Baseline Patient Characteristics Research Articles

P-418 What is the optimal midluteal phase circulating progesterone level during a fresh IVF cycle? The answer differs from what one expects in a natural cycle

Abstract Study question Do midluteal phase circulating progesterone (P4) levels relate to the fresh embryo transfer clinical outcome and is rescue P4 useful in such cases? Summary answer Live birth rate (LBR) was significantly lower when P4 levels were below 20ng/ml and did not seem to benefit from rescue intramuscular P4. What is known already Preceding literature on the predictive value of midluteal P4 for LBR has shown conflicting results and frequently included small sample sets and heterogeneous ovarian stimulation protocols. The findings reported ranged from the lack of an association between P4 serum levels and clinical outcome to worse success rates seen either in the groups with the highest or the lowest P4 in midluteal phase. Furthermore, while rescue P4 has been empirically proposed, it has lacked formal assessment thus far. Study design, size, duration In total, 652 patients who underwent a fresh single blastocyst transfer in an IVF cycle in our center between 2014 and 2021 were included in this retrospective cohort study. All were GnRH-antagonist cycles using hCG trigger and luteal support with micronized vaginal progesterone 200mg twice daily. Rescue intramuscular progesterone was systematically administered whenever low midluteal P4 (below 1 standard deviation of the center’s mean) levels were detected. Participants/materials, setting, methods The cycles were subdivided into three groups according to the midluteal P4 levels: <10ng/ml, 10-20ng/ml and >20ng/ml. The primary outcome assessed was LBR, with secondary outcomes including clinical pregnancy (CPR) and pregnancy loss rates. Maternal age and body mass index (BMI), year of treatment, ovarian response, endometrial thickness, cause of infertility and embryo quality were controlled for using multivariable logistic regression. Main results and the role of chance The mean age ± standard deviation of patients was 36.8±3.8 years, while mean weight and BMI were 63.2±11.5kg and 23.3±3.9kg/m2, respectively. LBR in the group with P4>20ng/ml (46.5%) was significantly higher than in the groups with low and intermediate P4 serum levels (23.1% and 28.1%, respectively, p < 0.001). The same was true for CPR (54.5%, 30.8% and 37.9%, respectively, p < 0.001). Conversely, the rate of pregnancy loss in the group with P4>20ng/ml (23.8%) was significantly lower than in the groups with low and intermediate P4 levels (42.6% and 37.5%, respectively, p = 0.018). The multivariable logistic regression confirmed that, after controlling for the confounding variables described above, P4>20ng/ml remained significantly associated with a higher LBR (OR: 2.285; 95% CI: 1.506-3.469) and a lower pregnancy loss rate (OR: 0.488; 95% CI: 0.273-0.873), irrespective of the use of rescue IM P4. Finally, a multivariable linear regression analysis of the patients baseline characteristics suggested that the only parameter predictive of midluteal P4 levels was the female patients’ weight, with an inverse relationship (adjusted regression coefficient: -0,012; 95% CI: -0,016/-0,009). Limitations, reasons for caution As the pituitary suppression, ovulation trigger and luteal support protocols used in the cycles included in the study were homogeneous (in order to maximize the internal validity of the results), this limits the extrapolibility of the results to other stimulation protocols. Furthermore, we caution that this is a retrospective study. Wider implications of the findings The usefulness of both midluteal P4 serum measurements and rescue P4 should continue to be assessed. The reasons behind the need for higher levels of P4 in a fresh cycle, when compared to natural cycles, must also be investigated. Luteal support may require personalization according to female body weight. Trial registration number Not Applicable

Discussing on the Aortic Coverage in Type B Aortic Dissection Treatment: A Comprehensive Scoping Review.

The objective of this study is to investigate and address the question surrounding the determination of the optimal endograft length of coverage during TEVAR for type B aortic dissection (TBAD), with a particular emphasis on the distal landing zone (DLZ). MEDLINE, Scopus, and Web of Science databases were used. The PRISMA-ScR statement was followed. Several variables can contribute to the length of coverage during TEVAR in TBAD patient. Baseline patient's characteristics, TBAD-related features, the type of endoprosthesis, and postoperative graft behaviour may contribute to the choice of coverage. No robust data have been published regarding the optimal length of TEVAR. Therefore, reporting the percentage of covered aorta and improving computational studies should be valorised to improve postoperative outcomes.

Efficacy of Intravenous 20% Mannitol vs 3% Hypertonic Saline in Reducing Intracranial Pressure in Nontraumatic Brain Injury: A Systematic Review and Meta-analysis.

Nontraumatic brain injury encompasses various pathological processes and medical conditions that result in brain dysfunction and neurological impairment without direct physical trauma. The study aimed to assess the efficacy of intravenous administration of 20% mannitol and 3% hypertonic saline to reduce intracranial pressure in nontraumatic brain injury. The Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines were followed for study selection and data extraction. The search was conducted in the PubMed, Embase, and Scopus databases, including articles published in English from January 2003 to December 2023. Our study included randomized controlled trials, comparative studies, prospective analyses, and retrospective cohort studies. We extracted data on baseline characteristics of patients, intervention details, major outcomes, and complications. Quality assessment was performed using the Jadad scale and the Robvis assessment tool for risk of bias. A total of 14 studies involving 1,536 patients were included in the analysis. Seven studies reported hypertonic saline as more effective in reducing intracranial pressure, while three studies found similar effectiveness for both interventions. Adverse events were reported in only three studies. The studies that reported complication rates ranged from 21 to 79%. A meta-analysis was conducted on five studies, showing varying rates of adverse events associated with mannitol and hypertonic saline. Both hypertonic saline solution and mannitol have been explored as treatment options for decreasing intracranial pressure in nontraumatic brain injuries. While some studies indicate the superiority of hypertonic saline, others report similar effectiveness between the two interventions. Choudhury A, Ravikant, Bairwa M, Jithesh G, Kumar S, Kumar N. Efficacy of Intravenous 20% Mannitol vs 3% Hypertonic Saline in Reducing Intracranial Pressure in Nontraumatic Brain Injury: A Systematic Review and Meta-analysis. Indian J Crit Care Med 2024;28(7):686-695.

Prescription Patterns of Sodium-glucose Cotransporter-2 Inhibitors in Adults With Type 2 Diabetes and Heart Failure With Reduced Ejection Fracture Admitted to a Tertiary Care Centre in Ontario, Canada

ObjectivesOur aim in this study was to assess early adoption patterns of sodium-glucose cotransporter-2 inhibitors (SGLT2i) in eligible patients with type 2 diabetes (T2DM) and heart failure with reduced ejection fracture (HFrEF), and to identify gaps in practice. MethodsA retrospective chart review was conducted of patients with T2DM and HFrEF admitted with decompensated heart failure to The Ottawa Hospital under cardiology or general internal medicine from June 2019 to May 2021. Patterns were assessed at 8-month intervals (1 period before release of the Diabetes Canada 2020 guidelines and 2 periods afterward). Baseline patient characteristics, comorbidities, and prescriber information were collected. ResultsOf the 98 patients who met the inclusion criteria, 36.7% had a prescription for an SGLT2i, either on admission, discharge, or follow-up. Trends showed a gradual increase over time. On admission, 9.8% of patients were on an SGLT2i in period 1, 19.2% in period 2, and 23.3% in period 3. Patients receiving a prescription for SGLT2i on discharge were 0.0% in period 1, 10.0% in period 2, and 9.5% in period 3, all of whom were admitted under cardiology. On follow-up, 13.9% of eligible patients were started on an SGLT2i in period 1, 21.1% in period 2, and 35.0% in period 3. Endocrinology was the main prescriber of SGLT2i in the outpatient setting, followed by cardiology. ConclusionsOverall, trends show a slow but steady increase in early prescriptions of SGLT2i. However, most eligible patients were not started on therapy during our study period with variability in practice between specialties, highlighting opportunities to boost uptake in the future.

Association of the incidence of postherpetic neuralgia with early treatment intervention of herpes zoster and patient baseline characteristics: a systematic review and meta-analysis of cohort studies

Association of the incidence of postherpetic neuralgia with early treatment intervention of herpes zoster and patient baseline characteristics: a systematic review and meta-analysis of cohort studies

Complete versus incomplete revascularization in patients with a non-ST-elevation myocardial infarction: Analysis from the e-ULTIMASTER registry

BackgroundIncomplete revascularization (ICR) has been associated with a worse prognosis after a percutaneous coronary intervention (PCI). In NSTEMI patients with multivessel disease (MVD) however, the benefit of a complete revascularization (CR) remains unclear. MethodsPatients presenting with an NSTEMI and MVD were selected from the global e-ULTIMASTER registry and grouped according to completeness of revascularization at index hospitalization discharge. The primary endpoint was the patient oriented composite endpoint (POCE) defined as all death, any myocardial infarction, and any revascularization at 1 year. Target lesion failure (TLF) was defined as the composite of cardiac death, target vessel related myocardial infarction and clinically driven target lesion revascularization. Inverse propensity score weighting (IPSW) was performed to harmonize the patient's baseline characteristics between the groups. ResultsCR was achieved in 1800 patients (47.0 %) and ICR in 2032 patients (53.0 %). The incidence of POCE at 1 year was lower in the CR group compared to the ICR group: 7.0 % vs. 12.9 %, p < 0.0001. Similarly for TLF at 1 year: 3.6 % vs. 5.5 %, p < 0.01. After IPSW, the incidence of POCE was 7.7 % vs. 12.0 %, p < 0.0001, due to a lower all-cause mortality: 2.7 % vs. 4.2 %, p = 0.02 and less revascularizations: 4.9 % vs. 7.9 %, p < 0.001. The incidence of TLF was no longer statistically significant: CR 3.9 % vs. IR 5.0 %, p = 0.10. ConclusionsPatients with a NSTEMI and multi vessel disease undergoing a percutaneous coronary revascularization with a complete revascularization during index hospitalization have better 1-year clinical outcomes. Randomized studies are warranted to confirm these results.

IRON: A retrospective international multicenter study on robotic versus laparoscopic versus open approach in gallbladder cancer

ObjectiveFor patients with T1b gallbladder cancer or greater, an adequate lymphadenectomy should include at least 6 nodes. Studies comparing short- and long-term outcomes of the open approach with those of laparoscopy and robotic approaches are limited, with small sample sizes, and there are none comparing laparoscopic and robotic approaches. This study compared patients who underwent robotic, laparoscopic, and open resection of gallbladder cancer, evaluating short- and long-term outcomes. MethodsWe conducted a multicenter retrospective study of patients with T1b gallbladder cancer or greater (excluding combined organ resection and T4) who underwent open, laparoscopic, and robotic liver resection and lymphadenectomy between January 2012 and December 2022. The 3 groups were matched in terms of patient baseline and disease characteristics based on propensity score matching, comparing robotic with open and robotic with laparoscopic groups. ResultsWe enrolled 575 patients from 37 institutions. After propensity score matching, the median number of harvested nodes was higher in the robotic group than in the open (7 vs 5; P = .0150) and laparoscopic groups (7 vs 4; P < .001). The Pringle maneuver time was shorter with robotic resection than with laparoscopy (38 vs 59 minutes; P = .0034), and the robotic group also had a lower conversion rate (3% vs 14%, respectively; P = .005) and less estimated blood loss than open and laparoscopic resections. The perioperative morbidity and mortality rates did not differ. The robotic and laparoscopic approaches were associated with faster functional recovery than the open group. In the multivariate analysis, the factors related to the retrieval of at least 6 nodes were the robotic approach over open (odds ratio, 5.1529) and over laparoscopy (odds ratio, 6.7289) and the center experience (≥20 minimally invasive liver resections/year) (odds ratio, 4.962). After a mean follow-up of 42.6 months, overall survival and disease-free survival were not different between groups. ConclusionCompared with open and laparoscopic surgeries, the robotic approach for gallbladder cancer performed in a center with appropriate experience in minimally invasive surgery can provide adequate node retrieval.

Long- and short-term outcomes after transvenous lead extraction in a large single-centre patient cohort using the clinical frailty scale as a risk assessment tool

Background and aimsThe rate of cardiac implantable electronic device (CIED) implantations and the need for transvenous lead extraction (TLE) are growing worldwide. This study examined a large Swedish cohort with the aim of identifying possible predictors of post-TLE mortality with special focus on systemic infection patients and frailty. MethodsThis was a single centre study. Records of patients undergoing TLE between 2010 and 2018 were analysed. Statistical analyses were conducted to compare baseline characteristics of patients with different indications and identify risk factors of 30-day and 1-year mortality. ResultsA total of 893 patients were identified. Local infection was the dominant indication and pacemaker was the most common CIED. The mean age was 65 ± 16 years, 73 % were male and median follow-up was 3.9 years. Heart failure was the most common comorbidity. Patients with systemic infection were significantly older, frailer and had significantly higher levels of comorbidities. 30-day mortality and 1-year mortality rates were 2.5 % and 9.9 %, respectively. Systemic infection and chronic kidney disease (CKD) were independently associated with 30-day and 1-year mortality. Clinical frailty scale (CFS) 5–7 correlated independently with 1-year mortality in the entire cohort and specifically in systemic infection patients. CKD, cardiac resynchronization therapy and CFS 5–7 were significant risk factors for long-term mortality (death >1 year after TLE) in multivariable analysis. ConclusionsSystemic infection, kidney failure in addition to the novel parameter of frailty were associated with post-TLE all-cause mortality. These risk factors should be considered during pre-procedure risk stratification to improve post-TLE outcomes.

Characteristics and outcomes of patients with low back pain with and without radiating leg pain following the GLA:D back program

BackgroundSome patients with low back pain (LBP) also report radiating leg pain which is a prognostic factor for poorer clinical outcomes. We aimed: 1) to compare the baseline characteristics of patients with LBP with - (LBP + leg pain) and without radiating leg pain (LBP - alone); 2) to investigate whether patients with LBP + leg pain show similar post-treatment outcomes as compared to LBP – alone, after participation in an exercise and patient education program, i.e. the GLA:D Back program. MethodsThe patient sample included 3508 patients in the GLA:D Back program between March 2018 and August 2022. The outcomes were mean changes in LBP intensity, back-related activity limitation, self-efficacy and fear of movement measured from baseline to 3, 6 and 12 months. Baseline characteristics were compared with descriptive statistics, and linear mixed models were used to estimate group differences in changes from baseline to 3-, 6- and 12 months. Results1915 (55%) of the patients were in the group LBP- alone and 1593 (45%) in the LBP + leg pain. The LBP + leg pain group displayed higher STarT back classification (greater risk of chronicity) compared to the LBP–alone. The LBP + leg pain group showed almost similar improvements in all outcomes compared to LBP – alone after the GLA:D Back program. ConclusionIn long-lasting (chronic) LBP patients, the LBP + leg pain group improved to the same extent as LBP - alone regarding LBP intensity, disability, and fear of movement following an exercise and patient education program, GLA:D Back.

Predictors of In-Hospital Mortality in Type A Acute Aortic Syndrome: Data From the RENADA-RO Registry

This study aimed to analyse the baseline characteristics of patients admitted with acute type A aortic syndrome (ATAAS) and to identify the potential predictors of in-hospital mortality in surgically managed patients. Data regarding demographics, clinical presentation, laboratory work-up, and management of 501 patients with ATAAS enrolled in the National Registry of Aortic Dissections-Romania registry from January 2011 to December 2022 were evaluated. The primary endpoint was in-hospital all-cause mortality. Multivariate logistic regression was conducted to identify independent predictors of mortality in patients with acute Type A aortic dissection (ATAAD) who underwent surgery. The mean age was 60±11 years and 65% were male. Computed tomography was the first-line diagnostic tool (79%), followed by transoesophageal echocardiography (21%). Cardiac surgery was performed in 88% of the patients. The overall mortality in the entire cohort was 37.9%, while surgically managed ATAAD patients had an in-hospital mortality rate of 29%. In multivariate logistic regression, creatinine value (OR 6.76), ST depression on ECG (OR 6.3), preoperative malperfusion (OR 5.77), cardiogenic shock (OR 5.77), abdominal pain (OR 4.27), age ≥70 years (OR 3.76), and syncope (OR 3.43) were independently associated with in-hospital mortality in surgically managed ATAAD patients. Risk stratification based on the variables collected at admission may help to identify ATAAS patients with high risk of death following cardiac surgery.

Long- and short-term outcomes after transvenous lead extraction in a large single-centre patient cohort using the clinical frailty scale as a risk assessment tool

Background and aimsThe rate of cardiac implantable electronic device (CIED) implantations and the need for transvenous lead extraction (TLE) are growing worldwide. This study examined a large Swedish cohort with the aim of identifying possible predictors of post-TLE mortality with special focus on systemic infection patients and frailty. MethodsThis was a single centre study. Records of patients undergoing TLE between 2010 and 2018 were analysed. Statistical analyses were conducted to compare baseline characteristics of patients with different indications and identify risk factors of 30-day and 1-year mortality. ResultsA total of 893 patients were identified. Local infection was the dominant indication and pacemaker was the most common CIED. The mean age was 65 ± 16 years, 73% were male and median follow-up was 3.9 years. Heart failure was the most common comorbidity. Patients with systemic infection were significantly older, frailer and had significantly higher levels of comorbidities. 30-day mortality and 1-year mortality rates were 2.5% and 9.9%, respectively. Systemic infection and chronic kidney disease (CKD) were independently associated with 30-day and 1-year mortality. Clinical frailty scale (CFS) 5-7 correlated independently with 1-year mortality in the entire cohort and specifically in systemic infection patients. CKD, cardiac resynchronization therapy and CFS 5-7 were significant risk factors for long-term mortality (death >1 year after TLE) in multivariable analysis. ConclusionsSystemic infection, kidney failure in addition to the novel parameter of frailty were associated with post-TLE all-cause mortality. These risk factors should be considered during pre-procedure risk stratification to improve post-TLE outcomes.

Comparative effectiveness of combination therapy with nirmatrelvir–ritonavir and remdesivir versus monotherapy with remdesivir or nirmatrelvir–ritonavir in patients hospitalised with COVID-19: a target trial emulation study

Remdesivir (Veklury, Gilead Sciences, Foster City, CA, USA) and nirmatrelvir-ritonavir (Paxlovid, Pfizer, New York, NY, USA) were reported to improve the outcome of patients with mild-to-moderate COVID-19 symptoms. Preclinical data suggest that nirmatrelvir-ritonavir might be more effective than remdesivir alone or in combination with nirmatrelvir-ritonavir for people at high risk of severe COVID-19. We aimed to assess the safety and effectiveness of combining remdesivir and nirmatrelvir-ritonavir compared with using each drug alone for adults hospitalised with COVID-19. In this target trial emulation study, we used electronic health records of patients aged 18 years or older who received either combination treatment of nirmatrelvir-ritonavir and remdesivir or monotherapy of either drug between March 16 and Dec 31, 2022, within 5 days of hospitalisation for COVID-19 in Hong Kong. Inverse probability of treatment weighting was applied to balance baseline patient characteristics across the treatment groups. The primary outcome was all-cause mortality. Cox proportional hazards regression adjusting weighting was used to compare the risk of all-cause mortality, intensive care unit (ICU) admission, or ventilatory support for 90 days of follow-up between groups. Between March 16 and Dec 31, 2022, 18 196 participants were identified from electronic health records and assigned to receive remdesivir (n=4232), nirmatrelvir-ritonavir (n=13 656), or nirmatrelvir-ritonavir and remdesivir (n=308). By applying an inverse probability of treatment weighting, a weighted sample composed of 18 410 recipients of nirmatrelvir-ritonavir and remdesivir combination treatment, 18 178 recipients of remdesivir monotherapy, and 18 287 recipients of nirmatrelvir-ritonavir monotherapy was obtained. After a median follow-up of 84 days (IQR 45-90), risk of mortality was lower in patients who received nirmatrelvir-ritonavir monotherapy (hazard ratio [HR] 0·18 [95% CI 0·15 to 0·20]; absolute risk reduction [ARR] -16·33% [95% CI -16·98 to -15·68]) or remdesivir and nirmatrelvir-ritonavir combination therapy (HR 0·66 [95% CI 0·49 to 0·89]; ARR -6·52% [95% CI -7·29 to -5·74]) than in patients who received remdesivir monotherapy. Similar results were observed for ICU admission or ventilatory support (nirmatrelvir-ritonavir monotherapy: HR 0·09 [95% CI 0·07 to 0·11]; ARR -10·04% [95% CI -10·53 to -9·56]; combination therapy: HR 0·68 [95% CI 0·42 to 1·12]; ARR -3·24% [95% CI -3·84 to -2·64]). Compared with combination therapy, nirmatrelvir-ritonavir monotherapy was associated with lower risk of mortality (HR 0·27 [95% CI 0·20 to 0·37]; ARR -9·81% [95% CI -10·39 to -9·24]) and ICU admission or ventilatory support (HR 0·13 [95% CI 0·08 to 0·22]; ARR -6·80% [95% CI -7·22 to -6·39]). Our study highlighted the potential for reduced risk of mortality, ICU admission, or the need for ventilatory support in patients hospitalised with COVID-19 treated with nirmatrelvir-ritonavir as a monotherapy compared with treatment regimens based on nirmatrelvir-ritonavir and remdesivir combination therapy or remdesivir monotherapy. Further randomised controlled trials are needed to support the validity of the current results. The Health and Medical Research Fund Commissioned Research on COVID-19. For the Chinese translation of the abstract see Supplementary Materials section.

Systematic screening by a heart team and a machine learning approach contribute to unraveling novel risk factors in revascularization candidates with complex coronary artery disease.

The baseline characteristics affecting mortality following percutaneous or surgical revascularization in patients with left main and / or 3‑vessel coronary artery disease (CAD) observed in real‑world practice differ from those established in randomized controlled trials (RCTs) due to the constraints of inclusion / exclusion criteria. This study aimed to assess whether systematic screening enables identification of novel and registry‑specific baseline patient characteristics influencing long‑term mortality. Least absolute shrinkage and selection operator (LASSO) regression was used to screen 42 baseline patient characteristics shared by the SYNTAX (Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) trial and a single‑center Polish registry of 1035 consecutive patients with complex CAD who received revascularization and were followed-up for 5 years. After screening, a classic Cox regression analysis was performed to examine the suitability of a linear model for predicting 5‑year mortality, which was then compared with the mortality predicted in the same cohort using the SYNTAX score II 2020 (SS2020). The 5‑year mortality rate in the registry was 12.3%, and the strongest predictors were pulmonary hypertension, chronic obstructive pulmonary disease, and insulin‑dependent diabetes. In an internal validation, the linear model constructed after LASSO screening and combined with a classic Cox regression analysis improved the prediction of 5‑year mortality, as compared with the SS2020 (concordance index of 0.92 and 0.75, respectively). A machine learning approach improved the detection of registry‑specific risk factors in all‑comer patients amenable to surgical or percutaneous revascularization who were evaluated by a heart team. The risk factors identified in RCTs are not necessarily the same as those detected in real clinical practice when systematic screening is applied.

β-blockades and the risk of atrial fibrillation in patients with cardiovascular diseases.

β-blockers have been widely used in patients with extensive cardiovascular disease (CVD) and have provided benefits. However, they are more likely to cause symptomatic bradycardia, hypotension, or glucose metabolism disorders, which may lead to an increased risk of atrial fibrillation (AF), but evidence is lacking. This study was to analyze the association between the use of β-blockers and the risk of developing AF. This nationwide, prospective cohort study utilized data from the 2013-2020 National Health and Nutrition Examination Survey (NHANES). The patients were stratified into a β-blocker treatment group (n = 2585) and a non-β-blocker treatment group (n = 8525). Univariate and multivariate logistic regression analyses were performed to identify the relationship between β-blockades and the risk of AF. Propensity matching analysis was used to balance patient baseline characteristics and to control for confounders. A total of 11,110 subjects were included in this study (mean [SD] age, 59.89 [15.07] years; 5657 [49.7%] males). A total of 111/2585 subjects developed AF in the β-blocker treatment group, and 75/8525 developed AF in the non-β-blocker treatment group (incidence rate, 4.2% vs. 0.8%). Compared with the non-β-blocker group, the β-blocker group had an increased risk of incident AF (aOR, 2.339; 95% CI, 1.614-3.410). Some sensitivity analyses also revealed consistent findings of increased AF risk associated with β-blocker treatment. The findings from this study suggest that β-blocker treatment is associated with an increased risk of incident AF and may help physicians select a modest medication for patients while also assessing the risk of AF.

WITHDRAWN: Corrigendum to “Comparison of baseline patient characteristics in Italian oncology drug monitoring registries and clinical trials: a real-world cross-sectional study” [The Lancet Regional Health – Europe 41 (2024) 100912]

WITHDRAWN: Corrigendum to “Comparison of baseline patient characteristics in Italian oncology drug monitoring registries and clinical trials: a real-world cross-sectional study” [The Lancet Regional Health – Europe 41 (2024) 100912]

CO174 Baseline Characteristics of Patients with Asthma and Prior Oral Systemic Corticosteroid Use Initiating Dupilumab in a Real-World Registry (RAPID)

CO174 Baseline Characteristics of Patients with Asthma and Prior Oral Systemic Corticosteroid Use Initiating Dupilumab in a Real-World Registry (RAPID)

Filgotinib induction-study baseline characteristics of patients with ulcerative colitis who achieve sustained corticosteroid-free remission: post hoc analysis of the phase 2b/3 SELECTION study.

Obtaining and maintaining corticosteroid-free remission are important goals of treatment for ulcerative colitis (UC). Characteristics associated with achieving corticosteroid-free remission were assessed in filgotinib-treated patients in SELECTION, a 58-week, phase 2b/3 trial in moderately to severely active UC. This post hoc analysis used data from filgotinib-treated patients receiving corticosteroids at maintenance baseline in SELECTION. Univariate logistic regression was performed to assess induction baseline characteristics associated with 6 months of corticosteroid-free remission at week 58, defined as clinical remission without using corticosteroids for at least 6 months. At maintenance baseline, 92 and 81 patients were receiving corticosteroids in the filgotinib 200 mg and filgotinib 100 mg groups, respectively. Age, body mass index, history of pancolitis, disease duration, fecal calprotectin levels, C-reactive protein levels, Mayo Clinic Score, concomitant corticosteroids, immunomodulators, and aminosalicylates had no statistically significant effect on the likelihood of achieving corticosteroid-free remission. Baseline characteristics associated with increased odds of corticosteroid-free remission were Mayo Clinic Endoscopic Subscore of 2 (vs. 3) in the filgotinib 200 mg and filgotinib 100 mg groups, and female (vs. male) sex, current (vs. former or never) smoking, and being biologic‑naive (vs. experienced) in the filgotinib 200 mg group. Steroid tapering can be achieved in patients with UC receiving filgotinib 200 mg independently of baseline characteristics such as clinical activity and duration of illness. However, the likelihood of achieving corticosteroid-free remission was higher among patients who were biologic-naive, current smokers, had low endoscopic inflammatory burden and who were female.

Enfortumab vedotin-related cutaneous toxicity correlates with overall survival in patients with urothelial cancer: a retrospective experience.

Enfortumab vedotin (EV) is an antibody drug conjugate approved for advanced urothelial cancer, consisting of a monomethyl auristatin E payload linked to a human monoclonal antibody targeting nectin-4. No validated biomarker predictive of or correlated with response exists for EV. Cutaneous toxicity is among the most common EV-related toxicities and typically emerges in early cycles. This retrospective experience of patients with urothelial cancer treated with EV monotherapy evaluated whether EV-related cutaneous toxicity correlated with improved outcomes including progression-free (PFS) and overall (OS) survival and overall response rate (ORR). Patients treated with EV monotherapy at Johns Hopkins were identified, and baseline characteristics, treatment, and toxicity details were extracted through chart review. Univariable Cox hazard ratios (HRs) were calculated for assessing the effect of baseline patient characteristics and cutaneous toxicity in PFS and OS. Based on the univariable analysis and known risk factors, all subsequent analyses were adjusted for: Eastern Cooperative Oncology Group performance status, visceral metastases at baseline, gender as well as EV dose, and weight to account for dosing differences. Multivariable Cox proportional HRs were used for comparing PFS and OS between patients with and without cutaneous toxicity, assessing toxicity and EV dose as a time-dependent variables. Adjusted p-values were calculated to compare ORR and disease control rate (DCR) between groups using the Poisson regression model. Of the 78 patients analyzed, 42 (53.8%) experienced EV-related cutaneous toxicity that appeared early during treatment (median time to occurrence 0.5 months from EV initiation). Cutaneous toxicity correlated with significantly improved OS [HR, 0.48; 95% confidence interval (CI), 0.25, 0.9; P = 0.0235], ORR (68.3% vs. 20.7%, P = 0.0033) and DCR (82.9% vs. 48.3%, P = 0.0122). Median PFS was numerically longer in the cutaneous toxicity group (6.3 vs. 1.7 months), although no significance was achieved in the multivariable analysis (HR, 0.62; 95% CI: 0.35, 0.108; P = 0.0925). In this retrospective study, EV-related cutaneous toxicity was associated with improved patient outcomes. Confirming this observation and understanding its mechanism could lead to discovery of a new clinical biomarker of EV response that can emerge in the first cycle.

Developing a Coordinated Registry Network for devices used for acute ischemic stroke intervention: basilar artery occlusion quality assessment pilot

BackgroundReal-world data can be helpful in evaluating endovascular therapy (EVT) in ischemic stroke care. We conducted a pilot study to aggregate data on basilar artery occlusion (BAO) EVT from existing...

Percutaneous repair of moderate-to-severe or severe functional mitral regurgitation in patients with symptomatic heart failure: Baseline characteristics of patients in the RESHAPE-HF2 trial and comparison to COAPT and MITRA-FR trials.

The RESHAPE-HF2 trial is designed to assess the efficacy and safety of the MitraClip device system for the treatment of clinically important functional mitral regurgitation (FMR) in patients with heart failure (HF). This report describes the baseline characteristics of patients enrolled in the RESHAPE-HF2 trial compared to those enrolled in the COAPT and MITRA-FR trials. The RESHAPE-HF2 study is an investigator-initiated, prospective, randomized, multicentre trial including patients with symptomatic HF, a left ventricular ejection fraction (LVEF) between 20% and 50% with moderate-to-severe or severe FMR, for whom isolated mitral valve surgery was not recommended. Patients were randomized 1:1 to a strategy of delivering or withholding MitraClip. Of 506 patients randomized, the mean age of the patients was 70 ± 10 years, and 99 of them (20%) were women. The median EuroSCORE II was 5.3 (2.8-9.0) and median plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) was 2745 (1407-5385) pg/ml. Most patients were prescribed beta-blockers (96%), diuretics (96%), angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor-neprilysin inhibitors (82%) and mineralocorticoid receptor antagonists (82%). The use of sodium-glucose cotransporter 2 inhibitors was rare (7%). Cardiac resynchronization therapy (CRT) devices had been previously implanted in 29% of patients. Mean LVEF, left ventricular end-diastolic volume and effective regurgitant orifice area (EROA) were 31 ± 8%, 211 ± 76 ml and 0.25 ± 0.08 cm2, respectively, whereas 44% of patients had mitral regurgitation severity of grade 4+. Compared to patients enrolled in COAPT and MITRA-FR, those enrolled in RESHAPE-HF2 were less likely to have mitral regurgitation grade 4+ and, on average, HAD lower EROA, and plasma NT-proBNP and higher estimated glomerular filtration rate, but otherwise had similar age, comorbidities, CRT therapy and LVEF. Patients enrolled in RESHAPE-HF2 represent a third distinct population where MitraClip was tested in, that is one mainly comprising of patients with moderate-to-severe FMR instead of only severe FMR, as enrolled in the COAPT and MITRA-FR trials. The results of RESHAPE-HF2 will provide crucial insights regarding broader application of the transcatheter edge-to-edge repair procedure in clinical practice.