Drug-eluting Stents In Clinical Practice Research Articles

Report of an ESC-EAPCI Task Force on the evaluation and use of bioresorbable scaffolds for percutaneous coronary intervention: executive summary.

A previous Task Force of the European Society of Cardiology (ESC) and European Association of Percutaneous Cardiovascular Interventions (EAPCI) provided a report on recommendations for the non-clinical and clinical evaluation of coronary stents. Following dialogue with the European Commission, the Task Force was asked to prepare an additional report on the class of devices known as bioresorbable scaffolds (BRS). Five BRS have CE-mark approval for use in Europe. Only one device -the Absorb bioresorbable vascular scaffold- has published randomized clinical trial data and this data show inferior outcomes to conventional drug-eluting stents (DES) at 2-3 years. For this reason, at present BRS should not be preferred to conventional DES in clinical practice. The Task Force recommends that new BRS devices should undergo systematic non-clinical testing according to standardized criteria prior to evaluation in clinical studies. A clinical evaluation plan should include data from a medium sized, randomized trial against DES powered for a surrogate end point of clinical efficacy. Manufacturers of successful devices receive CE- mark approval for use and must have an approved plan for a large-scale randomized clinical trial with planned long-term follow-up.

Report of an ESC-EAPCI Task Force on the evaluation and use of bioresorbable scaffolds for percutaneous coronary intervention: executive summary.

A previous Task Force of the European Society of Cardiology (ESC) and European Association of Percutaneous Cardiovascular Interventions (EAPCI) provided a report on recommendations for the non-clinical and clinical evaluation of coronary stents. Following dialogue with the European Commission, the Task Force was asked to prepare an additional report on the class of devices known as bioresorbable scaffolds (BRS). Five BRS have CE-mark approval for use in Europe. Only one device-the Absorb bioresorbable vascular scaffold-has published randomized clinical trial data and this data show inferior outcomes to conventional drug-eluting stents (DES) at 2-3 years. For this reason, at present BRS should not be preferred to conventional DES in clinical practice. The Task Force recommends that new BRS devices should undergo systematic non-clinical testing according to standardized criteria prior to evaluation in clinical studies. A clinical evaluation plan should include data from a medium sized, randomized trial against DES powered for a surrogate end point of clinical efficacy. Manufacturers of successful devices receive CE-mark approval for use and must have an approved plan for a large-scale randomized clinical trial with planned long-term follow-up.

Histopathology of vascular response to drug-eluting stents: an insight from human autopsy into daily practice.

Drug-eluting stents (DES) were developed with the primary purpose of inhibiting neointimal overgrowth following percutaneous coronary intervention (PCI). While DES have significantly reduced the rates of restenosis compared with bare metal stent (BMS), they have not completely eliminated it. Moreover, late stent thrombosis (LST), attributed to delayed arterial healing or abnormal vessel responses to DES, have emerged as a major safety concern. Although newer DES or other novel devices are expected to show promising results, the problems in interventional technologies have not been completely resolved. In this review, we will consider the current status of DES in clinical practice and discuss the strengths and limitations of recent advances from the view of histopathology.

Unprotected left main coronary artery stenting with everolimus (Xience V) drug-eluting stents: A single center retrospective experience

Objectives: We sought to evaluate the efficacy and safety of unrestricted implantation of everolimus eluting stent Xience V (EES-XV) in a cohort of real- world patients with unprotected left main coronary disease (ULMCD). Background: The second-generation EES-XV stent is currently one of the most commonly used drug-eluting stents in clinical practice. It has been shown to be superior to paclitaxel-eluting stents, but its relative merits on unprotected left main coronary disease have been less extensively assessed. Methods: Between 2007 and 2010, in this single-center registry, we evaluated the clinical outcomes of 98 patients with ULMCD who underwent percutaneous coronary intervention (PCI) with EES-XV. Results: There were no in-hospital deaths. At 25.63 ± 14.41 months of follow-up, 17 patients (17.3%) experienced major adverse coronary event (MACE), death from cardiovascular disease (n = 6; 6.1%) and target lesion revascularization (TLR; n = 7; 7.1%). The predictors of death from cardiovascular disease were: previous PCI and left ventricular dysfunction. The only predictor of TLR was the placement of 2 stents in the left main coronary artery. Conclusions: In this single- center real-world registry, we found that elective ULMCD stenting with EES-XV provided good short-, medium- and long-term outcomes, with an estimated cumulative need for TLR of 7.1%, a cardiac mortality rate of 6.1%, and a MACE rate of 17.3% at 2 years.

Everolimus-eluting versus sirolimus-eluting stents: an updated meta-analysis of randomized trials

Everolimus-eluting stents (EES; Xience V) are among the most commonly used newer generation drug-eluting stents in clinical practice and have clearly proven superiority over paclitaxel-eluting stents. Nevertheless, the relative merits of EES against the previous gold-standard sirolimus-eluting stent (SES; Cypher) have been less extensively assessed. We aimed to compare the clinical outcomes of EES with SES in patients with coronary artery disease undergoing percutaneous coronary intervention. We identified eight eligible randomized trials comparing EES with SES including 11,167 patients. The primary endpoint was the incidence of major adverse cardiac events (MACE). Secondary endpoints were target lesion revascularization (TLR) and the composite of definite and probable stent thrombosis. The follow-up ranged from 9 to 36 months. No heterogeneity across the trials was observed regarding the selected endpoints. There was no difference in risk of MACE (HR 0.91 [0.79-1.04]; p = 0.15), TLR (HR 0.86 [0.72-1.04]; p = 0.12) and the composite of definite and probable stent thrombosis (HR 0.84 [0.54-1.29], p = 0.42). The risk of definite stent thrombosis was significantly lower in patients receiving EES (HR 0.49 [0.27 to 0.91]; p = 0.02). Using the largest available dataset of patients treated in randomized trials, the present meta-analysis demonstrated that the use of EES versus SES was associated with comparable incidence of overall clinical events. However, EES may be associated with a lower risk of definite stent thrombosis.

EVEROLIMUS-ELUTING VERSUS SIROLIMUS-ELUTING STENTS: AN UPDATED META-ANALYSIS OF RANDOMIZED TRIALS

Everolimus-eluting stents (EES) are among the most commonly used second-generation drug-eluting stents in clinical practice and have clearly-proven superiority over paclitaxel-eluting stents. Nevertheless, the relative merits of EES against the previous gold-standard sirolimus-eluting stent (SES)

Everolimus-Eluting Versus Sirolimus-Eluting Stents

Background— The aim of the study was to compare the outcomes after placement of the everolimus-eluting stent (EES; Xience V) and the sirolimus-eluting stent (SES; Cypher) in patients with coronary artery disease. The second-generation EES is currently one of the most commonly used drug-eluting stents in clinical practice. Although it has clearly been shown superior to paclitaxel-eluting stents, its relative merits against SES have been less extensively assessed. Methods and Results— We identified 5 eligible randomized trials comparing EES with SES in 7370 patients. The primary end point was major adverse cardiac events. Secondary end points were cardiac death, myocardial infarction, repeat revascularization, and the composite of definite and probable stent thrombosis. Overall hazard ratios (HR) and 95% confidence intervals (CI) were calculated for EES versus SES for each of the end points. No heterogeneity across the trials was observed regarding the primary and secondary end points. The risk of major adverse cardiac events (HR, 0.91 [95% CI, 0.77 to 1.08]; P =0.28), cardiac death (HR, 1.02 [95% CI, 0.73 to 1.41]; P =0.92), myocardial infarction (HR, 0.97 [95% CI, 0.66 to 1.35]; P =0.76), repeat revascularization (HR, 0.85 [95% CI, 0.68 to 1.07]; P =0.16), and composite of definite and probable stent thrombosis (HR, 0.79 [95% CI, 0.49 to 1.27], P =0.33) were not significantly different between EES and SES. Conclusions— This meta-analysis did not show significant differences between EES and SES in terms of clinical efficacy and safety. Future studies with longer follow-up are needed to better define the relative merits of these drug-eluting stents.

Lessons for the treatment of bifurcation lesions: from nowadays to the future

The use of drug-eluting stents in clinical practice has altered the treatment perspective for bifurcation lesions; however, relatively high rates of stent thrombosis and restenosis are still observed. All bifurcations are unique; therefore, a crucial issue in bifurcation angioplasty regards the selection of the most appropriate strategy for an individual bifurcation. When stenting is used, a major question to address is whether both the main vessel and the side branch should be stented. Moreover, plaque debulking in conjuction with directional coronary atherectomy or modification with a scoring device before stent deployment could minimize arterial injury and subsequent neointimal proliferation and prevent restenosis formation. Dedicated bifurcation stents represent an alternative treatment option for restenosis. We believe that biodegradable stents will replace metal stents leaving behind only the healed natural vessel.

Drug-eluting stents: A study of international practice

We aimed to analyze trends in drug-eluting stents (DES) use in four international health care and regulatory settings. Accounts suggest a differential approach to DES internationally and recent reductions in use following reports of late stent thrombosis. Current studies of clinical practice are limited in their scope. Data were pooled from angioplasty registries in Alberta (Canada), Belgium, Mayo Clinic (Rochester, MN), and Scotland (UK) that have routinely recorded consecutive patients treated since 2003. Trend analysis was performed to examine variations in DES use over time and by clinical subgroup. A total of 178,504 lesions treated between January 2003 and September 2007 were included. In the Mayo Clinic Registry, rapid adoption to a peak of 91% DES use for all lesions by late 2004 was observed. In contrast, Alberta and Scotland showed delayed adoption with lower peak DES use, respectively, 56% and 58% of lesions by early 2006. Adoption of DES in Belgium was more gradual and peak use of 35% lower than other registries. Reductions in DES use were seen in all data sets during 2006, although this varied in absolute and relative terms and by clinical subgroup. Adoption and use of DES showed wide variation in four countries. The determinants of use are complex, and it is likely that nonclinical factors predominate. Recent reductions in use may be as a consequence of publicity and concerns regarding late stent thrombosis. The optimum application of DES in clinical practice is unclear and is reflected in the degree of international variation demonstrated.

Assessing the Landscape of Stent Thrombosis: The Drug-Eluting Versus Bare-Metal Stent Controversy

Within labeled indications, drug-eluting stents (DES) are as safe as bare-metal stents (BMS). Data from key randomized, controlled trials comparing paclitaxel-eluting stents with BMS or sirolimus-eluting stents with BMS show no difference in risk of death/myocardial infarction or stent thrombosis using uniform definitions of stent thrombosis. However, these trials and other analyses indicate a difference in time distribution of stent thrombosis, with more cases of stent thrombosis occurring later (ie, after 1 year) in patients with DES--a problem to which the lack of adequate antiplatelet therapy appears to be a main contributor. A consistent finding from randomized, controlled trials of DES versus BMS is the significantly reduced need for reintervention associated with DES use. In the absence of any other differences in safety between DES and BMS, this reduced need for reintervention constitutes a significant advantage for DES in clinical practice.

Applying Drug-Eluting Stents in Clinical Practice

The use of percutaneous coronary interventions has resulted in significant improvement in patient care; however, the risk for restenosis remains a major limitation. Drug-eluting stents represent an impressive breakthrough in the evolution of interventional cardiology, but it is important to understand the limits to their added benefit. Safety of the procedure must continue to be the first consideration, and technique must not be compromised to accommodate new technology.

Update on drug-eluting coronary stents

The introduction of drug-eluting stents (DES) to interventional cardiology practice has resulted in a significant improvement in the long-term efficacy of percutaneous coronary interventions. DES successfully combine mechanical benefits of bare-metal stents and stabilizing the lumen, with direct delivery and the controlled elution of a pharmacologic agent to the injured vessel wall to suppress further neointimal proliferation. The dramatic reduction in restenosis has resulted in the implementation of DES in clinical practice, and has rapidly expanded the whole spectrum of successfully treatable coronary conditions, particularly in high-risk patients and complex lesions. In this review the authors present current data on DES. Currently, two types of DES are available in the USA: sirolimus-eluting stents (SES) CYPHER™ (Cordis Corp., FL, USA) and paclitaxel-eluting stents (PES) TAXUS™(Boston Scientific, MA, USA), and many more are on the way to approval. In addition to sirolimus and paclitaxel, several other drugs have been successfully used in DES. Everolimus and ABT-578 are both analogs of sirolimus that also have immunosuppressive and antiproliferative properties. Another approach in the development of DES is to use drugs that can accelerate re-endothelialization and restore normal endothelial function following vascular injury. Recent advances in vascular gene transfer have also demonstrated potential new treatment modalities for cardiovascular disease, particularly in the treatment of vascular restenosis.

An Evidence-Based Approach to the Use of Drug-Eluting Stents in Clinical Practice

Less than a year after their release, drug-eluting stents are being used in more than 70% of patients who undergo percutaneous intervention for obstructive coronary disease in the United States. This unprecedented quick adoption was fueled by results of several randomized trials that demonstrated a profound reduction in restenosis rates compared with bare-metal stents. Subset analysis of the drug-eluting stent trials shows a strong restenosis reduction rate across a wide range of patient characteristics; however, these broad beneficial effects are based on randomized subjects who may not represent the actual population currently being treated with coronary stents. This review presents an analysis of the available data on the approved drug-eluting stents, including patient subsets that may or may not benefit; potential stent-specific complications; and a discussion of costs, risks, and cost-effectiveness.