymptomatic angiographic restenosis (>50% diameter stenosis) in the ostium of the side branch was seen in two patients in the double-stent group. At 6 months, MACE-free was comparable between groups (89.3% vs. 88%, P = 0.7). CONCLUSIONS: When treating bifurcation lesions with sirolimus-eluting stents, restenosis following a single stent procedure is comparable to stenting both parent and side branch vessels. Thus, stenting the main-branch lesion, coupled with balloon angioplasty in the side branch, produces a high success rate and good clinical outcomes at 6 months.     

Side Balloon Stenting of the Left Main Bifurcation: A Three‐Year Angiographic Follow‐Up

None of the currently used interventional techniques yield durable results for coronary bifurcation lesions. We successfully treated a patient with unprotected left main bifurcation disease using a side balloon stent technique with a drug‐eluting stent (DES). This technique produced excellent immediate and long‐term results.     

Provisional hybrid 2‐stent Strategy utilizing bioresorbable vascular scaffold and drug‐eluting metal stent: “T‐stenting and small protrusion” technique

We present a case of side‐branch restenosis after T‐stenting and small protrusion (TAP) technique using a bioresorbable vascular scaffold and a drug‐eluting metallic stent. According to intravascular ultrasound imaging findings, the simultaneous balloon deflation after kissing balloon post‐dilatation was the likely cause of restenosis. In cases where bifurcation treatment requires the TAP technique, operators should pay particular attention to perform kissing balloon inflation with sequential deflation (main branch first, side branch last). © 2015 Wiley Periodicals, Inc.     

First‐in‐Man Study of Dedicated Bifurcation Sirolimus‐eluting Stent: 12‐month Results of BiOSS LIM® Registry

Objectives

The aim was to assess the effectiveness and safety profile of a new dedicated bifurcation stent ‐ sirolimus‐eluting BiOSS LIM® (Balton, Poland) in 12‐month Registry.

Background

The optimal approach to coronary bifurcations treatment by percutaneous coronary intervention (PCI) has been still a subject of debate. Dedicated bifurcation stents are one of the proposed solutions.

Methods

This was the international, 3‐center registry, which enrolled patients with non‐ST‐elevation acute coronary syndrome (NSTE‐ACS) and stable angina. Provisional T‐stenting was the obligatory strategy of the treatment. Angiographic control was planned at 12 months. The primary endpoint was cumulative rate of death, myocardial infarction (MI) and target lesion revascularization (TLR) at 12 months.

Results

A total of 60 patients with coronary bifurcations were enrolled (mean age 66.4 ± 11 years, 28.3% of female). There were 21.7% of patients with NSTE‐ACS, 78.3% with hypertension, 38.3% with diabetes, 28.3% had previous MI, and 46.7% and 10% underwent prior revascularization, respectively, PCI and coronary artery bypass graft. The device success rate was 100%. Side branch was treated with an additional classical drug‐eluting stent implantation in 23.3% of cases. At 12 months, the cumulative major adverse cardiovascular events rate was 11.7%. During follow‐up (11 ± 1 months) there was 1 non‐cardiac death (1.7%), 1 non‐ST‐elevated myocardial infarction (1.7%) due to restenosis and no case of stroke or in‐stent thrombosis. Overall TLR was 8.3% (clinically driven TLR – 1.7%, angiographically driven – 6.6%). Mean late lumen loss was as follows: In main vessel – 0.35 ± 0.33 mm, in main branch – 0.34 ± 0.27 mm and in side branch – 0.18 ± 0.38 mm.

Conclusion

Dedicated bifurcation stent BiOSS® LIM proved to be feasible device, with promising safety and long‐term clinical effectiveness in the treatment of coronary bifurcation lesions, including distal left main stem stenosis. (J Interven Cardiol 2015;28:51–60)

     

Long‐Term Clinical Outcomes of the One‐Stent Technique versus the Two‐Stent Technique for Non‐Left Main True Coronary Bifurcation Disease in the Era of Drug‐Eluting Stents

Background

Few studies have compared the long‐term major adverse cardiac events (MACEs) between the one‐stent technique (stenting only the main branch) and the two‐stent technique (stenting of both the main and side branches) for the treatment of true coronary bifurcation lesions in the drug‐eluting stent era. Therefore, we investigated this issue using the large nationwide coronary bifurcation registry.

Methods

The 1,147 patients with non‐left main coronary true bifurcation lesions underwent percutaneous coronary intervention in the Korea Coronary Bifurcation Stent (COBIS) registry. All patients were stratified based on the stent placement technique: one stent (n = 898) versus two stents (n = 249). MACE, including death, nonfatal myocardial infarction (MI), and repeat vessel and lesion revascularization (TVR and TLR), were evaluated.

Results

The median follow‐up duration was 20 months. The MACEs did not differ between the 2 groups. Findings from the one‐stent group were similar to those of the two‐stent group in composite of death, MI, or TVR, based on analysis by crude, multivariate Cox hazard regression model, inverse‐probability‐of‐treatment weighting (hazard ratio [HR] 0.911, 95% confidence interval (CI) 0.614–1.351; HR 0.685 95% CI 0.381–1.232; HR 1.235, 95% CI 0.331–4.605, respectively). In further analysis with propensity score matching, the overall findings were consistent.

Conclusions

The findings of the present study indicate that the one‐stent technique was not inferior to the two‐stent technique for the treatment of non‐left main true coronary bifurcation lesions in terms of long‐term MACEs. (J Interven Cardiol 2013;26:245–253)

     

A modified provisional stenting approach to coronary bifurcation lesions: clinical application of the "jailed-balloon technique"

Objectives: To demonstrate the application of a novel provisional side branch (SB) stenting strategy for coronary bifurcation lesions using a “jailed‐balloon” technique (JBT). Background: Adverse cardiac events are higher for percutaneous coronary intervention (PCI) of bifurcation lesions. Recent studies support the use of provisional SB stenting, but a risk of SB closure and a higher rate of target lesion revascularization (TLR) remain important limitations. Methods: From December 2007 to August 2010, 100 patients with 102 bifurcation lesions underwent PCI using the JBT. Baseline and postprocedural quantitative coronary angiography (QCA) analysis were performed. Procedural and immediate clinical outcomes were reviewed. Results: The majority of patients presented with acute coronary syndrome (68%) and had Medina class 1,1,1 bifurcation lesions (91%). TIMI 3 flow was established in 100% of main branch and 99% of SB lesions. QCA revealed preservation of the bifurcation angle after PCI (pre‐PCI: 59.6 ± 30.0; post‐PCI: 63.3 ± 26.8, P = 0.41). Nine patients (9%) had lesions that required rewiring and two patients (2%) required provisional stenting of the SB. SB loss occurred in one patient (1%). The jailed‐balloon or wire was not entrapped during any PCI. One patient (1%) suffered a periprocedural myocardial infarction (MI). Conclusions: Provisional stenting of complex coronary bifurcation lesions using a JBT is associated with a high procedural success rate, improved SB patency, and a low rate of immediate cardiac events. Further study is warranted to evaluate the role of JBT in improving long‐term clinical outcomes in PCI of complex bifurcation lesions. (J Interven Cardiol 2012;25:289–296)     

A novel stenting technique for coronary artery bifurcation stenosis

A novel stenting technique, using one stent strategy, designed to treat type Medina 1,0,0 coronary bifurcation lesions, is described. The atherosclerotic plaque burden in this category of bifurcation lesions is located in the proximal segment of the main branch (MB) of a coronary bifurcation in which the side branch has a sharp angulation (T‐ or reverse‐shaped) relative to the MB. The advantages of this technique are the accurate placement of the stent tailored to cover solely the bifurcation lesion, shoving the plaque burden away from the side branch ostium during stent expansion and the ability to maintain guide wire access in the branch at highest risk of occlusion obviating the need for more cumbersome and time consuming percutaneous coronary intervention procedure. © 2009 Wiley‐Liss, Inc.     

Expanding the armamentarium for the treatment of left main disease

• The BiOSS LIM stent is a dedicated device for the treatment of bifurcation lesions that present a proximal and distal part with two different diameters and a middle zone with two connecting struts facilitating side branch rewiring.
• In this study, after implanting the BiOSS LIM stent in the left main, rewiring to the side branch was easier compared to standard metallic stent.
• The device may be very useful in the treatment of bifurcation lesions for provisional stenting strategies or for two‐stent strategies such as T‐stenting or T‐and‐Protruding (TAP).

     

Long-term outcomes of sirolimus-eluting stents vs. paclitaxel-eluting stents in unprotected left main coronary artery bifurcation lesions

Background:

The treatment of unprotected left main coronary artery (uLMCA) bifurcation lesions remains challenging.

Hypothesis:

We hypothesized that the type of drug‐eluting stent would correlate with clinical outcomes for the treatment of uLMCA bifurcation lesions.

Methods:

One hundred fifteen patients who underwent stent implantation using a provisional T‐stenting technique with sirolimus‐eluting stents (SES) or paclitaxel‐eluting stents (PES) for uLMCA bifurcation lesions were enrolled. A major adverse cardiac event (MACE) was defined as a composite of cardiac death, myocardial infarction, or target lesion revascularization.

Results:

Ninety‐four patients were treated with SES and 21 patients with PES. Baseline characteristics were similar between the 2 groups. Angiographic follow‐up was performed in 99 (86%) patients. Late loss in the LMCA to the left anterior descending coronary artery was significantly lower in the SES group than in the PES group (0.28 ± 0.54 mm vs 1.03 ± 0.45 mm, P<0.001). One case of stent thrombosis occurred in the SES group. During follow‐up with a median of 712 days, the SES group had a lower MACE compared with the PES group (10.6% vs 28.6%, P = 0.032). Cox proportional hazards models including age, sex, diabetes, acute coronary syndrome, true bifurcation, stenting strategy, and type of drug‐eluting stent used (SES vs PES) demonstrated that stent type was the only predictor of MACE (hazard ratio of PES vs SES: 3.88, 95% confidence interval: 1.29–11.67, P = 0.016).

Conclusions:

According to the results of the present study, SES may be associated with more favorable outcomes than PES for stenting of uLMCA bifurcation, which should be further studied by larger trials. © 2011 Wiley Periodicals, Inc. The authors have no funding, financial relationships, or conflicts of interest to disclose.