Effect of Argatroban Plus Dual Antiplatelet in Branch Atherosclerosis Disease: A Randomized Clinical Trial

Stroke, Ahead of Print. BACKGROUND:Branch atherosclerosis disease (BAD) is prone to early neurological deterioration (END). The purpose of this study was to assess the efficacy and safety of argatroban plus dual antiplatelet therapy (DAPT) for preventing END in high-risk branch atherosclerosis disease patients.METHODS:This multicenter, open-label, blinded end point, randomized controlled trial including branch atherosclerosis disease patients with mild stroke (National Institutes of Health Stroke Scale score ≤5) was conducted at 4 centers in China from May 18, 2021 to February 8, 2023. Within 48 hours after symptom onset, patients were randomly assigned to receive argatroban plus DAPT or DAPT alone in a 1:1 ratio. The primary end points were the incidence of END (National Institutes of Health Stroke Scale score increase ≥2) within 7 days and excellent functional outcome (modified Rankin Scale score of 0 to 1) at 90 days.RESULTS:A total of 111 patients were randomized, with 11 excluded for specific reasons, resulting in 100 patients included in the modified intention-to-treat population. Among the 100 patients, 49 received argatroban plus DAPT and 51 received DAPT alone, 63 (63.0%) were men, and the median age was 64 (range, 55–74) years. END occurred in 20.4% (10/49) of the argatroban plus DAPT group and 47.1% (24/51) of the DAPT group (risk difference, 26.7% [95% CI, 14.1–39.2]; risk ratio, 2.31 [95% CI, 1.49–3.58];P=0.006). At the 90-day follow-up, 87.8% (43/49) in the argatroban plus DAPT group and 68.6% (35/51) in the DAPT group achieved an excellent functional outcome (risk difference, −19.1% [95% CI, −30.3 to −8.0]; risk ratio, 0.78 [95% CI, 0.67–0.91];P=0.025). There was 1 minor hemorrhage in each group.CONCLUSIONS:Argatroban plus DAPT is a safe and effective strategy to reduce END occurrence and improve 90-day functional outcome in high-risk branch atherosclerosis disease patients.REGISTRATION:URL:https://www.chictr.org.cn; Unique Identifier: ChiCTR21000 46487.

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Electronic Informed Consent in MOST: An Acute Ischemic Stroke Clinical Trial

Stroke, Ahead of Print. BACKGROUND:Obtaining timely informed consent is a key barrier in acute ischemic stroke clinical trial recruitment. Electronic consent (eConsent) allows electronic delivery and documentation of the informed consent process, which may optimize recruitment. eConsent in acute ischemic stroke clinical trials, however, is limited and understudied. We conducted a post hoc analysis of eConsent adoption in MOST (Multi-Arm Optimization of Stroke Thrombolysis Trial), a phase III acute ischemic stroke clinical trial, and studied the impact on recruitment.METHODS:From October 10, 2019, to July 5, 2023, MOST enrolled 514 participants at 57 sites in the United States. Study databases were reviewed to determine informed consent modality for each participant: paper—in person, paper—remote, eConsent—in person, and eConsent—remote. Study sites could use paper consent or eConsent for each enrollment. eConsent adoption trends and participant demographic diversity were reported using descriptive statistics. We utilized χ2and Kruskal-Wallis tests to compare individual site enrollment, remote consent utilization, baseline neuroimaging-to-randomization times, data clarification requests, and reportable consent-related unanticipated events.RESULTS:eConsent was utilized for 173 (33.7%) of 514 participants. Of 57 sites, 32 (56.1%) utilized eConsent at least once: those sites had higher median enrollment over the course of the entire trial than non-eConsent sites (7.5 [interquartile range, 5–17] versus 3 [interquartile range, 2–4];P

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Interplay of health-related quality of life and comorbidities in people with type 2 diabetes mellitus treated in primary care settings in Austria: a countrywide cross-sectional study

Objectives
This study assessed the health-related quality of life (HRQoL) and its relationship with clinical factors and comorbidities in people with type 2 diabetes mellitus (T2DM) treated in primary care settings.

Design
Cross-sectional study design: This study assessed the HRQoL using a 36-item Short Form Survey (SF-36) tool in eight domains. The HRQoL scores ranged from 0% to 100% for each domain, with higher scores indicating better HRQoL. Linear regression was used to assess the association of HRQoL domain scores with clinical covariates and comorbidities.

Setting
A countrywide study was conducted on individuals with established T2DM (N=635) attending primary healthcare services for various conditions across nine federal states of Austria from 2021 to 2023.

Participants
A total of 635 individuals, aged above 50 years and diagnosed with T2DM, were recruited by the attending physician to evaluate their HRQoL in relation to T2DM and its associated comorbidities.

Results
The mean SF-36 scores for physical functioning (69±28), role-physical (62±42), mental health (72±20), role-emotional (73±41), social functioning (79±25), bodily pain (67±28) and vitality (55±22) were satisfactory, except for general health (41±10). Age and body mass were inversely associated with physical, mental and social HRQoL (p

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Cost savings of a nationwide project preventing healthcare-associated infections in adult, paediatric and neonatal critical care settings in Brazil: a micro-costing study

Objective
To provide evidence of the cost savings of a quality improvement (QI) initiative preventing healthcare-associated infections (HAIs) in critical care settings.

Design
A micro-costing study focused on financial data related to a nationwide multicentric project preventing central line-associated bloodstream infection (CLABSI), ventilator-associated pneumonia (VAP) and catheter-associated urinary tract infection (CAUTI).

Setting
Brazilian public healthcare system.

Participants
Adult, paediatric and neonatal intensive care units (ICUs) participating in the QI initiative.

Intervention
This collaborative QI project implemented a multifaceted strategy to enhance infection-control measures. Participating ICUs reported the number of patients with and without HAIs and information on each HAI’s aggregate average cost (AC), which was analysed following the Brazilian Ministry of Health’s micro-costing guidelines. The 1-year preintervention period evidenced an aggregated AC in adult, paediatric and neonatal ICUs, respectively, of Intl$21 763.5 (95% CI 20 683.6 to 22 843.0), Intl$34 062.4 (95% CI 25 819.6 to 42 304.9) and Intl$32 903.2 (95% CI 29 203.6 to 36 602.4) for CLABSI; Intl$25 202.5 (95% CI 24 276.6 to 26 127.8), Intl$44 753.6 and Intl$17 238.4 for VAP and Intl$19 166.3 (95% CI 17 676.2 to 20 656.1) and Intl$55 873.3 (95% CI 43 563.1 to 68 183.1) for CAUTI (not included neonatal ICUs).

Primary outcome
The cost savings were estimated using the HAIs prevented—expenses avoided—during the QI intervention period from September 2021 to December 2023. The HAIs prevented were estimated using the difference between observed and predicted infections based on the aggregated preintervention baseline.

Results
Of the 188 participating ICUs, 31 voluntarily completed and provided the requested financial data with 100% accuracy. Considering the prevented 7342 HAIs for adult, paediatric and neonatal ICUs, respectively: 1647, 86 and 205 CLABSI; 3775, 114 and 118 VAP; and 1377 and 20 CAUTI, we estimated a saving of Intl$175.3 million (95% CI 153.2 to 180.9 million) to the Brazilian unified health system and a resultant estimated return on investment (ROI) of 890%.

Conclusion
This QI collaborative is a value-based initiative preventing HAIs in adult, paediatric and neonatal ICUs in South American settings. The substantial cost savings and a remarkable ROI underscore the economic viability of investing in comprehensive QI infection prevention strategies.

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Diagnosis and Treatment of Polycythemia Vera—Reply

In Reply The Letters in response to our recent Review on PV from Dr Aoun and colleagues as well as Dr Ammatuna highlight emerging data on SGLT2 inhibitors as a cause of secondary erythrocytosis, which is particularly relevant given their increasing use for a variety of indications. Since first reported by Gupta et al in 2020, many studies have reported JAK2 variant–negative erythrocytosis after initiation of an SGLT2 inhibitor. In a single-center series of 100 patients, there was a median hemoglobin increase of 2.5 g/dL from baseline to a peak hemoglobin level of 18 g/dL that was recorded a median of 9 months after initiation of an SGLT2 inhibitor. Erythropoietin levels were inappropriately normal or elevated in all cases.

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