Kissing drug eluting balloons for in‐stent restenosis complicating bifurcations treated with drug‐eluting stents

The management of in‐stent restenosis (ISR) complicating bifurcation lesions is technically challenging and implant of further stents may not be feasible. The use of drug‐eluting balloons provides an attractive option for treatment of such lesions allowing a technically simple procedure without the need for further complex stenting. The SeQuent Please paclitaxel‐eluting balloon (B. Braun, Berlin, Germany) has been shown to be superior to a paclitaxel eluting stent or balloon angioplasty for ISR complicating a bare‐metal stent. However, there is no data on the efficacy of the SeQuent Please in ISR complicating drug‐eluting stents or bifurcation lesions. We report two cases where the SeQuent Please was used in this setting with angiographic success and freedom from target vessel failure and angina at 24 months. In both cases the Sheathless Eau Cath guide (Asahi Intecc, Japan) was employed to perform a kissing‐balloon dilatation with the SeQuent Please, so allowing treatment via radial access. © 2012 Wiley Periodicals, Inc.     

Patient preferences prompt a peek at priorities

• Patients rate the downsides of bare metal stents (higher restenosis rates) as being of similar magnitude to the downsides of drug eluting stents (longer dual anti‐platelet therapy).
• Patient preferences regarding choice of bare metal versus drug eluting stents should be elicited before coronary stenting.
• This article does not study actual patient preferences for stent type. Future studies should assess how personalized discussions of trade‐offs of stent types affect patient preferences.

     

Acquired peri-stent evaginations in a second generation durable polymer drug eluting stent

Hypersensitivity reaction towards the stent polymer resulting in formation of evaginations has been detected predominantly after treatment by the first generation drug eluting stents. This case shows that despite the use of more biocompatible polymers in second generation drug eluting stents there will still be patients developing adverse vessel wall reactions consistent with a hypersensitivity reaction towards the implanted stent.     

Drug‐eluting stent fracture: Incidence,contributing factors,and clinical implications

Stent fracture has been observed in noncoronary vessels, especially in the superficial femoral and popliteal arteries and with bare metal stents in saphenous vein grafts of coronary arteries. Since the introduction of drug‐eluting stents, stent fractures have also been reported in small studies and case reports. We reviewed these publications to assess what is known regarding the incidence, contributing factors, and clinical implications of drug‐eluting stent fracture in coronary arteries. The reported rate of drug‐eluting stent fracture in coronary arteries ranges from 1 to 8%, although much of the available literature is derived from single‐center studies that are heterogeneous in their study methods. A higher risk of stent fracture may be associated with the right coronary artery location, excessive tortuosity or angulation of the vessel, overlapping stents, and longer stents. The closed‐cell design of the Cypher stent has been associated with increased rigidity that may increase the risk of stent fracture, although these studies did not assess the overall outcomes between the Cypher and Taxus stents in a head‐to‐head comparison. Stent fracture has been shown by most studies to be associated with a statistically increased incidence of focal in‐stent restenosis, and some have shown an increased risk of target lesion revascularization. Other complications observed with stent fracture include stent thrombosis, coronary aneurysms, myocardial infarction, and sudden death. © 2009 Wiley‐Liss, Inc.     

Stent fracture associated with drug‐eluting stents: Clinical characteristics and implications

Objective : To evaluate the clinical characteristics and implications of stent fracture in drug‐eluting stents. Background : Approximately 2.5 million drug‐eluting stents are implanted every year worldwide. In 10 randomized controlled trials involving 2,602 patients, no incidence of stent fracture was recognized or reported. Methods : From April 2003 to December 2005, 2,728 patients underwent drug‐eluting stenting. The angiograms of all 530 patients who underwent repeat angiography were analyzed to identify the presence of stent fracture. We then documented the incidence of adverse events associated with drug‐eluting stent fracture and systematically analyzed the clinical, procedural, and structural factors, which might predispose to stent fracture. Results : Stent fracture was identified in 10 patients. None of these fractures were detectable at the time of stent placement. The median time interval from stent implantation to detection of fracture at repeat angiography was 226 days (range, 7–620 days). Adverse clinical outcomes associated with stent fracture occurred in 7 patients (6 patients had binary restenosis and 1 patient had stent thrombosis), all necessitating repeat intervention. Analysis of potential predisposing clinical, procedural, and structural factors revealed that 4 patients had excessive tortuosity in the proximal segment, and overlapping stents were used in 5 cases. All fractures occurred in sirolimus‐eluting stents. Conclusions : Stent fracture may represent a new potential mechanism of restenosis and stent thrombosis in drug‐eluting stents. Predisposing clinical and procedural factors may be vessel tortuosity and use of overlapping stents. The most important predisposing factor, however, may be stent structure, since all fractures occurred in sirolimus‐eluting stents. © 2006 Wiley‐Liss, Inc.     

In‐Stent Restenosis

The introduction of coronary stents marked a major turning point in the practice of interventional cardiology. Whereas the efficacy of balloon angioplasty was challenged both by immediate mechanical complications and by a high incidence of restenosis, coronary stents offered cardiologists a means by which to not only augment immediate procedural success, but also to reduce the incidence of restenosis following coronary intervention. However, despite technological advances and an improved understanding of the restenotic process, the overall rate of in‐stent restenosis following bare metal stent implantation remains high. Although the introduction of drug‐eluting stents has further reduced the incidence of restenosis, the “real‐world” application of drug‐eluting stents in increasingly complex lesion and patient subsets has given way to the even greater clinical challenge of managing drug‐eluting stent restenosis. Although the standard treatment of bare metal stent restenosis typically involves placement of a drug‐eluting stent, the optimal therapeutic approach to drug‐eluting stent restenosis remains less defined. The issue of in‐stent restenosis (especially following implantation of a drug‐eluting stent) remains a clinical challenge, and investigation into therapeutic options remains ongoing. As technology evolves, such investigation will likely incorporate novel approaches including drug‐coated balloons novel stent designs.     

Indications of drug eluting stents

The publication in 2001 of the first in-man results showing zero restenosis after sirolimus eluting stent implantation produced enormous excitement in the cardiological community. Today, both sirolimus and paclitaxel eluting stents have been shown in randomized trials to reduce restenosis as compared with conventional metallic stents. However, since drug eluting stents become available in Europe very little has changed in the every life of almost all interventional laboratories in Europe. The limitation currently impeding more widespread use of the new technology is nontechnical, nonmedical but economic. The high price of drug eluting stents relative to bare stents has been an obstacle to more widespread utilization of drug eluting stents.     

Drug eluting stents: from evidence based medicine to clinical practice

Drug eluting stents have been developed in order to reduce in-stent restenosis observed with a 20 to 40% rate in bare-stents. Neoinitimal smooth muscular cells proliferation have been characterized as the corner stone of in-stent restenosis. Consequently, many anti-mitotic and anti-inflammatory drugs have been evaluated in a new stent generation, so called coated stents or drug eluting stents. Three major components must be considered to evaluate the beneficial effects: the bare-stent, the drug, and the deliverance system, most usually a polymer. For the present, sirolimus eluting stent and paclitaxel eluting stent are available in the market with the european conformity label considering evidence based medicine established in randomized trials. Both stents have been shown to reduce in-stent restenosis incidence to less than 7%. Long-term follow-up still remain expected and would give answers to two safety queries: what is about the incidence of late stent thrombosis, what is about mal-apposition consequences in clinical feature. Utilization of drug eluting stent in clinical practice must considered materials with european conformity and must applied French society of cardiology guidelines restricting implantation to patients who meet high-risk restenosis criteria. Medicoeconomic approach must be considered beneficial at the present only in patients with high restenosis risk. Long-term antiplatelet regimen of aspirin and clopidogrel must be considered to avoid late stent thrombosis.     

OCT对于DES术后晚期或晚晚期血栓治疗的指导作用

目的 观察光学相干断层成像（OCT）技术对于药物洗脱支架（DES）术后发生晚期或晚晚期血栓治疗对策的指导作用.方法 选取2010年7月至2013年11月本院收治的行DES支架置入术后发生晚期或晚晚期支架内血栓患者22例,对患者行OCT检查,根据OCT结果采取进一步治疗措施.结果 DES术后晚期或晚晚期血栓的OCT表现为：支架内皮化不全6例、贴壁不良12例、支架内新生动脉粥样硬化斑块形成8例,支架内纤维过度增生较为少见2例,有些患者上述情况同时存在.治疗对策：单纯支架内皮化不全及支架贴壁不良者采取单纯球囊扩张术12例,新生动脉粥样硬化斑块形成或纤维过度增生者采取球囊扩张加支架置入术10例.结论 OCT可以准确了解DES术后晚期或晚晚期血栓的原因,提供更为合适的治疗方案.     

Percutaneous therapy of bifurcation lesions with drug‐eluting stent implantation: the Culotte technique revisited

INTRODUCTION: The most effective strategy for bifurcation stenting is currently undefined. The Culotte technique was developed as a method that ensures complete bifurcation lesion coverage. However, it went out of favour due to a high rate of restenosis when utilizing bare metal stents. Drug‐eluting stents reduce the rate of restenosis and need for repeat lesion revascularization compared with bare metal stents; we re‐evaluated this technique with drug‐eluting stent implantation. METHODS: Between April 2002 and October 2003, 207 patients were treated for at least one bifurcation lesion with drug‐eluting stent implantation to both the main vessel and side branch. Of these, 23 were treated with the Culotte technique (11.1%) for 24 lesions. Sirolimus‐eluting stents were used in 8.3%, and paclitaxel‐eluting stents in the remaining 92.7%. RESULTS: Clinical follow‐up was obtained in 100%. One patient had a myocardial infarction at 14 days (maximum rise in creatine kinase 872IU/L) related to thrombosis occurring in another lesion, and underwent repeat revascularization. There were no episodes of stent thrombosis in the Culotte lesions. At eight months follow‐up, there were no deaths and no further myocardial infarction. One patient required target lesion revascularization (TLR), and a second underwent target vessel revascularization. The cumulative rates of survival‐free of TLR and major adverse cardiac events were 94.7% and 84.6% respectively. Angiographic follow‐up was obtained in 16 patients (69.6%) at a mean period of 8.3±4.3months. The late lumen loss for the main vessel and side branch were 0.48±0.56?mm and 0.53±0.33?mm respectively, with binary restenosis rates of 18.8% and 12.5%.

CONCLUSIONS: In this small study of bifurcation stenting utilizing the Culotte technique with drug‐eluting stent implantation, there was a low rate of major adverse events and need for target lesion revascularization at eight months, when compared with historical data of bifurcation stenting with bare metal stents. Further re‐evaluation of this technique utilizing drug‐eluting stents, is warranted in the setting of larger randomized studies.     

State of treatment of coronary artery disease by drug releasing stents

BACKGROUND: Despite improved technologies restenosis remains the main drawback of catheter-based interventions in coronary artery disease. Local application of anti-proliferative drugs through drug releasing stents is a promising concept addressed to solve this problem. DRUG RELEASING STENTS: Today, given the technical capabilities for controlled drug release from coronary stents, the development of drug eluting stents has emerged as one of the main research areas in interventional cardiovascular medicine. Several different approaches for drug loading on coronary stents as well as a variety of antiproliferative and anti-inflammatory agents, such as paclitaxel, actinomycin D, sirolimus, tacrolimus, everolimus and dexamethasone are under clinical investigation. RESULTS: Since the first enthusiastic reports from first in-man observations with drug coated stents, the success of the combination of both a biological and a mechanical approach has been proved in several controlled studies with restenosis rates between 0% in the RAVEL trial (sirolimus, Cordis Bx Velocity trade mark stent), 0% in the TAXUS I trial (paclitaxel, Boston Scientific NIRx trade mark stent) and 4% in the ASPECT Study (paclitaxel, Cook V-Flex plus trade mark stent). The risk of stent thrombosis seems to depend on the dose of the antiproliferative drug - in the SCORE trial stent thrombosis occurred in 6.3% of patients with high dose of QP2 and the antiplatelet therapy, in the ASPECT subgroup with cilostazol instead of clopidogrel and high dose of paclitaxel in up to 25%, whereas in RAVEL and TAXUS I no stent thrombosis was observed. CONCLUSION: If the "one digit" restenosis rate observed in clinical trials could be confirmed in clinical practice without increase of complications, especially stent thrombosis using multiple and/or long stents, we can expect in the near future that implanting drug eluting stents in larger patient groups and lesion subsets will cause a reduction of patients with need for surgical revascularization.     

国产药物洗脱支架对急性ST段抬高心肌梗死患者的疗效观察

目的探讨国产雷帕霉素药物洗脱支架Firebird在急性ST段抬高心肌梗死(STEMI)患者急诊经皮冠状动脉介入治疗(PCI)中应用的安全性和有效性。方法选择STEMI且在发病12h内接受急诊置入Firebird支架的患者96例,记录住院期间、术后9个月时不良心脏事件(MACE)的发生率。结果96处梗死相关病变置入150枚Firebird支架,支架置入成功率为100%,介入治疗后血流TIMI3级86例(89.6%),无复流现象3例,其中术中死亡1例;心脏破裂死亡2例;早期支架内血栓形成2例,其中死亡1例。住院期间MACE发生率为5.2%(5/96),PCI临床成功率为86.5%(83/96)。对82例患者进行了6～24个月的随访,平均(9.6±3.4)个月,因心力衰竭死亡2例,随访时MACE发生率2.4%(2/82)。结论国产雷帕霉素药物洗脱支架Firebird在STEMI急诊PCI中应用安全有效。     

Infrapopliteal drug‐eluting stents for chronic limb ischemia

Objective: We report our experience with the elective placement of below‐knee, drug‐eluting stents in patients with chronic limb ischemia. Background: Infrapopliteal percutaneous transluminal angioplasty has been associated with a lower rate of procedural success and high rate of restenosis because of the small size of the tibial vessels and the prevalence of calcified and diffuse atherosclerotic disease. Prior published data reports 3‐year patency rates below 25%. Bare metal stents have been reported in bailout situations. Drug‐eluting stents have markedly reduced restenosis compared to bare metal stents in the coronary vasculature, but there is little data supporting the use of these devices below the knee. Methods: Elective placement of drug‐eluting stents in infrapopliteal lesions was performed on 10 patients with severe (≥Fontaine Stage IIb) claudication (n = 1) or limb‐threatening ischemia (n = 9) (rest pain, nonhealing ulcers and gangrene). Results: A total of 17 drug‐eluting stents were electively placed in 12 below‐knee arteries in 10 patients, resulting in an average of 1.7 ± 0.7 stents per patient. The mean lesion length was 24.8 ± 10.9 mm, the mean total stent length was 38.3 ± 19.1 mm, and the mean nominal stent diameter was 2.8 ± 0.3 mm. One patient required target vessel revascularization (TVR) at 3 weeks because of stent thrombosis. TVR was 10% at 12.4 ± 6.5 months of follow‐up. Clinically driven angiography in three different patients was performed at 4, 15, and 16 months and confirmed drug‐eluting stent patency in each case. Conclusions: The use of below‐knee drug‐eluting stents is feasible and appears to be safe in our small series of complex infrapopliteal lesions causing chronic limb ischemia. The occurrence of a single case of stent thrombosis warrants continued observation in this cohort. Prospective clinical trials will be necessary to confirm the benefits and justify the costs of this strategy for treating patients with infrapopliteal culprit lesions and chronic limb ischemia. © 2008 Wiley‐Liss, Inc.     

Late restenosis following placement of a sirolimus eluting stent for in-stent restenosis

Drug eluting stents (DES) are rapidly replacing intravascular brachytherapy for the treatment of bare metal in-stent restenosis (ISR). To date, there are no long-term follow up data supporting this practise. We report symptomatic repeat in-stent restenosis occurring 27 months after sirolimus eluting stent deployment for de novo in-stent restenosis. This case suggests that in a subgroup of patients with ISR, as with brachytherapy, the drug eluting stent may be simply delaying rather than inhibiting the restenotic process.     

Paclitaxel‐eluting balloon: From bench to bed

Since the first clinical angioplasty by Gruntzig in 1977, restenosis has been the primary drawback of percutaneous coronary intervention (PCI). In the balloon era. restenosis was correlated with elastic recoil and negative remodeling of the arterial wall. Later, introduction of stents proved to be a significant advance in reducing the elastic recoil and negative remodeling at the treatment site but stimulated proliferation, migration of smooth muscle cells, and neointimal hyperplasia, thereby generating a new type of restenosis, in‐stent restenosis. Brachytherapy and drug‐eluting stents (DES) may be considered the two breakthroughs against neointimal hyperplasia. However, concerns about stent thrombosis and incomplete elimination of in‐stent restenosis with DES in complex lesions and patients justify the pursuit of research in this field. Non‐stent based local drug delivery and particularly the use of paclitaxel‐eluting balloons could be one of these strategies. We aimed to review the concept, preclinical‐, and clinical data available with non‐stent based local drug delivery and, in particular, with paclitaxel‐eluting balloons. © 2009 Wiley‐Liss, Inc.     

Bare metal stent thrombosis 13 years after implantation

There has been a great deal of recent controversy regarding the risk of very late stent thrombosis with drug eluting stents, especially in the context of antiplatelet therapy cessation. We report a case of very late stent thrombosis of a bare metal stent initially implanted for treatment of a myocardial infarction. The patient presented thirteen years later with a recurrent myocardial infarction three days after discontinuing aspirin. Angiography demonstrated thrombotic occlusion and severe underlying restenosis of the stent. To our knowledge, this is the latest bare metal stent thrombosis described in the world medical literature.     

Coronary Stent Fracture: A Recently Appreciated Phenomenon with Clinical Relevance

In the stent era, in addition to restenosis, there are many important consequences deserving more attention. Firstly described in peripheral vascular interventions, it took several years for stent fracture to be known as an appreciable complication of coronary intervention. Especially with the introduction of drug eluting stents and the use of coronary stents in more complex cases, its prevalence has raised and new data have been published concerning its mechanism, predictors, diagnosis, clinical course and treatments. This review will discuss the available literature about stent fracture.     

Diffuse coronary ectasia and intracoronary thrombus involving left circumflex coronary artery and presenting as acute coronary syndrome: report of two cases

Stent thrombosis is a feared complication of percutaneous coronary intervention. Promises and problems, late complications and early stent thrombosis have been reported after drug eluting stents implantation too. Moreover some patients with imperative cardiologic indications for combination therapy with aspirin and clopidogrel (stent placement and/or acute coronary syndrome) have a history of allergy to aspirin. We present a case of catastrophic early drug eluting stents thrombosis in a 79-year-old Italian woman with aspirin hypersensitivity.     

中国冠心病患者接受不同支架治疗预后的荟萃分析

目的比较中国冠心病患者置入药物洗脱支架(DES)和裸支架(BMS)或西罗莫司洗脱支架(SES)和紫杉醇洗脱支架(PES)之间,临床预后的差别。方法检索数据库,纳入随访时间≥6个月的、比较DES和BMS或SES和PES的临床研究。用STATA 10.0作荟萃分析,比较不同类型支架的临床预后,包括主要心血管不良事件(MACE)、靶病变血运重建(TLR)、靶血管血运重建(TVR)、支架内血栓形成和心肌梗死的发生情况。结果共纳入文献11篇(3780例),随访时间从6个月至3年。与BMS相比,DES可减少MACE(OR=0.471,95%CI0.336～0.662,P<0.001)、减少TVR(OR=0.250,95% CI0.148～0.422,P<0.001),但支架内血栓形成在两组间差异无统计学意义。而SES与PES相比,在MACE、TLR、TVR、支架内血栓、心肌梗死方面差异均无统计学意义。结论药物洗脱支架有效性、安全性高,药物支架中,西罗莫司支架和紫杉醇支架差异无统计学意义。