scholarly journals The impact of non-medical cannabis legalization and other exposures on retention in longitudinal cannabis research: a survival analysis of a prospective study of Canadian medical cannabis patients

2021 ◽  
Vol 3 (1) ◽  
Author(s):  
Philippe Lucas ◽  
Susan Boyd ◽  
M.-J. Milloy ◽  
Zach Walsh
Keyword(s):  
Survival Analysis ◽  
Prospective Study ◽  
Patient Characteristics ◽  
High Rate ◽  
Medical Cannabis ◽  
Convenience Sample ◽  
Repeated Calls ◽  
Lost To Follow Up ◽  
The Impact

Abstract Background Despite repeated calls by medical associations to gather evidence on the harms and benefits of cannabis, there are ongoing methodological challenges to conducting observational and clinical studies on cannabis, including a high rate of patients that are lost to follow-up (LTFU). This study explores factors potentially associated with retention in a large prospective study of Canadian medical cannabis patients, with the goal of reducing the probability that patients will be lost to follow-up in future cannabis research. Methods The Tilray Observational Patient Study (TOPS) was a multi-site, prospective study assessing the impact of medical cannabis over 6 months in a broad population of authorized Canadian cannabis patients. The study took place from 2016 to 19, and we conducted a series of exploratory analyses including a Kaplan–Meier survival analysis and logistic regressions to assess the potential association between study retention and variables including patient characteristics, cannabis and prescription drug use, quality of life, and the legalization of non-medical cannabis. Results Overall, 1011 participants were included in this analysis, contributing 287 patient-years of data. Retention was 728 (72%) at 3 months, and 419 (41.4%) at 6 months. Our analyses found significantly lower adjusted odds of retention following legalization (AOR 0.28, 95% CI 0.18–0.41), and in patients that used prescription opioids at baseline (AOR 0.62, 95% CI 0.46–0.85), while increased odds of retention were found in patients with a higher baseline psychological score (AOR 1.43, 95% CI 1.08–1.90) or that used anti-seizure medications at baseline (AOR 1.91, 95% CI 1.30–2.81). Discussion TOPS provided a unique opportunity to examine patient characteristics and other variables that may be associated with retention in prospective medical cannabis studies. Our findings highlight some of the challenges of conducting medical cannabis research at a time when patients have a multitude of cannabis access options, including legal adult dispensaries and a robust illicit market. High LTFU rates can impact the validity of studies, and potentially lead to misestimations of the harms and benefits of medical cannabis use. Despite being a multi-site prospective study, this was a convenience sample, thereby limiting the generalizability of these findings. Additionally, data regarding the use of cannabis was self-reported by patients, so is subject to potential recall bias. Conclusion We found evidence that external policy changes that affect access to cannabis such as the legalization of non-medical adult use and patient characteristics associated with patient physical/psychological capacity can impact retention in prospective medical cannabis studies. Evidence-based strategies to reduce study burden on participants, such as minimizing in-person visits by providing digitized internet-based surveys and phone or telemedicine follow-up options as well as ensuring adequate participant compensation could improve retention. Additionally, policy-related changes aimed at improving access to medical cannabis, including increased cost-coverage and community-based distribution, could encourage patients to remain in the federal medical cannabis program and thereby reduce LTFU in associated studies.

99 Barriers of Follow Up within the Burn and Wound Population.

2021 ◽  
Vol 42 (Supplement_1) ◽  
pp. S67-S68
Author(s):  
Erika Tay ◽  
Ché R Ochtli ◽  
Katharine A Kirby ◽  
Melissa Carmean ◽  
Nicole O Bernal ◽  
...  
Keyword(s):  
Drug Dependence ◽  
Multiple Logistic Regression Analysis ◽  
Univariate Analysis ◽  
Patient Characteristics ◽  
Psychiatric Disease ◽  
Medical Comorbidities ◽  
Burn Care ◽  
Neuropsychiatric Comorbidities ◽  
Lost To Follow Up

Abstract Introduction Access to quality health care services is important for acute burn care, but comprehensive burn care goes beyond acute hospitalization. Follow up is an essential part of recovery, where providers can assess late effects of burn and help the patients with community re-integration, injury rehabilitation, and mental health. However, not all patients return for follow up after burn injury due to barriers in care and patient characteristics. We hypothesized that patients with neuropsychiatric comorbidities and 0–10% of total body surface (TBSA%) are more likely to be lost at follow up compared to patients with no neuropsychiatric comorbidities and higher TBSA. Methods A retrospective analysis was completed on patients that were admitted to a verified Burn Center from January 2016 to June 2019. Patients that were under 18 years of age and patients that died prior to discharge were excluded. Patient characteristics included were age, gender, TBSA, discharge location, payer, and comorbidities. Univariate analysis was completed using Tableau and multiple logistic regression analysis using Stata. Neuropsychiatric comorbidities were defined as dementia, alcoholism, major psychiatric disease, and drug dependence. Lost to follow up was defined as no follow up in clinic after inpatient discharge date within 1 month. Results Of 562 patients, 35.94% (n=202) were female and 65.12% (n=366) were Caucasian followed by Asian 13.7% (n=77) and Other Race 13.7% (n=77). Of the 562 patients, 157 (27.95%) were lost to follow up. After adjusting for insurance type, race, and medical comorbidities, patients with neuropsychiatric comorbidities had double the risk (OR 2.052; 1.377 - 3.057 p< 0.001) to be lost at follow up compared with those that did not have neuropsychiatric disorders. Homelessness was collinear with neuropsychiatric comorbidities suggesting an association. Patients with a TBSA >20% (n=37) were 3 times more likely to be lost at follow up in comparison with patients with 0–10% TBSA. (OR 2.921; 1.455–5.861 p< 0.003). Race, medical comorbidities, and insurance status had no significant impact on follow up. Conclusions Patients with dementia, alcoholism, major psychiatric disease, and drug dependence were more likely to be lost at follow up. Contrary to intuition, patients with burns >20% TBSA were also less likely to follow-up. Additional research is needed to better identify how psychosocial factors affect follow up in our burn patients and how to address those barriers. By focusing on our population and their needs, we can adjust our practices to make sure that we are providing holistic burn care.

scholarly journals 992. Rethinking the 28-day HIV nPEP Dispensing Practice: A Pediatric ID Clinic Analysis

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S524-S525
Author(s):  
David Zhang ◽  
Julia Rosebush ◽  
Palak Bhagat ◽  
Allison Nelson ◽  
Veena Ramaiah ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Wholesale Price ◽  
Cost Savings ◽  
Patient Characteristics ◽  
Post Exposure Prophylaxis ◽  
Exposure Prophylaxis ◽  
The Cost ◽  
The University ◽  
Lost To Follow Up

Abstract Background In July 2017, The University of Chicago Comer Children’s Hospital Emergency Department (ED) transitioned from a 5-day to a 28-day HIV nPEP (non-occupational post-exposure prophylaxis) dispensation model in an effort to increase adherence. Anecdotal reports of patients lost to follow-up after ED discharge called into question the utility and cost-effectiveness of this practice. We analyzed HIV nPEP follow-up rates in our clinic, explored reasons for nonadherence, and performed basic cost-savings analyses to inform potential changes to our dispensation model. Methods A retrospective review of both electronic health and pharmacy records was conducted for patients prescribed 28-days of HIV nPEP in the ED and scheduled for outpatient follow-up in Pediatric ID clinic from July 2017-June 2019. Clinic provider documentation of nPEP adherence and reasons for nonadherence were examined. Patients were given an initial dose of nPEP regimen in the ED and provided all subsequent doses to complete at home. Using average wholesale price (AWP), we calculated the total cost of each regimen and potential savings if a shorter duration of HIV nPEP supply was dispensed. Results 50 patients received a 28-day supply of HIV nPEP. Please refer to Table 1 regarding baseline patient characteristics. Of these, only 19 (38%) patients had documented outpatient follow-up after nPEP initiation. Median time to follow-up was 6 days (IQR: 3.0-9.0 days). Of the 19 patients with follow-up, 3 admitted to medication non-adherence. Although side effects were elicited in a total of 9 patients (18%), only 1 cited medication intolerance as the reason for discontinuing their nPEP. Given the relatively short time to follow-up, a potential savings of $1720-2211/patient could be achieved if a 10-14 day supply was dispensed. Conclusion Outpatient follow-up after 28-day HIV nPEP dispensation in our ED was < 40%, calling into question the cost-effectiveness of this dispensation model. While our current practice alleviates nPEP interruption due to potential insurance issues and pick-up delays, follow-up and adherence are not assured. The significant cost-savings with a shorter supply at the outset may encourage more robust follow-up and adherence. Disclosures All Authors: No reported disclosures

Opt-out screening for HIV, hepatitis B and hepatitis C: observational study of screening acceptance, yield and treatment outcomes

2019 ◽  
Vol 37 (2) ◽  
pp. 102-105 ◽  
Author(s):  
Conor Grant ◽  
Sarah O'Connell ◽  
Darren Lillis ◽  
Anne Moriarty ◽  
Ian Fitzgerald ◽  
...  
Keyword(s):  
Hepatitis C ◽  
Hepatitis B ◽  
Screening Programme ◽  
Linkage To Care ◽  
Opt Out ◽  
B Virus ◽  
Lost To Follow Up ◽  
The Impact ◽  
Test Result

BackgroundWe initiated an emergency department (ED) opt-out screening programme for HIV, hepatitis B virus (HBV) and hepatitis C virus (HCV) at our hospital in Dublin, Ireland. The objective of this study was to determine screening acceptance, yield and the impact on follow-up care.MethodsFrom July 2015 through June 2018, ED patients who underwent phlebotomy and could consent to testing were tested for HIV, HBV and HCV using an opt-out approach. We examined acceptance of screening, linkage to care, treatment and viral suppression using screening programme data and electronic health records. The duration of follow-up ranged from 1 to 36 months.ResultsOver the 36-month study period, there were 140 550 ED patient visits, of whom 88 854 (63.2%, 95% CI 63.0% to 63.5%) underwent phlebotomy and 54 817 (61.7%, 95% CI 61.4% to 62.0%) accepted screening for HIV, HBV and HCV, representing 41 535 individual patients. 2202 of these patients had a positive test result. Of these, 267 (12.1%, 95% CI 10.8% to 13.6%) were newly diagnosed with an infection and 1762 (80.0%, 95% CI 78.3% to 81.7%) had known diagnoses. There were 38 new HIV, 47 new HBV and 182 new HCV diagnoses. 81.5% (95% CI 74.9% to 87.0%) of known patients who were not linked were relinked to care after screening. Of the new diagnoses, 86.2% (95% CI 80.4 to 90.8%) were linked to care.ConclusionAlthough high proportions of patients had known diagnoses, our programme was able to identify many new infected patients and link them to care, as well as relink patients with known diagnoses who had been lost to follow-up.

Incidence and characterization of venous thromboembolic events (VTE) in patients with pancreatic cancer: Effect of timing of VTE on survival.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 4037-4037
Author(s):  
Maithili A Shethia ◽  
Aparna Hegde ◽  
Xiao Zhou ◽  
Michael J. Overman ◽  
Saroj Vadhan-Raj
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Survival Analysis ◽  
Kaplan Meier ◽  
Hazard Ratios ◽  
Venous Thromboembolic Events ◽  
Venous Thromboembolic ◽  
One Year ◽  
The Impact

4037 Background: Patients (pts) with pancreatic cancer are at high risk for VTE, and the occurrence of VTE can affect pts’ prognosis. The purpose of this study was to evaluate the incidence of VTE and the impact of timing of VTE (early vs. late) on survival. Methods: Medical record of 260 pts with pancreatic cancer, newly referred to UT MDACC during one year period from 1/1/2006 to 12/31/2006, were reviewed for the incidence of VTE during a 2-year follow-up period from the date of diagnosis. All VTE episodes were confirmed by radiologic studies. Survival analysis was conducted using Kaplan-Meier analysis and Cox proportional hazard models. Results: Of the 260 pts, 47 pts (18%) had 51 episodes of VTE during the 2-year follow-up. The median age of the pts with VTE was 61 years (range: 28-86) and 53% were males. Of the 47 pts with VTE, 27 (57%) had PE, 19 (40%) had DVT and 1 had concurrent PE/DVT. Three pts had recurrent VTE during the study period. Median follow-up time for OS was 192 days (range: 1-1652 days). Kaplan-Meier Survival analysis showed that those who developed VTE earlier (within 30 or 90 days) had shorter median overall survival (OS) compared with those who had VTE beyond these time points. The hazard ratios, 95% CI, and median OS at 1 year are summarized in the table below. Conclusions: The incidence of VTE is high in pts with pancreatic cancer. The timing of VTE had a significant impact on OS; pts who had an early development of VTE had a shorter overall survival. [Table: see text]

Measuring the impact of integrating palliative care into a multidisciplinary brain and spine oncology clinic.

2015 ◽  
Vol 33 (29_suppl) ◽  
pp. 163-163
Author(s):  
Matthew Manning ◽  
Mary Larach ◽  
Susan Boyles ◽  
Abigail Stern
Keyword(s):  
Palliative Care ◽  
Treatment Options ◽  
Disease Status ◽  
Patient Characteristics ◽  
High Rate ◽  
Do Not Resuscitate ◽  
Goals Of Care ◽  
Cancer Centers ◽  
Metastatic Lung ◽  
The Impact

163 Background: Recent literature indicates that palliative care (PC) improves the outcomes of patients with cancer. Integration of PC providers into cancer centers is increasingly recognized to enhance symptom management with a beneficial effect on patient survival. In order to predict the impact of widespread PC integration, we hypothesized that a small pilot program may provide evidence supporting broader implementation. The current study endeavors to measure the result of adding a dedicated PC provider to a multidisciplinary brain and spine oncology program. Methods: Over the six month study period, a PC nurse practitioner was integrated into an existing weekly multidisciplinary brain and spine oncology conference and clinic. The provider participated in the multidisciplinary conference reviewing recent MRIs and discussing current disease status and treatment options. Following conference, the PC provider would consult on up to four of the clinic patients. Data were recorded regarding patient characteristics, goals of care, and changes in therapy. Results: The PC provider participated in 14 multidisciplinary clinics with a total of 180 subjects. Of those, 24 subjects met with the PC provider in formal consultation. The most common diagnoses were 41.6% with metastatic lung cancer and 25% with glioblastoma. For goals of care, an Advanced Directive discussion was documented in 100%. Do Not Resuscitate (DNR) orders were activated in 37.5% and documented in 54%. Medical Orders for Scope of Treatment (MOST) forms were introduced in 87.5% and completed in 25%. For changes in therapy, enrollment in hospice occurred in 33.3%. Pain medication was changed in 33.3%. Other symptoms including fatigue, weakness, anorexia, constipation, anxiety, lymphedema, dysphagia, depression, insomnia, and alopecia were managed in 87.5%. Conclusions: This study suggests that the integration of a PC provider into an existing multidisciplinary cancer program can produce a high rate of establishing goals of care and result in changes in treatment in a significant number of cases. Further study on the impact of integrating PC in cancer centers seems to be warranted.

Family building preferences among young women with invasive breast cancer.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e24057-e24057
Author(s):  
Angelena Crown ◽  
Nadia Abdo ◽  
Ariela Noy ◽  
Cassandra Chang ◽  
Mary Gemignani ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Prospective Study ◽  
Fertility Preservation ◽  
Young Women ◽  
Invasive Breast Cancer ◽  
Reproductive History ◽  
High Rate ◽  
Childbearing Age ◽  
Family Building

e24057 Background: The American Society of Clinical Oncology guidelines recommend discussing the possibility of infertility in cancer patients of childbearing age being treated with gonadotoxic therapies. This prospective study examines the reproductive history and future family building preferences of young women with breast cancer. Methods: This is an Institutional Review Board approved prospective study of women < 45 years of age with non-metastatic invasive breast cancer who completed a questionnaire on reproductive history and family building preferences between April 2013 and December 2019. Questionnaires were administered at initial diagnosis and then annually. Results: Baseline questionnaires were completed by 164 women with a median age of 39 years old (range 20-45); 110 (59%) completed the 1 year follow up survey. Clinicopathologic features and treatment are shown in the table. The majority of women (n = 90, 55%) were parous and many had previous infertility (n = 60, 37%) at time of diagnosis. Most women (n = 87, 53%) wanted additional children or were unsure. Interest in embryo and/or oocyte cryopreservation was common (n = 51, 31%) as was interest in adoption (n = 52, 32%). Of the 110 women who completed the one year follow-up, 39 (35%) saw a reproductive endocrinologist, including 22 (20%) who elected embryo (n = 14) or oocyte (n = 8) cryopreservation. Overall, 88 (80%) women declined fertility preservation. The most common reasons included worrying about delay in cancer treatment (n = 10, 9%), fear of hormonal exposure (n = 7, 6%), and feeling rushed into making a decision (n = 6, 6%). Of 92 women with available data regarding satisfaction with their decision to pursue fertility preservation or not, 84% (n = 77) reported satisfaction whereas 14% (n = 15) reported mixed feelings or regret. Conclusions: Young women with breast cancer expressed a significant interest in family building options. However, pursuit of fertility preservation was uncommon despite a high rate of prior infertility in this cohort of mostly parous women. Decisional satisfaction was common. Further study of factors contributing to patient decision-making regarding fertility preservation and alternative family building options is warranted. Clinical trial information: NCT01788839 . [Table: see text]

scholarly journals The Impact of Universal Test and Treat Program on Highly Active Anti Retroviral Therapy Outcomes (Coverage, Adherence and Lost to Follow Up) at Wangaya Hospital in Denpasar, Bali-Indonesia: A Retrospective Cohort Study

2021 ◽  
Vol 15 (1) ◽  
pp. 28-34
Author(s):  
Ketut Suryana
Keyword(s):  
Cohort Study ◽  
Retrospective Cohort Study ◽  
Retrospective Cohort ◽  
Hiv Treatment ◽  
Highly Active ◽  
Universal Test And Treat ◽  
High Adherence ◽  
Lost To Follow Up ◽  
The Impact

Background: World Health Organization (WHO) (2015) recommended that all people diagnosed with human immunodeficiency virus (HIV)-positive initiate Highly Active Anti Retroviral Therapy (HAART) immediately (less than a week), irrespective of CD4 count (Universal Test and Treat / UTT) Program. Objective: To evaluate the impact of UTT as a current therapeutic program on HIV treatment outcomes, coverage, adherence, and lost to follow-up (LTFU) at Wangaya Hospital in Denpasar, Bali, Indonesia. Methods: A Retrospective cohort study was conducted during July 2017 - June 2018 (Pre-UTT) and September 2018 – August 2019 (Post-UTT). Around 402 medical records were selected, reviewed, and enrolled. Data were analyzed using SPSS software for windows version 24.0. Bivariate analysis (Chi-square test) was performed on all variables with a statistically significant t level of 0.05. Results: Among 4,322 new visitors; 3,585 (82.95%) agreed to take HIV test and 402(11.21%) were confirmed HIV reactive. Most participants confirmed HIV reactive occured at age 25-34 years old and 230 (57.21%) were male. The majority education level were primary (Junior high school) 302(75.12%), 379(94.28%) were employed and 281 (69.90%) stayed in Denpasar. About 350 (87.06%) received HAART, 298 (85.14%) with high adherence and 52 (14.86%) LTFU. Pre-UTT, HAART coverage; 83.03% (181), were statistically significant increased to 91.85% (169) post UTT (p=0.000). High adherence pre-UTT; 79.56% (144) was significantly increased to 91.12% (154) post UTT (p=0.006) and LTFU were significantly decreased; 20.44% (37) to 8.87% (15) (p=0.006). Conclusion: UTT program significantly improve the HIV treatment outcome (increased coverage, adherence, and decreased LTFU).

scholarly journals Exercise-based cardiac rehabilitation for chronic heart failure: the EXTRAMATCH II individual participant data meta-analysis

2019 ◽  
Vol 23 (25) ◽  
pp. 1-98 ◽  
Author(s):  
Rod S Taylor ◽  
Sarah Walker ◽  
Oriana Ciani ◽  
Fiona Warren ◽  
Neil A Smart ◽  
...  
Keyword(s):  
Heart Failure ◽  
Chronic Heart Failure ◽  
Exercise Capacity ◽  
Meta Analysis ◽  
Patient Characteristics ◽  
Individual Participant Data ◽  
Significant Difference ◽  
Individual Participant ◽  
The Impact

Background Current national and international guidelines on the management of heart failure (HF) recommend exercise-based cardiac rehabilitation (ExCR), but do not differentiate this recommendation according to patient subgroups. Objectives (1) To obtain definitive estimates of the impact of ExCR interventions compared with no exercise intervention (control) on mortality, hospitalisation, exercise capacity and health-related quality of life (HRQoL) in HF patients; (2) to determine the differential (subgroup) effects of ExCR in HF patients according to their age, sex, left ventricular ejection fraction, HF aetiology, New York Heart Association class and baseline exercise capacity; and (3) to assess whether or not the change in exercise capacity mediates for the impact of the ExCR on final outcomes (mortality, hospitalisation and HRQoL), and determine if this is an acceptable surrogate end point. Design This was an individual participant data (IPD) meta-analysis. Setting An international literature review. Participants HF patients in randomised controlled trials (RCTs) of ExCR. Interventions ExCR for at least 3 weeks compared with a no-exercise control, with 6 months’ follow-up. Main outcome measures All-cause and HF-specific mortality, all-cause and HF-specific hospitalisation, exercise capacity and HRQoL. Data sources IPD from eligible RCTs. Review methods RCTs from the Exercise Training Meta-Analysis of Trials for Chronic Heart Failure (ExTraMATCH/ExTraMATCH II) IPD meta-analysis and a 2014 Cochrane systematic review of ExCR (Taylor RS, Sagar VA, Davies EJ, Briscoe S, Coats AJ, Dalal H, et al. Exercise-based rehabilitation for heart failure. Cochrane Database Syst Rev 2014;4:CD003331). Results Out of the 23 eligible RCTs (4398 patients), 19 RCTs (3990 patients) contributed data to this IPD meta-analysis. There was a wide variation in exercise programme prescriptions across included studies. Compared with control, there was no statistically significant difference in pooled time-to-event estimates in favour of ExCR, although confidence intervals (CIs) were wide: all-cause mortality had a hazard ratio (HR) of 0.83 (95% CI 0.67 to 1.04); HF-related mortality had a HR of 0.84 (95% CI 0.49 to 1.46); all-cause hospitalisation had a HR of 0.90 (95% CI 0.76 to 1.06); and HF-related hospitalisation had a HR of 0.98 (95% CI 0.72 to 1.35). There was a statistically significant difference in favour of ExCR for exercise capacity and HRQoL. Compared with the control, improvements were seen in the 6-minute walk test (6MWT) (mean 21.0 m, 95% CI 1.57 to 40.4 m) and Minnesota Living with Heart Failure Questionnaire score (mean –5.94, 95% CI –1.0 to –10.9; lower scores indicate improved HRQoL) at 12 months’ follow-up. No strong evidence for differential intervention effects across patient characteristics was found for any outcomes. Moderate to good levels of correlation (R 2 trial > 50% and p > 0.50) between peak oxygen uptake (VO2peak) or the 6MWT with mortality and HRQoL were seen. The estimated surrogate threshold effect was an increase of 1.6 to 4.6 ml/kg/minute for VO2peak. Limitations There was a lack of consistency in how included RCTs defined and collected the outcomes: it was not possible to obtain IPD from all includable trials for all outcomes and patient-level data on exercise adherence was not sought. Conclusions In comparison with the no-exercise control, participation in ExCR improved the exercise and HRQoL in HF patients, but appeared to have no effect on their mortality or hospitalisation. No strong evidence was found of differential intervention effects of ExCR across patient characteristics. VO2peak and 6MWT may be suitable surrogate end points for the treatment effect of ExCR on mortality and HRQoL in HF. Future studies should aim to achieve a consensus on the definition of outcomes and promote reporting of a core set of HF data. The research team also seeks to extend current policies to encourage study authors to allow access to RCT data for the purpose of meta-analysis. Study registration This study is registered as PROSPERO CRD42014007170. Funding The National Institute for Health Research Health Technology Assessment programme.

scholarly journals Apixaban for treatment of embolic stroke of undetermined source (ATTICUS) randomized trial – update of patient characteristics and study timeline after interim analysis

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
S Poli ◽  
C Meissner ◽  
H J Baezner ◽  
A Kraft ◽  
F Hillenbrand ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Secondary Prevention ◽  
Embolic Stroke ◽  
High Rate ◽  
Cardiac Monitoring ◽  
Severe Bleeding ◽  
Current Standard ◽  
Private Company ◽  
The Impact

Abstract Background Secondary prevention after embolic stroke of undetermined source (ESUS) has not yet been established. ESUS is associated with high risk of recurrent ischemic stroke and clinically silent ischemic lesions. Secondary prevention with aspirin is the current standard therapy in ESUS patients, despite high prevalence of occult atrial fibrillation (AF). Purpose To determine whether the direct oral factor Xa inhibitor apixaban, started within 28 days after index stroke, is superior to aspirin in preventing new ischemic lesions in subjects with remote cardiac monitoring. Primary endpoint was detection of new ischemic lesions in flair and diffusion-weighted (DWI) MR imaging at 12 months follow-up. Methods The study enrolled ESUS patients with risk profile for cardiac thromboembolism (i.e., left atrium (LA) size &gt;45 mm, spontaneous echo contrast in LA appendage, LA appendage flow velocity ≤0.2 cm/s, atrial high rate episodes, CHA2DS2-Vasc score ≥4, patent foramen ovale). Patients were randomized 1:1 into the aspirin and apixaban arms. Study drug was initiated within 3–28 days after minor/moderate stroke and 14–28 days after major stroke. MRI (Flair/DWI) was conducted within 7 days of AF detection by remote cardiac monitors and at 12 months. ClinicalTrials.gov Identifier: NCT02427126. Funding: The trial is supported by BMS-Pfizer Alliance. Results Enrollment was stopped after interims analysis (including 200 patients) due to futility. Overall, 373 patients were screened with 353 being enrolled (178 and 175 in apixaban and ASA arms, respectively). So far, 130 (73.0%) and 120 (68.6%) subjects from apixaban and ASA arms, respectively, completed the study. 2% death, 1.7% withdrawal, and 1.7% were lost to follow-up. 3.9% did not completed the study for other reasons. Mean age of the ATTICUS population was 68.5 years with 51% males. 80% of the subjects suffered from hypertension. Mean systolic blood pressure at enrollment was 132 mmHg, BMI was 27.7, and CHA2DS-VASc-Score was 4.9. So far, adverse events (AE) occurred in 63% of the subjects, 30% was documented as severe. 6.8% cases of recurrent ischemic stroke and no case of hemorrhagic stroke were reported. Only 1 case of severe bleeding was reported in the aspirin arm. Newly detected AF was reported in 80 patients (23%), 42 occurring in the aspirin arm. As required by protocol, latter were immediately switched from aspirin to apixaban. Due to ongoing data clearing, numbers and % will change until presentation. Conclusions In contrast to the recently published NAVIGATE and RESPECT ESUS trials, patients enrolled in ATTICUS need to exhibit additional AF predicting factors. Furthermore, mandatory cardiac remote monitoring will help to elucidate the impact of AF and the effects of early oral anticoagulation with apixaban compared to antiplatelet therapy with aspirin on the incidence of new ischemic lesions after ESUS. Preliminary data will be presented and discussed in the context of current literature. FUNDunding Acknowledgement Type of funding sources: Private company. Main funding source(s): The trial is supported by BMS-Pfizer Alliance.

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