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Drug-eluting Stents (drug-eluting + stent)
Terms modified by Drug-eluting Stents Selected AbstractsDrug-Eluting Stents Versus Bare Metal Stents Following Rotational Atherectomy for Heavily Calcified Coronary Lesions: Late Angiographic and Clinical Follow-Up ResultsJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 2 2007AHMED A. KHATTAB M.D. Objectives: To study the effectiveness of drug-eluting stents following rotablation of severely calcified lesions. Background: Drug-eluting stents are increasingly showing promising results in complex lesions and high-risk patients. Heavily calcified stenoses have not been adequately studied, and form a challenge both for the immediate and late outcomes. Methods: Single-center prospective study among 27 patients treated by rotablation followed by a drug-eluting stent implantation for angiographically heavily calcified lesions, compared with a historical control of 34 patients treated by rotablation followed by bare stent implantation for the same indication. The primary endpoint was the late lumen loss at 9 months; secondary endpoints were binary restenosis and major adverse cardiac events at 9 months. A 2-year follow-up directed to death and myocardial infarction was added. Results: Both groups were comparable regarding baseline and procedural characteristics. Angiographic success was 100% for both groups. At 9 months, there was a significant difference in the late lumen loss (0.11 ± 0.7 mm in the DES group and 1.11 ± 0.9 mm in the BMS group, P = 0.001). This difference was manifest in the clinical event rates at late follow-up (combined incidence of death due to any cause, MI, and TLR was 7.4% in the DES group and 38.2% in the BMS group; P = 0.004). At 2 years, there were 5 deaths in each group (P = 0.5) and 2 infarctions in the BMS group versus none in the DES group (P = 1.0). Conclusion: The combination of rotablation and drug-eluting stent implantation (Rota-DES) has a favorable effect on clinical and angiographic outcomes at 9 months when treating heavily calcified lesions compared to rotablation followed by bare metal stent implantation. No safety concerns are observed at 2 years. [source] Is there a preferable DES in diabetic patients?CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 7 2008A critical appraisal of the evidence Abstract Drug-eluting stent (DES) therapy reduces restenosis in patients with diabetes when compared with bare metal stent implantation. There are significant differences between commercially available DES platforms both in terms of design characteristics and clinical outcomes. Randomized active-comparator inter-DES trials powered for clinical endpoints are unlikely to be performed in patients with diabetes, however, direct comparison randomized trials utilizing surrogate endpoints support a superior anti-restenotic efficacy with sirolimus- versus paclitaxel-eluting stents. Thrombotic stent occlusion may be higher in patients with diabetes compared with nondiabetic patients, though there is no clear signal of a safety differential between the two platforms. Insufficient data on comparative performance in diabetics exist in relation to the approved zotarolimus-eluting and everolimus-eluting stent platforms. If all other factors are equal, then there seems to be no reason why the diabetic patient should not receive treatment with the sirolimus-eluting stent, which appears to have superior antirestenotic efficacy in this patient group. © 2008 Wiley-Liss, Inc. [source] Interaction of endothelial cells with self-assembled monolayers for potential use in drug-eluting coronary stentsJOURNAL OF BIOMEDICAL MATERIALS RESEARCH, Issue 2 2009Gopinath Mani Abstract Drug-eluting stents (DES) are implanted in patients to treat in-stent restenosis. Commercially available DES use polymers for coating and releasing drugs. Several studies have showed that polymer coatings cause adverse reactions. Delayed endothelialization of polymer-coated DES leads to late stent thrombosis. Recently, the potential for using self-assembled monolayers (self-assembled monolayers (SAMs),organic constructs composed of (a) chemical groups which attach to metal surfaces, (b) long hydrocarbon chains, and (c) terminal functional groups) as an alternate drug delivery system for coronary stents has been demonstrated. In this study, the interaction of human aortic endothelial cells (HAECs) with SAMs and therapeutic SAMs (therapeutic self-assembled monolayers (TSAMs),SAMs derivatized with the drug, flufenamic acid) was investigated. HAECs were cultured on plain glass, control, SAMs-, and TSAMs-coated titanium (Ti) and gold (Au) specimens. The viability and proliferation of HAECs were investigated using MTT colorimetric assay. The adhesion of HAECs on SAMs and TSAMs was equivalent to that of control metal surfaces and superior to that of plain glass surfaces. The cells continued to proliferate on both SAMs and TSAMs even though the rate of proliferation was slower than plain glass or control-Ti. The spreading of HAECs on TSAMs with typical polygonal shape indicated that these surfaces are conducive to endothelialization. The expression of surface adhesion protein, platelet endothelial cell adhesion molecule-1, on TSAMs indicated that the endothelial cells preserved their phenotype on these surfaces. Thus, this study demonstrated that SAMs and TSAMs do not elicit an adverse response from endothelial cells in in vitro conditions. © 2009 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 2009 [source] An Overview of the TAXUS® Express®, Paclitaxel-Eluting Stent Clinical Trial ProgramJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 5 2006JOHN M. LASALA M.D., Ph.D. Restenosis remains a problem following percutaneous coronary intervention in patients with coronary artery disease. Drug-eluting stents (DES), which combine mechanical and pharmacologic properties, have been shown to prevent or reduce neointimal growth after deployment. This review describes the TAXUS paclitaxel-eluting stent clinical trial expansion program (TAXUS® Express®, Boston Scientific, Natick, MA). This program comprises the largest data set of randomized controlled trials (RCTs) of DES to date, with over 6,200 patients enrolled since 2000. The program includes treatment of de novo lesions, as well as higher-risk lesion and patient populations. In this review, we discuss the results from the TAXUS family of randomized clinical trials, and compare the findings with data from TAXUS registries. The data from the randomized clinical trials suggest that the paclitaxel-eluting stent provides consistent and durable benefits across multiple lesion and patient types. Evidence from peri-and postapproval registries, where patient populations are more heterogeneous than those eligible and included in the RCTs, corroborate these findings, with overall low rates of cardiac events, including reinterventions. [source] Polymer-Based Paclitaxel-Eluting Stents in Percutaneous Coronary Intervention:JOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 5 2004A Review of the TAXUS Trials Drug-eluting stents have altered the practice of interventional cardiology by dramatically reducing the risk of angiographic and clinical restenosis following percutaneous coronary intervention. Based on extensive preclinical study and clinical trial data, the polymer-based, slow rate-release paclitaxel-eluting TAXUS stent has recently received Food and Drug Administration approval for sale in the United States. In the current article, we review the available data from the TAXUS trials that have demonstrated that implantation of the slow rate-release TAXUS stent is safe and, in terms of restenosis, markedly superior to bare metal stenting for the treatment of de novo lesions <28 mm in length in arteries 2.5,3.75 mm in diameter. Additional trials in the TAXUS program are currently examining the role of slow and moderate rate-release polymer-based, paclitaxel-eluting stents in a broader range of clinical settings and lesion subsets. [source] The Problem of Stent Thrombosis Associated With Drug-Eluting Stents and the Optimal Duration of Dual Antiplatelet TherapyPREVENTIVE CARDIOLOGY, Issue 2 2009Susana Ayyanathan MD Drug-eluting stents have significantly reduced the problem of restenosis, but there is an association between drug-eluting stents and stent thrombosis that can be a significant clinical problem resulting in myocardial infarction or death. The risk for stent thrombosis increases in certain clinical situations and has been reduced through the use of dual antiplatelet therapy for prolonged periods. Until new therapies are developed, it is essential that patients who have had drug-eluting stents implanted continue with dual-antiplatelet therapy for at least 1 year and possibly for an indefinite period. [source] Clinical Use of Sirolimus-Eluting StentsCARDIOVASCULAR THERAPEUTICS, Issue 4 2007Ajay J. Kirtane ABSTRACT Drug-eluting stents, or intracoronary stents that combine the local delivery of antirestenotic pharmacologic therapies while maintaining the mechanical advantage of bare metal stents over balloon angioplasty alone, are a highly complex technology that have profoundly affected the practice of percutaneous coronary intervention over the last 5 years. These devices were designed specifically to treat the neointimal hyperplasia occurring after conventional bare metal stent placement, and have been remarkably successful in this regard. However, recent concerns have been raised regarding the long-term safety of these devices, particularly when used outside of the specific patient and lesion subsets studied in the pivotal randomized trials that led to device approval by regulatory bodies within the United States and abroad. This review aims to present a brief description of the sirolimus-eluting stent device platform and its mechanism of action, followed by an overview of current data regarding efficacy and safety regarding the clinical use of sirolimus-eluting stent technology. [source] Overview of the 2006 Food and Drug Administration Circulatory System Devices Panel meeting on drug-eluting stent thrombosisCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 7 2007Tina L. Pinto Slottow Abstract Drug-eluting stents (DES) seemed likely to mitigate the problem of restenosis and have become the predominant stent deployed during percutaneous coronary intervention (PCI). Sustained concerns about the rate of stent thrombosis (ST), particularly very late ST (>1 year following PCI) led to a meeting of the Circulatory System Devices Advisory Panel to address "on-label" and "off-label" use as well as appropriate duration of dual antiplatelet therapy following DES. Over 40 presentations by members of the FDA, industry personnel, and leaders in the field of interventional cardiology helped set forth the body of data available on DES. Standardized definitions of ST created by the Academic Research Consortium were applied to existing randomized trials and registries. At the end of the 2-day session, the consensus of the panel was that "on-label" DES use is not associated with increased incidence of death and myocardial infarction (MI), although it is associated with increased rates of very late ST. "Off-label" use is associated with increased risk of death or MI when compared with "on-label" use. Insufficient data exist to determine the duration of clopidogrel that would minimize ST and bleeding risk, but the panel agreed with the current ACC/AHA/SCAI guidelines regarding dual antiplatelet therapy for at least 12 months in patients at low risk for bleeding, especially with "off-label" use. More data from trials designed with better control arms and prespecified analyses of complex patients and lesions subsets over longer periods of follow-up are needed. © 2007 Wiley-Liss, Inc. [source] Drug-eluting stents for secondary prevention of restenosisCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 3 2004Adnan Kastrati MD No abstract is available for this article. [source] Drug-eluting stents for the prevention of restenosis: Standing the test of timeCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 1 2002Andrew J. Carter DO No abstract is available for this article. [source] Drug-eluting stents,safety concernsCLINICAL CARDIOLOGY, Issue 11 2006C. Richard Conti M.D., M.A.C.C. Editor-in-Chief No abstract is available for this article. [source] Drug-eluting stents versus bare metal stentsCLINICAL CARDIOLOGY, Issue 11 2003C. Richard Conti M.D., M.A.C.C. Editor-in-Chief No abstract is available for this article. [source] Real World, Long-Term Outcomes Comparison Between Paclitaxel-Eluting and Sirolimus-Eluting Stent PlatformsJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 2 2010M.B.A., MANDEEP S. SIDHU M.D. We compare real-world, extended target vessel revascularization (TVR)-free survival following percutaneous coronary intervention (PCI) for patients receiving either sirolimus-eluting stents (SES) or paclitaxel-eluting stents (PES) following an index drug-eluting stent (DES) supported procedure. We analyzed 2,363 consecutive patients having first DES-supported PCI at receiving PES (n = 1,012) or SES (n = 1,332) from April 2004 to July 2006. Baseline clinical and procedural characteristics and in-hospital outcomes were recorded during the time of the index procedure and extended clinical outcomes data were obtained thereafter. TVR and all cause mortality were identified during the study period. Adjusted Kaplan-Meier and Cox's proportional hazard survival methods were performed. TVR-free survival at 2.3 years was 91.3% for SES compared with 88.9% for PES (P = 0.06). Kaplan-Meier survival curves did not significantly differ (adjusted hazard ratio ,1.39 [95% CI 0.99,1.97]) between the SES and PES patient cohorts. TVR was similar between the stent platforms at one (96.6% for SES [95% CI 95.3,97.6] vs. 95.7% for PES [95% CI 94.1,96.9]) and two (95.0%[95% CI 93.0,96.4] for SES vs. 93.7% for PES [95% CI 91.6,95.3]) years. Overall survival at 2 years was 96.2% for SES (95% CI 94.7,97.3) and 95.3% for PES (95% CI 93.7,96.5). SES and PES drug-eluting stent platforms have good and similar extended outcomes in this real world registry of unselected patients having PCI. (J Interven Cardiol 2010;23:167-175) [source] The Short-Term Effect on Restenosis and Thrombosis of a Cobalt-Chromium Stent Eluting Two Drugs in a Porcine Coronary Artery ModelJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 5 2009YINGYING HUANG Ph.D. The aim of this article was to study the effect of dual drug-eluting stent (DES) on both restenosis and thrombosis in a porcine coronary artery model. This study reports on the use of two drugs coated on the stent to simultaneously minimize both restenosis and thrombosis. The DES was prepared by spray coating a bare metal stent with a biodegradable polymer loaded with sirolimus and triflusal, to treat against restenosis and thrombosis, respectively. The two-layered dual drug-coated stent was characterized in vitro for surface properties before and after expansion, as well as for possible delamination by cross-sectioning the stent in vitro. In vivo animal studies (in a pig model) were then performed for acute thrombosis, inflammation, and restenosis. The results show a significant reduction in restenosis with a stent coated with both drugs compared with the controls (a bare metal stent, a sirolimus-coated, and a pure polymer-coated stent). The reduction in restenosis with a sirolimus/triflusal-eluting stent is associated with an inhibition of inflammation and thrombus formation, suggesting that such dual DES have a role to play for the treatment of coronary artery diseases. [source] Efficacy of Sirolimus-Eluting Stents as Compared to Paclitaxel-Eluting Stents for Saphenous Vein Graft InterventionJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 2 2006Ph.D., WILLIAM W. CHU M.D. Background: Saphenous vein graft (SVG) intervention is associated with a significantly increased rate of periprocedural complications and late clinical and angiographic restenosis. In the contemporary drug-eluting stent (DES) era, the comparison of the efficacy of sirolimus-eluting stents (SES) with paclitaxel-eluting stents (PES) in SVG interventions is currently unknown. We conducted this retrospective analysis to investigate this issue. Methods and Results: Forty-seven patients with 50 SVG lesions who underwent standard percutaneous coronary intervention (PCI) with SES (SES group) were compared with 42 patients with 45 SVG lesions with PES (PES group). All patients received distal protection devices (DPDs) during the interventions. The in-hospital, 30-day, and 6-month clinical outcomes in both groups were compared. Baseline clinical and procedural characteristics were balanced between both groups except for the proximal and mid lesions. There were no deaths or Q-wave myocardial infarctions (MIs) during the index hospitalization. Non-Q-wave MI was similar between the two groups (SES vs PES, 4.3% vs 7.1%, P = 0.55). At 30-day and 6-month follow-ups, all the clinical outcomes were similar between the two groups. There was no subacute thrombosis (SAT) or late thrombosis in either group. The event-free survival at 6 months was also similar between both groups (P = 0.75). Conclusions: The use of DES in patients undergoing SVG intervention with a DPD is clinically safe and feasible. As compared to SES, PES have the same efficacy and clinical outcomes in SVG interventions up to 6 months. [source] Latest news and product developmentsPRESCRIBER, Issue 4 2007Article first published online: 3 APR 200 Low-dose aspirin may reduce asthma risk Low-dose aspirin may reduce the risk of new-onset asthma, according to a US analysis (Am J Respir Crit Care Med 2007;175:120-5). Prompted by speculation of such a link, the authors conducted a post-hoc analysis of the Physicians' Health Study, a placebo-controlled study of aspirin 325mg on alternate days involving 22 071 men aged 40-84. The risk of developing a new diagnosis of asthma during the five-year study was reduced by 22 per cent (p=0.045) among those taking aspirin. However, the number of cases was low: 113 among aspirin recipients and 145 with placebo. The clinical importance of this finding is therefore uncertain, though it received wide coverage in the lay media. Lifestyle changevsdrugs in type 2 diabetes Modifying lifestyle is at least as effective as drugs in delaying the onset of type 2 diabetes in people with impaired glucose tolerance, according to a study from Leicester (BMJ online. doi: 10.1136/bmj.39063.689375.55). The meta-analysis of 17 trials involving 8084 participants found that lifestyle change or orlistat approximately halved the risk of progressing to diabetes, whereas oral hypoglycaemic agents reduced the risk by 30 per cent. A Chinese herb, jiang tang bushen, reduced the risk by two-thirds. The analysis was conducted before the findings of major trials of rosiglitazone (Avandia) , DREAM and ADOPT , were published. Optician prescribing The diagnosis and treatment of disorders such as conjunctivitis by opticians is to be an enhanced service that PCTs can commission according to local need, a Department of Health review has concluded. The General Ophthalmic Services Review considered new arrangements to support PCTs provide ophthalmic services. Professional representatives proposed that the diagnosis and treatment of some eye conditions should be classed as ,additional services' that PCTs should be obliged to commission. While the Department agreed that opticians can play an important role, it found a lack of evidence of benefits and concluded that PCTs should be able to determine their level of services. A commissioning toolkit has been produced to help implement the review's findings. Warfarin stroke risk A four-fold increase in warfarin use has been linked with an increased incidence of intracerebral haemorrhage in a US study (Neurology 2007;68:116-21). Reviewing all first admissions for haemorrhagic stroke in the Cincinnati area, the study found that the proportion of cases associated with warfarin or heparin increased from 5 per cent in 1988 to 9 per cent in 1993/94 and 17 per cent in 1999. The annual incidence among patients aged 80 or older increased from 2.5 to 46 per 100 000 from 1988 to 1999. During the same period, warfarin distribution increased four-fold and there was no change in the incidence of thromboembolic strokes. Co-proxamol will go, MHRA reaffirms The MHRA has confirmed that it still intends to withdraw co-proxamol from the market despite protestations from MPs. The issue was raised by two MPs , one a member of the Health Select Committee , in a House of Commons debate. Both called for the withdrawal process to be abandoned, arguing that GPs should have the right to prescribe a drug for which there may be no alternative. The MHRA has restated its view that the risk from overdose with co-proxamol outweighs its benefits, adding: ,The avoidable death toll from co-proxamol overdose cannot be ignored. Sometimes regulation has to balance the needs of the individual against the benefits at a population level. In this case the removal of marketing authorisations with continued use possible in exceptional circumstances is the best balance that could be achieved. The public health gain is already becoming apparent.' Co-proxamol may still be prescribed as an unlicensed drug after its product licence is withdrawn at the end of this year. Guide to pharmacy services A guide to community pharmacy services has been published for patients, carers and members of patient organisations. Developed by the South East Local Pharmaceutical Committee Forum, Understanding and Making the Best Use of Community Pharmacy explains what pharmacies offer and the services available under the 2005 pharmacy contract. Copies can be downloaded from www.psnc.org.uk/resources. Little benefit from opioids for back pain There is little evidence that opioids relieve chronic back pain but the risk of abuse is high, according to a US analysis (Ann Intern Med 2007;146:116-27). The systematic review of trials of oral, topical and transdermal opioids in the treatment of chronic back pain found no trials lasting more than 16 weeks. There was no significant reduction in pain in placebo-controlled trials and limited, nonsignificant pain reductions in comparative trials. By contrast, estimates of prevalence of current substance misuse were as high as 43 per cent and that of ,aberrant medication-taking behaviours' ranged from 5 to 24 per cent. Dual antiplatelet therapy with drug-eluting stents Patients with drug-eluting stents should not stop dual antiplatelet therapy prematurely (Circulation 2007; published online 15 January; DOI: 10.1161/CIRCUL ATIONAHA.106.180944). Although 12 months' treatment with low-dose aspirin plus a thienopyri- dine, eg clopidogrel (Plavix) and ticlopidine, has been shown to reduce cardiac events after implanting a drug-eluting stent, it is not uncommon for the thienopyridine to be discontinued. Health professionals must do more to educate patients about their treatment and the risks associated with stopping. Scottish approval The SMC (www.scottishmedicines.org.uk) has approved varenicline (Champix) for use within NHS Scotland as part of a smoking cessation programme; it notes that the benefits of extending a course of treatment beyond the initial 12 weeks are modest. Controversially, the SMC has not approved omalizumab (Xolair) as add-on therapy for severe persistent allergic asthma on the grounds that an economic case had not been made. Asthma UK criticised the decision as unjust and inhumane. NICE is due to publish an appraisal of omalizumab later this year. No decline with anti- psychotics Treatment with anti- psychotics does not hasten cognitive decline in patients with Alzheimer's disease, say investigators from London (J Neurol Neurosurg Psychiatry 2007;78:25-9). Their prospective study of 224 patients found no difference in the rate of cognitive decline in those treated with antipsychotics (atypical or otherwise) for at least six months. Label translation online Health IT consultancy Rxinfo has developed a website offering translations of the most common types of labelling. The site (www.translabel.co.uk) offers translations into 13 Asian and European languages for 15 standard labelling phrases covering oral medicines and ENT formulations. A free application can be downloaded to allow direct-to-printer printing. Copyright © 2007 Wiley Interface Ltd [source] Antiplatelet drug response variability and the role of platelet function testing: A practical guide for interventional cardiologists,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 1 2009Dominick J. Angiolillo MD Abstract Antiplatelet therapy is the cornerstone of treatment for patients with acute coronary syndrome and is also of particular importance in those who undergo percutaneous coronary intervention with stent implantation. Dual antiplatelet therapy with aspirin and clopidogrel is associated with improvement in long-term clinical outcomes in such patients and is presently the antiplatelet therapy of choice for secondary prevention of thrombotic events. However, a significant number of patients experience recurrent events despite antiplatelet therapy. Although poor patient compliance can account for some of these events, particularly in those patients who receive a drug-eluting stent, increasing evidence indicates that there is variability in response to antiplatelet therapy and patients who have higher levels of platelet reactivity are at increased risk for recurrent ischemic events. However, the lack of a consistent definition of inadequate platelet response, as well as the lack of a standardized measurement technique, has made it difficult to define how to treat these patients. To translate findings associated with variability in platelet response into improved patient care, it is necessary to gain a better understanding of what variable platelet response is, how it is measured, who it should be measured in, and what its clinical relevance is. The objective of this review is to evaluate the data regarding interindividual response variability to antiplatelet therapy with the aim of providing practical considerations and where possible, recommendations, regarding this topic for interventional cardiologists. © 2008 Wiley-Liss, Inc. [source] PCI versus CABG for multivessel coronary disease in diabetics,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 1 2009Giuseppe Tarantini MD Abstract Objectives: To explore the clinical performance of a strategy of revascularization by percutaneous coronary intervention (PCI) with drug-eluting stent (DES) in diabetic patients with multivessel disease (MVD) compared with coronary artery bypass graft (CABG), when it is based on clinical judgment. Background: Diabetes mellitus (DM) is a major risk factor for poor outcome after PCI. However, PCI may result in better outcome if the choice of revascularization (PCI versus CABG) is based on the physician decision, rather than randomization. Limited experiences have compared revascularization by DES-PCI versus CABG in DM patients with MVD. Methods: From August 2004 to August 2005, 220 consecutive DM patients with MVD underwent DES-PCI (93) or CABG (127) at our Institution. The type of revascularization was dependent on patient and/or physician choice. Major adverse cardiac and cerebrovascular events (MACCE) included death, myocardial infarction, repeat coronary revascularization, and stroke. Results: Compared with PCI patients, CABG patients had higher prevalence of 3-vessel disease (P < 0.001), significant LAD involvement (P < 0.001), presence of total occlusions (P = 0.04), collateral circulation (P < 0.001). At 2-year follow-up, MACCE were not different between CABG group and DES-PCI group (OR 1.2; P = 0.6) and, only when the clinical judgment on the revascularization choice was excluded at propensity analysis, DES-PCI increased the risk of 24-month MACCE in total population (OR 1.8; P = 0.04). Conclusions: For patients with DM and MVD, a clinical judgment-based revascularization by DES-PCI is not associated with worse 2-year outcome compared with CABG. © 2008 Wiley-Liss, Inc. [source] Temporal Trends in the Use of Drug-eluting Stents for Approved and Off-label Indications: A Longitudinal Analysis of a Large Multicenter Percutaneous Coronary Intervention RegistryCLINICAL CARDIOLOGY, Issue 2 2010Sarah K. Gualano MD Background We sought to examine the temporal variations in the rate of both bare-metal stent (BMS) and drug-eluting stent (DES) use for off-label indications after the reports of an increased risk of very late stent thrombosis in patients with DES at the 2006 meeting of the European Society of Cardiology (ESC). Hypothesis To determine whether the decrease in use of DES has affected both on and off-label indications. Methods The study cohort included patients undergoing coronary intervention in a large regional registry, the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2). Patient demographic and clinical characteristics for patients with DES in the third quarter of 2006 (pre-ESC) were compared to those from the fourth quarter of 2008 (post-guideline changes). Use of DES for off-label indications, such as ST-segment elevation myocardial infarction (STEMI), in-stent restenosis (ISR), and saphenous vein graft (SVG) interventions, were evaluated. Results The overall deployment of DES fell sharply from 83% pre-ESC to a plateau of 58% in the first quarter of 2008. This corresponded to a rise in BMS use, while angioplasty procedures stayed the same. The STEMI subgroup showed the most dramatic change, from 78% to only 36%. Off-label use in SVGs showed a similar trend, from 74% to 43%. Drug-eluting stent deployment for ISR was less affected, though it also fell 25% (from 79%,56%). Conclusions The use of DES has fallen dramatically from June 2006 to December 2008, particularly for nonapproved indications. Our study provides a real-world assessment of contemporary change in DES use in response to the presentation of negative observational studies. Copyright © 2010 Wiley Periodicals, Inc. [source] Biomarkers on Admission for the Prediction of Cardiovascular Events After Primary Stenting in Patients with ST-Elevation Myocardial InfarctionCLINICAL CARDIOLOGY, Issue 12 2008Young-Hoon Jeong MD Abstract Background Several cardiac biomarkers have been shown to have predictive values for the development of cardiovascular disease and clinical outcome after events, and are now broadly used by clinicians. Little is known about the utility of these biomarker values on admission in ST-elevation myocardial infarction (STEMI) cases of primary drug-eluting stent (DES) implantation and intense medical therapy. Hypothesis Because little is known about the utility of these biomarkers on admission in ST-elevation myocardial infarction (STEMI) in cases primary drug-eluting stent (DES) implantation and intense medical therapy, we evaluated clinical outcomes. Methods We enrolled 207 consecutive STEMI patients treated with primary stenting (mean age, 57.3 ± 12.0 y). We evaluated the association between B-type natriuretic peptide (BNP), cardiac troponin I (cTnI), high-sensitivity C-reactive protein (hs-CRP) on admission, and death, reinfarction, and new or worsening congestive heart failure (CHF) through 1 y. Results In backward-elimination models including all biomarkers, only the cTnI level was retained as a predictor of 1-y CHF (odds ratio [OR]: 1.017, 95% confidence interval [CI]: 1.001,1.034, p = 0.039). There were no predictors in terms of 1-y death, reinfarction, and composite endpoint. When we applied a simple score system, in which patients were categorized on the basis of the number of elevated biomarkers, the 1-y risks of death (p = 0.600), reinfarction (p = 0.185), and composite endpoint (p = 0.620) did not increase in proportion to the number of elevated biomarkers on admission. One-y CHF only tended to increase according to the number of elevated biomarkers (p = 0.067). Conclusions The use of cardiac biomarkers on admission, in each or in combination, had only a minimal impact for the prediction of long-term cardiovascular events after primary stenting in STEMI patients. Copyright © 2008 Wiley Periodicals, Inc. [source] Meta-analysis comparing clinical effectiveness of drug-eluting stents, bare metal stents and coronary artery bypass surgeryINTERNATIONAL JOURNAL OF EVIDENCE BASED HEALTHCARE, Issue 3 2007Eun-Hwan Oh PhD MPH MHA BA Abstract Objective, To compare clinical outcomes among patients receiving drug-eluting stents, bare metal stents, or coronary artery bypass grafting surgery (CABG) to treat coronary artery disease. Data sources, Randomised controlled trials were systematically selected from electronic database for head-to-head comparisons. The results from these head-to-head comparisons were used for an adjusted indirect comparison. Methods, Published randomised controlled trials were reviewed for outcome data in patients treated for coronary artery disease with drug-eluting stents, bare metal stents, or CABG. Head-to-head comparisons were conducted for drug-eluting stents versus bare metal stents and for CABG versus bare metal stents. Adjusted indirect comparison was used to compare drug-eluting stents and CABG. Mid-term clinical outcomes (range: 6,12 months) were investigated and included rates of mortality, myocardial infarction, thrombosis, target lesion revascularisation, target vessel revascularisation, restenosis and major adverse cardiac events. Results, Systematic literature search identified 23 randomised controlled trials (15 for drug-eluting stents vs. bare metal stents, 8 for CABG vs. bare metal stents). Head-to-head comparisons for both single and multiple vessel disease demonstrated that compared with bare metal stents, drug-eluting stents had better outcomes for target lesion revascularisation, target vessel revascularisation, restenosis and major adverse cardiac events. Except target lesion revascularisation, data were similarly favourable for CABG when compared with bare metal stents. Adjusted indirect comparison between drug-eluting stents and CABG in single vessel disease failed to detect significant differences in any of the measured outcomes. Multiple vessel disease data analysis demonstrated that target vessel revascularisation (odds ratio 3.41 [95% CI 2.29,5.08]) and major adverse cardiac events (1.89 [1.28,2.79]) were superior to drug-eluting stents in patients undergoing CABG. Conclusions, Drug-eluting stents and CABG were superior to bare metal stents in terms of target lesion revascularisation (drug-eluting stents only), target vessel revascularisation, restenosis and major adverse cardiac events. There was no difference in clinical outcomes when comparing CABG and drug-eluting stents in patients with single vessel disease, and CABG may be superior to drug-eluting stents for target vessel revascularisation and major adverse cardiac events in patients with multiple vessel disease. However, results may vary between subpopulations with different clinical or socioeconomic differences. [source] Management of Multivessel Coronary Disease: Let Us Not Shortchange Drug-Eluting StentsJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 3 2008F.A.C.C., KISHORE J. HARJAI M.D. A recent observational study of coronary artery graft (CABG) versus drug-eluting stents (DES) performed in the state of New York reported that CABG was superior to DES for multivessel disease. Our comment provides rational criticism of this study, reviews the data that support a role for DES in the management of multivessel coronary disease, and emphasizes the need for ongoing prospective clinical trials in this area. Till randomized trial data become available, physicians should continue to use their clinical judgment based on existing evidence in managing their patients with multivessel coronary artery disease (CAD). [source] Observance of Antiplatelet Therapy after Stent Implantation in Patients under Chronic Oral Anticoagulant TreatmentJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 3 2008JOSÉ VALENCIA M.D., Ph.D. Purpose: Patients undergoing coronary stenting must take dual antiplatelet therapy during a variable period. The combination of chronic oral anticoagulants (COA) with antiplatelet therapy has been related to an increased risk of hemorrhage. The aim of this study was to evaluate the level of the antiplatelet therapy observance in those patients and the incidence of adverse events after 1 year. Methods: Patients with prior COA treatment with coronary lesions suitable for stenting were included. Clinical assessment was performed on admission, with follow-up at 1, 6, and 12 months. Antiplatelet and COA treatment, adverse cardiac events, and hemorrhagic episodes were registered. Results: A total of 70 patients were included. Mean age was 70.5 ± 8.7 years. The most common cause of COA was atrial fibrillation. Conventional stents were used in 40% and drug-eluting stents (DES) in 60%. Treatment at discharge was: ASA + clopidogrel + COA 64.2%, ASA + clopidogrel 25.4%, COA + clopidogrel 7.5%, and COA + ASA 3%. Observance of antiplatelet and COA therapy at 1-6-12 month follow-up after conventional stent was: COA 73.1-70.8-69.6%; ASA 92.3-75.4-65.2%; clopidogrel 92.3-62.5-43.5%. In patients receiving DES, it was: COA 76.9-78.9-80.6%, ASA 79.5-65.8-55.7%, and clopidogrel 94.9-84.2-61.1%. Dual antiplatelet therapy in patients with DES over these periods was taken in 79.5-51.4-27.8%, respectively. The incidence of adverse events was minor bleeding 11.4%, major bleeding 8.6%, myocardial infarction 4.3%, stent thrombosis 1.4%, and death 12.8%. Conclusions: There is a great variability in the treatment prescribed at discharge. Low observance with dual antiplatelet therapy has been detected in these patients, particularly after DES implantation, and they present a very high rate of complications in the follow-up. [source] Endovascular Interventions in Iliac and Infrainguinal Occlusive Artery DiseaseJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 6 2004JOHANNES RUEF M.D., M.Sc. Percutaneous endovascular procedures are increasingly applied to treat symptomatic peripheral occlusive artery disease. While the primary technical success and recanalization rates in iliac and infrainguinal interventions are high, differences in the long-term patency rates exist with respect to the anatomic localization, separating the iliac, femoropopliteal, and infrapopliteal arterial regions. In iliac arteries, even complex lesions can be recanalized with good long-term patency rates, especially when using self-expanding nitinol stents. In the infrainguinal arteries the method of choice is still under debate (e.g., balloon angioplasty vs stent implantation). A high restenosis rate represents one of the major limitations in femoropopliteal and infrapopliteal interventions. Therefore, additional methods and treatment strategies for peripheral interventions with the potential for future applications are under investigation and will be discussed such as drug-eluting stents, brachytherapy, subintimal angioplasty, laser angioplasty, atherectomy/thrombectomy, cutting balloon, polytetrafluoroethylene (PTFE)-covered stent grafts, biodegradable stents, and cryoplasty. The increasing amount of data on successful peripheral interventions supports the necessity to adapt and reevaluate the current consensus guidelines that were put together in 2000. [source] Diffuse In-Stent RestenosisJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 6 2001HANS STÖRGER M.D. Stent restenosis, especially the diffuse pattern, has developed into a significant clinical and economical problem. It has been estimated that up to 250,000 patients developed in-stent restenosis in 2,000 alone, two thirds of them can be expected to have diffuse in-stent restenosis, which is difficult to treat because of high recurrence rates. None of the conventionally available interventional treatment modalities provides optimal long-term results. Intravascular radiation therapy is currently the only effective percutaneous therapy, for combating in-stent restenosis. Late thrombotic complications have largely been eliminated by extended antiplatelet regimens. Geographical miss, a major reason for recurrence of in-stent restenosis after brachytherapy, can be reduced by an improved radiation technique. The first preliminary data on drug-eluting stents, showing only minimal neointimal proliferation at 6-month postimplantation, could represent a major breakthrough in the quest to solve restenosis. [source] Latest news and product developmentsPRESCRIBER, Issue 4 2007Article first published online: 3 APR 200 Low-dose aspirin may reduce asthma risk Low-dose aspirin may reduce the risk of new-onset asthma, according to a US analysis (Am J Respir Crit Care Med 2007;175:120-5). Prompted by speculation of such a link, the authors conducted a post-hoc analysis of the Physicians' Health Study, a placebo-controlled study of aspirin 325mg on alternate days involving 22 071 men aged 40-84. The risk of developing a new diagnosis of asthma during the five-year study was reduced by 22 per cent (p=0.045) among those taking aspirin. However, the number of cases was low: 113 among aspirin recipients and 145 with placebo. The clinical importance of this finding is therefore uncertain, though it received wide coverage in the lay media. Lifestyle changevsdrugs in type 2 diabetes Modifying lifestyle is at least as effective as drugs in delaying the onset of type 2 diabetes in people with impaired glucose tolerance, according to a study from Leicester (BMJ online. doi: 10.1136/bmj.39063.689375.55). The meta-analysis of 17 trials involving 8084 participants found that lifestyle change or orlistat approximately halved the risk of progressing to diabetes, whereas oral hypoglycaemic agents reduced the risk by 30 per cent. A Chinese herb, jiang tang bushen, reduced the risk by two-thirds. The analysis was conducted before the findings of major trials of rosiglitazone (Avandia) , DREAM and ADOPT , were published. Optician prescribing The diagnosis and treatment of disorders such as conjunctivitis by opticians is to be an enhanced service that PCTs can commission according to local need, a Department of Health review has concluded. The General Ophthalmic Services Review considered new arrangements to support PCTs provide ophthalmic services. Professional representatives proposed that the diagnosis and treatment of some eye conditions should be classed as ,additional services' that PCTs should be obliged to commission. While the Department agreed that opticians can play an important role, it found a lack of evidence of benefits and concluded that PCTs should be able to determine their level of services. A commissioning toolkit has been produced to help implement the review's findings. Warfarin stroke risk A four-fold increase in warfarin use has been linked with an increased incidence of intracerebral haemorrhage in a US study (Neurology 2007;68:116-21). Reviewing all first admissions for haemorrhagic stroke in the Cincinnati area, the study found that the proportion of cases associated with warfarin or heparin increased from 5 per cent in 1988 to 9 per cent in 1993/94 and 17 per cent in 1999. The annual incidence among patients aged 80 or older increased from 2.5 to 46 per 100 000 from 1988 to 1999. During the same period, warfarin distribution increased four-fold and there was no change in the incidence of thromboembolic strokes. Co-proxamol will go, MHRA reaffirms The MHRA has confirmed that it still intends to withdraw co-proxamol from the market despite protestations from MPs. The issue was raised by two MPs , one a member of the Health Select Committee , in a House of Commons debate. Both called for the withdrawal process to be abandoned, arguing that GPs should have the right to prescribe a drug for which there may be no alternative. The MHRA has restated its view that the risk from overdose with co-proxamol outweighs its benefits, adding: ,The avoidable death toll from co-proxamol overdose cannot be ignored. Sometimes regulation has to balance the needs of the individual against the benefits at a population level. In this case the removal of marketing authorisations with continued use possible in exceptional circumstances is the best balance that could be achieved. The public health gain is already becoming apparent.' Co-proxamol may still be prescribed as an unlicensed drug after its product licence is withdrawn at the end of this year. Guide to pharmacy services A guide to community pharmacy services has been published for patients, carers and members of patient organisations. Developed by the South East Local Pharmaceutical Committee Forum, Understanding and Making the Best Use of Community Pharmacy explains what pharmacies offer and the services available under the 2005 pharmacy contract. Copies can be downloaded from www.psnc.org.uk/resources. Little benefit from opioids for back pain There is little evidence that opioids relieve chronic back pain but the risk of abuse is high, according to a US analysis (Ann Intern Med 2007;146:116-27). The systematic review of trials of oral, topical and transdermal opioids in the treatment of chronic back pain found no trials lasting more than 16 weeks. There was no significant reduction in pain in placebo-controlled trials and limited, nonsignificant pain reductions in comparative trials. By contrast, estimates of prevalence of current substance misuse were as high as 43 per cent and that of ,aberrant medication-taking behaviours' ranged from 5 to 24 per cent. Dual antiplatelet therapy with drug-eluting stents Patients with drug-eluting stents should not stop dual antiplatelet therapy prematurely (Circulation 2007; published online 15 January; DOI: 10.1161/CIRCUL ATIONAHA.106.180944). Although 12 months' treatment with low-dose aspirin plus a thienopyri- dine, eg clopidogrel (Plavix) and ticlopidine, has been shown to reduce cardiac events after implanting a drug-eluting stent, it is not uncommon for the thienopyridine to be discontinued. Health professionals must do more to educate patients about their treatment and the risks associated with stopping. Scottish approval The SMC (www.scottishmedicines.org.uk) has approved varenicline (Champix) for use within NHS Scotland as part of a smoking cessation programme; it notes that the benefits of extending a course of treatment beyond the initial 12 weeks are modest. Controversially, the SMC has not approved omalizumab (Xolair) as add-on therapy for severe persistent allergic asthma on the grounds that an economic case had not been made. Asthma UK criticised the decision as unjust and inhumane. NICE is due to publish an appraisal of omalizumab later this year. No decline with anti- psychotics Treatment with anti- psychotics does not hasten cognitive decline in patients with Alzheimer's disease, say investigators from London (J Neurol Neurosurg Psychiatry 2007;78:25-9). Their prospective study of 224 patients found no difference in the rate of cognitive decline in those treated with antipsychotics (atypical or otherwise) for at least six months. Label translation online Health IT consultancy Rxinfo has developed a website offering translations of the most common types of labelling. The site (www.translabel.co.uk) offers translations into 13 Asian and European languages for 15 standard labelling phrases covering oral medicines and ENT formulations. A free application can be downloaded to allow direct-to-printer printing. Copyright © 2007 Wiley Interface Ltd [source] The Problem of Stent Thrombosis Associated With Drug-Eluting Stents and the Optimal Duration of Dual Antiplatelet TherapyPREVENTIVE CARDIOLOGY, Issue 2 2009Susana Ayyanathan MD Drug-eluting stents have significantly reduced the problem of restenosis, but there is an association between drug-eluting stents and stent thrombosis that can be a significant clinical problem resulting in myocardial infarction or death. The risk for stent thrombosis increases in certain clinical situations and has been reduced through the use of dual antiplatelet therapy for prolonged periods. Until new therapies are developed, it is essential that patients who have had drug-eluting stents implanted continue with dual-antiplatelet therapy for at least 1 year and possibly for an indefinite period. [source] Randomized evaluation of two drug-eluting stents with identical metallic platform and biodegradable polymer but different agents (paclitaxel or sirolimus) compared against bare stents: 1-Year results of the PAINT trial,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 5 2009Pedro A. Lemos MD Abstract Objectives: We tested two novel drug-eluting stents (DES), covered with a biodegradable-polymer carrier and releasing paclitaxel or sirolimus, which were compared against a bare metal stent (primary objective). The DES differed by the drug, but were identical otherwise, allowing to compare the anti-restenosis effects of sirolimus versus paclitaxel (secondary objective). Background: The efficacy of novel DES with biodegradable polymers should be tested in the context of randomized trials, even when using drugs known to be effective, such as sirolimus and paclitaxel. Methods: Overall, 274 patients with de novo coronary lesions in native vessels scheduled for stent implantation were randomly assigned (2:2:1 ratio) for the paclitaxel (n = 111), sirolimus (n = 106), or bare metal stent (n = 57) groups. Angiographic follow-up was obtained at 9 months and major cardiac adverse events up to 12 months. Results: Both paclitaxel and sirolimus stents reduced the 9-month in-stent late loss (0.54,0.44 mm, 0.32,0.43 mm, vs. 0.90,0.45 mm respectively), and 1-year risk of target vessel revascularization and combined major adverse cardiac events (P < 0.05 for both, in all comparisons), compared with controls. Sirolimus stents had lower late loss than paclitaxel stents (P < 0.01), but similar 1-year clinical outcomes. There were no differences in the risk of death, infarction, or stent thrombosis among the study groups. Conclusion: Both novel DES were effective in reducing neointimal hyperplasia and 1-year re-intervention, compared to bare metal stents. Our findings also suggest that sirolimus is more effective than paclitaxel in reducing angiographic neointima, although this effect was not associated with better clinical outcomes.© 2009 Wiley-Liss, Inc. [source] Outcomes with drug-eluting stents versus bare metal stents in acute ST-elevation myocardial infarction: Results from the Strategic Transcatheter Evaluation of New Therapies (STENT) Group,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 7 2008Bruce R. Brodie MD Abstract Objectives: This study compares outcomes with drug-eluting stents (DES) versus bare metal stents (BMS) in patients with ST-elevation myocardial infarction (STEMI). Background: DESs have been effective in elective percutaneous coronary intervention (PCI), but their safety and efficacy in patients with STEMI have not been well studied. Methods: The STENT Registry is a multicenter United States registry evaluating outcomes of DES. Our study population includes patients with STEMI treated with either a DES or BMS who completed 9-month or 2-year follow-up. Outcomes were adjusted using propensity score analysis. Results: DES patients were younger, had less prior infarction and prior bypass surgery, but had smaller vessels and longer lesions. After adjusting for differences in baseline variables, there were no significant differences between DES and BMS in death, reinfarction, or major adverse cardiac events (MACE). DES had lower rates of stent thrombosis at 9 months (1.0% vs. 2.7%, HR 0.40 [0.17,0.95]) and lower rates of target vessel revascularization (TVR) at 9 months (4.0% vs. 7.5%, HR 0.55 [0.34,0.88]) and 2 years (8.0% vs. 11.3%, HR 0.57 [0.35,0.92]). There was a nonsignificant increase in stent thrombosis with DES versus BMS from 1 to 2 years (1.1% vs. 0.3%, P = 0.28). Conclusions: Our data suggest that DES used with primary PCI for STEMI are more effective than BMS in reducing TVR and are safe for up to 2 years. Whether DES are safe beyond 2 years and whether the reduction in TVR is enough to justify their use in STEMI will have to wait for the results of large randomized trials. 2008 Wiley-Liss, Inc. [source] The off- versus on-label use of medical devices in interventional cardiovascular medicine: Clarifying the ambiguity between regulatory labeling and clinical decision-making, Part 1: PCI,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 4 2008Matthew J. Price MD Abstract The Food and Drug Administration convened a special public meeting of the Circulatory System Devices Advisory Panel in late 2006 in response to data suggesting a small but potentially significant increased risk of stent thrombosis with drug-eluting stents (DES). This panel concluded that "off-label" DES use was associated with an increased risk of adverse outcomes compared with "on-label" use. In this commentary, we will discuss the role of product labeling in clinical decision-making during percutaneous coronary intervention, elucidate the issues that may arise from the conflation of the responsibilities of regulatory bodies and physicians, and offer a potential framework for their resolution. © 2008 Wiley-Liss, Inc. [source] | ||||||||||