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Medicine Jul 2017Controversies have been observed among network meta-analyses comparing biodegradable polymer drug-eluting stents (BP-DES) with durable polymer drug-eluting stents... (Meta-Analysis)
Meta-Analysis Review
Adverse cardiovascular events associated with biodegradable polymer drug-eluting stents and durable polymer everolimus-eluting stents: A systematic review and meta-analysis of 10 randomized controlled trials.
BACKGROUND
Controversies have been observed among network meta-analyses comparing biodegradable polymer drug-eluting stents (BP-DES) with durable polymer drug-eluting stents (DP-DES). We aimed to compare the adverse cardiovascular events associated with BP-DES and durable polymer everolimus-eluting stents (DP-EES) using a large number of patients obtained from randomized controlled trials (RCTs).
METHODS
Electronic databases were searched for randomized trials comparing BP-DES with DP-EES. Adverse cardiovascular outcomes observed between 6 months and 3 years were considered as the clinical endpoints in this analysis. Odds ratios (ORs) with 95% confidence intervals (CIs) were calculated and the pooled analyses were performed with RevMan 5.3 software. All authors had full access to the data, and they have read and agreed to the manuscript as written.
RESULTS
Ten trials involving a total number of 13,218 patients (7451 patients treated by BP-DES and 5767 patients treated by DP-EES) were included. No significant difference was observed when analyzing mortality and myocardial infarction between BP-DES and DP-EES with OR 1.08, 95% CI 0.87-1.34, P = .47 and OR 1.04, 95% CI 0.84-1.28, P = .72 respectively. Target vessel revascularization, target lesion revascularization, major adverse cardiac events, and stroke were also not significantly different with OR 1.11, 95% CI 0.92-1.33, P = .28; OR 1.11, 95% CI 0.94-1.33, P = .22; OR 1.12, 95% CI 0.99-1.27; P = .07; and OR 1.13, 95% CI 0.69-1.84; P = .62 respectively. In addition, total stent thrombosis (ST) was similarly reported between BP-DES and DP-EES with OR 0.85, 95% CI 0.59-1.21; P = .37. However, even if BP-DES were associated with a higher rate of definite ST with OR 1.69, 95% CI 0.92-3.08, P = .09 and DP-EES were associated with a higher rate of probable ST with OR 0.67, 95% CI 0.38-1.17, P = .16, these results were not statistically significant.
CONCLUSIONS
Between 6 months and 3 years, BP-DES were similar in terms of cardiovascular outcomes compared to DP-EES. However, further long-term follow-up research is recommended.
Topics: Absorbable Implants; Cardiovascular Diseases; Drug Implants; Drug-Eluting Stents; Everolimus; Humans; Immunosuppressive Agents; Polymers; Randomized Controlled Trials as Topic
PubMed: 28700502
DOI: 10.1097/MD.0000000000007510 -
International Journal of Molecular... Aug 2023The use of platelet-rich plasma (PRP) has gained increasing interest in recent decades. The platelet secretome contains a multitude of growth factors, cytokines,... (Review)
Review
The use of platelet-rich plasma (PRP) has gained increasing interest in recent decades. The platelet secretome contains a multitude of growth factors, cytokines, chemokines, and other biological biomolecules. In recent years, developments in the field of platelets have led to new insights, and attention has been focused on the platelets' released extracellular vesicles (EVs) and their role in intercellular communication. In this context, the aim of this review was to compile the current evidence on PRP-derived extracellular vesicles to identify the advantages and limitations fortheir use in the upcoming clinical applications. A total of 172 articles were identified during the systematic literature search through two databases (PubMed and Web of Science). Twenty publications met the inclusion criteria and were included in this review. According to the results, the use of PRP-EVs in the clinic is an emerging field of great interest that represents a promising therapeutic option, as their efficacy has been demonstrated in the majority of fields of applications included in this review. However, the lack of standardization along the procedures in both the field of PRP and the EVs makes it extremely challenging to compare results among studies. Establishing standardized conditions to ensure optimized and detailed protocols and define parameters such as the dose or the EV origin is therefore urgent. Further studies to elucidate the real contribution of EVs to PRP in terms of composition and functionality should also be performed. Nevertheless, research on the field provides promising results and a novel basis to deal with the regenerative medicine and drug delivery fields in the future.
Topics: Blood Platelets; Cell Communication; Extracellular Vesicles; Platelet-Rich Plasma; Regenerative Medicine
PubMed: 37685849
DOI: 10.3390/ijms241713043 -
EuroIntervention : Journal of EuroPCR... Jun 2016Several studies have suggested good procedural and similar clinical outcomes between everolimus-eluting Absorb bioresorbable stents (BRS) versus conventional... (Comparative Study)
Comparative Study Meta-Analysis Review
AIMS
Several studies have suggested good procedural and similar clinical outcomes between everolimus-eluting Absorb bioresorbable stents (BRS) versus conventional drug-eluting stents (DES), but the evidence is not definitive. Our aim was to perform a systematic review and meta-analysis to investigate the effects of BRS versus conventional drug-eluting and bare metallic stents on the cardiovascular endpoints and all-cause mortality.
METHODS AND RESULTS
The follow-up in the included studies was up to 13 months. The following endpoints were evaluated: all-cause mortality, cardiac death, patient-oriented major adverse cardiac events (POCE), device-oriented major adverse cardiac events (DOCE), any-cause myocardial infarction (MI), target vessel MI (TVMI), target vessel revascularisation (TVR) and target lesion revascularisation (TLR). The results of 10 studies with 5,773 subjects showed a statistically significant increase in the risk of TVMI between BRS and conventional stents (odds ratio [OR]: 1.45, 95% confidence interval [CI]: 1.03-2.05, p=0.032). None of the other differences reached statistical significance: all-cause mortality (OR: 0.67, 95% CI: 0.30-1.49, p=0.333), cardiac death (OR: 1.00, 95% CI: 0.47-2.12, p=0.996), POCE (OR: 0.91, 95% CI: 0.68-1.22, p=0.546), DOCE (OR: 1.12, 95% CI: 0.86-1.46, p=0.387), any-cause MI (OR: 1.34, 95% CI: 0.98-1.82, p=0.064), TVR (OR: 0.99, 95% CI: 0.73-1.33, p=0.934) and TLR (OR: 0.92, 95% CI: 0.66-1.29, p=0.641). Similar results were observed after restricting the meta-analysis to the comparison of BRS vs. EES.
CONCLUSIONS
Our meta-analysis suggests a significantly higher risk of TVMI with BRS compared with conventional stents and no significant differences in the rates of occurrence of the other outcomes during one-year follow-up. Further studies with larger samples sizes, longer follow-up, different clinical scenarios and more complex lesions are required to confirm or refute our findings.
Topics: Absorbable Implants; Coronary Thrombosis; Drug-Eluting Stents; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Treatment Outcome
PubMed: 27290677
DOI: 10.4244/EIJY16M06_02 -
Health Technology Assessment... Nov 2017Non-infectious intermediate uveitis, posterior uveitis and panuveitis are a heterogeneous group of inflammatory eye disorders. Management includes local and systemic... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Non-infectious intermediate uveitis, posterior uveitis and panuveitis are a heterogeneous group of inflammatory eye disorders. Management includes local and systemic corticosteroids, immunosuppressants and biological drugs.
OBJECTIVES
To evaluate the clinical effectiveness and cost-effectiveness of subcutaneous adalimumab (Humira; AbbVie Ltd, Maidenhead, UK) and a dexamethasone intravitreal implant (Ozurdex; Allergan Ltd, Marlow, UK) in adults with non-infectious intermediate uveitis, posterior uveitis or panuveitis.
DATA SOURCES
Electronic databases and clinical trials registries including MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects and the World Health Organization's International Clinical Trials Registry Platform were searched to June 2016, with an update search carried out in October 2016.
REVIEW METHODS
Review methods followed published guidelines. A Markov model was developed to assess the cost-effectiveness of dexamethasone and adalimumab, each compared with current practice, from a NHS and Personal Social Services (PSS) perspective over a lifetime horizon, parameterised with published evidence. Costs and benefits were discounted at 3.5%. Substantial sensitivity analyses were undertaken.
RESULTS
Of the 134 full-text articles screened, three studies (four articles) were included in the clinical effectiveness review. Two randomised controlled trials (RCTs) [VISUAL I (active uveitis) and VISUAL II (inactive uveitis)] compared adalimumab with placebo, with limited standard care also provided in both arms. Time to treatment failure (reduced visual acuity, intraocular inflammation, new vascular lesions) was longer in the adalimumab group than in the placebo group, with a hazard ratio of 0.50 [95% confidence interval (CI) 0.36 to 0.70; < 0.001] in the VISUAL I trial and 0.57 (95% CI 0.39 to 0.84; = 0.004) in the VISUAL II trial. The adalimumab group showed a significantly greater improvement than the placebo group in the 25-item Visual Function Questionnaire (VFQ-25) composite score in the VISUAL I trial (mean difference 4.20; = 0.010) but not the VISUAL II trial (mean difference 2.12; = 0.16). Some systemic adverse effects occurred more frequently with adalimumab than with placebo. One RCT [HURON (active uveitis)] compared a single 0.7-mg dexamethasone implant against a sham procedure, with limited standard care also provided in both arms. Dexamethasone provided significant benefits over the sham procedure at 8 and 26 weeks in the percentage of patients with a vitreous haze score of zero ( < 0.014), the mean best corrected visual acuity improvement ( ≤ 0.002) and the percentage of patients with a ≥ 5-point improvement in VFQ-25 score ( < 0.05). Raised intraocular pressure and cataracts occurred more frequently with dexamethasone than with the sham procedure. The incremental cost-effectiveness ratio (ICER) for one dexamethasone implant in one eye for a combination of patients with unilateral and bilateral uveitis compared with limited current practice, as per the HURON trial, was estimated to be £19,509 per quality-adjusted life-year (QALY) gained. The ICER of adalimumab for patients with mainly bilateral uveitis compared with limited current practice, as per the VISUAL trials, was estimated to be £94,523 and £317,547 per QALY gained in active and inactive uveitis respectively. Sensitivity analyses suggested that the rate of blindness has the biggest impact on the model results. The interventions may be more cost-effective in populations in which there is a greater risk of blindness.
LIMITATIONS
The clinical trials did not fully reflect clinical practice. Thirteen additional studies of clinically relevant comparator treatments were identified; however, network meta-analysis was not feasible. The model results are highly uncertain because of the limited evidence base.
CONCLUSIONS
Two RCTs of systemic adalimumab and one RCT of a unilateral, single dexamethasone implant showed significant benefits over placebo or a sham procedure. The ICERs for adalimumab were estimated to be above generally accepted thresholds for cost-effectiveness. The cost-effectiveness of dexamethasone was estimated to fall below standard thresholds. However, there is substantial uncertainty around the model assumptions. In future work, primary research should compare dexamethasone and adalimumab with current treatments over the long term and in important subgroups and consider how short-term improvements relate to long-term effects on vision.
STUDY REGISTRATION
This study is registered as PROSPERO CRD42016041799.
FUNDING
The National Institute for Health Research Health Technology Assessment programme.
Topics: Adalimumab; Adult; Anti-Inflammatory Agents; Antibodies, Monoclonal, Humanized; Cost-Benefit Analysis; Dexamethasone; Humans; Quality-Adjusted Life Years; Technology Assessment, Biomedical; Uveitis, Intermediate; Uveitis, Posterior
PubMed: 29183563
DOI: 10.3310/hta21680 -
The Cochrane Database of Systematic... Jan 2015Primary congenital glaucoma (PCG) manifests within the first few years of a child's life and is not associated with any other systemic or ocular abnormalities. PCG... (Review)
Review
BACKGROUND
Primary congenital glaucoma (PCG) manifests within the first few years of a child's life and is not associated with any other systemic or ocular abnormalities. PCG results in considerable morbidity even in developed countries. Several surgical techniques for treating this condition, and lowering the intraocular pressure (IOP) associated with it, have been described.
OBJECTIVES
To compare the effectiveness and safety of different surgical techniques for PCG.
SEARCH METHODS
We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2014, Issue 6), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to June 2014), EMBASE (January 1980 to June 2014), (January 1982 to June 2014), PubMed (January 1946 to June 2014), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov), the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 23 June 2014.
SELECTION CRITERIA
We included all randomized and quasi-randomized trials in which different types of surgical interventions were compared in children under five years of age with PCG.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures specified by The Cochrane Collaboration.
MAIN RESULTS
We included a total of six trials (four randomized and two quasi-randomized) with 102 eyes in 61 children. Two trials were conducted in the USA and one trial each in Egypt, Israel, Lebanon and Saudi Arabia. All trials included children aged younger than one year when diagnosed with PCG, and followed them for periods ranging from six months to five years.No two trials compared the same pair of surgical interventions, so we did not perform any meta-analysis. One trial compared trabeculotomy versus goniotomy; a second trial compared combined trabeculectomy-trabeculotomy with mitomycin C versus trabeculectomy-trabeculotomy with mitomycin C and deep sclerectomy; a third trial compared combined trabeculotomy-trabeculectomy versus trabeculotomy; a fourth trial compared one goniotomy versus two goniotomies; a fifth trial compared trabeculotomy versus viscocanalostomy; and the sixth trial compared surgical goniotomy versus neodymium-YAG laser goniotomy. For IOP change and surgical success (defined by IOP achieved), none of the trials reported a difference between pairs of surgical techniques. However, due to the limited sample sizes for all trials (average of 10 children per trial), the evidence as to whether a particular surgical technique is effective and which surgical technique is better still remains uncertain. Adverse events, such as choroidal detachment, shallow anterior chamber and hyphema, were reported from four trials. None of the trials reported quality of life or economic data.These trials were neither designed nor reported well overall. Two trials were quasi-randomized trials and judged to have high risk of selection bias; four trials were at unclear or high risk for performance bias and detection bias; and we judged one trial to have high risk of attrition bias due to high proportions of losses to follow-up. Due to poor study design and reporting, the reliability and applicability of evidence remain unclear.
AUTHORS' CONCLUSIONS
No conclusions could be drawn from the trials included in this review due to paucity of data. More research is needed to determine which of the many surgeries performed for PCG are effective.
Topics: Child, Preschool; Glaucoma; Glaucoma Drainage Implants; Humans; Infant; Infant, Newborn; Mitomycin; Postoperative Complications; Randomized Controlled Trials as Topic; Sclera; Trabecular Meshwork; Trabeculectomy
PubMed: 25636153
DOI: 10.1002/14651858.CD008213.pub2 -
The Oncologist 2013CD30(+) lymphoproliferative disorders represent a spectrum of diseases with distinct clinical phenotypes ranging from reactive conditions to aggressive systemic... (Review)
Review
CD30(+) lymphoproliferative disorders represent a spectrum of diseases with distinct clinical phenotypes ranging from reactive conditions to aggressive systemic anaplastic lymphoma kinase (ALK)(-) anaplastic large cell lymphoma (ALCL). In January 2011, the U.S. Food and Drug Administration (FDA) announced a possible association between breast implants and ALCL, which was likened to systemic ALCL and treated accordingly. We analyzed existing data to see if implant-associated ALCL (iALCL) may represent a distinct entity, different from aggressive ALCL. We conducted a systematic review of publications regarding ALCL and breast implantation for 1990-2012 and contacted corresponding authors to obtain long-term follow-up where available. We identified 44 unique cases of iALCL, the majority of which were associated with seroma, had an ALK(-) phenotype (97%), and had a good prognosis, different from the expected 40% 5-year survival rate of patients with ALK(-) nodal ALCL (one case remitted spontaneously following implant removal; only two deaths have been reported to the FDA or in the scientific literature since 1990). The majority of these patients received cyclophosphamide, doxorubicin, vincristine, and prednisolone with or without radiation, but radiation alone also resulted in complete clinical responses. It appears that iALCL demonstrates a strong association with breast implants, a waxing and waning course, and an overall good prognosis, with morphology, cytokine profile, and biological behavior similar to those of primary cutaneous ALCL. Taken together, these data are suggestive that iALCL may start as a reactive process with the potential to progress and acquire an aggressive phenotype typical of its systemic counterpart. A larger analysis and prospective evaluation and follow-up of iALCL patients are necessary to definitively resolve the issue of the natural course of the disease and best therapeutic approaches for these patients.
Topics: Adult; Aged; Aged, 80 and over; Breast Implantation; Female; Humans; Ki-1 Antigen; Lymphoma, Large-Cell, Anaplastic; Lymphoproliferative Disorders; Middle Aged
PubMed: 23429741
DOI: 10.1634/theoncologist.2012-0238 -
Molecules (Basel, Switzerland) Aug 2022Hydroxyapatite (HA) is a well-known calcium phosphate ingredient comparable to human bone tissue. HA has exciting applications in many fields, especially biomedical... (Review)
Review
Hydroxyapatite (HA) is a well-known calcium phosphate ingredient comparable to human bone tissue. HA has exciting applications in many fields, especially biomedical applications, such as drug delivery, osteogenesis, and dental implants. Unfortunately, hydroxyapatite-based nanomaterials are synthesized by conventional methods using reagents that are not environmentally friendly and are expensive. Therefore, extensive efforts have been made to establish a simple, efficient, and green method to form nano-hydroxyapatite (NHA) biofunctional materials with significant biocompatibility, bioactivity, and mechanical strength. Several types of biowaste have proven to be a source of calcium in forming HA, including using chicken eggshells, fish bones, and beef bones. This systematic literature review discusses the possibility of replacing synthetic chemical reagents, synthetic pathways, and toxic capping agents with a green template to synthesize NHA. This review also shed insight on the simple green manufacture of NHA with controlled shape and size.
Topics: Animals; Bone and Bones; Cattle; Drug Delivery Systems; Durapatite; Humans; Nanostructures; Osteogenesis
PubMed: 36080349
DOI: 10.3390/molecules27175586 -
JACC. Cardiovascular Interventions Jun 2016This study sought to perform a systematic review and network meta-analysis to compare the relative safety and efficacy of contemporary DES and BVS. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
This study sought to perform a systematic review and network meta-analysis to compare the relative safety and efficacy of contemporary DES and BVS.
BACKGROUND
To improve outcomes of patients undergoing percutaneous coronary revascularization, there have been advances in the design of drug-eluting stents (DES), including the development of drug-eluting bioresorbable vascular scaffolds (BVS).
METHODS
Prospective, randomized, controlled trials comparing bare-metal stents (BMS), paclitaxel-eluting stents (PES), sirolimus-eluting stents (SES), Endeavor zotarolimus-eluting stents (E-ZES), cobalt-chromium (CoCr) everolimus-eluting stents (EES), platinum-chromium (PtCr)-EES, biodegradable polymer (BP)-EES, Resolute zotarolimus-eluting stents (R-ZES), BP biolimus-eluting stents (BP-BES), hybrid sirolimus-eluting stents (H [Orsiro]-SES), polymer-free sirolimus- and probucol-eluting stents, or BVS were searched in online databases. The primary endpoint was definite or probable stent thrombosis at 1 year.
RESULTS
A total of 147 trials including 126,526 patients were analyzed in this study. All contemporary DES were superior to BMS and PES in terms of definite or probable stent thrombosis at 1 year. CoCr-EES, PtCr-EES, and H-SES were associated with significantly lower risk than BVS. CoCr-EES and H-SES were superior to SES and BP-BES. The risk of myocardial infarction was significantly lower with H-SES than with BVS. There were no significant differences regarding all-cause or cardiac mortality. Contemporary devices including BVS showed comparably low risks of repeat revascularization.
CONCLUSIONS
Contemporary DES, including biocompatible DP-DES, BP-DES, and polymer-free DES, showed a low risk of definite or probable stent thrombosis at 1 year. BVS had an increased risk of device thrombosis compared with CoCr-EES, PtCr-EES, and H-SES. Data from extended follow-up are warranted to confirm the long-term safety of contemporary coronary devices.
Topics: Absorbable Implants; Bayes Theorem; Coronary Disease; Coronary Thrombosis; Drug-Eluting Stents; Humans; Markov Chains; Monte Carlo Method; Network Meta-Analysis; Odds Ratio; Percutaneous Coronary Intervention; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome
PubMed: 27262860
DOI: 10.1016/j.jcin.2016.03.038 -
Biomolecules Mar 2022Cochlear implantation initiates an inflammatory cascade in which both acute insertion trauma and chronic foreign body reaction lead to intracochlear fibrosis and loss of... (Review)
Review
Cochlear implantation initiates an inflammatory cascade in which both acute insertion trauma and chronic foreign body reaction lead to intracochlear fibrosis and loss of residual hearing. Several strategies have been proposed to attenuate the local reactive process after implantation, including intracochlear drug delivery. The present study gives an overview of what is being investigated in the field of inner ear therapeutics and cochlear implant surgery. The aim is to evaluate its potential benefit in clinical practice. A systematic search was conducted in PubMed, Embase, and Cochrane Library databases identifying comparative prospective studies examining the effect of direct inner ear drug application on mechanical cochlear trauma. Both animal and human studies were considered and all studies were assessed for quality according to the validated risk of bias tools. Intracochlear administration of drugs is a feasible method to reduce the local inflammatory reaction following cochlear implantation. In animal studies, corticosteroid use had a significant effect on outcome measures including auditory brainstem response, impedance, and histological changes. This effect was, however, only durable with prolonged drug delivery. Significant differences in outcome were predominantly seen in studies where the cochlear damage was extensive. Six additional reports assessing non-steroidal agents were found. Overall, evidence of anti-inflammatory effects in humans is still scarce.
Topics: Animals; Cochlear Implantation; Cochlear Implants; Ear, Inner; Hearing; Prospective Studies
PubMed: 35454118
DOI: 10.3390/biom12040529 -
International Journal of Antimicrobial... Jan 2024Adjunctive rifampicin for implant-associated infections is controversial. This study investigated the clinical outcomes of rifampicin combination therapy compared with... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
Adjunctive rifampicin for implant-associated infections is controversial. This study investigated the clinical outcomes of rifampicin combination therapy compared with monotherapy in treating prosthetic joint infection (PJI) or prosthetic valve endocarditis (PVE) due to staphylococci and streptococci.
METHODS
A systematic search was performed from inception to 13 June 2022 in Embase, MEDLINE, Cochrane and Web of Science to investigate the clinical outcomes of rifampicin combination therapy compared with monotherapy in treating staphylococcal and streptococcal PJI or PVE. Randomised controlled trials (RCTs) and observational studies were included in the systematic review and meta-analysis.
RESULTS
Fourteen studies were included. A moderate quality of evidence was found in favour of rifampicin in patients with staphylococcal PJI who underwent a debridement, antibiotics and implant retention (DAIR) procedure [odds ratio = 2.49, 95% confidence interval (CI) 1.93-3.23]. Including the two RCTs only, adding rifampicin to the antibiotic regimen after DAIR was also in favour of rifampicin, but this was not statistically significant (risk ratio = 1.27, 95% CI 0.79-2.04; n = 126). Pooling data for patients with staphylococcal PJI who underwent a two-stage procedure showed that adding rifampicin was not associated with therapeutic success. Limited evidence was found for the use of rifampicin for PVE caused by staphylococci.
CONCLUSIONS
Adding rifampicin in the treatment of staphylococcal PJI treated by DAIR clearly increased the likelihood for therapeutic success. The clinical benefit of adjunctive rifampicin in the treatment of other staphylococci and streptococci implant-associated infections is still unclear.
Topics: Humans; Anti-Bacterial Agents; Arthritis, Infectious; Debridement; Prosthesis-Related Infections; Retrospective Studies; Rifampin; Staphylococcus; Streptococcus; Treatment Outcome
PubMed: 37875179
DOI: 10.1016/j.ijantimicag.2023.107015