Category: 8. Health

Health Secretary Robert F. Kennedy Jr. appears to be pushing for more members for the influential government vaccine advisory panel that he recently gutted, weeks before it’s expected to consider childhood shot schedules and Covid booster recommendations.

Catherine Stein, a professor at Case Western University, said that government health officials have reached out to her about joining the Advisory Committee on Immunization Practices and that she’s accepted. They’re currently processing her paperwork, she said, which was extensive and included questions on her potential conflicts of interest.

Dual antiplatelet therapy (DAPT) was not more effective than aspirin alone for the prevention of major adverse cardiovascular events and increased major bleeding in patients with acute coronary syndrome (ACS) who underwent coronary artery bypass grafting (CABG), according to late-breaking research presented in a Hot Line session today at ESC Congress 20251 and simultaneously published in New England Journal of Medicine.

ESC Guidelines recommend DAPT with aspirin plus a P2Y12 inhibitor over single antiplatelet therapy for patients with ACS (heart attacks or unstable angina) who have undergone CABG.

These recommendations are mainly based on extrapolation of data from non-CABG studies, sub-studies of ACS trials and smaller randomised studies with surrogate endpoints. Data from larger randomised trials with clinically relevant endpoints are lacking. We conducted the TACSI trial to investigate whether 12 months of DAPT with ticagrelor and aspirin would reduce the risk of all-cause death and cardiovascular events compared with aspirin alone in ACS patients after CABG.”

Anders Jeppsson, Principal Investigator, Professor from Sahlgrenska University Hospital, Gothenburg, Sweden

The TACSI trial was an investigator-initiated pragmatic, open-label, registry-based randomised trial conducted in all 22 cardiothoracic surgery centres in Sweden, Denmark, Norway, Finland and Iceland. Patients undergoing their first isolated CABG were randomised 1:1 within 3-14 days to either DAPT (ticagrelor 90 mg twice daily plus aspirin 75 mg once daily) or aspirin only (75-160 mg daily according to local protocols) for 12 months. The primary efficacy endpoint of major adverse cardiovascular events (MACE) was a composite of all-cause death, myocardial infarction, stroke or new coronary revascularisation within 12 months. The primary safety endpoint was major bleeding.

The 2,201 patients included had a mean age of 66 years and 14.4% were women. The primary endpoint of MACE occurred in a similar proportion of patients in each group: 4.8% of patients in the DAPT group and 4.6% in the aspirin only group (hazard ratio [HR] 1.09; 95% confidence interval [CI] 0.74 to 1.60; log rank p=0.77). Major bleeding was more frequent in the DAPT group (4.9% vs. 2.0%; HR 2.50; 95% CI 1.52 to 4.11).

A key secondary endpoint of net adverse clinical events (the primary endpoint plus major bleeding) was higher in the DAPT group than in the aspirin group (9.1% vs. 6.4%; HR 1.45; 95% CI 1.07 to 1.97). A total of 0.7% of patients with DAPT and 0.2% with aspirin only died during the first year after randomisation (HR 4.01; 95% CI 0.85 to 18.9).

Concluding, Professor Jeppsson said: “Our 12-month data do not support the use of DAPT over aspirin alone in ACS patients after CABG, given the lack of improvement in MACE and the increased risk of major bleeding. However, further long-term follow-up is needed.”

Discontinuing oral anticoagulation (OAC) therapy resulted in a lower risk of a composite of stroke, systemic embolism or major bleeding than continuing OAC therapy in patients who had successful ablation for atrial fibrillation at least 12 months previously, according to results from a late-breaking trial presented in a Hot Line session today at ESC Congress 2025 and simultaneously published in The Journal of the American Medical Association.

Atrial fibrillation (AF) is a common type of arrhythmia characterised by an abnormal irregular heartbeat that can increase the risk of stroke and thromboembolism (blood clots). Ablation can be used to destroy small sections of heart tissue that may be causing abnormal heartbeats. Oral anticoagulation (OAC) is recommended in all patients for at least 2 months after AF ablation to reduce the risk of stroke or thromboembolism. Thereafter, guidelines recommend continuing OAC depending on the patient’s risk of stroke.

Explaining why the ALONE-AF trial was conducted, its Principal Investigator, Professor Boyoung Joung from Yonsei University, Seoul, South Korea, said: “Many patients who have had a successful ablation and have stroke risk factors remain on OAC for the rest of their lives, although there is no evidence from randomized trials to indicate that this is necessary. We compared direct OAC therapy with no OAC therapy among patients 1 year after successful AF ablation who had at least one risk factor for stroke.“

The ALONE-AF trial was an open-label randomized superiority trial conducted at 18 sites in South Korea. Eligible patients had non-valvular AF, had undergone their first catheter-based AF ablation, had no atrial arrhythmia recurrence for at least 12 months post-ablation and had at least one stroke risk factor as determined by the CHA2DS2-VASc score (CHA2DS2-VASc ≥1 for males or ≥2 for females). Patients were randomized 1:1 to receive direct OAC or no OAC therapy. Patients randomized to the OAC group received standard doses of apixaban, rivaroxaban or edoxaban, unless established dose-reduction criteria applied. The primary endpoint of net adverse clinical events was a composite of stroke, systemic embolism and major bleeding at 24 months.

The study population included 840 randomized patients who had a mean age of 64 years, with one-quarter (25%) being women.

At 24 months, OAC was associated with a higher risk of net adverse clinical events than no OAC (2.2% vs. 0.3%; absolute difference −1.9%; 95% confidence interval [CI] −3.5 to −0.3; log-rank p=0.024).

No significant difference was observed in the incidence of ischaemic stroke or systemic embolism at 24 months between the OAC and no-OAC groups (0.8% vs. 0.3%, respectively; absolute difference −0.5%; 95% CI −1.6 to 0.6). Major bleeding occurred in 1.4% of patients in the OAC group and 0% in the no-OAC group (absolute difference -1.4%; 95% CI −2.6 to −0.2).

Concluding, Professor Joung said: “In the first randomized trial to address this question, receiving no OAC treatment resulted in a lower risk of harmful events than OAC treatment. A limitation was that the trial was not designed to detect a potential difference in ischemic events, which occurred at a lower-than-expected rate. Our findings indicate that lifelong OAC might not be necessary in all patients who have had successful AF ablation at least 1 year previously. “

CHAMPAIGN, Ill. — Antibodies are the critical targeting agents of the immune system and the crux of immune therapy and vaccine development, but studying them is slow, expensive and labor-intensive. Now, researchers at the University of Illinois Urbana-Champaign have developed a new high-volume method that can rapidly build and test large numbers of antibodies at once. With it, they have already uncovered common aspects of how antibodies bind across variants of a key influenza target protein.

Dubbed the oPool+ display, the method could drastically accelerate antibody research and the development of new antibody-based treatments, immune therapies and vaccines, said Illinois biochemistry professor Nicholas Wu, leader of the study.

The researchers published their findings in the journal Science Translational Medicine.

“More than 150 different FDA-approved antibody therapeutics are being used in clinical settings to treat diseases from cancer to infectious disease to autoimmune diseases. With a rapid, high-throughput method like ours, if we can search for a potential antibody candidate that’s really good against a certain disease, then it has great potential in becoming an effective therapeutic,” said graduate student Wenhao “Owen” Ouyang, the first author of the study.

Traditionally, antibodies have been synthesized and studied one at a time — a daunting prospect, considering that the body can make trillions of different antibodies.

 “In a research lab, each antibody can take one person weeks to months to produce and analyze. So we asked, how can we scale this up in a way that we can further understand this extremely diverse class of molecules?” Ouyang said.

The researchers began by creating a library of antibodies against a key influenza immune target called hemagglutinin. Since individual immune responses vary, meaning different people can create different antibodies to the same target, the researchers included about 300 identified antibody variants from many different sources in their library. They then combined existing high-volume synthesis tools and a binding analysis platform, which allowed them to create the hundreds of antibodies and test them against an array of different hemagglutinin variants from assorted influenza mutations to characterize how the antibodies bound to the hemagglutinins.

“Instead of analyzing one antibody at a time, this approach let us evaluate thousands of antibody–antigen interactions in just a few days. It not only significantly accelerated the pace of our research but also lowered the cost, both of materials and labor,” said Wu, who also is a professor in the Carle Illinois College of Medicine at the U. of I. ““We can reduce 80-90% of the cost just from the materials and supplies alone.”

With the oPool+ display, the researchers built profiles of exactly what each antibody binds, which helps identify the best candidates for treatment development. They also identified features of hemagglutinin antibody activity that were shared across antibodies from many people.

”This is one of the key research areas for influenza vaccination research, because we would like to have a vaccine that works for everyone,” Ouyang said. “Each of our immune systems is actually quite different, so sometimes it is hard to have a broadly effective vaccine, solely because of the intrinsic differences between our bodies. With this platform, we found these common antibody features among different individuals very quickly.”

Next, the researchers plan to further expand the capacity of oPool+ display from hundreds to thousands or even tens of thousands of antibodies. The platform could be used to characterize antibodies against many other pathogens as well, whether viruses, bacteria or even cancer.

“If there’s another mysterious pathogen in the future that emerges the way COVID-19 did, then once we have identified the targets on the pathogen, we could characterize all antibody response against it in a very fast way and quickly identify candidates for antibody treatments or vaccines,” Ouyang said.

The researchers also plan to use oPool+ display to validate and refine artificial intelligence models that suggest antibody structures based on a target antigen.

“We could easily create an AI model that can make a lot of predictions, but we don’t really have an idea of how accurate they are because we haven’t had any way to systematically validate the results,” Ouyang said. “So we are excited about using AI to create predictions of antibodies and then validating them in real time with oPool+, and feeding the results back to the AI model to continually improve it.”

This work is supported by the U.S. National Institutes of Health, the Searle Scholars Program and the Howard Hughes Medical Institute Emerging Pathogens Initiative.

Procedure-related infection rates were similar with reconditioned and new pacemakers, according to late-breaking research presented in a Hot Line session today at ESC Congress 2025.

Explaining the rationale for Project My Heart Your Heart, Doctor Thomas Crawford from the University of Michigan, Ann Arbor, USA, said: “Patients in many low- and middle-income countries (LMICs) still have very limited access to cardiac pacing despite its routine use in higher-income countries. Indeed, access to pacemaker implantation is around 200-fold lower in Africa than in Europe. To facilitate the use of reconditioned devices, Project My Heart Your Heart has developed a comprehensive protocol for cleaning, functional testing and sterilisation, and has gained FDA approval for their export to countries whose governments have provided express permission for pacemaker importation. We initiated a clinical trial to investigate the safety of implanting pacemakers reconditioned using our protocol compared with new devices in several LMICs.”

A randomized controlled trial was conducted in Kenya, Mexico, Mozambique, Nigeria, Paraguay, Sierra Leone and Venezuela from May 2022 to June 2024. Adult patients with life expectancy of at least two years, a class I indication for pacemaker therapy and no financial means to acquire a new device were randomized 1:1 to receive a reconditioned pacemaker or a new pacemaker. The primary endpoint was procedure-related infection at 12 months.

The trial included 306 patients who had a mean age of around 71 years. Approximately half were female. Follow-up data at 12 months were available for 259 patients (84.9%).

Over 12 months, there were two pocket infections requiring explantation in the reconditioned pacemaker group and three in the new pacemaker group. There was one case of superficial cellulitis responsive to antibiotics in the new pacemaker group. Overall, the incidence of procedure-related infections at 12 months was 1.6% in patients in the reconditioned pacemaker group and 3.1% in the new group. The upper bound of the 90% confidence interval for the difference in infection rates between the groups was 2.2%, which is within the pre-specified noninferiority margin of 5%.

There were no device malfunctions in either group. Lead revisions occurred in nine patients in the reconditioned pacemaker group and five in the new group. Unrelated to the implantation procedure, there were four deaths in the reconditioned pacemaker group and two in the new group.

Concluding, Doctor Crawford said: “Our trial demonstrates the safety of pacemakers reconditioned using a specific protocol, with noninferior infection rates to new pacemakers and no malfunctions. The work of Project My Heart Your Heart serves as a blueprint that can be replicated by other organisations to enable wider pacemaker reuse. We would also like to expand into reconditioned implantable cardioverter-defibrillator devices, which are even more expensive and out of reach for many patients across the world.“

A recently published study of more than 44,000 patients with idiopathic intracranial hypertension (IIH) showed that glucagon-like peptide 1 receptor agonists (GLP-1 RAs) offer therapeutic benefits including lowered medication use, procedures, and improved symptoms. While more prospective studies are needed to confirm these findings, the data support the potential of these medications as a management strategy.

The retrospective study identified 44,373 patients with IIH from the TriNetX US Collaborative Network who started GLP-1 RAs within 6 months of diagnosis (n = 603) and compared them with nonusers (n = 43,770) on various outcomes. After matching, the analysis included 550 patients for each group, with the GLP-1 group using the following medications: lixisenatide, albiglutide, dulaglutide, semaglutide, liraglutide, and exenatide.

Published in JAMA Neurology, results showed that those on GLP-1s were less likely to require any medication compared with the control group (29.7% vs 56.4%; P <.001), and demonstrated significantly lower mortality (≤2.0% vs 5.0%; P = .003). In addition, those on these medications had a lower prevalence of IIH symptoms such as headache (12.3% vs 27.4%; P <.001), visual disturbances/blindness (7.0% vs 11.7%; P = .007), and papilledema (2.2% vs 11.5%; P <.001).

“We know every guideline for IIH emphasizes weight loss, but getting patients to achieve it is incredibly difficult,” senior author Dennis Rivet, MD, told NeurologyLive. “GLP-1 agonists are very effective for weight loss, and there’s already evidence they work on multiple systems, including the brain. Receptors in the choroid plexus, which helps regulate spinal fluid, suggest a possible direct mechanism beyond just weight loss, making them especially interesting for this disease.”

Rivet, the Harold I. Nemuth Chair in Neurological Disorders at Virginia Commonweath University, believes these data hold significant implications for the use of GLP-1 RAs, which have gained attention in other areas of neurodegenerative disorders, sleep disorders, and weight loss.

In the study, those on GLP-1 RAs had fewer procedures overall (6.8% vs 15.7%; P <.001), including bariatric surgery (5.4% vs 10.1%; P = .004) and cerebrospinal fluid shunt procedures (≤1.8% vs 5.2%; P = .002) than nonusers. In terms of specific medications, investigators noticed a significant decline in use of tricyclic antidepressants (6.8% vs 12.3%; P = .002), furosemide (6.8% vs 14.4%; P <.001), and acetazolamide (8.6% vs 24.0%; P <.001). There was no change in the use of valproate (GLP-1: 2.7% vs nonusers: 3.4%; P = .49).

READ MORE: Real-World Data Points to Greater Impact of Semaglutide Over Tirzepatide in Reducing Heart Attack, Stroke Risk

“Bariatric surgery is effective in IIH, but it carries significant morbidity,” Rivet noted. “What surprised us was that while surgery worked, we didn’t see the same mortality benefit. In contrast, patients on GLP-1 agonists had lower all-cause mortality at one year, which is an intriguing and unexpected finding.”

A subgroup analysis stratifying patients based on body mass index (BMI)–using a benchmark of 40–was conducted, with data confirming all significant associations from the primary analysis except for dizziness, which did not differ in GLP-1 RA users and nonusers with a BMI of 40 or greater. When looking at bariatric surgery and conventional management with bariatric surgery, there were some noted differences, with bariatric surgery associated with greater weight loss in both comparisons.

Overall, the subgroup findings revealed that despite lower 1-year BMI in the surgery group, GLP-1 RA users had lower medication use, fewer symptoms/signs, and procedures. Conversely, among GLP-1 RA nonusers, bariatric surgery resulted in lower medication use and fewer symptoms/signs but required more procedures and had higher mortality. Overall, this suggested that while greater weight loss may be achieved through bariatric surgery, GLP-1 RAs may provide better outcomes through other means.

Rivet added, “A retrospective database study is a signal—it’s encouraging, but it’s not definitive. The obvious next step is a placebo-controlled trial, and I think it could be done, even in a rare condition like IIH. But the reality is many of these patients already meet on-label indications for GLP-1 use, so clinical practice may shift before such a trial is ever performed.”

In terms of where else GLP-1 agonists might play a role, Rivet noted that secondary stroke prevention is an area of need that holds promise. In addition, he suggested that beyond stroke, the rapid effect of these medications on inflammatory markers could leave for potential in diseases like psoriatic arthritis and other inflammatory conditions.

REFERENCE
1. Sioutas GS, Mualem W, Reavey-Cantwell J, et al. GLP-1 Receptor Agonists in Idiopathic Intracranial Hypertension. JAMA Neurol. Published July 14, 2025. doi:10.1001/jamaneurol.2025.2020

Coronary artery calcium (CAC) scoring derived from non-gated low-dose computed tomography (LDCT) scans demonstrates significant capability for predicting long-term cardiovascular mortality, according to a new study involving over 8,700 participants.

For the prospective study, recently published in Radiology, researchers reviewed Early Lung and Cardiac Action Program (ELCAP) CAC scoring for 8,782 participants who underwent LDCT screening between 2000 and 2004. The cohort was comprised of current and former smokers between the ages of 40-85, and there was a median follow-up period of 22.6 years, according to the study.

The researchers found that the cumulative incidence of cardiovascular disease (CVD) death for those with high-risk CAC scoring (4-12) was 30.5 percent in comparison to 16.5 percent for participants with intermediate risk CAC scoring (1-3) and 9.4 percent for people with low-risk CAC scoring (0).

Cumulative all-cause mortality incidence was 63.2 percent for those with high-risk CAC scores, 44.5 percent for cohort participants with intermediate-risk CAC scoring and 30.3 percent for people with low-risk CAC scores, according to the study authors.

The study authors pointed out that adjusted multivariable analysis revealed that high ELCAP-CAC scoring was associated with nearly double the risk of CVD mortality and over a 2.8-fold higher risk of all-cause mortality in contrast to low ELCAP-CAC scoring.

“Our findings show that a single ELCAP-CAC score at LDCT is a powerful long-term predictor of CVD death (hazard ratio, 1.98), while also confirming the prognostic value of absent CAC. Our study brings to light the potential for combining early detection of CVD and lung cancer, which are the top causes of death in the United States,” wrote lead study author Joseph Shemesh, M.D., who is affiliated with the Department of Cardiology at Sheba Medical Center in Ramat Gan, Israel, and colleagues.

Three Key Takeaways

1. CAC scoring from non-gated LDCT strongly predicts long-term cardiovascular and all-cause mortality. High-risk scores nearly doubled CVD death risk and nearly tripled all-cause mortality compared to low CAC scores.
2. Absent CAC on LDCT confers favorable long-term prognosis. This reinforces the prognostic value of CAC scoring even in a high-risk cohort of current and former smokers.
3. Integrating CAC scoring into lung cancer screening programs may enhance preventive care. This could provide additive risk stratification beyond traditional methods and supporting its use as a potential public health measure.

Emphasizing the additive benefit with chest CT screening for lung cancer in current and past smokers, the researchers posited that CAC scoring can significantly enhance risk stratification beyond traditional laboratory-based methods for evaluating the potential for CVD.

“Given the risk stratification afforded by ELCAP-CAC scoring, it becomes even more urgent that CAC scoring be acted on in the context of a screening program and perhaps even as a public health measure,” implored Shemesh and colleagues.

(Editor’s note: For related content, see “CT-Based Coronary Artery Calcium Score Helps Predict Post-Op Survival Risks in Elderly Lung Cancer Patients,” “Computed Tomography Study Examines Potential of Automated Coronary Artery Calcium Scoring with Deep Learning” and “Study Says CT Scan is More Predictive than Genetic Risk Factors for Coronary Heart Disease Risk.”)

In regard to study limitations, the authors noted that subtle calcifications may have been missed with thicker section thickness thresholds (up to 5 mm) in older image acquisition with LDCT. Not only could this have led to misclassification of participants having an ELCAP-CAC of zero, but the researchers conceded the potential impact in reducing the predictive value associated with higher ELCAP-CAC scores.

In patients with heart failure (HF) caused by Chagas disease, sacubitril/valsartan was superior to enalapril for the composite primary endpoint, predominantly driven by a significant reduction in N-terminal pro-B-type natriuretic peptide (NT-proBNP), according to late-breaking research presented in a Hot Line session today at ESC Congress 2025.

Chagas disease, caused by Trypanosoma cruzi infection, remains a serious health problem affecting more than 7 million people, primarily from Latin America. T. cruzi parasites are mainly transmitted by contact with faeces/urine of infected triatomine bugs. T. cruzi can also be transmitted by consumption of contaminated food/beverages, during pregnancy or birth, through blood/blood products, organ transplantation and laboratory accidents. Chagas disease is spreading around the world, predominantly due to migration of infected patients to other regions, including North America, Europe, Asia and Australia. Chagas cardiomyopathy is considered the most common and serious manifestation of chronic Chagas disease, occurring in 30-40% of infected people during long-term follow-up.

HF caused by Chagas disease has unique clinical features with worse prognosis than other causes of HF despite the fact that patients are often younger and have fewer comorbidities. There have been no prospective randomized trials testing the effects of standard treatments in patients with Chagas disease and HF. In the general HF population, the angiotensin receptor-neprilysin inhibitor, sacubitril/valsartan improved HF outcomes vs. the angiotensin-converting enzyme inhibitor, enalapril, and we compared these two agents in the largest trial in patients with Chagas disease and HF conducted to date.”

Professor Renato Lopes from Duke University Medical Center, Durham, USA, Principal Investigator of the PARACHUTE-HF trial

PARACHUTE-HF was an academic-led, open-label, blinded-endpoint adjudication, randomized trial conducted at more than 80 sites in Brazil, Argentina, Mexico and Colombia. Eligibility criteria included a diagnosis of Chagas disease confirmed by at least two different serological tests positive for Trypanosoma cruzi infection, left ventricular ejection fraction (LVEF) ≤40%, New York Heart Association functional class II to IV symptoms and NT-proBNP ≥600 pg/ml or ≥400 pg/ml and hospitalization for HF within the last 12 months. Participants were randomized 1:1 to either sacubitril/valsartan (50 or 100 mg twice daily titrated to a target of 200 mg twice daily) or enalapril (2.5 or 5 mg twice daily titrated to a target of 10 mg twice daily). The primary endpoint was a hierarchical composite outcome consisting of cardiovascular death, first hospitalization for HF and the relative change from baseline to week 12 in NT-proBNP, analysed using a win ratio approach.

In total, 922 patients were randomized. The mean age was 64 years, 42.0% were women, mean LVEF was 29.8% and 44.4% had had prior hospitalization for HF.

Following pairwise comparisons, sacubitril/valsartan was associated with a 52% higher likelihood of a better primary outcome compared with enalapril (stratified unmatched win ratio 1.52; 95% confidence interval [CI] 1.28 to 1.82; p<0.001). Over a median of 25 months’ follow-up, rates were similar for sacubitril/valsartan vs. enalapril for cardiovascular death (hazard ratio [HR] 0.95; 95% CI 0.73 to 1.23) and first HF hospitalization (HR 0.92; 95% CI 0.70 to 1.20). The significant difference in the primary outcome was predominantly driven by the percent change in NT-proBNP from baseline to 12 weeks: logarithmic median change from baseline was −30.6% in those assigned to sacubitril-valsartan and −5.5% in those assigned to enalapril (ratio of adjusted geometric mean change 0.68; 95% CI 0.62 to 0.75).

The safety profiles of the two agents were similar, with discontinuations due to adverse events occurring in 6.1% of patients with sacubitril/valsartan and 9.8% with enalapril.

Concluding, Professor Lopes said: “In patients with HF caused by Chagas disease, sacubitril/valsartan was superior to enalapril with respect to the primary outcome, predominantly driven by the 32% reduction in NT-proBNP levels at week 12. Our study provides the first randomized trial evidence to support a pharmacological treatment specifically in this high-risk population. PARACHUTE-HF shows that much-needed studies to better characterise chronic Chagas cardiomyopathy and to define the benefit/risk of new therapies in this condition are possible. In line with the global health spotlight of ESC Congress, the PARACHUTE-HF trial provides a successful model for international collaborations – in this field among cardiologists and infectious disease physicians − with the shared goal of evaluating the impact of new therapies on cardiovascular outcomes in patients with neglected diseases.”