METHODS: Demographic, histopathologic and clinical outcomes of 93 PABC patients obtained from our database were compared to 1424 non-PABC patients.
RESULTS: PABC patients presented at a younger age. They had higher tumor and nodal stages, higher tumor grade, were more likely to be hormone receptor negative and had a higher incidence of multicentric and multifocal tumors. Histological examination after definitive surgery showed no significant difference in tumor size and number of positive lymph nodes suggesting similar neoadjuvant treatment effects. Despite this, PABC patients had worse outcomes with poorer overall survival and disease-free survival, OS (P treatment may help improve survival.
OBJECTIVE: To determine the efficacy of ivermectin in preventing progression to severe disease among high-risk patients with COVID-19.
DESIGN, SETTING, AND PARTICIPANTS: The Ivermectin Treatment Efficacy in COVID-19 High-Risk Patients (I-TECH) study was an open-label randomized clinical trial conducted at 20 public hospitals and a COVID-19 quarantine center in Malaysia between May 31 and October 25, 2021. Within the first week of patients' symptom onset, the study enrolled patients 50 years and older with laboratory-confirmed COVID-19, comorbidities, and mild to moderate disease.
INTERVENTIONS: Patients were randomized in a 1:1 ratio to receive either oral ivermectin, 0.4 mg/kg body weight daily for 5 days, plus standard of care (n = 241) or standard of care alone (n = 249). The standard of care consisted of symptomatic therapy and monitoring for signs of early deterioration based on clinical findings, laboratory test results, and chest imaging.
MAIN OUTCOMES AND MEASURES: The primary outcome was the proportion of patients who progressed to severe disease, defined as the hypoxic stage requiring supplemental oxygen to maintain pulse oximetry oxygen saturation of 95% or higher. Secondary outcomes of the trial included the rates of mechanical ventilation, intensive care unit admission, 28-day in-hospital mortality, and adverse events.
RESULTS: Among 490 patients included in the primary analysis (mean [SD] age, 62.5 [8.7] years; 267 women [54.5%]), 52 of 241 patients (21.6%) in the ivermectin group and 43 of 249 patients (17.3%) in the control group progressed to severe disease (relative risk [RR], 1.25; 95% CI, 0.87-1.80; P = .25). For all prespecified secondary outcomes, there were no significant differences between groups. Mechanical ventilation occurred in 4 (1.7%) vs 10 (4.0%) (RR, 0.41; 95% CI, 0.13-1.30; P = .17), intensive care unit admission in 6 (2.4%) vs 8 (3.2%) (RR, 0.78; 95% CI, 0.27-2.20; P = .79), and 28-day in-hospital death in 3 (1.2%) vs 10 (4.0%) (RR, 0.31; 95% CI, 0.09-1.11; P = .09). The most common adverse event reported was diarrhea (14 [5.8%] in the ivermectin group and 4 [1.6%] in the control group).
CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of high-risk patients with mild to moderate COVID-19, ivermectin treatment during early illness did not prevent progression to severe disease. The study findings do not support the use of ivermectin for patients with COVID-19.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04920942.
MATERIALS AND METHODS: This was a prospective single-centre study regarding the utility of OA in the treatment of calcified coronaries. Intravascular ultrasound (IVUS) or optical coherence tomography (OCT) was used in all cases to characterise the severity of calcium pre-procedure, guide vessel sizing and assess procedural success. The primary endpoint was procedural success, defined by successful stent implantation following OA treatment. The secondary endpoint was in-hospital and 30-day major adverse cardiovascular event (MACE).
RESULTS: Ten patients with severely calcified lesions were successfully treated with OA. The primary endpoint was achieved in all patients. All of the lesions were severely calcified with concentric calcium. None of the patients suffered in-hospital or 30-day MACE. The average minimal luminal diameter at baseline was 1.7 ± 0.3 mm and the post- PCI luminal diameter was 3.0 ± 0.3 mm, with a significant luminal gain of 1.3 ± 0.3 mm (p < 0.01). Slow flow during procedure occurred in 2 (20%) cases and dissection occurred in 1 (10%) case during procedure. These were successfully treated with stent delivery to achieve TIMI III flow. There were no cases of stent thrombosis or vessel perforation.
CONCLUSION: Our experience demonstrates the feasibility and safety of OA in the management of calcified coronary stenosis. Intravascular imaging is an important adjunct to the use of OA to assess the severity of calcified coronary lesions, success of OA treatment and to aid sizing of the vessel for stent implantation. OA is an effective treatment approach to disrupt coronary calcification, facilitating stent implantation with optimal results. It is a safe procedure with good success rate and low rate of complications.
METHODS: This prospective, multicenter, randomized controlled trial was conducted in 27 international heart centers and was designed to randomly assign 1776 patients with angiographic multivessel coronary artery disease to receive PCI with everolimus-eluting stents or CABG. After inclusion of 880 patients (438 in the PCI group and 442 in the CABG group) between July 2008 and September 2013, the study was terminated early because of slow enrollment. The primary end point was the composite of death from any cause, myocardial infarction, or target vessel revascularization.
RESULTS: During a median follow-up of 11.8 years (interquartile range, 10.6-12.5 years; maximum, 13.7 years), the primary end point occurred in 151 patients (34.5%) in the PCI group and 134 patients (30.3%) in the CABG group (hazard ratio [HR], 1.18 [95% CI, 0.88-1.56]; P=0.26). No significant differences were seen in the occurrence of a safety composite of death, myocardial infarction, or stroke between groups (28.8% and 27.1%; HR, 1.07 [95% CI, 0.75-1.53]; P=0.70), as well as the occurrence of death from any cause (20.5% and 19.9%; HR, 1.04 [95% CI, 0.65-1.67]; P=0.86). However, spontaneous myocardial infarction (7.1% and 3.8%; HR, 1.86 [95% CI, 1.06-3.27]; P=0.031) and any repeat revascularization (22.6% and 12.7%; HR, 1.92 [95% CI, 1.58-2.32]; P<0.001) were more frequent after PCI than after CABG.
CONCLUSIONS: In patients with multivessel coronary artery disease, there were no significant differences between PCI and CABG in the incidence of major adverse cardiac events, the safety composite end point, and all-cause mortality during the extended follow-up.
REGISTRATION: URL: https://www.
CLINICALTRIALS: gov; Unique identifiers: NCT05125367 and NCT00997828.
OBJECTIVES: This study sought to understand the role of a novel SCB for the treatment of coronary artery disease.
METHODS: EASTBOURNE (All-Comers Sirolimus-Coated Balloon European Registry) is a prospective, multicenter, investigator-driven clinical study that enrolled real-world patients treated with SCB. Primary endpoint was target lesion revascularization (TLR) at 12 months. Secondary endpoints were procedural success, myocardial infarction (MI), all-cause death, and major adverse clinical events (a composite of death, MI, and TLR). All adverse events were censored and adjudicated by an independent clinical events committee.
RESULTS: A total population of 2,123 patients (2,440 lesions) was enrolled at 38 study centers in Europe and Asia. The average age was 66.6 ± 11.3 years, and diabetic patients were 41.5%. De novo lesions (small vessels) were 56%, in-stent restenosis (ISR) 44%, and bailout stenting occurred in 7.7% of the patients. After 12 months, TLR occurred in 5.9% of the lesions, major adverse clinical events in 9.9%, and spontaneous MI in 2.4% of the patients. The rates of cardiac/all-cause death were 1.5% and 2.5%, respectively. The primary outcome occurred more frequently in the ISR cohort (10.5% vs 2.0%; risk ratio: 1.90; 95% CI: 1.13-3.19). After multivariate Cox regression model, the main determinant for occurrence of the primary endpoint was ISR (OR: 5.5; 95% CI: 3.382-8.881).
CONCLUSIONS: EASTBOURNE, the largest DCB study in the coronary field, shows the safety and efficacy of a novel SCB in a broad population of coronary artery disease including small vessels and ISR patients at mid-term follow-up. (The All-Comers Sirolimus-Coated Balloon European Registry [EASTBOURNE]; NCT03085823).
STUDY DESIGN: A parallel-group, single-blinded randomized controlled trial.
METHODS: Eighty adults with KOA were randomly allocated to experimental (n=40) and control (n=40) groups. All participants underwent their usual physiotherapy care weekly for eight weeks. The experimental group received a structured HBE+EDU program to their usual care, while the control group performed home stretching exercises to equate treatment time. The Knee Injury and Osteoarthritis Outcome Score (KOOS) for the disability level, visual analogue scale (VAS) for pain, and timed up-and-go test (TUG) for mobility were measured pre-post intervention.
RESULTS: After eight weeks, the experimental group demonstrated significant improvements in the KOOS (all subscales), pain VAS, and TUG scores compared to baseline (P<0.001); meanwhile, only KOOS (activities of daily living and sports subscales) was significant in the control group. Relative to the control, the experimental group presented higher improvements (P<0.001) by 22.2%, 44.1%, and 15.7% for KOOS, pain VAS, and TUG, respectively.
CONCLUSION: Integrating the HBE+EDU program into usual KOA rehabilitation could reduce pain and disability, while it improved functional mobility. The finding of this study suggests a combination of a structured HBE and EDU program to be considered as part of mainstream KOA management.
MATERIALS AND METHODS: This was a multi-institutional, retrospective study involving all consecutive patients (>15 years old) with patent ductus arteriosus and severe pulmonary hypertension. Patients who had patent ductus arteriosus closure were divided into the Good (no death or hospital admissions due to worsening pulmonary hypertension) and the Poor Outcome groups and these groups were compared.
RESULTS: Thirty-seven patients [male: 9 (24.3%); mean age: 30.49 ± 9.56 years; median follow-up: 3 (IQR: 1.5,10) years] were included from four centers. Twenty-two patients who underwent patent ductus arteriosus closure, 15 (71.4%) had good outcomes while 7 (28.6%) had poor outcomes. Pulmonary vascular resistance index and pulmonary to systemic resistance ratio (Rp:Rs) were lower in the Good Outcome Group (14.35 ± 1.66 Wood units x m2 vs. 20.07 ± 2.44; p = 0.033 and 0.44 ± 0.16 vs. 1.08 ± 1.21; p = 0.042). Haemoglobin concentrations (<14.3 g/dL) were associated with good long-term outcomes in the Closed Group.
CONCLUSIONS: Patients with patent ductus arteriosus with severe pulmonary hypertension have a dismal outcome with or without closure. High haemoglobin levels at the time of occlusion predict a worse outcome for patients with patent ductus arteriosus and pulmonary hypertension.
METHODS: A number of 6579 patients from the TOWER group registry were divided into pre-stented (group 1) and non-pre-stented groups (group 2). Patients aged ≥18 years old, with normal calyceal anatomy were enrolled. Patients with ureteric stones, anomalous kidneys, bilateral stones, planned for ECIRS were excluded.
RESULTS: Patients are homogeneously distributed in both groups (3112 vs. 3467). The predominant indication for pre-stenting was symptom relief. Overall stone size was comparable, whilst group 1 had a significantly more multiple (1419 vs. 1283, P<0.001) and lower-pole (LP) stones (1503 vs. 1411, P<0.001). The mean operative time for group 2 was significantly longer (68.17 vs. 58.92, P<0.001). Stone size, LP stones, age, recurrence and multiple stones are contributing factors for residual fragments at the multivariable analysis. The incidence of postoperative day 1 fever and sepsis was significantly higher in group 2, indicating that pre-stenting is associated with a lower risk of post-RIRS infection and a lower overall complications rate (13.62% vs. 15.89%) (P<0.001).
CONCLUSIONS: RIRS without pre-stenting can be considered safe without significant morbidity. Multiple, lower-pole and large stone is a significant contributor towards residual fragments. Patients who were not pre-stented had significantly higher but low-grade complications, especially for lower pole and large volume stones. While we do not advocate routine pre-stenting, a tailored approach for these patients should include proper counselling regarding pre-stenting.
OBJECTIVES: This study sought to examine the different prognostic effects of revascularization strategies according to the diabetes status from the randomized BEST (Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease) trial.
METHODS: Patients (n = 880) with MVD were randomly assigned to undergo PCI with an everolimus-eluting stent vs CABG stratified by diabetics (n = 363) and nondiabetics (n = 517). The primary endpoint was the composite of death, myocardial infarction, or target vessel revascularization during a median follow-up of 11.8 years (IQR: 10.6-12.5 years).
RESULTS: In diabetics, the primary endpoint rate was significantly higher in the PCI group than in the CABG group (43% and 32%; HR: 1.53; 95% CI: 1.12-2.08; P = 0.008). However, in nondiabetics, no significant difference was found between the groups (PCI group, 29%; CABG group, 29%; HR: 0.97; 95% CI: 0.67-1.39; P = 0.86; Pinteraction= 0.009). Irrespective of the presence of diabetes, no significant between-group differences were found in the rate of a safety composite of death, myocardial infarction, or stroke and mortality rate. However, the rate of any repeat revascularization was significantly higher in the PCI group than in the CABG group.
CONCLUSIONS: In diabetics with MVD, CABG was associated with better clinical outcomes than PCI. However, the mortality rate was similar between PCI and CABG irrespective of diabetes status during an extended follow-up. (Ten-Year Outcomes of Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease [BEST Extended], NCT05125367; Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease [BEST], NCT00997828).
METHODS: This is a retrospective cohort study utilizing data from the National Cardiovascular Disease (NCVD)-PCI registry. The data collected (N = 28,007) were split into training set (n = 24,409) and testing set (n = 3598). Four predictive models (logistic regression [LR], random forest method, support vector machine [SVM], and artificial neural network) were developed and validated. The outcome on risk prediction were compared.
RESULTS: The demographic and clinical features of patients in the training and testing cohorts were similar. Patients had mean age ± standard deviation of 58.15 ± 10.13 years at admission with a male majority (82.66%). In over half of the procedures (50.61%), patients had chronic stable angina. Within 1 year of follow up mortality, target vessel revascularization (TVR), and composite event of mortality and TVR were 3.92%, 9.48%, and 12.98% respectively. LR was the best model in predicting mortality event within 1-year post-PCI (AUC: 0.820). SVM had the highest discrimination power for both TVR event (AUC: 0.720) and composite event of mortality and TVR (AUC: 0.720).
CONCLUSIONS: This study successfully identified optimal prediction models with the good discriminatory ability for mortality outcome and good discrimination ability for TVR and composite event of mortality and TVR with a simple machine learning framework.
METHODS: Searches were conducted between December 2019 and September 2020 in databases PubMed, Scopus, Web of Science and Ovid Medline using search terms including traditional, complementary, psoriasis, Kushtha, Ayurveda, Siddha, Unani, Homeopathy and clinical. Controlled trials, case series and case reports published from India were included.
RESULTS: Data of 17 selected studies were extracted. Treatment efficacy in terms of improvement in Psoriasis Area and Severity Index (PASI) score or/and percentage reduction in score (PASI 50, PASI 75 and PASI 90) or/and patient-reported outcomes using instruments like Dermatology Life Quality Index and Psoriasis Disability Index were noted. All studies reported good improvement as per the study specific outcome. However, study characteristics, including study design, sample size, follow-up period, inclusion and exclusion criteria were heterogeneous, and the choice of outcome measures was not adequate to conclude the effectiveness of intervention. The use of some herbs as common ingredients in several formulations across different systems of medicines were noted in analyzing individual formulation.
CONCLUSIONS: Future studies must incorporate a comprehensive study design with specific outcome measures like PASI, PASI 75, PASI 90, quality of life parameters, compliance to medications, adverse reactions, remission period, relapse rate and cost-effectiveness with long term follow-up. The currently available evidence on the roles of these herbs at molecular level in psoriasis is preliminary.