Percutaneous coronary angioplasty of a bifurcation lesion in the Y saphenous vein graft

BackgroundThe use of Y-shaped aorto-coronary saphenous vein grafts is most commonly driven by efforts to replace the poor quality (length) of the vein grafts or to minimise manipulation of the atheromatous ascending aorta (Jarvis [1]). We found only a few case reports describing PCI of bifurcation lesions in vein grafts in the available scientific literature (Karalis [2], Prosser and Bailey [3], Chan et al. [4]).MethodWe present two case reports of patients with bifurcation lesions in Y saphenous vein grafts. In case No. 1, implantation of a dedicated bifurcation stent Tryton (4.0/3.5×18 mm) and DES Promus Element (4.0×20 mm) was used to treat the Y-graft bifurcation lesion. In case No. 2, due to satisfying result of side branch stenosis predilation, the bifurcation lesion was treated by a drug-eluting balloon catheter SeQuent Please (4.0×15 mm) and only a short stent (Liberte 4.0×8 mm) was implanted in the proximal residual stenosis of the main branch.ResultsIn both cases satisfying periprocedural angiographic results with final TIMI flow 3 were achieved. During the 12-month follow-up no MACE (CV death, AMI, TVR) has been recorded and both patients were without residual angina pectoris. Persistent satisfying angiographic results were confirmed on MS-CT coronarography.ConclusionPCI of the bifurcation lesions in the vein grafts is a rare but complicated condition. In our two case reports we demonstrated that the use of a dedicated bifurcation Tryton Side Branch Stent, as well as the SeQuent Please paclitaxel coated balloon catheter for PCI of the bifurcation lesions in Y vein grafts, is technically feasible with satisfactory long-term results.     

Clinical outcome of patients with de novo coronary bifurcation lesions treated with the Tryton Side Branch Stent. The SAFE-TRY prospective multicenter single arm study

Background

Coronary bifurcation lesions represent a difficult problem regularly confronting interventional cardiologist, in part due to the lack of dedicated device.

Objective

To investigate the feasibility, safety and effectiveness of the Tryton™ Side Branch Stent (Tryton Medical, Durham, NC, USA), a dedicated bare metal stent deployed in conjunction with a standard drug-eluting stent to treat bifurcation lesions.

Methods

The SAFE-TRY is a prospective single arm multicenter registry including patients with de novo bifurcation lesions in native coronary arteries and syntax score < 32. The primary endpoint was target vessel failure (TVF) at 30 days that comprised cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularization. Secondary endpoints included device, angiographic and procedural success, 9-month major adverse cardiac and cerebrovascular event (MACCE), and stent thrombosis (ST) rates (ClinicalTrials.gov identifier: NCT01174433).

Results

Among 252 enrolled patients, 24% had diabetes and 35.3% unstable angina. True bifurcation lesions involving both branches occurred in 96.8% of cases with Medina classification 1.1.1 in 62%. The left anterior descending artery and the left main were treated in 70% and 8.3% of the patients, respectively. A 6 Fr guide catheter was used in 61% of the cases. Device, angiographic and procedural success rates were 99.6%, 99.6% and 97.2% respectively. The 30-day TVF was 2.8%; the 9-month MACCE rate was 13.7%, with target lesion revascularization being 4.4%. No definite ST occurred.

Conclusions

This prospective, multicenter study confirmed the feasibility, safety and effectiveness of the Tryton Side Branch Stent to treat patients with de novo complex bifurcation lesions.     

应用双药物洗脱支架治疗分叉病变的近期临床疗效

目的探讨应用双药物洗脱支架（DES）治疗分叉病变的临床近期疗效。方法自2003年10月至2005年2月入选应用双DES治疗分叉病变患者71例,72处病变。分叉病变的类型为前降支／对角支45例（62．5％）,左冠状动脉主干分叉病变20例（27．8％）,回旋支／钝缘支6例,右冠状动脉远端分又病变1例。72处分叉病变中采用Crush技术42处,包括标准Crush技术16处和改良Crush26处;“T”型支架置入19处;改良“Y”型支架置入5处;“V”型支架置入3处和Culotte技术3处。结果入选71例患者中男性59例（83．1％）,女性12例,平均年龄57岁。72处分叉病变中（144处病变）使用Cypher或Cypher Select DES 59个,TAXUS DES48个,Firebird DES 25个和金属裸支架24个。72处分叉病变置入双支架后60处（83．3％）完成了对吻球囊扩张技术。手术成功率为100％。住院期间1例发生亚急性血栓致急性心肌梗死（AMI）,再次经皮冠状动脉介入治疗成功。住院期间主要心脏不良事件（MACE,包括死亡、AMI、再次血管重建）发生率为1．4％（1／71）。71例中16例完成了6个月的临床随访,无死亡和AMI发生,1例6个月时冠状动脉造影显示对角支口部完全闭塞,随访期间MACE发生率为6．3％（1／16）。结论本研究结果显示对于分支口径〉2．5mm且口部有严重狭窄性病变的分叉病变,采用双DES治疗是安全的,近期临床疗效十分满意,远期临床疗效初步显示也是满意的,但仍有待进一步证实。     

Titanium-nitride-oxIde-coated stents multicenter registry in diaBEtic patienTs: the TIBET registry

We sought to explore the immediate clinical and angiographic results of the Titan^? stent implantation in diabetic patients, as well as the major adverse cardiac events (MACE) at 6-month follow-up. We enrolled 156 consecutive diabetic patients admitted to undergo percutaneous intervention for at least one significant (50%) coronary lesion. All lesions were treated with the Titan^? stent implantation according to the contemporary interventional techniques. Patients were prospectively followed-up for at least 6?months. The primary endpoint was MACE at 6-month follow-up [cardiac death, myocardial infarction (MI), or target lesion revascularization (TLR)]. Secondary endpoints included angiographic and clinical procedural success, in-hospital MACE, TLR at 6-month follow-up, and stent thrombosis. The mean age was 66.7?±?9.6?years, (68.4% males). A total of 197 Titan^? stents were implanted in 163 lesions. Direct stenting was performed in 45.2% of the cases. The mean stent diameter was 3.1?±?0.61?mm, and the mean length was 18.0?±?8.9?mm. Average stent deployment pressure was 13.9?±?4.2 bars. Angiographic procedural success was achieved in 154 (98.7%) cases, and clinical procedural success was achieved in 153 (98.1%) cases. One patient developed in-hospital non-Q-wave MI following the procedure. Clinical follow-up was completed in 155 (99.4%) patients. Three patients (1.9%) died of a cardiac or unknown cause, and two (1.3%) developed MI. TLR was performed in 11 patients (7.1%). Cumulative MACE at 6-month follow-up occurred in 16 (10.3%) patients. No patient suffered stent thrombosis. Titan^? stent implantation in diabetic patients achieves an excellent immediate clinical and angiographic outcome, with a low incidence of MACE at mid-term follow-up.     

Predictors of restenosis after treatment of bifurcational lesions with paclitaxel eluting stents: a multicenter prospective registry of 150 consecutive patients.

OBJECTIVES: The aim of the study was the assessment of the clinical, angiographic and procedural characteristics correlated with freedom from adverse events at 1 year in a real life setting of consecutive bifurcation lesions. BACKGROUND: Even if stent implantation has shown to be superior to conventional balloon angioplasty in most coronary lesions, bifurcation treatment with stent implantation both in main and in side branch (SB) still raises controversy. METHODS: We reviewed the results obtained in a prospective multicenter registry of 150 patients with 158 bifurcation lesions involving a SB of sufficient diameter to be treated, if necessary, with a polymer based paclitaxel eluting stent (PES, TAXUS). Two stents were used in 118 lesions (74.7%). Final kissing balloon inflation was performed in 87/118 lesions (73.7%) and in 30/40 lesions (75.0%) of the 2 and 1 stent group respectively. RESULTS: At 1-year clinical follow-up we observed 4 stent thromboses, all involving the SBs of the 2 stents group (2.7%). Unlike previous reports, revascularization involved the main vessel in the majority of patients (21/150, 14.0%). After an exploratory multivariable analysis the only parameter predictive of target lesion revascularization (TLR) (HR 0.52; CI 95% 0.11-0.86; p = 0.02) and target vessel revascularization (TVR) (HR 0.47; CI 95% 0.14-0.90; p = 0.03) was postprocedural main branch minimal lumen diameter (MB-MLD). CONCLUSIONS: In a real life setting of consecutive bifurcation lesions, thrombosis rate, concentrated in the SB and the 2-stents group, and need for target lesion revascularization remain higher than in less complex lesion subgroups treated with PES. No differences in immediate success and TLR were observed between 2 stents and 1 stent groups. The frequently observed suboptimal stent expansion and final MB-MLD predict 1 year revascularization.     

Comparable clinical outcomes with paclitaxel- and sirolimus-eluting stents in unrestricted contemporary practice.

OBJECTIVES: This study was designed to compare the outcomes of paclitaxel-eluting stents (PES) and sirolimus-eluting stents (SES) in a contemporaneous cohort of real-world patients. BACKGROUND: A number of randomized comparisons of PES and SES have shown unequivocal advantages for SES in angiographic end points such as late loss. However, the data on clinical outcomes are less consistent. METHODS: All consecutive patients successfully treated with only SES or PES in de novo native vessel lesions between March 2003 and March 2005 were analyzed. Our end points were major adverse cardiac events (MACE), a composite of death, myocardial infarction (MI), target vessel revascularization (TVR), and target lesion revascularization (TLR). We also analyzed late loss and angiographic restenosis. RESULTS: There were 609 patients (1,064 lesions) treated with PES and 674 patients (1,205 lesions) treated with SES. Diabetes mellitus was present in 26.8% of patients and multivessel disease in 75% of patients. Bifurcations made up 16.3% of lesions, chronic occlusions 9.5%, left main 4.8%, and American Heart Association/American College of Cardiology type B2/C 75.4%. Despite a higher late loss in the PES group (p = 0.0001), there were no differences in angiographic restenosis (PES 18% vs. SES 17.8%, p = 0.95), TLR (PES 11.9% vs. SES 11%, p = 0.47), or MACE (PES 21.3% vs. SES 21.1%, p = 0.95). The relative risk of MACE for the PES group was 1.02 (95% confidence interval [CI] 0.78 to 1.33). Multivariable analysis confirmed the lack of association of stent type with MACE (odds ratio 1.03 [95% CI 0.77 to 1.38], p = 0.83) and TLR (odds ratio 1.08 [95% CI 0.81 to 1.44], p = 0.61). CONCLUSIONS: In this complex cohort, both stent platforms demonstrated similar clinical outcomes despite different late loss.     

雷帕霉素涂层支架治疗老年人冠心病的疗效及再狭窄的随访分析

目的 观察雷帕霉素涂层冠状动脉Cypher支架治疗老年冠心病患者的临床疗效及再狭窄情况。方法 2002年11月至2005年5月在我院心导管室接受Cypher支架治疗的328例60岁以上的老年冠心病患者，观察术后即刻效果，随访6个月记录心脏性死亡、心肌梗死、再次血管重建事件，并进行冠状动脉造影复查。328例中，ST段抬高的急性心肌梗死66例，非ST段抬高的急性心肌梗死21例，不稳定心绞痛149例，稳定型心绞痛92例。结果 支架植入成功率99．1％（325／328），住院期间无死亡。随访6个月出现急性和亚急性血栓各1例，晚期血栓致心肌梗死2例，心力衰竭死亡1例，进行血管重建术7例。住院其间主要心脏不良事件发生率0．6％（2／328），6个月心脏不良事件发生率3．7％（12／328）。术后6个月84例患者冠状动脉造影复查显示，再狭窄率为8．3％（7／84），支架内为2．4％（2／84），靶病变重建率为5．9％（5／84）。结论 应用Cypher支架治疗老年人冠心病是安全和有效的，主要心脏不良事件发生率低，支架内再狭窄率和靶病变重建率明显低于普通金属支架。     

Six‐month clinical follow‐up of the tryton side branch stent for the treatment of bifurcation lesions

Background: Treatment of bifurcation lesions with the Tryton Sidebranch stent has been shown to be feasible with an acceptable clinical outcome and low side branch late loss in the first in man trial. Objective: To report acute procedural and six month clinical follow‐up after the use of the Tryton Sidebranch stent in an “all comer” registry. Methods: The first 100 coronary bifurcation lesions assigned for treatment with the Tryton stent were included in a prospective registry. Procedural and angiographic success rates were determined from patient charts and pre‐ and postprocedural quantitative coronary angiography. Results: Totally, 96 patients with 100 lesions were included in the study. Seventy‐two percent presented with stable angina, 25% with unstable angina/NSTEMI, and 3% STEMI. The bifurcation was located in the left main in 8%. Two lesions were chronic total occlusions. Sixty‐nine percent were true bifurcation lesions. One failure of stent delivery occurred. Acute gain in SB was 0.76 ± 0.64mm and three patients had residual stenosis of >30%. Angiographic success rate was 95%; procedural success rate reached 94%. Peri‐procedural MI occurred in two and there was one cardiac death during hospitalization. At a median six months follow‐up, TLR rate was 4%, MI 3%, and cardiac death 1%. The percentage MACE‐free survival at six months was 94%. No cases of definite stent thrombosis occurred. Conclusions: In a real world the use of the Tryton Sidebranch stent is associated with good procedural safety and angiographic success rate and acceptable outcome at six months of follow‐up. © 2011 Wiley‐Liss, Inc.     

Cypher~(TM)支架治疗冠心病的疗效观察

目的评价雷帕霉素洗脱冠状动脉支架(CypherTM)应用于冠心病的临床疗效及再狭窄情况。方法选择接受CypherTM支架治疗的348例冠心病患者,观察术后即刻效果、术后6个月心脏性死亡、心肌梗死、再次血管重建及冠状动脉造影复查情况。病例中包括ST段抬高的急性心肌梗死86例,非ST段抬高的急性心肌梗死21例,不稳定型心绞痛149例,稳定型心绞痛92例。结果支架植入成功率99.3%,住院期间无死亡,术后出现急性和亚急性血栓各1例,1例晚期血栓致心肌梗死,1例心衰死亡,另有5例随访中进行了血管重建术,术后6个月主要心脏不良事件发生率2.9%。术后6个月56例冠状动脉造影复查的再狭窄率为7.1%(支架内为1.8%),支架内平均晚期管腔丢失为0.16mm(病变段内为0.20mm),靶病变重建率为5.4%。结论应用CypherTM支架治疗冠心病是安全和有效的,主要心脏不良事件发生率低,支架内再狭窄率和靶病变重建率明显低于普通金属支架。     

Randomized Comparisons Between Different Stenting Approaches for Bifurcation Coronary Lesions With or Without Side Branch Stenosis

ObjectivesThis study sought to evaluate the optimal percutaneous coronary intervention techniques using drug-eluting stents for bifurcation coronary lesions.BackgroundThe optimal bifurcation stenting technique needs to be evaluated.MethodsThe trial included 2 randomization studies separated by the presence of side branch (SB) stenosis for patients having non–left main bifurcation lesions. For 306 patients without SB stenosis, the routine final kissing balloon or leave-alone approaches were compared. Another randomization study compared the crush or single-stent approaches for 419 patients with SB stenosis.ResultsBetween the routine final kissing balloon and leave-alone groups for nondiseased SB lesions, angiographic restenosis occurred in 17.9% versus 9.3% (p = 0.064), comprising 15.1% versus 3.7% for the main branch (p = 0.004) and 2.8% versus 5.6% for the SB (p = 0.50) from 214 patients (69.9%) receiving 8-month angiographic follow-up. Incidence of major adverse cardiac events including death, myocardial infarction, or target vessel revascularization over 1 year was 14.0% versus 11.6% between the routine final kissing balloon and leave-alone groups (p = 0.57). In another randomization study for diseased SB lesions, 28.2% in the single-stent group received SB stents. From 300 patients (71.6%) receiving angiographic follow-up, between the crush and single-stent groups, angiographic restenosis rate was 8.4% versus 11.0% (p = 0.44), comprising 5.2% versus 4.8% for the main branch (p = 0.90) and 3.9% versus 8.3% for the SB (p = 0.12). One-year major adverse cardiac events rate between the crush and single-stent groups was 17.9% versus 18.5% (p = 0.84).ConclusionsAngiographic and clinical outcomes were excellent after percutaneous coronary intervention using drug-eluting stents with any stent technique for non–left main bifurcation lesions once the procedure was performed successfully.     

Evaluation of long stent implantation in diffuse coronary lesions for octogenarians

Objective To evaluate angiographic and clinical outcomes of≥20mm long stents or overlapped stent implantation in diffuse coronary lesions for octogenarians, in comparison with patients under sixty. Methods Two groups (Group O: 47 lesions in 44 octogenarians, aged 81±3 years; Group Y: 64 lesions in 58 patients under sixty, aged 54±4 years) were compared with a 6-month follow-up. Results Success rate of the procedures was 100%. None had in-hospital major adverse cardiac events (MACE). There was no significant difference in angiographic restenosis between the groups at follow-up (Group O vs Group Y, 29.8% vs 26.6% , P = NS) . The revascularization of target vessel and MACE was less in Group Y, but these showed no statistical significance (15.6% vs 23.4% and 20.7% vs 25.0%, respectively). Conclusions Long stent implantation for diffuse coronary lesions in octogenarians appears safe and feasible, with high procedural success and favorable long-term outcomes. (J Geriatr Cardiol 2005;2( 1):29-35).     

The Frontier stent registry: safety and feasibility of a novel dedicated stent for the treatment of bifurcation coronary artery lesions

OBJECTIVES: The goal of this study was to evaluate the safety and performance of the Multi-Link Frontier coronary bifurcation stent system (Guidant Corp., Santa Clara, California), a novel dedicated device designed for permanent side branch (SB) access, stent delivery by simultaneous kissing balloon inflation, and optimal main branch (MB) and SB ostium scaffolding. BACKGROUND: The treatment of coronary bifurcation lesions remains challenging, and various approaches using stents have been proposed. METHODS: The primary end point was the 180-day incidence of major adverse cardiac events (MACE) per intent-to-treat analysis. Secondary end points included device success, 30-day MACE, angiographic restenosis, and target lesion revascularization (TLR) rates at 180 days. RESULTS: After a learning phase of two cases per center, 105 patients were prospectively included in 11 centers. The left anterior descending coronary artery/diagonal bifurcation was the target in 80% of cases. The Frontier stent was successfully implanted in 96 patients (91%), and procedural success was obtained in 93%. Two patients suffered in-hospital myocardial infarction (MI) secondary to SB occlusion, and one patient underwent elective coronary artery bypass grafting. At 30 days and 6 months, the MACE rates were 2.9% and 17.1% (no death, no subacute stent thrombosis, Q-wave MI 1.0% and 1.9%, non-Q-wave MI 1.0% and 1.9%, TLR 1.0% and 13.3%). The MB in-stent restenosis was 25.3%, in-segment 29.9%. The SB restenosis was 29.1%. The overall restenosis rate for any branch was 44.8%. CONCLUSIONS: The results of this Frontier registry demonstrate the safety and performance of this dedicated stent system for the treatment of bifurcation lesions. The device can be successfully implanted in more than 90% of all cases, with a high procedural success rate and low 30-day and 6-month MACE rates.     

Impact of the Complexity of Bifurcation Lesions Treated With Drug-Eluting Stents: The DEFINITION Study (Definitions and impact of complEx biFurcation lesIons on clinical outcomes after percutaNeous coronary IntervenTIOn using drug-eluting steNts)

ObjectivesThe present study established criteria to differentiate simple from complex bifurcation lesions and compared 1-year outcomes stratified by lesion complexity after provisional stenting (PS) and 2-stent techniques using drug-eluting stents.BackgroundCurrently, no criterion can distinguish between simple and complex coronary bifurcation lesions. Comparisons of PS and 2-stent strategies stratified by lesion complexity have also not been reported previously.MethodsCriteria of bifurcation complexity in 1,500 patients were externally tested in another 3,660 true bifurcation lesions after placement of drug-eluting stents. The primary endpoint was the occurrence of a major adverse cardiac event (MACE) at 12 months. The secondary endpoint was the rate of stent thrombosis (ST).ResultsComplex (n = 1,108) bifurcation lesions were associated with a higher 1-year rate of MACE (16.8%) compared with simple (n = 2,552) bifurcation lesions (8.9%) (p < 0.001). The in-hospital ST and 1-year target lesion revascularization rates after 2-stent techniques in the simple group (1.0% and 5.6%, respectively) were significantly different from those after PS (0.2% [p = 0.007] and 3.2% [p = 0.009], respectively); however, 1-year MACE rates were not significantly different between the 2 groups. For complex bifurcation lesions, 2-stent techniques had lower rates of 1-year cardiac death (2.8%) and in-hospital MACE (5.0%) compared with PS (5.3%, p = 0.047; 8.4%, p = 0.031).ConclusionsComplex bifurcation lesions had higher rates of 1-year MACE and ST. The 2-stent and PS techniques were overall equivalent in 1-year MACE. However, 2-stent techniques for complex lesions elicited a lower rate of cardiac death and in-hospital MACE but higher rates of in-hospital ST and revascularization at 1 year for simple lesions.     

Inter–Core Lab Variability in Analyzing Quantitative Coronary Angiography for Bifurcation Lesions: A Post-Hoc Analysis of a Randomized Trial

ObjectivesThis study sought to evaluate inter–core lab variability in quantitative coronary angiography (QCA) analysis of bifurcation lesions.BackgroundQCA of bifurcation lesions is challenging. To date there are no data available on the inter–core lab variability of bifurcation QCA analysis.MethodsThe randomized Tryton IDE (Tryton Pivotal IDE Coronary Bifurcation Trial) compared the Tryton Side Branch Stent (Tryton Medical, Durham, North Carolina) with balloon angioplasty as side branch treatment. QCA was performed in an angiographic subcohort (n = 326) at 9-month follow-up. Inter-core lab variability of QCA analysis between the Cardiovascular Research Foundation and the Cardialysis core labs was evaluated before and after alignment of the used QCA methodology using angiographic data derived from this angiographic follow-up cohort.ResultsIn the original analysis, before alignment of QCA methodology, the mean difference between the core labs (bias) was large for all QCA parameters with wide 95% limits of agreement (1.96 × SD of the bias), indicating marked variability. The bias of the key angiographic endpoint of the Tryton trial, in-segment percentage diameter stenosis (%DS) of the side branch, was 5.5% (95% limits of agreement: –26.7% to 37.8%). After reanalysis, the bias of the in-segment %DS of the side branch reduced to 1.8% (95% limits of agreement: –16.7% to 20.4%). Importantly, after alignment of the 2 core labs, there was no longer a difference between both treatment groups (%DS of the side branch: treatment group A vs. group B: 34.4 ± 19.4% vs. 32.4 ± 16.1%, p = 0.340).ConclusionsOriginally, a marked inter–core lab variability of bifurcation QCA analysis was found. After alignment of methodology, inter–core lab variability decreased considerably and impacted angiographic trial results. This latter finding emphasizes the importance of using the same methodology among different core labs worldwide. (Tryton Pivotal 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)     

The angiographic and clinical outcomes after coronary stenting in patients with metabolic syndrome

BackgroundMetabolic syndrome (MetS) is regarded as a risk factor for coronary artery disease (CAD). But the influence of MetS on morbidity and mortality after stent implantation in CAD patients remains unknown.MethodsThis article presents a meta-analysis of available data on the association between the MetS and the risk of angiographic and clinical outcomes following stent implantation.ResultsMetS was associated with a significant increased risk of post-stent all-cause mortality (odd ratio (OR), 2.17, 95% CI, 1.56–3.01), in-lesion restenosis (OR, 1.35, 95% CI, 1.00–1.84) and major adverse cardiac events (MACE) (OR 1.35, 95% CI 1.13–1.61) in CAD patients. Even with drug-eluting stent (DES) implantation, significant increased risk in all-cause mortality (OR, 2.25, 95% CI, 1.61–3.15) and MACE (OR 1.42, 95% CI 1.14–1.76) were remain in patients with MetS. However, the OR of cardiovascular (CV) mortality (1.25, 95% CI 0.71–2.22), MI (1.27, 95% CI 0.87–1.85) and TLR (OR 1.21, 95% CI 0.96–1.53) was not statistically different between the patients with and without metabolic syndrome.ConclusionsMetabolic syndrome is an important risk factor in patients with CAD following stent implantation. Although DES implantation decreased the incidence of angiographic events, further progress in adequate treatment of MetS is still required to improve the clinical outcome.     

Percutaneous coronary intervention of unprotected left main disease: Five-year outcome of a single-center registry

Introduction and AimsPercutaneous coronary intervention (PCI) is increasingly used as a treatment option for unprotected left main coronary artery (ULMCA) lesions. We aimed to evaluate the long-term outcome of patients undergoing ULMCA PCI.Methods and ResultsWe retrospectively analyzed 95 consecutive patients (median EuroSCORE I 2.9 [IQR 1.4;6.1]) who underwent ULMCA PCI between 1999 and 2006, included in a single-center prospective registry. The primary outcome was major adverse cardiovascular events (MACE) defined as all-cause death, myocardial infarction (MI) and target lesion revascularization (TLR) at five years. Forty patients (42.1%) were treated in the setting of acute coronary syndrome and 81 patients (85%) had at least one additional significant lesion (SYNTAX score 24.2±11.8). Single ULMCA PCI was performed in 33% (81.1% with drug-eluting stents) and complete functional revascularization was achieved in 79% of the patients. During the observation period, 20 patients died (21.1%), 6 (6.3%) had MI and 11 (11.6%) had TLR (total combined MACE 28.4%). Independent predictors of MACE were previous MI (HR 2.9 95% CI 1.23–6.92; p=0.015), hypertension (HR 5.7 95% CI 1.86–17.47; p=0.002) and the EuroSCORE I (HR 1.1 95% CI 1.03–1.12; p=0.001). Drug-eluting stent implantation was associated with a significantly lower MACE rate, even after propensity score adjustment (AUC=0.84; HR [corrected] 0.1; 95% CI 0.04–0.26; p<0.001).ConclusionsUnprotected left main percutaneous coronary intervention, particularly using drug-eluting stents, can be considered a valid alternative to coronary artery bypass grafting, especially in high-risk surgical patients and with favorable anatomic features.     

应用双药物洗脱支架治疗分叉病变的近远期临床疗效

目的探讨应用双药物洗脱支架（DES）治疗分叉病变的临床疗效。方法选择分支开口有严重狭窄且分支口径≥2．50mm的分叉病变患者为本研究的入选对象。2003年10月至2005年6月共入选应用双DES治疗分叉病变的患者112例,113处病变。分叉病变的类型为前降支／对角支62例（54．9％）,左冠状动脉主干分叉病变32例（28．3％）,回旋支／钝缘支18例（15．9％）,右冠状动脉远端分叉病变1例。113处分叉病变中采用Crush技术64处,“T”型支架置入27处;改良“Y”型支架置入11处;对吻支架置入5处;“V”型支架置入和Culotte技术置入各3处。结果入选112例患者113处分叉病变中（226处病变）使用Cypher或Cypher select DES 91个,TAXUS DES 74个,Firebird DES 67个。64处分叉病变采用Crush技术置入双支架后60处（93．7％）完成了最后的对吻球囊扩张技术。手术成功率为100％。住院期间1例发生亚急性血栓致急性心肌梗死（AMI）,再次介入治疗成功。住院期间心脏事件发生率（MACE,包括死亡、AMI、再次血管重建）为0．89％（1／112）。112例均完成了9个月的临床随访,无死亡发生,1例发生AMI由晚期血栓形成所致。48例完成了9个月的冠状动脉造影随访（42．9％）,8例发生了支架内再狭窄,其中1例进行了冠状动脉旁路移植术,5例再次行介入治疗,总再狭窄发生率为16．7％（8／48）。随访期间MACE发生率为8．04％（9／112）。结论本研究结果显示对于分支口径≥2．5mm且口部有严重狭窄性病变的分叉病变,采用双DES治疗是安全的,近、远期临床疗效是满意的。与Cypher DES相比较,TAXUS DES的再狭窄发生率有增加的趋势。     

A randomized comparison of balloon angioplasty and stent implantation in the percutaneous treatment of coronary bifurcations

OBJECTIVE: A prospective randomized multicentre pilot trial, comparing stenting with balloon angioplasty as a treatment for coronary lesions, located in a bifurcation was performed. METHODS AND RESULTS: After balloon dilatation, with a < 30% residual stenosis in the main vessel and < 50% residual stenosis in the side branch, patients were randomized to stay in a "balloon-only" group or to stenting. The stents used were the AVE S 670 for the main vessel and the Bestent, if needed, for the side branch. The primary end point was the incidence of major adverse cardiac events (MACE) at 6 months, secondary end points were in-hospital MACE, acute angiographic results, use of materials and duration of the procedure. One hundred eleven patients were randomized: 55 in the balloon group, 56 in the stent group. No differences in MACE-rates were found at 6 months (22% versus 20%, p = 0.78). The target vessel revascularization rate was 16% in the balloon group and 12.5% in the stent group (p = 0.56). The acute angiographic results were significantly better in the stent group (residual stenosis 8% versus 26% [p < 0.05]). More materials were used, with a near doubling of the duration of the procedure in the stent group (p < 0.05). CONCLUSIONS: Although stenting resulted in better immediate angiographic results during percutaneous treatment of lesions located in a bifurcation, as compared to balloon angioplasty alone, clinical events were comparable in the two treatment arms.     

Immediate and mid-term outcomes of sirolimus-eluting stent implantation for chronic total occlusions.

AIMS: To evaluate the outcomes of sirolimus-eluting stent (SES) implantation for the treatment of chronic total occlusion (CTO). METHODS AND RESULTS: We identified 122 patients who underwent revascularization in CTO lesions with SES from April 2002 to April 2004 (SES group). A control group was composed of 259 consecutive patients with CTO lesions treated with bare metal stents (BMS) in the 24 months immediately before the introduction of SES (BMS group). At 6-month follow-up, the cumulative rate of major adverse cardiac events (MACE) was 16.4% in the SES group and 35.1% in the BMS group (P<0.001). The incidence of restenosis was 9.2% in the SES group and 33.3% in the BMS group (P<0.001). The need for revascularization in the SES group was significantly lower, both target lesion revascularization (7.4 vs. 26.3%, P<0.001) and target vessel revascularization (9.0 vs. 29.0%, P<0.001). BMS implantation (HR: 2.97; 95% CI: 1.80-4.89; P<0.001), lesion length (>20 mm) (HR: 2.02; 95% CI: 1.37-2.99; P=0.0004), and baseline reference vessel diameter (>2.8 mm) (HR: 0.62; 95% CI: 0.42-0.92; P=0.02) were identified as predictors of MACE during 6-month follow-up. CONCLUSION: Compared with BMS, SES implantation in CTO lesions appears to be effective in reducing the incidence of restenosis and the need for revascularization at 6 months.     

Angiographic and Clinical Outcomes after Implantation of Drug Eluting Stents in Bifurcation Lesions with Crush or Kissing Stent Technique

Background

Long‐term outcome after bifurcation stenting with drug‐eluting stents (DES) for obstructive coronary artery disease is poorly understood. In this study, we report 6–9‐month angiographic follow‐up and long‐term clinical outcomes after implantation of drug‐eluting stents by crush and kissing stent technique for coronary bifurcation lesions.

Methods

Consecutive patients undergoing bifurcation stenting with DES by crush or kissing stent technique were enrolled in a prospective registry. Angiographic follow‐up was obtained at 6–9 months and clinical follow‐up completed for a median of 38 months.

Results

A total of 86 patients participated in the study. Bifurcation stenting by crush technique was performed in 73 (85%) and by kissing stent in 13 (15%) patients. Stenting of left main bifurcation was applied in 24 (28%) patients. Angiographic follow‐up was completed in 75 (87%) patients and showed restenosis in the main for 8 (11%) and side branch for 20 (27%) patients. Clinical follow‐up was available for a median duration of 38 months. During follow‐up, 2 (2%) patients died, 4 (5%) experienced myocardial infarction (MI), and 11 (13%) underwent target vessel revascularization (TVR) with an overall major adverse cardiac event (MACE) rate of 16%. In left main cohort, angiographic restenosis occurred in 9 (37%) patients, and 3 (12%) patients required TVR. There were no deaths or stent thrombosis. A comparison of crush and kissing stent technique showed significantly higher angiographic restenosis with crush (26% vs 13% in kissing stent patients, P = 0.046) and 95% of restenosis in crush group involved ostium of the side branch. There was no difference in clinical outcomes between the crush and kissing stent groups. Final kissing balloon dilatation (FKB) was successful in 65 (89%) patients in the crush group and associated with a significant reduction in MACE (8% in FKB successful vs 37% in FKB unsuccessful, P = 0.04) during follow‐up.

Conclusion

Bifurcation stenting with crush or kissing stent technique is safe and associated with a low rate of TLR and MACE on long‐term follow‐up. Crush stenting is associated with a significantly higher rate of side branch restenosis compared to kissing stent technique. FKB is associated with significant reduction in MACE during follow‐up. (J Interven Cardiol 2013;26:145–152)