Multiple stent fractures at the site of coronary artery bypass insertion

Drug eluting stents have led to a substantial reduction of in‐stent restenosis. Stent fracture (SF) is an important cause for the cases of restenosis which still occur. Sites of increased vessel movement, long stents, and overlapping stents have been observed to be more prone to fracture. We report the case of a patient with multiple drug eluting SFs at the site of coronary artery bypass insertion. The decision to implant stents at the site of bypass insertion should be made carefully. SF should be considered when gaps between previously implanted stents are observed. © 2008 Wiley‐Liss, Inc.     

Acute coronary syndrome due to early multiple and complete fractures in sirolimus‐eluting stent: A case report and brief literature review

Despite drug eluting stents (DES), as compared to bare metal stents, have reduced in‐stent restenosis, complex and long lesions remains a challenge for interventional cardiologist. Their treatment is often associated with an unfavorable outcome, related to in‐stent restenosis, stent thrombosis, and target lesion revascularization. These complications may derive from the contact between metallic structures and coronary artery endothelium, and consequent overexpression of platelet activating factors, growth factors, and inflammatory cytokines. Recently, an additional mechanism has emerged as new cause of these complications: “stent fracture.” Several factors are involved in this phenomenon including material and stent platform, target vessel features, stent implantation technique, and implant duration. We reported a case of 69 years old man with rare early and complex DES fractures on right coronary that caused acute coronary syndrome 36 hr after a previous percutaneous coronary intervention.© 2012 Wiley Periodicals, Inc.     

Giant coronary artery aneurysm following implantation of Endeavour stent presenting with fever

Coronary artery aneurysms are a known but uncommon complication of percutaneous coronary intervention (PCI) probably related to effects of vessel wall trauma and possibly a combination of hypersensitivity and incomplete endothelisation associated with drug-eluting stents (DES). We present here a case of giant coronary artery aneurysm 3 months following implantation of a zotarolimus eluting endeavour stent presenting with fever.     

Rationale and design of the Drug‐Eluting Stents vs Bare‐Metal Stents in Saphenous Vein Graft Angioplasty (DIVA) Trial

VA Cooperative Studies Program #571 (DIVA) was designed to evaluate the efficacy of drug‐eluting stents (DES) for reducing aortocoronary saphenous vein bypass graft (SVG) failure when compared with bare‐metal stents (BMS) in participants undergoing stenting of de novo SVG lesions. Participants undergoing clinically indicated stenting of de novo SVG lesions were randomized in a 1:1 ratio to DES or BMS. Randomization was stratified by presence/absence of diabetes mellitus and the number of target SVG lesions (1 vs ≥2) within each participating site. At sites that did not routinely administer 12‐months of dual antiplatelet therapy after SVG stenting participants without acute coronary syndromes received 1 month of open‐label clopidogrel, followed by 11 months of clopidogrel for those assigned to DES and 11 months of placebo for those assigned to BMS. The primary endpoint was the 12‐month incidence of target‐vessel failure (defined as the composite of cardiac death, target‐vessel myocardial infarction, or target‐vessel revascularization). Secondary endpoints included the incidence of other clinical endpoints and the incremental cost‐effectiveness of DES relative to BMS. Due to lower‐than‐anticipated target‐vessel failure rates, target enrollment was increased from 519 to 762. The study had randomized 599 participants when recruitment ended in December 2015. The DIVA trial will provide clarity on the appropriate stent type for de novo SVG lesions.     

Seven‐year safety and efficacy of the unrestricted use of drug‐eluting stents in saphenous vein bypass grafts

Objectives : The aim was to investigate the 7‐year clinical outcomes of patients treated with either drug‐eluting stents (DES) or bare‐metal stents (BMS) for saphenous vein graft disease (SVG). Background : Atherosclerotic disease in SVG has several peculiarities which make it difficult to extrapolate outcomes of the use of DES as compared to BMS, from outcomes observed in native coronary arteries. To date no long‐term safety and efficacy results for DES in SVG have been published. Methods : Between January, 2000 and December, 2005 a total of 250 consecutive patients with saphenous vein graft disease were sequentially treated with DES (either sirolimus‐ or paclitaxel‐eluting stents) or with BMS. Yearly follow‐up was performed. Results : At 87 months (7.25 years), a total of 101 patients died (58 [46%] in the BMS group and 43 [42%] in the DES group, P‐value= 0.4). There was no significant difference in the combined endpoint mortality or myocardial infarction. Cumulative target vessel revascularisation (TVR) was higher in the BMS group compared to the DES group (41% vs. 29%, respectively; adjusted hazard ratio [HR] 0.63, 95% confidence interval [CI]: 0.39–1.0). The cumulative incidence of major adverse cardiac events was 73% vs. 68% in the BMS and DES groups, respectively (adjusted HR 0.93, 95% CI: 0.67–1.3). Conclusions : In the present study, the unrestricted use of DES for SVG lesions appeared safe and effective up to 7.25 years‐ and the use of DES resulted in a clinically relevant lower rate of TVR. © 2011 Wiley Periodicals, Inc.     

The fine balance of quality and quantity: the time has come to define quality of PCI!

Drug‐eluting stents (DES) have revolutionized the treatment of coronary bifurcation lesions. Among different DES types, sirolimus‐eluting stents (SES) showed better outcomes than paclitaxel‐eluting stents. Because novel sirolimus analogues have been implemented in DES, a prospective observational comparison was undertaken to compare major mammalian target of rapamycin inhibitor‐eluting stents in the treatment of bifurcation lesions according to the provisional T‐stenting and small protrusion (TAP) technique. Overall, 187 patients (165 men, 65 ± 10 years) were enrolled in the study: 80 patients received a SES, whereas zotarolimus‐eluting stents (ZES) were implanted in 53 patients and everolimus‐eluting stents (EvES) in 62 patients. Primary end‐point of the study was the 12‐month incidence of target bifurcation failure (TBF) defined as occurrence of cardiovascular death, nonfatal myocardial infarction (MI), and target vessel revascularization (TVR) or angiographic documentation of >50% restenosis on the main vessel or TIMI flow <3 on the side branch. Groups were homogeneous according to main clinical and angiographic characteristics. Overall, 17 (9.1%) patients had TBF: 4 (2.1%) patients had nonfatal non‐ST‐segment elevation MI, 9 (4.8%) patients underwent TVR, and 6 (3.2%) patients had an angiographic restenosis. The rate of TBF was statistically different among the three groups (7.9% in SES group, 18% in ZES group, and 3.3% in EvES group, P = 0.024). Previous MI was associated with a worse outcome (P = 0.025), whereas final kissing balloon was associated with a better outcome (P = 0.045). In conclusion, in this prospective registry, significant differences between DES were found in the outcome of patients treated for coronary bifurcation lesions according to provisional TAP technique. Thus, prospective randomized trials in this field are needed. © 2010 Wiley‐Liss, Inc.     

Very late stent thrombosis due to DES fracture: Description of a case and review of potential causes

Stent fracture and subsequent stent thrombosis are known complications after stent implantation, especially in stents with closed cell design like the first generation sirolimus drug eluting stents (DES). Late stent thrombosis is very rarely encountered in our patient population, majority Chinese. We report a case of non‐ST elevation myocardial infarction as a result of very late stent thrombosis (three years after implantation) due to stent fracture at the site of overlap of two first generation sirolimus DES. There were initial difficulties in restoring coronary flow by conventional reperfusion therapies but a successful outcome after implantation of an endothelial progenitor cell capture stent, with no further recurrence of ischemic event after 12 months. An attempt was made to analyze all existing factors present and contributing to the stent fracture and stent thrombosis in this case, as reported in the literature. © 2011 Wiley Periodicals, Inc.     

Drug-eluting stenting is superior to bare metal stenting in saphenous vein grafts.

This study compared the outcomes of percutaneous coronary intervention (PCI) of saphenous vein grafts (SVGs) with drug-eluting stents (DES) with bare metal stents (BMS). PCI of degenerated SVG is associated with worse outcomes and high incidence of in-stent restenosis compared with PCI of native coronary arteries. There is a paucity of data on the outcomes of PCI of SVG with DES. Data from 223 consecutive patients who underwent PCI of SVG were imputed into a dedicated clinical database. We assessed the clinical outcomes at a mean follow-up of 9.1+/-2.1 months. A total of 139 patients underwent PCI of SVG with DES and 84 patients with BMS. The mean age of the SVG was 7.6+/-3.8 years in the DES group and 7.7+/-2.8 years in the BMS group (P=0.38). Procedural success was achieved in all patients except for one patient in the BMS group who underwent emergent coronary artery bypass graft surgery for SVG dissection. There were no other in-hospital cardiac events in both groups. There was one cardiac death in the DES group and three deaths in the BMS group (P=0.03). When compared to the BMS, PCI of SVG with DES was associated with a lower incidence of myocardial infarction (4.3% vs. 20.2%; P=0.04) and target vessel revascularization (10.1% vs. 36.9%; P=0.035). When compared with BMS, PCI of SVG with DES was associated with a lower incidence of death, myocardial infarction, and target vessel revascularization.     

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.     

Long‐term outcomes of drug‐eluting stents versus bare‐metal stents in saphenous vein graft disease: Results from the Prairie “Real World” Stent Registry

Objectives:

This study was designed to compare long‐term clinical outcomes of drug‐eluting stents (DES) versus bare metal stents (BMS) in patients with saphenous vein graft (SVG) disease in the “real world.”

Background:

The safety and efficacy of DES versus BMS in SVG remains uncertain due to contradictory reports of either lower revascularization rates with DES; or clinical equivalence to BMS; or even an excess of clinical events associated with DES use.

Methods:

We identified consecutive patients who underwent stent placement within a de novo SVG lesion between May 1, 2003 and July 31, 2007. Follow‐up was obtained at regular intervals. The Kaplan–Meier method was used to produce actuarial survival estimates. Cox regression analysis was used to predict the risk associated with stent type, and propensity scores were generated to risk‐adjust the results.

Results:

The study group included 379 stent recipients (284 DES; 95 BMS) with 410 stented lesions. BMS were placed more frequently in current smokers, acute myocardial infarctions, larger vessels, and longer lesions. In‐hospital mortality was higher in BMS recipients than in their DES counterparts (3.2% vs. 0, respectively; P = 0.015). At 3 years, there was no significant difference in clinical adverse event rates between DES and BMS recipients, even after risk adjustment.

Conclusions:

Three‐year adverse event rates are similar among patients treated with DES or BMS in SVG lesions. Therefore, while DES are safe, they do not appear to offer an advantage in terms of long‐term graft patency. © 2009 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.     

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.     

Current percutaneous treatment strategies for saphenous vein graft disease

Coronary artery bypass graft surgery remains one of the most widely performed surgical procedures in North America and aortocoronary saphenous vein grafts (SVG) are the most frequently used surgical conduits. SVG disease (SVGD) remains the leading cause of symptomatic coronary artery disease postcoronary artery bypass graft. When optimal medical therapy is ineffective, repeat surgery is associated with higher mortality combined with less favorable clinical and angiographic results, thus percutaneous revascularization on SVG is currently the standard of care for the revascularization of SVGD. Balloon angioplasty, bare metal stents, polytetrafluoroethylene‐covered stents, and drug‐eluting stents have been extensively investigated for SVG interventions. Multiple recent randomized trials and meta‐analyses have confirmed the pathophysiologic and clinical differences between SVGD and coronary artery disease. Decisions such as patient selection, premedication, stent, and protection device characteristics should be carefully considered to achieve optimal procedural and clinical results. Acute coronary syndromes due to SVG involvement, chronic total occlusions, retrograde approaches, and SVG perforation management are newer fields requesting additional research. © 2013 Wiley Periodicals, Inc.     

Restenosis after PCI: Battered but not beaten

• In patients with bare‐metal stent (BMS) restenosis, drug‐eluting stents (DES) are superior to vascular brachytherapy (VBT), leading to a lower risk of clinical restenosis and target vessel revascularization, but not to less stent thrombosis, myocardial infarction, or death; these benefits persist for 2–5 years.
• The optimal management of DES restenosis is unknown, but recent studies suggest that drug‐eluting balloons (DEB) and DES have similar efficacy and safety.
• Since DEB are not commercially available in the United States, VBT may be a reasonable alternative to repeated DES.

     

A case of early drug-eluting stent fracture

Although stent fracture following femoro-popliteal intervention is well recognized, coronary stent fracture represents an underrecognized entity. Its incidence is low but it represents an important clinical entity as it may complicate with stent thrombosis causing acute coronary syndromes, or may predispose to instent restenosis. Although coronary stent fracture may involve both bare metal stents (BMS) and drug-eluting stents (DES), a recent analysis of the literature indicates that reports of stent fracture have increased since DES was introduced. Furthermore, chronic stretch at specific vessel sites as bends may lead to late occurrence of fracture. We present the case of a patient with a non-ST-segment elevation acute coronary syndrome caused by the early fracture of an everolimus-eluting stent (Xience?) implanted only three days before.     

Percutaneous intervention on the saphenous vein bypass grafts—Long‐term outcomes

Background/Objective : In this era of drug eluting stents (DES), the long‐term outcome of percutaneous intervention (PCI) on saphenous venous grafts (SVG) is unknown. The objective of the study was to compare the long‐term outcomes of DES versus bare metal stent (BMS) in this population and to determine the predictors of outcomes. Methods : We reviewed the medical records of all patients who had PCI performed during January 2003 to February 2005 to obtain data cardiac risk factors, medications at discharge, angiographic details and outcomes. Results : One hundred and nine patient had PCI to SVG; of these, 37 patients received DES and the remaining had BMS. Over a mean follow‐up of 33 months, the PCI using DES was associated with 30% restenosis, 35% target vessel revascularization (TVR) and major adverse cardiac event (MACE) rate of 46% versus 35% restenosis, 38% TVR and 50% MACE rate with BMS. There was no significant difference in long‐term outcome with DES as compared to BMS. Conclusion : There was no difference in the long‐term outcomes of PCI on SVG irrespective of the type of stent used. © 2008 Wiley‐Liss, Inc.     

对比两种完全血运重建对冠状动脉多支血管病变伴慢性肾脏疾病患者临床预后的影响

目的:对比药物洗脱支架(DES)和冠状动脉旁路移植术(CABG)两种完全血运重建方式对冠状动脉多支病变伴慢性肾脏疾病(CKD)患者临床预后的影响.方法:根据改良MDRD公式,对因冠状动脉多支病变接受DES和CABG的患者的肾功能进行评估,筛选出824例CKD患者接受了完全血运重建治疗,其中冠状动脉双支病变409例(DES 312例,CABG 97例),冠状动脉三支病变415例(DES 167例,CABG 248例).为校正基线资料的差异,对冠状动脉双支病变和三支病变置入DES和接受了CABG的临床预后进行分别对比.首要终点为2年内全因死亡、心肌梗死以及脑血管事件的复合终点事件,次级终点为2年内再次血运重建.结果:在冠状动脉双支病变患者中,DES患者复合终点事件及再次血运重建的发生率均与CABG患者相近,差异无统计学意义(P>0.05).在三支病变患者中,DES患者复合终点的发生率与CABG患者相近,差异无统计学意义(P>0.05).而DES患者再次血运重建的发生率显著高于CABG患者,差异有统计学意义(P<0.05).Kaplan-Meier生存曲线分析:在冠状动脉三支病变患者中,DES患者2年内无复合终点事件的生存率与CABG患者相比,差异均无统计学意义(P>0.05);而再次血运重建生存率在DES患者明显低于CABG患者,差异有统计学意义(P<0.05).Cox多因素分析表明,冠状动脉三支病变人群中DES患者再次血运重建的风险显著高于CABG患者(风险比:2.32,95%可信区间:1.57～7.33,P=0.024).结论:在冠状动脉多支病变伴CKD患者中,CABG和DES两种血运重建策略显示出相同的无复合终点生存率.但在冠状动脉三支病变患者中,即使在同样接受完全血运重建治疗后,DES再次血运重建的风险依然高于CABG.     

Current Status of Drug‐Eluting Stents

First‐generation drug‐eluting stents (DES) with controlled release of sirolimus or paclitaxel from durable polymers compared with bare‐metal stents have been consistently shown to reduce the risk of repeat revascularization procedures due to restenosis. The superior efficacy was found across a wide range of patients and lesion subsets and persisted up to 5 years whereas similar outcomes have been observed in terms of death and myocardial infarction. Newer generation DES have been developed with the goal to further improve upon the safety profile of first‐generation DES while maintaining efficacy. These platforms include DES with improved and more biocompatible durable polymers, DES using bioabsorbable polymers for drug release, DES with polymer‐free drug release, and fully bioabsorbable DES. Newer generation DES with durable polymers such as zotarolimus‐eluting or everolimus‐eluting XIENCE V stents have been directly compared with first‐generation DES. Most recent results of large scale clinical trials are encouraging in terms of similar or increased efficacy while improving safety by reducing the rates of myocardial infarctions and stent thrombosis. DES using biodegradable polymers for drug release represent the next technological modification and preliminary results are favorable and demonstrate similar angiographic and clinical efficacy as first‐generation DES, but only longer term follow‐up and investigation in larger patient cohorts will determine whether their use is associated with improved long‐term safety. Fully bioabsorbable stents represent another innovative approach. Whether this innovative concept will enter into clinical routine remains yet to be determined.     

Decreased risk of stent fracture‐related restenosis between paclitaxel‐eluting stents and sirolimus eluting stents: Results of long‐term follow‐up

Objective: To compare the outcomes between paclitaxel‐eluting stents (PES) and sirolimus‐eluting stents (SES) for the treatment of drug‐eluting stent (DES) fracture. Background: DES fracture is considered as an important predictor of in‐stent restenosis (ISR). However, little data are available evaluating the optimal treatment for this complication of coronary stenting. Methods: From January 1, 2004 to December 31, 2008, patients with DES ISR treated with a second DES were identified and evaluated for stent fracture. Stent fracture was defined by the presence of strut separation in multiple angiographic projections, assessed by two independent reviewers. Target lesion revascularization (TLR) at 6 and 12 months were the primary end points. Results: Of 131 lesions with DES ISR treated with a second DES, we found 24 patients (24 lesions, 18.2%) with angiographically confirmed stent fracture. Of these, 20 patients (20 lesions) treated with either PES (n = 11/55%) or SES (n = 9/45%) were included in the study. TLR at 6 months occurred in 9% of patients treated with PES and 22% of those treated with SES (P = 0.41). After 12 months, TLR was 9% and 55.5%, respectively (P = 0.024). Conclusions: This study demonstrates a high incidence of stent fracture in patients presenting with DES ISR in need of further treatment with another DES. The suggested association between treatment of stent fracture‐associated DES ISR with PES as compared with SES, and better long‐term outcomes, is in need of confirmation by larger prospective registries and randomized trials. © 2011 Wiley Periodicals, Inc.     

Unprotected left main coronary artery stenting with zotarolimus (Endeavor) drug‐eluting stents

Objectives: To report the safety and efficacy of zotarolimus eluting stents for treatment of unprotected left main coronary artery disease. Background: Percutaneous stent insertion is an increasingly popular alternative to bypass surgery for the management of left main (LM) coronary artery disease. While data support the use of sirolimus‐ and paclitaxel‐coated stents in the LM coronary artery, there are no published series reporting results with Endeavor (zotarolimus) stents, particularly in the context of unprotected left main (ULM) lesions. Methods: We retrospectively identified 40 consecutive patients who had ULM disease treated with Endeavor stents (ZES) and who had follow‐up angiography. The primary endpoint was the prevalence of major adverse cardiac events (MACE), including cardiac/unexplained death, nonfatal myocardial infarction (MI), and in‐stent restenosis (ISR)/target lesion revascularization (TLR). Results: Angiographic and procedural success was achieved in all cases. Follow‐up angiography occurred on average 5.6 ± 0.9 months after the index procedure. There were three incidences of ISR requiring TLR and another patient who had a NSTEMI in the follow‐up period. At late follow‐up (12.4 ± 1.8 months) three patients underwent CABG (one for RCA stenosis) and four patients died without knowledge of the status of the ULM stent (two cardiovascular and two deaths related to cancer progression). Conclusions: In conclusion, our experience with Endeavor stents for the treatment of ULM disease demonstrates excellent angiographic and clinical outcomes, with a 7.5% ISR/TLR rate and a 15% MACE rate, respectively, at an average clinical follow‐up of 12.4 months. © 2011 Wiley Periodicals, Inc.