Risultati per: Progressi nel trattamento della psoriasi: review

Objective
Pilot and feasibility studies are intended to ensure that subsequent randomised controlled trials (RCTs) are feasible, economical and rigorous, especially in a challenging research environment such as emergency medicine (EM). We aimed to evaluate the methodological quality in conducting and reporting randomised pilot and feasibility studies in the EM literature and propose recommendations to improve their quality.

Design
Methodological systematic review.

Data sources and eligibility
We searched MEDLINE and Embase (2018–29 September 2023) for pilot or feasibility RCTs published as full texts in the five top-ranked and other first-quartile EM journals according to Scimago.

Data extraction and analysis
We assessed their methodological features and reporting quality primarily based on the Consolidated Standards of Reporting Trials (CONSORT) extension.

Results
A total of 24 randomised trials identified as pilot (n=13), feasibility (n=3) or both (n=8) were included. At least one feasibility outcome was assessed in 9 trials (feasibility trials), while 15 others only focused on treatment efficacy (efficacy trials). Only three (12.5%) studies progressed to the main trials. Among 12 feasibility trials, 55.6% reported their outcomes with uncertainty estimates, and 33.3% had clear progression criteria. Efficacy trials tended to draw clinical implications on their results. Studies from the five top-ranked journals had better methodological and reporting quality than those from other first-quartile journals.

Conclusion
Main methodological concerns for pilot and feasibility studies in first-quartile EM literature include misconceptions, misuses and suboptimal design and reporting quality. These issues were more prominent in lower-ranked first-quartile journals. Our findings highlight the need for resources and training for researchers, journal editors and peer reviewers on the value, objectives and appropriate conduct of pilot and feasibility studies. The conceptual framework and standardised methodological components should be emphasised. EM journals should reinforce the reporting standards and support their publication. These actions can lead to more methodologically rigorous pilot and feasibility studies in EM.

PROSPERO registration number
CRD42023468437.

In Reply We thank Drs Ben Salem and Ghariani for their comments about targeting TRMP8, the cold receptor, in the treatment of itch. We share an interest in this target, and our Review mentioned menthol, which is the prototype of TRMP8 agonists used for centuries to treat different types of itch. However, in our Review we decided to exclusively discuss treatments that are available in the US to treat itch. The TRMP8 agonists mentioned, icilin and cryosim-1, are not commercially available in the US. Although historically TRMP8 receptor activation has been considered to inhibit itch of different types, we have found that with psoriatic itch and, in particular, psoriatic scalp itch, TRMP8 is overexpressed in the skin and highly correlates with itch intensity. Additionally, a subpopulation of patients with atopic dermatitis report that cold exposure exacerbates their itch, and only 30% of patients with atopic dermatitis reported that cold reduces their itch. This highlights the need for studies to better understand which patients with pruritus (neuropathic, immunologic, or mixed etiology) may benefit from these agents. Moreover, in our clinical experience, the antipruritic effect of menthol and other currently available cooling agents is typically limited to minutes. We believe that additional studies using new TRMP8-specific agonists may help to identify the patients who will benefit the most from activation of cold receptors for the treatment of itch.

To the Editor In a recent Review about chronic pruritus, the authors did not mention transient receptor potential melastatin 8 (TRPM8) as a treatment option. Activation of TRPM8 induces a long-lasting cooling effect in the skin, and TRPM8 agonists such as icilin, menthoxypropanediol, and cryosim-1 can substantially improve recalcitrant pruritus associated with many conditions including eczema, urticaria, lichen sclerosus, and scalp itch.

Dinis-Ribeiro M, Shah S, El-Serag H, et al. The road to a world-unified approach to the management of patients with gastric intestinal metaplasia: a review of current guidelines. Gut 2024;73:1607-17.
The affiliation for Ernst J Kuipers has been corrected in the online version only to:
Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore

Objective
Potential coeliac disease (PCD) is characterised by positive serological and genetic markers of coeliac disease with architecturally preserved duodenal mucosa. The clinical outcomes and rates of progression to overt coeliac disease in patients with PCD remain uncertain. In this systematic review and meta-analysis, we aimed to evaluate the clinical outcomes of patients with PCD.

Design
We searched Medline, Embase, Scopus and Cochrane Library from 1991 through May 2024 to identify studies evaluating the clinical outcomes of patients with PCD. The progression rates to villous atrophy, seroconversion and response to a gluten-free diet (GFD) were analysed. A random-effect meta-analysis was performed, and the results were reported as pooled proportions with 95% CIs.

Results
Seventeen studies comprising 1010 patients with PCD were included in the final analyses. The pooled prevalence of PCD among patients with suspected coeliac disease was 16% (95% CI 10% to 22%). The duration of follow-up in most of the studies was at least 1 year, with follow-up periods within individual studies ranging from 5 months to 13 years. During follow-up, 33% (95% CI 18% to 48%; I2=96.4%) of patients with PCD on a gluten-containing diet developed villous atrophy, and 33% (95% CI 17% to 48%; I2=93.0%) had normalisation of serology. Among those who adhered to a GFD, 88% (95% CI 79% to 97%; I2=93.2%) reported symptomatic improvement.

Conclusion
Almost a third of patients with PCD develop villous atrophy over time, whereas a similar proportion experience normalisation of serology despite a gluten-containing diet. Most symptomatic patients benefit from a GFD. These findings highlight the importance of structured follow-up and individualised management for patients with PCD.

Circulation, Volume 150, Issue Suppl_1, Page A4140134-A4140134, November 12, 2024. Background:Cardiovascular diseases are the second leading cause of death among cancer patients, after cancer-related mortality. It has not been well established if a patient’s malignancy status increases their risk of cardiovascular events following a myocardial infarction (MI).Hypothesis:This study aims to assess the impact of cancer on cardiovascular outcomes following an acute myocardial infarction.Methods:We systematically searched electronic databases such as Pubmed, Embase and Cochrane Library from inception until March 2024 using the appropriate Mesh terms, “ cancer,” “myocardial infarction,” and “cardiovascular mortality”, “in-hospital mortality”. Pooled relative risk and their corresponding confidence interval were calculated using the random effect model. A p-value of

Circulation, Volume 150, Issue Suppl_1, Page A4148074-A4148074, November 12, 2024. Introduction/Background:Transradial cardiac catheterization (TRC) is recommended for patients with acute coronary syndrome over femoral artery catheterization. Randomized controlled trials show TRC has significantly lower rates of bleeding, vascular complications, and mortality in high-risk acute coronary syndrome patients. However, vascular complications like radial artery spasm, occlusion, arteriovenous fistula, perforation, and pseudoaneurysm (PSA) can still occur. Despite TRC’s widespread adoption, recent data summarizing radial artery pseudoaneurysm post-TRC is lacking.Research Question/HypothesisThis review aims to identify at-risk patients, present a case of catheterization-related radial artery pseudoaneurysm, and provide diagnostic and management insights. We hypothesize that older patients with hypertension are at higher risk and that early detection and management are associated with low complication rates.Methods/Approach:Systematic searches were conducted in PubMed, Web of Science, EMBASE, and CINAHL databases. Two researchers independently selected articles, extracted data, and evaluated study quality on RA PSA post-TRC (2003–2023). A third reviewer resolved conflicts. The Joanna Briggs Institute (JBI) tool was used to evaluate bias risk. Additionally, a case report is presented.Results:From 3,262 records, 43 studies were selected, involving 67 patients (58.8% female, median age 73.5 years). Hypertension (39.5%) and atrial fibrillation (27.9%) were the most common comorbidities. Percutaneous interventions like stenting and angioplasty caused 58.1% of cases; diagnostic catheterizations accounted for 37.2%. Ultrasonography diagnosed 83.7% of cases. Symptoms appeared a few hours to four months post-TRC, with pulsatile mass (21.4%) and swelling (14.3%) being the most common, and pain and ecchymosis at 2.4% each. More than half of the patients (51.2%) required surgical intervention, but 66.7% recovered without deficits. Severe complications were rare, affecting fewer than 5%.Conclusions:A literature review of 43 articles with 67 patients suggests older female patients with hypertension may be more prone to radial artery pseudoaneurysm post-TRC. It typically presents as a pulsatile, painful swelling detectable by ultrasound. This complication precludes the use of the radial artery as a conduit for coronary artery bypass grafting. The review highlights the importance of vigilant post-catheterization monitoring to enable early detection and treatment.

Circulation, Volume 150, Issue Suppl_1, Page A4148096-A4148096, November 12, 2024. Introduction:There is a lack of good risk prediction models in patients with stable coronary artery disease (SCAD). We conducted a meta-analysis of validation studies to compare and determine the discrimination abilities of Euroscore (ES) and Syntax score (SS) for prognostic outcomes in patients with SCAD.Methods:A comprehensive literature search was conducted across MEDLINE, Cochrane and Embase from inception till May 2024. All studies that reported C-statistic/AUC for predicting all cause mortality, cardiac death or Major adverse cardiovascular events (MACE) for patients with stable coronary artery disease (SCAD) were included in the analysis. Studies lacking confidence intervals (CI) for C-statistic or those which reported C-statistics in patients with acute coronary syndromes or mixed SCAD and ACS patients were excluded. A generic inverse variance method was used to pool C-statistics and their corresponding standard errors (SEs). The SEs were calculated from CI wherever needed. A pooled C statistic of >0.8 was considered to be a good discrimination ability.Results:A total of 5 studies with a patient population of 5903 were included in the meta-analysis. For ES, the pooled C-statistic for all cause mortality (n=2666) was 0.69[0.51-0.87] while for cardiac death (n=2666) it was 0.77[0.60-0.71]. The discrimination ability of ES for MACE as reported by one study (n=305) was 0.54[0.49-0.60]. For SS, the summary AUC for all cause mortality (n=2936) was 0.77[0.69-0.85] while for cardiac death (n=305) it was 0.52[0.46-0.57]. The pooled AUC of SS for occurrence of MACE(n=2666) was 0.56[0.45-0.66].Conclusion:None of the two scores have a a good discrimination ability for risk stratification in SCAD patients. The predictive accuracy of SS is comparatively better than ES for all cause mortality. However, ES performs better for predicting cardiac death. Better risk prediction models with large scale external validations are needed.

Circulation, Volume 150, Issue Suppl_1, Page A4144574-A4144574, November 12, 2024. Background:According to the American Cancer Society, there are currently over 18 million adult cancer survivors in the US, and by 2030, that figure is estimated to rise to over 22 million. While this is positive, more and more survivors are now at risk for cardiovascular disease (CVD).Hypothesis:This meta-analysis aims to evaluate the association between cancer survivors and cardiovascular event.Methods:A systematic search was conducted in electronic databases from inception until March 2024 using appropriate Mesh terms for ‘Cancer’, and ‘cardiovascular risk’. Pooled risk ratios (RR) with their corresponding 95% confidence intervals (CI) were calculated using random effects models. A p-value of

Circulation, Volume 150, Issue Suppl_1, Page A4120583-A4120583, November 12, 2024. Background:First generation drug eluting stents (DES) with thick polymers may contribute to local vascular inflammation and late stent thrombosis. Thinner-strut DES (ultrathin), particularly those with biodegradable polymers, aim to reduce this risk by minimizing flow disturbance and vascular injury. However, the long-term safety and efficacy of ultrathin biodegradable polymer sirolimus eluting stents (BP-SES) compared to durable polymer everolimus eluting stents (DP-EES) are still uncertain. Thus, we performed a meta analysis to compare outcomes of these two stents.Methods:Inclusion criteria comprised randomized controlled trials comparing ultrathin BP SES and thin DP EES in patients undergoing percutaneous coronary interventions with long term follow-up of at least 3 years. We excluded cohort studies, case reports, editorials, conference abstracts, and animal studies. Primary outcomes were target lesion failure (TLF), cardiac death (CD), target-vessel myocardial infarction (TV-MI), and clinically indicated target lesion revascularization (CI-TLR). We systematically searched PubMed, Cochrane CENTRAL, and Scopus. Cochrane’s ROB 2.0 tool assessed trial quality, and RevMan software (5.4) performed the meta-analysis.Results:Our analysis included ten RCTs, totaling 16,216 patients, with 9,108 in the BP SES group and 7,108 in the DP EES group. TLF occurred in 905 patients (9.94%) in the BP-SES group and 821 patients (11.55%) in the DP-EES group, with no statistically significant differences between the groups (RR = 0.92, 95% CI = 0.85 to 1.01, p = 0.08). Additionally, there were no significant differences in cardiac death (RR = 1.00, 95% CI = 0.84 to 1.19, p = 1.00), TV-MI (RR = 0.91, 95% CI = 0.78 to 1.05, p = 0.19), and CI-TLR (RR = 0.88, 95% CI = 0.78 to 1.01, p = 0.06) between the two groups.Conclusion:The use of BP-SES did not result in higher rates of TLF, CD, TV-MI, or CI-TLR compared to DP-DES. These findings suggest that both BP-SES and DP-DES are viable options for PCI procedures, with comparable long-term safety profiles. However, some trials used strut thicknesses exceeding 70µm in cases requiring wider diameters, similar to the strut thickness in the DP-EES group. This makes it challenging to assess whether, in addition to biodegradable polymers, lower strut thickness contributes to reducing target lesion-related events. Further research may be needed to explore other relevant outcomes and to confirm these findings in diverse patient populations.

Circulation, Volume 150, Issue Suppl_1, Page A4148089-A4148089, November 12, 2024. Background:Ventricular arrhythmias are major causes of morbidity and mortality in patients with cardiovascular disease. Implantable cardioverter-defibrillators (ICDs) are commonly used to prevent sudden cardiac death in these patients. However, patients with ICDs frequently experience recurrent arrhythmias and inappropriate shocks, which can impact their quality of life. Beta-blockers, specifically carvedilol and metoprolol, are commonly prescribed to manage these arrhythmias. This meta-analysis aims to compare the impact of both medications in this patient population.Methods:A comprehensive literature search was conducted to identify relevant studies comparing carvedilol to metoprolol in patients with ventricular arrhythmias or ICDs. Study outcomes included all-cause mortality, recurrent ventricular arrhythmia, and inappropriate ICD shocks. Effect estimates are presented as hazard ratios (HR) with 95% confidence intervals (CI).Results:1,453 studies were identified through database search. After full-text screening, a total of 5 studies involving 9,292 patients were included. We found no significant difference in the incidence of recurrent ventricular arrhythmias between carvedilol and metoprolol (HR = 0.99, 95% CI [0.75, 1.32], P = 0.97). Additionally, Carvedilol showed a trend toward reduction of all-cause mortality (HR = 0.83, 95% CI [0.68, 1.03], P = 0.09). On the other hand, Carvedilol was associated with a statistically significant reduction of inappropriate ICD shocks (HR = 0.61, 95% CI [0.48, 0.78], P < 0.001).Conclusion:Carvedilol may offer additional benefits over metoprolol in managing patients with ventricular arrhythmias or ICDs, particularly in minimizing the incidence of inappropriate ICD shocks. However, no significant difference was found in terms of all-cause mortality and recurrent ventricular arrhythmia incidence. Further research is needed to confirm these findings and guide clinical decision-making.

Circulation, Volume 150, Issue Suppl_1, Page A4136971-A4136971, November 12, 2024. Background:Non-sustained ventricular tachycardia (NSVT) has been shown to be independently associated with sudden cardiac death (SCD) among patients with hypertrophic cardiomyopathy (HCM). There is limited evidence regarding the efficacy of late gadolinium enhancement (LGE) on cardiac magnetic resonance imaging to predict the incidence of NSVT.Aims:To address this gap in knowledge, our meta-analysis aims to comprehensively evaluate the prognostic value of LGE on cardiac magnetic resonance in predicting the incidence of NSVT in HCM.Methods:PubMed, Embase and Cochrane CENTRAL databses were queried from inception until May 2024 for all studies assessing the prognostic value of LGE on CMR in patients with HCM and reported the incidence of NSVT. Data were combined using a random-effects model meta-analysis to determine the pooled sensitivity, specificity and accuracy of LGE in predicting NSVT in patients with HCM. The association between the LGE extent on CMR and NSVT incidence was also assessed, and weighted mean differences (WMDs) were reported with 95% condidence intervals (CIs). Heterogeneity across the studies was evaluated using the HigginsI2statistic.Results:A total of twenty studies were included in our analysis. The pooled senstivity, specificity, and accuracy of LGE in predicting the incidence of NSVT among HCM patients was 91.33%, 37.45%, and 52.86%, respectively. Moreover, we saw a significantly greater extent of LGE (5.95%, CI: 3.08-8.81, P

Circulation, Volume 150, Issue Suppl_1, Page A4145880-A4145880, November 12, 2024. Background:Patients with hematological malignancies may face increased cardiovascular risks, including acute myocardial infarction (AMI). This systematic review and meta-analysis aims to evaluate the incidence and outcomes of AMI in patients with hematological malignancies compared with the general population.Methods:A comprehensive literature search was conducted using the PubMed, Embase, and Google Scholar databases. Random effect models were utilized to calculate Mantel-Haenszel odds ratios (ORs) with 95% confidence intervals (CIs). The inverse variance method with DerSimonian–Laird (DL) of Tau2 was used to calculate standardized mean differences (SMDs) with CIs. Statistical significance was set at p < 0.05. The primary endpoint was the incidence of AMI, while secondary outcomes included in-hospital mortality, length of hospital stay, likelihood of undergoing invasive procedures, total hospital costs, bleeding events, and stroke outcomes.Results:Twenty-six articles, including approximately 6.33 million patients with hematological malignancies, were included in the meta-analysis. Hematological malignancies were not associated with an increased incidence of AMI compared with the general population (OR = 0.91; 95% CI 0.80 to 1.03; p

Circulation, Volume 150, Issue Suppl_1, Page A4141475-A4141475, November 12, 2024. Background:Acute Kidney Injury (AKI) is a multifactorial complication following repair of Stanford Type A aortic dissection (TAAD) with an alarmingly high incidence, varying from 20 to 77%. Postoperative AKI following life-threatening disease tends to be much more complex. However, the exact role of postprocedural AKI in the prognosis of patients undergoing TAAD repair has not been elucidated.Aims:This meta-analysis aimed to evaluate the prognostic significance of postprocedural AKI in patients undergoing TAAD repair.Methods:A literature search was conducted using PubMed, EMBASE, and SCOPUS databases. The primary endpoint was 30-day mortality with several secondary endpoints. Risk ratios (RR) with 95% confidence intervals (CIs) were pooled using Review Manager software. Statistical significance was set at p

Circulation, Volume 150, Issue Suppl_1, Page A4139964-A4139964, November 12, 2024. Background:Transthyretin amyloid cardiomyopathy (ATTR-CM) is estimated to occur in 120,000 US adults and remains underdiagnosed. However, awareness of ATTR-CM has improved following the introduction of new diagnostic tools and disease-modifying treatments. Hence, patients (pts) enrolled in contemporary clinical trials could be at an earlier stage of the disease than pts in past clinical studies.Aim:To assess temporal trends in the baseline risk of pts with ATTR-CM enrolled in clinical trials.Methods:Embase, MEDLINE, CENTRAL, and conference websites were searched on November 23, 2023, for peer-reviewed articles and abstracts. Randomized and single-arm clinical trials examining treatments for ATTR-CM were included, and baseline characteristics and outcomes in pts treated with placebo (PBO) were compared across studies.Results:We reviewed 39 publications derived from 4 randomized and 4 single-arm trials. Studies enrolled pts between 2008 and 2021, although 1 study (INOCARD, 2022) did not report years of enrollment. Several baseline characteristics were comparable across studies, including sex, age, race/ethnicity, genotype, and troponin I level. NYHA class at baseline varied with year of enrollment, with fewer NYHA class III pts in recent trials (Figure). Recent trials also showed a trend toward lower NT-proBNP levels (medians ranging from 1911-3178 pg/mL) and higher eGFR levels (means ranging from 54.7-69.0 mL/min/1.73 m2). In PBO groups, all-cause mortality (ACM) rates at 12 months dropped from 9% in ATTR-ACT (enrolled 2013-2015) to 6.9% in ATTRibute-CM (enrolled 2019-2020) and 5.6% in APOLLO-B (enrolled 2019-2021); ACM rates at 30 months dropped from 42.9% in ATTR-ACT to 25.7% in ATTRibute-CM.Conclusions:This systematic review found that disease-modifying treatments and diagnostic advances have led to earlier diagnosis of pts with ATTR-CM. Recent clinical trials appear to have enrolled pts with a better prognosis. Comparisons of results across these trials are limited and should acknowledge the potential impact of variability in baseline risks among trial populations.

Circulation, Volume 150, Issue Suppl_1, Page A4143120-A4143120, November 12, 2024. Introduction:In patients who have undergone catheter ablation due to atrial fibrillation (AF), recurrence of this condition can occur. The effect of Sacubitril/Valsartan (S/V) on preventing atrial fibrillation recurrence compared to Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin II Receptor Blocker (ARB) is not established. This meta-analysis aims to establish the best therapeutic choice for preventing AF recurrence after catheter ablation.Method:A systematic search was conducted in PubMed, Embase, and Cochrane databases for randomized clinical trial (RCT) and observational studies comparing the use of S/V with ACEI/ARB in patients who underwent catheter ablation. Results were presented as mean differences (MD) with a 95% confidence interval (CI). Heterogeneity was assessed by I2, and outcomes were expressed as relative risks (RR), using R software version 4.2.3.Results:Three randomized clinical trials and one cohort study, comprising 642 patients with 319 patients in the S/V group and 323 in the control group, were included. Follow-up ranged from 6 to 36 months, with mean ages ranging from 58.9 to 65.8 years. A significant reduction in persistent AF occurrence was demonstrated favoring the S/V group (RR: 0.54; 95% CI: 0.41 to 0.70; P=0.000004; I2: 80%) compared to the ACEI/ARB group. The analysis also showed a significant reduction in Left Atrial Volume Index (LAVI) (MD: -5.33; 95% CI: -8.76 to -1.90; P=0.002; I2: 57%) in the S/V group compared to ACEI/ARB. There was no significant difference in left ventricular ejection fraction (LVEF) with S/V use (MD: 1.23; 95% CI: -0.12 to 2.60; P=0.076; I2: 0%) compared to ACEI/ARB.Conclusion:This meta-analysis demonstrated the efficacy of S/V in reducing the incidence of AF in patients undergoing catheter ablation compared to the use of ACEI/ARB. However, more randomized clinical trials are needed for a comprehensive evaluation of its efficacy in reducing AF recurrence in post-catheter ablation patients in clinical practice.