Role Of Drug-eluting Stents Research Articles

Role of drug-eluting stent on Takayasu arteritis with renal artery stenosis

Takayasu arteritis (TA) is defined as granulomatous inflammation of large arteries involving the aorta and its primary branches. Takayasu arteritis with renal artery stenosis (TARAS) is a common cause of pediatric renovascular hypertension. The main purposes of TARAS management are to improve high blood pressure and recover renal function. When general medication fails to improve symptoms, renal revascularization may be attempted. Implantation of a drug-eluting stent (DES) has been used as an alternative strategy for pediatric renal revascularization. Here, we report on a 10-year-old, female, Javanese patient with bilateral TARAS who underwent DES implantation. Her clinical presentation was hypertensive crisis and worsened renal function. Bilateral renal artery DES implantation was performed successfully without complications. The child’s blood pressure was controlled using two anti-hypertensive medications after DES implantation and her renal function recovered. Dual anti-platelet therapy was given to minimize the risk of stent thrombosis.

CRT-702 Composite Outcomes In 2.25-mm Drug Eluting Stents: A Meta-analysis And Systematic Review

Percutaneous coronary intervention (PCI) of small vessels is associated with a high restenosis rate. Drug-eluting stents (DES) reduce restenosis in coronary arteries, but the role of DES in small coronary vessels has not been well defined. In our systematic review, we aim to summarize all known

Takayasu arteritis: surgical interventions.

Open and endovascular surgery remains important in the management of Takayasu arteritis. This review summarizes the indications and approaches available, the evidence for them and recent advances. The outlook in Takayasu arteritis has improved over the last decade, reflecting earlier diagnosis, increased use of noninvasive imaging and combination immunotherapy. This is likely to be reflected in a reduced requirement for vascular intervention in the next decade. An important role remains for open surgery, which is effective, well tolerated and improves long-term survival in those with severe disease. Primary angioplasty offers a less invasive option for specific arterial sites, although restenosis rates are higher. Interventional outcomes are significantly improved by adequate pre and postoperative immunosuppression to render arteritis inactive. Stent placement should be reserved predominantly for primary and secondary angioplasty failures. The role of drug-eluting stents is not yet established. Preliminary evidence suggests that stent grafts represent an important noninvasive option. Vascular intervention remains important for the treatment of stenosed and occluded arteries leading to organ ischaemia or hypertension, and for aneurysmal disease. Endovascular stent grafts are likely to be increasingly deployed, and targeted biologic therapies may reduce the need for vascular intervention.

Does endovascular treatment of infra-inguinal arterial disease with drug-eluting stents offer better results than angioplasty with or without bare metal stents?

A best evidence topic in vascular and endovascular surgery was developed according to a structured protocol. The question addressed was whether treatment of infra-inguinal arterial occlusive disease with drug-eluting stents (DESs) provides improved outcomes compared with bare metal stents (BMSs) or percutaneous balloon angioplasty (PTA) alone. Altogether, 136 papers were found using the reported searches, of which 5 provided the best evidence to answer the question. All papers represent either level 1 or 2 evidence. The authors, journal, date, country of publication, patient group studied, study type, relevant outcomes and results of these papers are tabulated. Main outcome measures varied among the studies, and included patency, in-stent restenosis, target lesion revascularization, major adverse events, clinical improvement and limb salvage. Evidence on the comparative efficacy of DESs in femoro-popliteal arterial disease is mainly based on two randomized, controlled trials. Paclitaxel-eluting stents were evaluated in the Zilver PTX trial and demonstrated superior 2-year results to either BMSs or PTA, as indicated/shown by patency (DES vs PTA, 74.8 vs 26.5%, P < 0.01), clinical benefit (DES vs PTA, P < 0.01) and event-free survival (DES vs PTA, 86.6 vs 77.9%, P = 0.02). However, the SIROCCO trial found that the sirolimus-eluting stent did not exhibit statistically significant differences in 2-year in-stent restenosis (22.9 vs 21.1%) and target lesion revascularization (6 vs 13%) compared with the BMS. Treatment of infra-politeal arterial disease with DESs was related with superior outcomes to those of BMSs, as indicated/shown by patency, freedom from target lesion revascularization and freedom from major adverse events. Furthermore, the ACHILLES trial, the only published trial comparing the infra-popliteal DES with PTA, revealed lower angiographic restenosis (22.4 vs 41.9%, P = 0.019) and greater vessel patency (75 vs 57.1%, P = 0.025) in the DES group at 1 year. However, data related to clinical parameters in patients with critical limb ischaemia secondary to infrageniculate arterial disease, such as limb salvage and ulcer healing, are insufficient. In conclusion, treatment of infra-inguinal arterial disease with DES is safe and seems to be superior to treatment with PTA alone or BMS. The role of DES in sustained improvement in clinical outcome end-points, such as limb salvage, remains to be elucidated.

Sirolimus-eluting versus paclitaxel-eluting stent in primary angioplasty: a pooled patient-level meta-analysis of randomized trials

Large interests have been focused on the role of drug-eluting stents in the setting of ST-segment elevation myocardial infarction (STEMI) and concerns have emerged regarding an higher risk of stent thrombosis. Aim of the current study was to perform a meta-analysis using individual patient data to evaluate the long-term safety and effectiveness of sirolimus-eluting stent (SES) as compared to paclitaxel-eluting stent (PES) in patients undergoing primary percutaneous coronary intervention (PCI) for STEMI. The literature was scanned by formal searches of electronic databases (MEDLINE and CENTRAL). We examined all completed randomized trials of SES versus PES for STEMI. No language restriction was applied. Primary study endpoint was the occurrence of major adverse cardiac events (MACE). Secondary endpoints were the occurrence of death, reinfarction, stent thrombosis, target-vessel revascularization (TVR). Individual patient data were obtained from 4 out of 5 trials identified, including a total of 1,000 patients, 504 (50.4 %) randomized to SES and 496 (49.6 %) randomized to PES. At long-term follow-up (1,021 [372–1,351] days), no difference was observed between SES and PES in terms of TVR (10 vs 11.6 %, HR [95 % CI 0.73 [0.45–1.16], p = 0.18, p het = 0.92]) (primary endpoint) or death (9.4 vs 10.4 %, HR [95 % CI 0.95 [0.58–1.54], p = 0.82, p het = 0.89]), reinfarction (8.2 vs 10.4 %, HR [95 % CI 0.91 [0.53–1.57], p = 0.73, p het = 0.83]), stent thrombosis (7.4 vs 4.6 %, HR [95 % CI 1.04 [0.55–2.05], p = 0.92, p het = 0.65]), and MACE (10 vs 13.6 %, HR[95 % CI 0.86 [0.63–1.18], p = 0.36, p het = 0.84]) (secondary endpoints). The present pooled patient-level meta-analysis demonstrates that, among STEMI patients undergoing primary PCI, SES and PES are associated with a similar outcome at long-term follow-up, in terms of death, reinfarction, stent thrombosis, TVR and MACE.

Abstract 504: Drug-Eluting Stent Placement for Treatment of Below-The-Knee Critical Limb Ischemia: A Report of Parameter for Wound Healing with Measurement of Transcutaneous Oxygen Tension

Objectives The aim of this study is to evaluate the efficacy of drug-eluting stents (DES) placed below-the-knee level in the parameters for wound healing. Background Critical limb ischemia (CLI) has a serious impact on quality of life with a major amputation rate of 30 percent within 12 months. Endovascular treatment has been used to perform revascularization of limbs over the past decade. However, the role of drug-eluting stent (DES) placement at below-the-knee level to improve wound healing is still inconclusive. Methods A single center retrospective study was conducted at Faculty of Medicine, Siriraj Hospital, Mahidol University. The outcomes of infrapopliteal DES placement among forty-six patients with critical limb ischemia (category 4-6 of Rutherford’s classification) from 2007 to 2011 were retrospectively reviewed. The primary endpoints were pre- and post-procedural Ankle-Brachial index (ABI) and transcutaneous oxygen tension (TcPO2). The secondary endpoints were limb salvage rate, time-to-major amputation and healing of ulcers. The differences between pre- and post-procedural parameters were analyzed with paired T-test. Results The mean follow-up time in the study was 490.21 days with limb salvage rate of 93.8 percent. Complete wound healing was observed in 81.3 percent of patients. Three of the patients underwent major amputations with the time-to-amputation ranging from 40 to 277 days post-procedure. The overall ABI was significantly improved from 0.64 ± 0.12 to 0.88 ± 0.28 (p-value &lt;0.001). Among subjects with isolated below-the-knee DES placement, ABI was also significantly improved from 0.62 ± 0.12 to 0.82 ± 0.26 (p-value 0.004). Furthermore, TcPO2 was also increased from 25.82 ± 15.77 to 40.18 ± 13.21 mmHg (p-value 0.023). Conclusions DES placement at below-the-knee level is both a safe and effective limb saving therapy in CLI patients. It has been shown to significantly improve parameters for wound healing: ABI and transcutaneous oxygen tension (TcPO2).

Treatment of Femoropopliteal In-Stent Restenosis With Paclitaxel-Eluting Stents

This study sought to evaluate the outcomes of drug-eluting stent treatment for femoropopliteal in-stent restenosis (ISR). ISR after femoropopliteal interventions is an increasing problem. Although the role of drug-eluting stents in the treatment of coronary ISR is well defined, no published studies have examined drug-eluting stents in the treatment of femoropopliteal ISR. This study examines 108 patients with 119 ISR lesions who were enrolled in the ZILVER-PTX single-arm study, a prospective, multicenter clinical trial of 787 patients. All patients were treated with paclitaxel-eluting nitinol stents. Mean patient age was 68.3 ± 9.4 years; 61.1% of patients were men. Mean lesion length was 133.0 ± 91.7 mm; 33.6% of lesions were >150 mm long and 31.1% of lesions were totally occluded. Procedural success was achieved in 98.2% of lesions with 2.1 ± 1.2 stents placed per lesion. Primary patency was 95.7% at 6 months and 78.8% at 1 year. Freedom from target lesion revascularization was 96.2% at 6 months, 81.0% at 1 year, and 60.8% at 2 years. Forty patients experienced major adverse events, exclusively target lesion revascularization. Before treatment, 81.1% of patients had Rutherford scores ≥3; at 2 years, 60.9% of patients had Rutherford scores ≤1. Both ankle brachial index and walking impairment questionnaire scores significantly improved following treatment. The 1-year fracture rate of stents used in ISR lesions was 1.2%. No significant risk factors associated with loss of patency were identified. Treatment of femoropopliteal ISR with paclitaxel-eluting stents results in favorable acute, midterm, and long-term outcomes. (Zilver PTX Global Registry [ZILVER-PTX]; NCT01094678).

Drug-eluting stents for treatment of focal infrapopliteal lesions

We have investigated the role of drug-eluting stents on patency rates after treatment of focal infrapopliteal lesions in patients with intermittent claudication and critical limb ischemia. Reports indicate that drug-eluting stents reduce the risk of restenosis after percutaneous infrapopliteal artery revascularization. A Pub Med, EMBASE, Cochrane database review search of non-randomized studies investigating patency rates, target lesion revascularisation rates, limb salvage rates and mortality rates in an up to 3-year follow-up period after drug-eluting stent placement was conducted. In addition, preliminary results of randomized studies comparing drug-eluting stents with bare-metal stents and plain balloon angioplasty in treatment of focal infrapopliteal lesions were included in this review. A total of 1039 patients from 10 non-randomized and randomized studies were included. Most commonly used drug-eluting stents were sirolimus-eluting. The mean follow-up period was 12.6 (range 8 - 24). The mean 1-year primary patency rate was 86 ± 5 %. The mean target lesion revascularization rate and limb salvage rate was 9.9 ± 5 % and 96.6 %±4 %, respectively. Results from non-randomized and preliminary results from prospective, randomized trials show a significant advantage for drug-eluting stents in comparison to plain balloon angioplasty and bare-metal stents concerning target lesion patency and in parts target lesion revascularisation. No trial reveals an advantage for drug-eluting stents with regard to limb salvage and mortality.

Impact of metabolic syndrome on re-stenosis development: Role of drug-eluting stents

Metabolic syndrome (MetS) is defined as a cluster of numerous cardiovascular risk factors, which encompasses obesity, dyslipidaemia, insulin resistance and hypertension. Patients with MetS are more prone to developing cardiovascular events than other patients. To date, several approaches such as physical exercise, dietary control and invasive and non-invasive therapeutic interventions for dyslipidaemia, hypertension and insulin resistance have been used to manage MetS. However, there is a progressive elevation in the incidence of fatal and non-fatal cardiovascular events due to the increased prevalence of obesity and diabetes. Percutaneous coronary intervention has emerged over the last few years as an effective revascularisation strategy for those with coronary artery disease, in parallel with the development of effective anti-platelet medications and newer drug-eluting stents. In recent years, considerable research efforts have been undertaken to elucidate the pathophysiology of re-stenosis and develop strategies to prevent re-stenosis following percutaneous transluminal coronary angioplasty and stent implantation. Although the rate of stent re-stenosis and target-lesion revascularisation has been reduced, there is little information in the literature on the outcome of MetS in the pathophysiology of re-stenosis. In this review article, we summarise the recent development and progress on re-stenosis and the role of drug-eluting stents, particularly in MetS.

Acute Myocardial Infarction – The Role of Drug-eluting Stents in Treatment Strategies

Although primary percutaneous coronary intervention (PCI) has become the cornerstone in the treatment of ST-segment elevation acute myocardial infarction (AMI), systemic fribrinolysis may still be considered for patients in areas where PCI is not accessible. The downside of initial plain balloon angioplasty, mainly coronary artery dissection and vessel re-occlusion, was effectively solved by the application of coronary stents. The incidence of target vessel failure, witnessed after bare metal stent (BMS) implantation, was dramatically reduced by the introduction of drug-eluting stents (DES), which significantly and effectively alleviate restenosis in the overall population. A minute incidence of late and very late DES thrombosis led to some safety concerns, which were soon rebutted, particularly by the development of newer generation DES. DES have consequently outplayed BMS among almost all anatomical and clinical subgroups of coronary artery disease patients. However, AMI remains one of the last contested territories. Today there is a growing body of evidence to support the use of DES as a safe and effective treatment of AMI.

Effect of drug-eluting stents in patients with acute ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention: a meta-analysis of randomised trials and an adjusted indirect comparison

The role of drug-eluting stent (DES) remains an unsettled issue in patients with ST-segment elevation myocardial infarction (STEMI). Therefore, we performed a meta-analysis of randomised trials to evaluate the clinical outcome of DES as compared with bare-metal stent (BMS) after percutaneous coronary intervention (PCI). We undertook a literature search until July 2009. Thirteen clinical trials met inclusion criteria, with 7,244 patients enrolled. Up to 1-year, patients treated with DES as compared with BMS experienced less target-vessel revascularisation (TVR) (5.11% versus 11.19% respectively, p<0.00001) and recurrent myocardial infarction rates (3.03% versus 3.70% respectively, p=0.02). In addition, no significant differences were found in terms of cardiac death (2.80% versus 3.52%, p=0.21) and stent thrombosis (2.65% versus 2.76%, p=0.37). Using the adjusted indirect comparison, a significant difference between sirolimus- and paclitaxel-eluting stent was found when TVR was evaluated (OR [95% CI] =0.59 [0.40-0.89], p=0.01), without differences in other clinical outcomes. In patients undergoing PCI for STEMI, treatment with DES is associated with decreased TVR and myocardial infarction rates, without increasing cardiac death or stent thrombosis occurrence. Sirolimus-eluting stent is associated with a greater TVR reduction as compared to paclitaxel-eluting stent.

Best Treatment of Saphenous Vein Graft Lesions

When used as conduits for coronary artery bypass surgery, saphenous vein grafts (SVG) develop atherosclerotic disease that may result in stenosis or occlusion in 50% of patients by 10 years. SVG intervention has become an attractive alternative to reoperation in these patients, but is associated with less favourable acute and long-term outcomes compared with percutaneous coronary intervention (PCI) of native vessels due to a higher incidence of periprocedural micro-embolisation and of late restenosis. The role of protection devices that reduce distal embolisation and no-reflow phenomenon has been well established, and they now represent a ‘must’ for almost all of the procedures of PCI in SVG. The potential role of drug-eluting stents (DES) in improving long-term results of SVG intervention is still debated and, to date, there is no clear evidence of their benefit in relevant clinical end-point. The aim of this article is to examine the best available therapeutic options for patients undergoing PCI of SVG lesions.

The Role of Drug-Eluting Stents in Treating Cardiac Transplant Vasculopathy

The Role of Drug-Eluting Stents in Treating Cardiac Transplant Vasculopathy

Letter by Barlis et al Regarding Article, “Two-Year Clinical Outcomes With Drug-Eluting Stents for Diabetic Patients With De Novo Coronary Lesions: Results From a Real-World Multicenter Registry

To the Editor: The role of drug-eluting stents within the field of interventional cardiology has recently come under close scrutiny in the wake of increasing concerns about late stent thrombosis and doubts on the overall cost-effectiveness of these devices. The prevailing view among experts, however, is that this technology retains an important role, particularly in patients at high risk of restenosis such as those with diabetes mellitus, as suggested by randomized trials.1 It was thus with great interest that we read the article by Ortolani et al,2 which presents the results …

Primary Percutaneous Coronary Intervention With Drug-Eluting Stents

Primary percutaneous coronary intervention (P-PCI) is the preferred reperfusion strategy for patients with ST-segment elevation myocardial infarction if it can be performed rapidly by an experienced team.1 Compared with balloon angioplasty, routine bare-metal stent (BMS) implantation decreases risk for target vessel revascularization (TVR) and possibly reduces myocardial reinfarction rates but does not reduce mortality rates.2,3 Therefore, BMS has become the dominant P-PCI strategy, despite initial concern about increased stent thrombosis rates from delayed healing or inadequate late stent apposition due to initial thrombus trapping. Less established is the role of drug-eluting stents (DES) in P-PCI. DES have the potential to further decrease TVR rates but may increase risk for stent thrombosis. In fact, the risk of stent thrombosis might even be higher in P-PCI than in electively treated patients because of the combination of increased platelet activation, delayed healing, lack of endothelialization, and the proinflammatory and prothrombotic environment in the infarct artery.4 Article see p 103 Several relatively small randomized clinical trials have shown inconsistent efficacy for DES over BMS for P-PCI. Three meta-analyses of these trials have concluded that there is no difference in death or myocardial infarction rates, but TVR rates are decreased.5–7 Variably included were 12 studies that differed in trial design, inclusion criteria, end-point definitions, stent types, duration of clopidogrel treatment, and type of follow-up (angiographic versus clinical). They were limited by sample size and duration of follow-up and usually required angiographic documentation of stent thrombosis, which may have underestimated its true incidence. In this issue of Circulation: Cardiovascular Interventions , Kukreja et al8 report a single-center registry study that is an expanded version of a previous publication.9 Again including the 185 ST-segment elevation myocardial infarction patients treated with Sirolimus-eluting stents (SES) from April 2002 to February 2003, they compare …

Abstract 2978: Long-Term Results After Unprotected Left Main Stenting With Drug-Eluting Stents. Insights From the French Left Main Taxus Registry

Drug-eluting stents (DES) have reduced restenosis rate and are now emerging as an alternative to bypass surgery (CABG) for treating unprotected left main (ULM) stenosis. A prospective registry was set up in France to explore the role of DES in this setting. Consecutive patients (Pts) with de novo ULM stenosis undergoing PCI with Paclitaxel eluting stent (PES) in 4 French centers were prospectively included in this real world study. Acute MI and cardiogenic shock were the only criteria for exclusion. Pts had a loading dose (450 to 600 mg) of plavix before the procedure, aspirin (≥75 mg) and plavix (75 to 150 mg/day) for at least 6 months. Clinical outcome was planned up to 3 years and repeat angiography was strongly recommended at 6 months. Between March 2003 and June 2005, 291 Pts were included: 69±11 yrs old, 77% male, 29% diabetic, 5% renal failure, 17% previous or recent MI, 38% acute coronary syndrome and 25% 3-vessel disease. Euroscore was 4.8±3.4 (predicted in-hospital mortality in case of CABG 6.3±10.4). Provisional T stenting (distal LM in 78.4%) was used in 92% of cases and final kissing balloon in 96.8%. Angiographic success was obtained in 99.7%. Other lesions (1.2±0.9) were treated during the same hospitalization in 77%. Repeat angiogram was performed in 182 Pts (63%) at 7.0±4.0 months. Restenosis was observed in 8.7%. The clinical outcome is summarized below: By multivariate analysis Euroscore (OR 1.245; 95% CI 1.077–1.439; p=0.003), terminal renal failure with dialysis therapy (OR 0.018; 95% CI 0.002– 0.172; p=&lt;0.001) and LM bifurcation angle T-type (OR 0.205; 95% CI 0.071– 0.593; p=0.003) were the only independent predictors of death. The incidence of definite or probable LM stent thrombosis (ST) as defined by the ARC was at 2-years 2.09% (3 early ST and 3 late or very late ST). LM stenting using PES with a strategy of provisional side branch T stenting in case of distal lesion provides excellent acute angiographic results and very acceptable long-term outcome.

Quel avenir pour le stent coronaire?

The future role of drug eluting stent will depend on several factors. First, there is a need for a better understanding of different mechanisms favoring stent thrombosis. Consequently, the optimal antiplatelet therapy has to be defined, patient by patient, with many unclear answers, particularly regarding the duration of treatment and the strategy for patient who are candidate to any general surgery. The validation of DES use in good CABG candidates is ongoing. Lastly, the development of new generation DES is crucial with many possible ways among which biobabsorbable coating, surface treatment and combination drugs are important approaches.

Toward Defining the Role of Drug-Eluting Stents

Toward Defining the Role of Drug-Eluting Stents

Drug-eluting stent era: will we improve 5-year outcomes?

Five-year outcomes after coronary stenting are determined by restenosis of the original stented lesion during the first year and, later, by disease progression at non-stented segments, owing to either gradual progression of atherosclerosis or instability of vulnerable plaques. Drug-eluting stents have demonstrated potent anti-restenosis benefits in a variety of lesion types and high-risk patients, including complex long lesions and diabetic patients. It is likely that this benefit will translate into improved 5-year outcomes, with reduction in need for repeat revascularization in many patients and possibly reduced incidence of myocardial infarction and death, especially in diabetic patients, in whom the risk for occlusive restenosis and 5-year death and myocardial infarction rates are known to be higher after bare-metal stents. Future studies will determine the role of drug-eluting stents in preventing adverse outcomes owing to later disease progression. Such strategies and proposed clinical trials may include identification and prophylactic stenting of individual vulnerable plaques or coronary segments, and comparisons with coronary artery bypass surgery for complete revascularization success. While the outlook for benefit of drug-eluting stents in 5-year outcomes is hopeful, it is likely that a true improvement in these outcomes will be realized more from a judicious use of drug-eluting stents coupled with other proven aggressive secondary prevention therapies.

Surgical, medical, and percutaneous therapies for patients with multivessel coronary artery disease

Patients with multivessel coronary artery disease (CAD) are now faced with a number of treatment choices, including coronary artery bypass graft surgery, medical therapy, and percutaneous coronary interventions (using bare-metal or drug-eluting stents). Each carries certain benefits and risks: bypass surgery is favored in the subset of patients with multivessel disease and diabetes or impaired left ventricular systolic function who are able to receive a left internal mammary artery graft; medical therapy consisting of beta-blockers, angiotensin-converting enzyme inhibitors, statins, aspirin, and nitrates is offered to patients with stable angina. Percutaneous procedures have previously been limited in their efficacy by restenosis and resulting morbidity, but contemporary stenting procedures appear to show equivalent mortality and morbidity outcomes (to bypass surgery) at 5 years. Drug-eluting stents are the newest percutaneous technique and show significant reduction in restenosis compared with older catheter-based therapies, but further investigation is needed to definitively define the role of drug-eluting stents in the treatment of multivessel CAD. This review summarizes the data comparing medical, surgical, and percutaneous treatment approaches for patients with multivessel CAD.