Drug Eluting Stents for Malignant Airway Obstruction: A Critical Review of the Literature.
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SUBMITTER: Hohenforst-Schmidt W
PROVIDER: S-EPMC4749359 | biostudies-literature | 2016
REPOSITORIES: biostudies-literature
Publications
Drug Eluting Stents for Malignant Airway Obstruction: A Critical Review of the Literature.
Hohenforst-Schmidt Wolfgang W Zarogoulidis Paul P Pitsiou Georgia G Linsmeier Bernd B Tsavlis Drosos D Kioumis Ioannis I Papadaki Eleni E Freitag Lutz L Tsiouda Theodora T Turner J Francis JF Browning Robert R Simoff Michael M Sachpekidis Nikolaos N Tsakiridis Kosmas K Zaric Bojan B Yarmus Lonny L Baka Sofia S Stratakos Grigoris G Rittger Harald H
Journal of Cancer 20160113 4
Lung cancer being the most prevalent malignancy in men and the 3(rd) most frequent in women is still associated with dismal prognosis due to advanced disease at the time of diagnosis. Novel targeted therapies are already on the market and several others are under investigation. However non-specific cytotoxic agents still remain the cornerstone of treatment for many patients. Central airways stenosis or obstruction may often complicate and decrease quality of life and survival of these patients. ...[more]
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Project description:BackgroundPolymer-free drug-eluting stents (PF-DES) have been demonstrated comparable to permanent polymer drug-eluting stents (PP-DES) during long-term follow-up. As a critical component of drug-eluting stents, antiproliferative drugs may be a confounding factor for the results. Thus, we sought to compare the outcomes of these stents during long-term follow-up, especially in consideration of different stent platforms with the same drugs.MethodsA systemic search was performed to identify the related randomized controlled trials comparing PF-DES with PP-DES. Primary outcomes included short (≤1 year) and long-term (>1 year) target lesion revascularization (TLR), short-term in-stent late luminal loss (LLL) and diameter stenosis (DS). Subgroup analyses stratified by the different platforms with the same proliferative drugs were conducted in TLR, LLL, and DS. Standardized mean differences (SMDs) and risk ratios (RRs) were estimated using fixed /random effects models RESULTS:: A total of 6927 patients extracted from 12 RCTs were enrolled in the meta-analysis. No differences were observed in clinical outcomes of short-term and long-term overall mortality, myocardial infarction and stent thrombosis and angiographic outcomes of short-term in-stent LLL and DS between PF-DES and PP-DES for patients with coronary artery lesions. Nevertheless, compared with PP-DES coated with the same proliferative drugs, PF-DES had significantly increased risks of in-stent LLL (SMD, 0.49; 95% confidence interval [CI], 0.25-0.72) and DS (SMD, 0.67; 95% CI, 0.27-1.07), and long-term TLR (RR, 1.64; 95% CI 1.13-2.39). There were no significant differences in other outcomes.ConclusionsUnder the condition of using same antiproliferative drugs (paclitaxel or sirolimus) in different stent systems, PF-DES are associated with the increased risk of restenosis compared to PP-DES.
| S-EPMC6485796 | biostudies-literature
Project description:BackgroundDrug-eluting stents have been seen as an attractive alternative to bare-metal stents for percutaneous coronary interventions (PCIs) because of the decreased need for revascularization. However, comparative clinical trials have shown no difference in patient outcomes, and drug-eluting stents are considerably more expensive than their bare-metal counterparts. We conducted a systematic review of all published comparative cost-effectiveness analyses to identify the factors contributing to the heterogeneity of their conclusions.MethodsWe retrieved all articles published between Jan. 1, 2000, and July 31, 2006, in which the cost-effectiveness, from a third-party payer perspective, of drug-eluting stents was compared with that of bare-metal stents for PCI in unrestricted patient populations. Electronic databases, Web sites from health technology assessment groups and references of identified articles were searched. Our outcome variable was whether the study's conclusions favoured widespread use of drug-eluting stents, as assessed by 4 independent reviewers. Study characteristics such as quality, funding source, country and year of publication were extracted. Two-by-2 tables and Fisher's exact test were used to study the association between covariates and the outcome variable. A classification and regression tree (CART) model was used for multivariate analysis.ResultsWe identified 19 cost-effectiveness analyses. Ten were in favour of widespread use of drug-eluting stents, and 9 favoured more restrained use. Only 1 of 9 high-quality studies supported widespread use, as compared with 9 of 10 lower quality studies (p < 0.001). All of the 7 sponsored studies argued in favour of widespread use, as compared with 3 of the 12 studies without sponsorship (p = 0.003). Studies from the United States were more likely than those from other countries to endorse unlimited use (p = 0.032). A CART model with 2 covariates--study quality and sponsorship--provided the best fit (error rate 10.5%).InterpretationConclusions drawn by cost-effectiveness analyses of drug-eluting stents for PCI are associated with the study's quality, funding source and country of origin. Vigilance regarding these study characteristics is required when interpreting findings from cost-effectiveness analyses.
| S-EPMC1764790 | biostudies-literature
Project description:ObjectiveTo compare the efficacy and safety of biodegradable polymer drug eluting stents with those of bare metal stents and durable polymer drug eluting stents.DesignMixed treatment comparison meta-analysis of 258,544 patient years of follow-up from randomized trials.Data sources and study selectionPubMed, Embase, and Central were searched for randomized trials comparing any of the Food and Drug Administration approved durable polymer drug eluting stents (sirolimus eluting, paclitaxel eluting, cobalt chromium everolimus eluting, platinum chromium everolimus eluting, zotarolimus eluting-Endeavor, and zotarolimus eluting-Resolute) or biodegradable polymer drug eluting stents, with each other or against bare metal stents.OutcomesLong term efficacy (target vessel revascularization, target lesion revascularization) and safety (death, myocardial infarction, stent thrombosis). Landmark analysis at more than one year was evaluated to assess the potential late benefit of biodegradable polymer drug eluting stents.ResultsFrom 126 randomized trials and 258,544 patient years of follow-up, for long term efficacy (target vessel revascularization), biodegradable polymer drug eluting stents were superior to paclitaxel eluting stents (rate ratio 0.66, 95% credibility interval 0.57 to 0.78) and zotarolimus eluting stent-Endeavor (0.69, 0.56 to 0.84) but not to newer generation durable polymer drug eluting stents (for example: 1.03, 0.89 to 1.21 versus cobalt chromium everolimus eluting stents). Similarly, biodegradable polymer drug eluting stents were superior to paclitaxel eluting stents (rate ratio 0.61, 0.37 to 0.89) but inferior to cobalt chromium everolimus eluting stents (2.04, 1.27 to 3.35) for long term safety (definite stent thrombosis). In the landmark analysis after one year, biodegradable polymer drug eluting stents were superior to sirolimus eluting stents for definite stent thrombosis (rate ratio 0.29, 0.10 to 0.82) but were associated with increased mortality compared with cobalt chromium everolimus eluting stents (1.52, 1.02 to 2.22). Overall, among all stent types, the newer generation durable polymer drug eluting stents (zotarolimus eluting stent-Resolute, cobalt chromium everolimus eluting stents, and platinum chromium everolimus eluting stents) were the most efficacious (lowest target vessel revascularization rate) stents, and cobalt chromium everolimus eluting stents were the safest with significant reductions in definite stent thrombosis (rate ratio 0.35, 0.21 to 0.53), myocardial infarction (0.65, 0.55 to 0.75), and death (0.72, 0.58 to 0.90) compared with bare metal stents.ConclusionsBiodegradable polymer drug eluting stents are superior to first generation durable polymer drug eluting stents but not to newer generation durable polymer stents in reducing target vessel revascularization. Newer generation durable polymer stents, and especially cobalt chromium everolimus eluting stents, have the best combination of efficacy and safety. The utility of biodegradable polymer stents in the context of excellent clinical outcomes with newer generation durable polymer stents needs to be proven.
| S-EPMC3898413 | biostudies-literature
Project description:ObjectiveSelf-expandable metallic (SEM) airway stents are an important approach to malignant central airway obstruction (CAO). SEM airway stent insertions are usually performed under fluoroscopic guidance over a guide wire placed through a flexible bronchoscope often resulting in a longer procedure time and exposure to radiation. In this pilot study, we designed a novel delivery system of the through-the-scope (TTS) SEM airway stent insertion and observed its feasibility.MethodsFrom Jan 2015 to Sept 2016, 25 consecutive patients with inoperable malignant CAO were enrolled requiring airway stent implantation. All patients were followed up to death or at least 6 months.Results36 TTS stents were inserted into 25 patients using a flexible bronchoscope under general anesthesia or local anesthesia. All stents were successfully deployed directly through the working channel (2.8 mm diameter) of the flexible bronchoscope in 91.7% (33/36) of the subjects. The mMRC score and stenosis grade improved significantly after stent implantation. The common stent-related complications were secretion retention (25%, 9/36), development of granulation tissue (13.9%, 5/36), tumor in-growth (13.9%, 5/36), and hemoptysis (8.3%, 3/36). The 6-month overall survival (OS) was 44% (11/25).ConclusionThe novel TTS stent release system was an effective and safe approach in malignant central airway obstruction.
| S-EPMC6535817 | biostudies-literature
Project description: Not available
| S-EPMC6483499 | biostudies-literature
Project description:Controlled drug delivery is a matter of interest to numerous scientists from various domains, as well as an essential issue for society as a whole. In the treatment of many diseases, it is crucial to control the dosing of a drug for a long time and thus maintain its optimal concentration in the tissue. Heart diseases are particularly important in this aspect. One such disease is an obstructive arterial disease affecting millions of people around the world. In recent years, stents and balloon catheters have reached a significant position in the treatment of this condition. Balloon catheters are also successfully used to manage tear ducts, paranasal sinuses, or salivary glands disorders. Modern technology is continually striving to improve the results of previous generations of stents and balloon catheters by refining their design, structure, and constituent materials. These advances result in the development of both successive models of drug-eluting stents (DES) and drug-eluting balloons (DEB). This paper presents milestones in the development of DES and DEB, which are a significant option in the treatment of coronary artery diseases. This report reviews the works related to achievements in construction designs and materials, as well as preparation technologies, of DES and DEB. Special attention was paid to the polymeric biodegradable materials used in the production of the above-mentioned devices. Information was also collected on the various methods of producing drug release coatings and their effectiveness in releasing the active substance.
| S-EPMC7594099 | biostudies-literature
Project description:Endovascular infrapopliteal treatment of patients with critical limb ischemia using percutaneous transluminal angioplasty (PTA) and bail-out bare metal stenting (BMS) is hampered by restenosis. In interventional cardiology, drug-eluting stents (DES) have shown better patency rates and are standard practice nowadays. An investigator-initiated, multicenter, randomized trial was conducted to assess whether DES also improve patency and clinical outcome of infrapopliteal lesions.Adults with critical limb ischemia (Rutherford category ?4) and infrapopliteal lesions were randomized to receive PTA±BMS or DES with paclitaxel. Primary end point was 6-month primary binary patency of treated lesions, defined as ?50% stenosis on computed tomographic angiography. Stenosis >50%, retreatment, major amputation, and critical limb ischemia-related death were regarded as treatment failure. Severity of failure was assessed with an ordinal score, ranging from vessel stenosis through occlusion to the clinical failures. Seventy-four limbs (73 patients) were treated with DES and 66 limbs (64 patients) received PTA±BMS. Six-month patency rates were 48.0% for DES and 35.1% for PTA±BMS (P=0.096) in the modified-intention-to-treat and 51.9% and 35.1% (P=0.037) in the per-protocol analysis. The ordinal score showed significantly worse treatment failure for PTA±BMS versus DES (P=0.041). The observed major amputation rate remained lower in the DES group until 2 years post-treatment, with a trend toward significance (P=0.066). Less minor amputations occurred after DES until 6 months post-treatment (P=0.03).In patients with critical limb ischemia caused by infrapopliteal lesions, DES provide better 6-month patency rates and less amputations after 6 and 12 months compared with PTA±BMS.URL: http://www.clinicaltrials.gov. Unique identifier: NCT00471289.
| S-EPMC4753788 | biostudies-literature
Project description:BackgroundsDrug-eluting stents (DES) with biodegradable polymers have been developed to address the risk of thrombosis associated with first-generation DES. We aimed to determine the efficacy and safety of biodegradable polymer biolimus-eluting stents (BES) versus durable polymer DES.MethodsSystematic database searches of MEDLINE (1950 to June 2013), EMBASE (1966 to June 2013), the Cochrane Central Register of Controlled Trials (Issue 6 of 12, June 2013), and a review of related literature were conducted. All randomized controlled trials comparing biodegradable polymer BES versus durable polymer DES were included.ResultsEight randomized controlled trials investigating 11,015 patients undergoing percutaneous coronary interventions were included in the meta-analysis. The risk of major adverse cardiac events did not differ significantly between the patients treated with the biodegradable polymer BES and the durable polymer DES (Relative risk [RR], 0.970; 95% CI, 0.848-1.111; p = 0.662). However, biodegradable polymer BES was associated with reduced risk of very late ST compared with the durable polymer DES, while the risk of early or late ST was similar (RR for early or late ST, 1.167; 95% CI 0.755-1.802; p = 0.487; RR 0.273; 95% CI 0.115-0.652; p = 0.003; p for interaction = 0.003).ConclusionsIn this meta-analysis of randomized controlled trials, treatments with biodegradable polymer BES did not significantly reduce the risk of major adverse cardiac events, but demonstrated a significantly lower risk of very late ST when compared to durable polymer DES. This conclusion requires confirmation by further studies with long-term follow-up.Prospero register numberhttp://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42013004364#.UnM2lfmsj6J.
| S-EPMC3823917 | biostudies-literature
Project description:BackgroundTo improve outcomes in patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention remain an unmet clinical need. The study aimed to evaluate the efficacy and safety of G2-DESs and BP-DESs in patients with and without DM in a single center in China.MethodsA total of 7666 consecutive patients who exclusively had G2-DES or BP-DES implantation throughout 2013 in our center were studied. The primary efficacy endpoint was any target lesion revascularization (TLR), whereas the primary safety endpoint was a composite of death or myocardial infarction (MI) at 2-year follow-up.ResultsG2-DESs had a similar occurrence of death, non-fatal MI, TLR, stroke, and stent thrombosis compared with BP-DESs in patients with DM (all P?>?0.05). The incidence of TVR and TLR was lower for G2-DESs than for BP-DESs in patients without DM (3.2% vs. 5.1%, P?=?0.002; 2.2% vs. 4.5%, P?<?0.001, respectively). Kaplan-Meier analysis also showed better TVR- and TLR-free survival rates for G2-DESs than for BP-DESs in patients without DM. Multivariate analysis showed that a BP-DES was an independent risk factor for TLR (hazard ratio 1.963, 95% confidence interval 1.390-2.772, P?<?0.001) in patients without DM, which was not predictive of other components of major adverse cardiac events (P?>?0.05).ConclusionsG2-DESs have better efficacy, represented by a reduced risk of TLR, and similar safety compared with BP-DESs in patients without DM. G2-DESs have similar efficacy and safety compared with BP-DESs in patients with DM at 2-year follow-up.
| S-EPMC6090623 | biostudies-literature
Project description:BackgroundWe sought to establish the long-term safety of drug-eluting stents compared with bare-metal stents in a usual care setting.MethodsUsing data from a prospective multicentre registry, we compared rates of death and of death or repeat revascularization during 3 years of follow-up of 6440 consecutive patients who underwent angioplasty with either drug-eluting or bare-metal stents between Apr. 1, 2003, and Mar. 31, 2006.ResultsDrug-eluting stents were inserted in 1120 patients and bare-metal stents in 5320. The drug-eluting stents were selected for patients who had a greater burden of comorbid illness, including diabetes mellitus (32.8% v. 20.8% in the bare-metal group, p < 0.001) and renal disease (7.4% v. 5.0%, p = 0.001). At 1-year follow-up, the drug-eluting stents were associated with a mortality of 3.0%, as compared with 3.7% with the bare-metal stents (adjusted odds ratio [OR] 0.62, 95% confidence interval [CI] 0.46-0.83). The rate of the composite outcome of death or repeat revascularization was 12.0% for the drug-eluting stents and 15.8% for the bare-metal stents (adjusted OR 0.40, 95% CI 0.33-0.49). In the subgroup of patients who had acute coronary syndromes, the adjusted OR for this composite outcome was 0.46 (95% CI 0.35-0.61). During the 3 years of observation, the relative risks for death and repeat revascularization varied over time. In year 1, there was an initial period of lower risk in the group with drug-eluting stents than in the group with bare-metal stents; this was followed by a shift toward outcome rates favouring bare-metal stents in years 2 and 3. The adjusted relative risk of the composite outcome of death or repeat revascularization associated with drug-eluting stents relative to bare-metal stents was 0.73 early in the first year of follow-up; it then rose gradually over time, to a peak of 2.24 at 3 years.InterpretationDrug-eluting stents are safe and effective in the first year following insertion. Thereafter, the possibility of longer term adverse events cannot be ruled out.
| S-EPMC2621281 | biostudies-literature