Tag: Heart

A game-changer in preventing heart failure and sudden cardiac deaths

[ad_1]

In a trial-level meta-analysis published in the journal Circulation, researchers assessed the effects of sodium-glucose co-transporter 2 (SGLT2) inhibitors (SGLT2i) on major adverse cardiovascular events (MACE) across three patient populations: diabetes at high risk for atherosclerotic cardiovascular disease (ASCVD), heart failure (HF), or chronic kidney disease (CKD). They found that SGLT2i reduced the rate of MACE by 9% with a consistent effect across all patient populations and key subgroups, primarily driven by a reduction in cardiovascular (CV) death, particularly HF and sudden cardiac death.

Study: Sodium Glucose Co-transporter 2 Inhibitors and Major Adverse Cardiovascular Outcomes: A SMART-C Collaborative Meta-Analysis. Image Credit: Lightspring / Shutterstock

Background

SGLT2i have been extensively studied in large, randomized, placebo-controlled trials involving diverse populations of patients, including those with type 2 diabetes mellitus (T2DM) and ASCVD, HF, and CKD. While SGLT2i was primarily developed for diabetes, the trials have consistently shown these drugs to reduce HF and kidney-related issues, regardless of diabetes status. However, their impact on MACE remains unclear, with variations observed among trial results. Prior meta-analyses failed to assess the effects on MACE components definitively. Uncertainty persists, particularly in subgroups without ASCVD or diabetes and those with advanced chronic kidney disease stages. Therefore, using data from all significant placebo-controlled trials, researchers in the present study performed a collaborative meta-analysis to explore SGLT2i’s effects on MACE risk and its components and death subtypes across relevant patient subgroups.

About the study

The researchers conducted a collaborative trial-level meta-analysis within the SGLT2i Meta-Analysis Cardio-Renal Trialists Consortium (SMART-C). A systematic literature search was conducted, and the included studies were phase 3 placebo-controlled, double-blind, randomized trials with ≥ 1,000 participants in every arm and median follow-up of six months and above. Combination SGLT1/2 inhibitors studies were excluded.

The study included 11 randomized trials comparing SGLT2i to placebo, with 78,607 participants in total. Among them, 54.2%, 26.4%, and 19.5% of individuals participated in trials focused on diabetes at high ASCVD risk, established HF, or CKD, respectively. The mean age of participants was between 62 and 72 years. While 34.4% of them were females, 74.5% of them were white. At baseline, about 79.7% of the patients had diabetes, 36% had HF, and 37.2% had eGFR (short for estimated glomerular filtration rate) less than 60 mL/min/1.73 m². Established ASCVD was present in 58.9%, and 28.5% had prior MI.

The median follow-up duration ranged between 2.4 – 4.2 years, 1.3 – 2.2 years, and 2.0 – 2.6 years for trials focused on diabetes at high ASCVD risk, HF, and CKD, respectively. The primary outcome was the composite of 3-point MACE, including cardiovascular death, myocardial infarction (MI), and all types of stroke. The analysis also assessed the individual components of MI and stroke, including fatal and non-fatal events. Additionally, all-cause mortality (ACM) and death subtypes such as fatal MI, fatal stroke, HF death, sudden cardiac death, as well as other CV and non-CV deaths were examined. The analysis treated each outcome as a time-to-event event, and the effect estimates from each trial were derived from intention-to-treat analysis.

Trial effect estimates were meta-analyzed within primary patient groups using fixed-effects models and then combined as random effects for overall estimates. Sensitivity analysis was conducted using fixed effects. Heterogeneity was assessed using the Cochrane Q statistic and Higgins and Thompson’s I2.

Results and discussion

About 10.1% of participants experienced MACE, with 5.3% experiencing CV death, 3.6% experiencing MI, and 2.8% experiencing a stroke. SGLT2i was found to reduce the rate of MACE by 9% overall, with consistent effects across trial populations. The most evident effect was observed on CV death, with reductions in HF death and sudden cardiac death driving the reduction in CV death. There was no significant effect on MI or stroke overall. SGLT2i were also found to reduce ACM, with the most significant effects observed in CKD trials.

Patients with established ASCVD were found to have higher MACE incidence rates across all trial types. SGLT2i consistently reduced the risk of MACE and CV death regardless of established ASCVD status at baseline. Similarly, the effects remained consistent across subgroups stratified by diabetes status, prior HF, kidney function, and baseline eGFR. Stratification by albuminuria suggested a potential benefit primarily among those with ≥30 mg/g albuminuria. Across all the Kidney Disease Improving Global Outcomes (KDIGO) risk groups, the benefits for MACE and CV death were found to be consistent.

The study is limited by fewer trials in each drug in each disease state and variations in eligibility criteria, follow-up duration, and subgroup definitions across studies. These restrictions restrict robust comparisons within the SGLT2i class and lower the generalizability of findings to broader patient populations.

Conclusion

In conclusion, SGLT2i consistently lowers the risk of MACE across diverse patient populations, regardless of baseline ASCVD, diabetes, or kidney function. This benefit predominantly comes from reduced cardiovascular death, notably HF and sudden cardiac death, with no significant impact on MI or stroke overall. These findings suggest the potential utility of SGLT2i across the spectrum of cardiovascular-kidney-metabolic disease, aiding in therapeutic decision-making.

[ad_2]

Source link

April 9, 2024
How incentives and games encourage exercise
[ad_1]
In a recent study published in the journal Circulation, researchers evaluated the effects of gamification and financial incentives on physical activity in individuals at risk of adverse cardiovascular events.

Higher physical activity is associated with a lower risk of adverse cardiovascular events and improved control of cardiovascular risk factors. By leveraging behavioral economic concepts, such as loss-framing, immediacy, and endowment effects, shorter-term analyses have implemented financial incentives and gamification interventions and observed increased physical activity in patients at risk of or with atherosclerotic cardiovascular disease (ASCVD). Nevertheless, the effect of these interventions over the long term remains unclear.

Study: Effect of Gamification, Financial Incentives, or Both to Increase Physical Activity Among Patients at High Risk of Cardiovascular Events: The BE ACTIVE Randomized Controlled Trial. Image Credit: Alliance Images / Shutterstock

About the study

In the present study, researchers evaluated the efficacy of financial incentives, gamification, or both to improve physical activity over the long term in individuals at risk of major cardiovascular events. This randomized controlled trial was conducted between May 2019 and January 2024. Eligible participants had ASCVD or a 10-year risk of stroke, myocardial infarction, or cardiovascular death.

Eligible subjects received a wearable device to track their step count. During the two-week run-in period, a baseline step count was established. Subsequently, participants were instructed to set a goal to increase their step count relative to baseline. Next, participants were randomized to attention control, financial incentives, gamification, or financial incentives plus gamification (combination).

The control group received text messages daily for 18 months, inquiring if they had achieved their step goal the previous day. In the gamification arm, participants signed a pre-commitment pledge to reach their step goal. They received 70 points at the beginning of each week. Points were retained if they succeeded in their daily goal; otherwise, 10 points were removed.

Their levels, viz., platinum, gold, silver, bronze, and blue, changed based on points at the end of the week. All participants began at the silver level; blue- or bronze-level participants were restarted at the silver level every eight weeks. Gold- or platinum-level participants were awarded a trophy after the intervention.

On the other hand, the financial incentives group was informed that $14 would be deposited in a virtual account each week. The balance did not change if the goal was achieved; otherwise, $2 was deducted. In the combination arm, participants completed interventions from both arms. After 12 months, interventions were discontinued; however, daily text messages recording the count continued for six additional months (follow-up).

The primary outcome was the change in daily step count from baseline to the end of the intervention. Secondary outcomes were the average changes in daily step count from baseline to follow-up, weekly moderate-to-vigorous physical activity (MVPA) minutes, and the proportion of participant weeks with at least 150 MVPA minutes.

Findings

Overall, 151, 304, 302, and 304 individuals were randomized to control, gamification, financial incentives, and combination arms, respectively. The average age of participants was 66.7 years; 60.5% were female, and 25% were Black. At baseline, the average daily step count was 5081, mean MVPA minutes were 5.8, and the average step count increase was 1867.

In total, 89.8% of participants completed the 18-month study. The control, financial incentives, gamification, and combination groups achieved a mean increase of 1418, 1915, 1954, and 2297 steps from baseline to the intervention period, respectively. The corresponding figures over the follow-up period were 1245, 1576, 1708, and 1831, respectively.

Over the 12-month intervention, compared to the control arm, participants had a greater increase in average daily step count. The combination arm was superior to financial incentives during the intervention period. Weekly MVPA increased by 39.6, 56.6, 54.7, and 65.4 minutes, on average, for control, financial incentives, gamification, and combination arms from baseline to intervention.

Over the follow-up period, weekly MVPA minutes increased by 37.3 for control, 50.7 for gamification, 50.9 for financial incentives, and 57.6 for combination groups. The proportion of participant weeks with at least 150 MVPA minutes was 0.16, 0.24, 0.23, and 0.27 for control, financial incentives, gamification, and combination arms, respectively. The combination group had greater odds of a week with at least 150 minutes of MVPA.

Conclusions

Taken together, interventions with financial incentives, gamification, or both significantly improved physical activity in adults at risk of cardiovascular events compared to attention control over the 12-month intervention. This effect was sustained over the six-month follow-up period after the end of the intervention in the combination group. The combination group also increased weekly MVPA minutes more than the control group. These interventions could be helpful components of strategies aimed at alleviating cardiovascular risks.
Journal reference:

Fanaroff AC, Patel MS, Chokshi N, et al. Effect of Gamification, Financial Incentives, or Both to Increase Physical Activity Among Patients at High Risk of Cardiovascular Events: The BE ACTIVE Randomized Controlled Trial. Circulation, 2024, DOI: 10.1161/CIRCULATIONAHA.124.069531, https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.124.069531
[ad_2]

Source link
April 9, 2024
“Ultra-processed” and “high in sugar” deter shoppers
[ad_1]
In a recent study published in the journal Nutrients, researchers investigated how United States (US) adults perceive “ultra-processed” labels on food packaging and their potential to influence consumer behavior towards healthier choices.

Study: How Promising Are “Ultraprocessed” Front-of-Package Labels? A Formative Study with US Adults. Image Credit: Drazen Zigic / Shutterstock

Background

Ultra-processed foods (UPFs), characterized by high processing and minimal whole ingredients, are prevalent in diets worldwide, especially in affluent countries like the US and the United Kingdom (UK). Despite their nutritional content, UPFs are associated with serious health problems such as heart disease, diabetes, and cancer, attributed to additives and processing methods that harm the body’s microbiome and food structure. While current front-of-package labels (FOPL) focus on nutritional content, there is an urgent need to include information about food processing levels. This reflects an evolving understanding of UPFs’ health impacts and the need for research on how “ultra-processed” labels might affect consumer choices and dietary habits.

About the study

In the present study, 600 US adults from an online Qualtrics panel evaluated product perceptions under three labeling conditions: control, “ultra-processed,” and “ultra-processed,” plus “high in sugar.” This within-subjects design aimed to understand the impact of novel “ultra-processed” labels versus traditional nutrient labels, using a popular yogurt brand to control for brand bias. The study, approved by the University of North Carolina at Chapel Hill’s Institutional Review Board, explored how these labels influence consumer perceptions, employing stringent criteria for participant eligibility and ensuring data integrity through Qualtrics’ platform features.

Study stimuli (control label, “ultraprocessed” label, combined “ultraprocessed” and nutrient labels, respectively).

Participants responded to questions assessing their attention to the labels, thoughts on the associated health risks, and the labels’ perceived message effectiveness (PME), with responses indicating the labels’ potential to discourage product purchase. The study also collected demographic data for analysis.

Analytical methods included post hoc power calculations and mixed-effects linear regression models to account for the within-subject design, using demographic characteristics as controls. The analysis aimed to detect minimal effect sizes and compare outcomes across different labeling conditions, employing Cohen’s d for effect size standardization and complete case analysis for handling missing data.

Study results

In the study examining consumer responses to food labeling, 600 participants with a mean age of 44.6 years were surveyed, where 74% identified as women. The demographic composition revealed 76% non-Hispanic white, 15% non-Hispanic Black, and 12% Hispanic participants. Educational attainment varied, with 29% having a high school diploma or less and 8% holding a graduate or professional degree.

To ensure the study’s integrity, the researchers checked if the sequence in which the participants viewed the labels was randomized properly to eliminate any bias from the order effects. A χ² test confirmed that the visualization order of the labeling conditions was evenly distributed across the participants, showing no significant deviation (χ² = 2.73, p > 0.05).

The study’s findings revealed varied responses to the labeling conditions. The “ultra-processed” label did not significantly capture more attention than the control label, with a negligible effect size (d = 0.04, β = 0.04, p > 0.05). However, labels that combined “ultra-processed” and “high in sugar” notices were found to be more attention-grabbing, scoring higher on average than the “ultra-processed” label alone (mean difference = 0.08, statistically significant with d = 0.07, β = 0.08, p < 0.05).

When it came to thinking about the risks associated with the product, the “ultra-processed” label alone prompted more contemplation (mean = 2.12) compared to the control (mean = 1.78, d = 0.24, β = 0.34, p < 0.01). This effect was even more pronounced with the combination of “ultra-processed” and “high in sugar” labels, leading to the highest levels of risk consideration (mean = 2.51 compared to the “ultra-processed” label alone, d = 0.26, β = 0.4, p < 0.01).

Regarding discouraging the purchase of the product, the “ultra-processed” label alone was more effective than the control label (mean = 1.99 vs. 1.62, d = 0.28, β = 0.38, p < 0.01). The discouragement increased further when participants were exposed to both “ultra-processed” and “high in sugar” labels, showcasing the highest level of purchase aversion (mean = 2.33 compared to the “ultra-processed” label alone, d = 0.22, β = 0.33, p < 0.01).

Conclusions

To summarize, the findings revealed that the “ultra-processed” label, especially when combined with “high in sugar” information, effectively heightened awareness of health risks and reduced purchasing intent among US adults. These results suggest that integrating processing information with nutrient content on labels could influence healthier consumer choices.
Journal reference:

D’Angelo Campos A, Ng SW, McNeel K, et al. How Promising Are “Ultraprocessed” Front-of-Package Labels? A Formative Study with US Adults. Nutrients. (2024), DOI- 10.3390/nu16071072, https://www.mdpi.com/2072-6643/16/7/1072
[ad_2]

Source link
April 9, 2024
Beta-blockers show no benefit for heart attack patients with normal heart function

[ad_1]

In a recent study published in The New England Journal of Medicine, researchers conducted the Randomized Evaluation of Decreased Usage of Beta-Blockers after Acute Myocardial Infarction (REDUCE-AMI) trial to determine whether long-term oral beta-blocker therapy could reduce the risk of any cause or incident MI-related mortality among individuals with acute myocardial infarction but preserved left ventricular ejection fraction compared to no beta-blocker treatment.

Study: Beta-Blockers after Myocardial Infarction and Preserved Ejection Fraction. Image Credit: aipicte / Shutterstock

Background

Beta-blockers are beneficial in treating heart failure patients and those with reducing ejection fractions; however, these findings are from 1980s trials of patients with massive myocardial infarctions and systolic dysfunction in the left ventricle. Meta-analytical research indicated that beta-blockers do not appear to lower mortality in contemporary reperfusion techniques.

There is a lack of data from recent randomized clinical studies on the efficacy of long-term use of beta-blockers among acute myocardial infarction patients with intact ejection fraction. Previous Cochrane reviews underscore the need for novel research studies in this target population. Despite the absence of convincing scientific evidence of medication benefit, current recommendations strongly advocate beta-blocker therapy following a myocardial infarction.

About the study

In the present open-label, prospective, parallel-group trial, researchers evaluated the impact of beta-blocker therapy on reducing mortality among acute MI patients.

The team conducted the registry-based trial between September 2017 and May 2023 at 45 sites across New Zealand, Sweden, and Estonia. They randomized participants with prior acute MI who underwent coronary angiographies and had ≥50% ejection fraction from the left ventricle to receive 1:1 long-term therapy with beta-blockers such as ≥100 mg/day of metoprolol or ≥5 mg/day of bisoprolol (intervention group) or no such therapy.

All participants had obstructive coronary heart disease, as determined from coronary angiographies (i.e., ≥50% stenosis, ≤0.8 fractional flow reserves, or ≤0.9 instant wave-free segment ratios) before randomization. The primary outcome was the composite measure of all-cause or incident MI-related mortality. Secondary outcomes included cardiovascular disease-related mortality and hospital admission for atrial fibrillations or heart failure.

Safety outcomes included hospital admission for hypotension, second and third-degree atrioventricular blocks, bradycardia, syncope, or pacemaker implantation, and hospital admission due to chronic obstructive pulmonary disease (COPD), asthma, or stroke. Other endpoints included dyspnea [diagnosed using the New York Heart Association (NYHA) recommendations] and angina pectoris (diagnosed using the Canadian Cardiovascular Society guidelines) six to 10.0 weeks or 11.0 to 13.0 months after treatment. The team used Cox proportional-hazards regressions to determine the hazard ratios (HR) for analysis. They performed sensitivity analyses, adjusting for age, country, diabetes, and prior myocardial infarction. The Swedish population registry provided data on death or emigration, and the Swedish Web System for Enhancement and Development of Evidence-based Care in Heart Disease Evaluated According to Recommended Therapies (SWEDEHEART) register collected data on incident myocardial infarctions. The national cause-of-death registry provided cardiovascular-related mortality data, while the national patient registry provided data on atrial fibrillation, heart failure, and safety outcomes.

Results

The researchers enrolled 5,020 MI patients (95% from Sweden) who followed up for a median of 3.50 years until November 16, 2023. The median participant age was 65.0 years, 23% were female, and 35% had myocardial infarction with an elevation in the ST segment. Among the participants, 46% were hypertensive, 14% were diabetic, and 7.1% had a prior myocardial infarction. Of 2,508 beta-blocker recipients, 1,560 (62%) and 948 (38%) received metoprolol and bisoprolol, respectively.

Coronary angiography showed one-vessel involvement among 55% of MI patients, two vessels involved among 27%, and three vessels involved among 17% of patients. The team performed percutaneous coronary interventions in 96% of patients, with coronary artery bypass grafting (CABG) among 3.9%. At hospital discharge, 97% received aspirin, P2Y12 receptor blockers, angiotensin-converting enzyme (ACE) inhibitors, and statins.

The researchers observed the primary endpoint among 7.9% (199 out of 2,508) of beta-blocker recipients and 8.3% (208 out of 2,512) of non-recipients (HR, 0.96). Beta-blockers did not lower the cumulative incidence rates of secondary endpoints (all-cause mortality, 3.90% and 4.10% among beta-blocker recipients and non-recipients, respectively); cardiovascular disease-related mortality, 1.50% and 1.30%, respectively; myocardial infarctions, 4.50% and 4.70%; hospital admission due to atrial fibrillations, 1.10% and 1.40%; and hospital admission due to heart failures, 0.80% and 0.90%).

Concerning safety endpoints, the researchers observed hospital admission due to atrioventricular blocks, bradycardia, syncope, hypotension, or pacemaker implantation among 3.40% of beta-blocker recipients and 3.20% of non-recipients; hospital admission due to COPD or asthma in 0.60% and 0.60%, respectively, and hospital admission due to stroke among 1.40% and 1.80% of beta-blocker recipients and non-recipients, respectively. Subgroup analyses yielded similar results.

Overall, the study findings showed that long-term use of beta-blockers did not reduce the risk of all-cause or incident myocardial infarction-related mortality in patients with an acute MI who underwent coronary angiography but retained ≥50% ejection fraction from the left ventricle compared to no treatment with beta-blockers.

[ad_2]

Source link

April 9, 2024
Adherence to the EAT-Lancet diet reduces the risk of heart failure

[ad_1]

A recent JACC: Heart Failure study determines whether the EAT-Lancet diet index influences the risk of heart failure (HF) and the plasma proteins that may influence this association.

Study: The EAT-Lancet Diet Index, Plasma Proteins, and Risk of Heart Failure in a Population-Based Cohort. Image Credit: monticello / Shutterstock.com

Background

The rapid rise in the prevalence of HF, particularly among the growing elderly population, remains a global health concern. Patients with HF often experience reduced quality of life and are at a greater risk of severe morbidity and mortality. Therefore, it is imperative to identify effective modifiable risk factors that can prevent HF.

Previous studies have shown that diet is a modifiable factor that can significantly influence the risk of HF. In 2019, the EAT-Lancet Commission proposed the EAT-Lancet that prevents specific diseases and promotes environmental sustainability.

The EAT-Lancet reference diet encourages a higher intake of fruits, vegetables, legumes, nuts, and whole grains while also reducing the intake of sugary and animal-sourced foods. As compared to the Mediterranean diet, the EAT-Lancet diet involves a greater emphasis on cereals and legumes.

It is important to understand whether adherence to the EAT-Lancet diet could reduce the risk of HF. To date, few studies have assessed the association between the EAT-Lancet diet and the risk of HF.

About the study

The current study hypothesized that adherence to the EAT-Lancet diet would reduce the risk of developing HF. Since plasma proteins play an important role in disease manifestations and are impacted by environmental factors, proteomics could be used to elucidate mechanisms that may connect diet and certain diseases.

The current study obtained all relevant data from the Malmö Diet and Cancer (MDC) and MDC Cardiovascular Cohort (MDC-CC) study. At baseline, blood samples were collected, and the participants’ diets were assessed.

A total of 23,260 participants fulfilled all eligibility criteria and were included in the study. A proteomic study of 4,742 individuals was also performed.

The EAT-Lancet diet index included less than 13, 14-16, 17-19, 20-22, and over 23 points. Study participants were divided into five groups in accordance with their degree of adherence to the baseline EAT-Lancet diet index.

The International Classification of Diseases (ICD) coding system from the Swedish Hospital Discharge Register was used to assess the prevalence and incidence of HF cases in Sweden. Blood samples were used to extract plasma, and a total of 149 plasma proteins were evaluated using the Olink proximity extension assays.

Study findings

The mean age of the study cohort was 57.8 years, approximately 39% of whom were male. Female participants with university degrees were more likely to adhere to the EAT-Lancet diet index, consume fewer calories, be non-smokers, and engage more in leisure-time physical activity.

The current prospective cohort study lasted for nearly thirty years. Greater adherence to the EAT-Lancet diet index was associated with a reduced risk of HF development.

This association was more significant among participants who did not have a family history of myocardial infarction (MI), thus implying that the protective effect of the EAT-Lancet diet on HF could be weakened due to genetic factors. In the future, more research is needed to elucidate the association between the EAT-Lancet diet and HF in the context of different genetic susceptibilities.

Eight plasma proteins including adrenomedullin (AM), interleukin 6 (IL-6), growth differentiation factor 15 (GDF15), transmembrane immunoglobulin and mucin domain (TIM), chemokine (C-C) motif ligand 20 (CCL20), cathepsin D (CTSD), follistatin (FS), and ferric uptake regulator (FUR) were associated with the EAT-Lancet diet index and risk of HF.

The study findings are consistent with previous studies indicating that plant-based diets, which are similar to the EAT-Lancet diet, reduce the risk of HF. Several components of the EAT-Lancet diet index, particularly fruits and unsaturated oils, significantly contribute to the inverse association between the EAT-Lancet diet and the risk of HF. As compared to higher intake, a moderate dairy intake at baseline also lowered the risk of HF.

Conclusions

The current study highlights that adherence to the EAT-Lancet diet reduces the risk of developing HF, in addition to promoting a sustainable environment by decreasing land/water use and greenhouse gas emissions. The identified plasma proteins also indicate the underlying mechanisms that lead to an inverse association between the EAT-Lancet diet and lower HF risk.

[ad_2]

Source link

April 9, 2024
Study shows reduced bleeding risk with ticagrelor monotherapy after percutaneous coronary intervention

[ad_1]

People who have had a heart attack or who are at risk for a heart attack and who stopped taking aspirin alongside the P2Y12 inhibitor ticagrelor one month after undergoing percutaneous coronary intervention (PCI) saw a significantly reduced risk of clinically meaningful bleeding with no increased risk of clotting-related adverse events at 12 months compared with patients who continued taking aspirin and ticagrelor for a full year, in a study presented at the American College of Cardiology’s Annual Scientific Session.

The ULTIMATE-DAPT study is the first placebo-controlled trial designed to examine ticagrelor monotherapy following one month of dual antiplatelet therapy (DAPT) after PCI, a procedure to open blocked arteries. The study focused on patients who underwent PCI for acute coronary syndromes (ACS)—life-threatening conditions which include heart attacks and chest pain caused by decreased blood flow to the heart—with stents containing drugs to prevent further plaque buildup.

In treating a broad range of patients with acute coronary syndromes in the era of contemporary drug-eluting stents, among those who were stable after one month of DAPT, continuing treatment with ticagrelor alone reduced bleeding with no increase in adverse ischemic thrombotic events. These data suggest that a 12-month duration of DAPT is not only not necessary in most patients with ACS but is harmful.”

Gregg Stone, MD, professor of cardiology and population health sciences at Icahn School of Medicine at Mount Sinai, New York and co-chair of the trial

Antiplatelet medications reduce clotting-related cardiovascular problems such as heart attacks and strokes by preventing platelets from sticking together. To reduce the risk of such events after PCI, current guidelines recommend that most patients should take two antiplatelet medications—aspirin and a P2Y12 inhibitor—for a full year. However, the bleeding risk associated with antiplatelet medications has fueled efforts to further optimize the duration of post-PCI antiplatelet therapy and the medications used to balance the benefits and risks.

For ULTIMATE-DAPT, researchers enrolled 3,400 patients who experienced no adverse cardiovascular or bleeding events in the first month following PCI for ACS at 58 medical centers in four countries in Asia and Europe. During the first 30 days after PCI, all patients took aspirin and ticagrelor, a potent P2Y12 inhibitor. Participants were then randomly assigned to continue with this same regimen for 11 more months or to switch to ticagrelor and a placebo.

The trial met its two primary endpoints, one assessing efficacy in terms of bleeding risk and the other assessing safety in terms of clotting-related events. The first endpoint, clinically relevant bleeding, occurred in 4.6% of patients assigned to continuing DAPT and 2.1% of patients assigned to take ticagrelor and a placebo, a significant reduction in favor of ticagrelor alone. The second endpoint, a composite of major adverse cardiovascular events and cerebrovascular events, showed no significant difference between groups, with 3.7% of patients who continued DAPT and 3.6% of those taking ticagrelor and a placebo experiencing such events.

The streamlined therapy of treating patients with ACS with ticagrelor alone one month after PCI was equally safe and effective in patients who presented with a heart attack (the highest risk group) or were at risk of a heart attack. Together, these findings suggest that patients who stopped taking aspirin after the first month had a substantially reduced risk of bleeding without any increased risk of thrombotic events, researchers said.

“The next question is how will physicians incorporate these results into their daily practice, and what will guideline committees ultimately do with these data,” Stone said. “I believe these results are very convincing and align with prior studies done without a placebo; hopefully they will impact guidelines and lead to the routine use of only one month of DAPT followed by a potent P2Y12 inhibitor such as ticagrelor in most patients with ACS after successful PCI.”

Since the trial only involved ticagrelor, researchers said that separate studies would be necessary to investigate the safety and efficacy of a similar approach using other P2Y12 inhibitors, such as prasugrel and clopidogrel.

The study was funded by the Chinese Society of Cardiology, the National Natural Scientific Foundation of China and the Jiangsu Provincial & Nanjing Municipal Clinical Trial Project. Stents were supplied by Medtronic Corp. (Minnesota, U.S.) and Microport Medical (Shanghai, China). Study medications were supplied by Yung Shin Pharmaceutical Industrial Co. (Kunshan, China) and Shenzhen Salubris Pharmaceuticals Co., Ltd (Shenzhen, China).

This study was simultaneously published online in The Lancet at the time of presentation.

Stone will be available to the media in a press conference on Sunday, April 7, 2024, at 11:15 a.m. ET / 15:15 UTC in Room B203.

Stone will present the study, “One-month Ticagrelor Monotherapy After PCI in Acute Coronary Syndromes: Principal Results from the Double-blind, Placebo-controlled Ultimate DAPT Trial,” on Sunday, April 7, 2024, at 9:45 a.m. ET / 13:45 UTC in the Hall B-1 Main Tent.

Source:

American College of Cardiology

[ad_2]

Source link

April 8, 2024
Impella CP pump shows survival benefit in cardiogenic shock

[ad_1]

Implantation of the Impella CP micro-axial flow pump in the hours after a heart attack significantly increased the rate of survival at six months among people suffering cardiogenic shock, according to a study presented at the American College of Cardiology’s Annual Scientific Session.

Cardiogenic shock occurs in about 5% to 10% of heart attacks and is among the main drivers of heart attack-related deaths. It occurs when the heart suddenly cannot pump enough blood to meet the body’s needs, depriving the heart and other vital organs of oxygen and often leading to death without immediate treatment. The study, which met its primary endpoint, suggests that by helping to restore the flow of oxygen-rich blood to the body, the device can help to improve survival in these severe cases.

“This is the first time in a very long time that we have a positive study for managing cardiogenic shock,” said Jacob E. Møller, MD, professor in the Department of Cardiology at the Odense University Hospital in Denmark, consultant at the cardiac intensive care unit of Copenhagen University Hospital Rigshospitalet and the study’s lead author. “I think this will be a routine device that will be used in these desperately ill patients.”

The Impella CP is a small percutaneous pump placed within the heart’s left chamber, where it expels oxygenated blood from the left ventricle to the body with a flow rate of up to 3.5 liters per minute. Previous trials evaluating the potential benefits of this and other heart pumps for cardiogenic shock have had mixed results. The new trial, called DanGer Shock, is the first trial powered to examine whether the use of micro-axial flow pumps can improve survival in ST-elevation myocardial infarctions (STEMI, the most serious type of heart attack) that are complicated by cardiogenic shock.

The trial enrolled 360 patients treated for STEMI with cardiogenic shock at 14 centers in Denmark, Germany and the United Kingdom. Patients who suffered out-of-hospital cardiac arrest with coma and increased risk of brain damage were excluded from the trial. Researchers randomly assigned patients to receive standard care or standard care plus treatment with an Impella CP pump. Participants were randomized before, during or up to 12 hours after receiving treatment in the cardiac catheterization laboratory, depending on when cardiogenic shock was diagnosed.

Among 355 patients who were included in the analysis, 58.5% of those who received standard care alone and 45.8% of those who received the Impella pump had died at six months after randomization; there was a 13 percentage point absolute reduction in the rate of death, the study’s primary endpoint, in favor of the heart pump. In addition, the results showed a reduction in a composite endpoint of additional mechanical heart support, heart transplant or death among patients who received the heart pump, but there was no difference between the two groups in the number of days out of the hospital.

What was a surprise for us was that the benefit seems to persist beyond 30 days. It’s not only that we are saving lives, it looks like we are also saving myocardium [heart muscle] so the patients keep surviving, and the survival curves continue to separate beyond the first 30 days.”

Jacob E. Møller, MD, Professor, Department of Cardiology, Odense University Hospital in Denmark

However, the results also showed significantly higher rates of complications among patients who received the heart pump, including bleeding, limb ischemia, renal replacement therapy and sepsis.

“It doesn’t come without a cost—we see significantly more serious complications in the Impella treated patients,” Møller said. “Overall, we have more complications, but we also save lives.”

Møller said that the study is not generalizable to all cases of cardiogenic shock as the trial was more selective than previous trials in identifying patients who were most likely to be able to benefit from the use of a heart pump, for example, by excluding those with a risk of brain damage. However, within this patient population, he said the results are likely translatable beyond northern Europe to large centers with the necessary expertise to employ the device.

Subgroup analyses suggested that patients with very low blood pressure and those with lesions in more than one coronary artery may see a greater benefit from the Impella pump. Møller said that further studies are needed to assess the benefits in more diverse patient populations and to examine how the duration of mechanical support might affect the rate of severe complications and identify opportunities to further optimize practices to minimize complications.

The study was funded by the Danish Heart Foundation and Abiomed/Johnson & Johnson, maker of the Impella CP.

This study was simultaneously published online in the New England Journal of Medicine at the time of presentation.

Møller will be available to the media in a press conference on Sunday, April 7, 2024, at 11:15 a.m. ET / 15:15 UTC in Room B203.

Møller will present the study, “Percutaneous Transvalvular Micro-axial Flow Pump in Infarct Related Cardiogenic Shock. Results of the Danger-shock Trial,” on Sunday, April 7, 2024, at 9:45 a.m. ET / 13:45 UTC in the Hall B-1 Main Tent.

Source:

American College of Cardiology

[ad_2]

Source link

April 8, 2024
Novel cholesterol removal strategy shows potential benefits post-heart attack

[ad_1]

The first trial of a novel strategy for removing cholesterol from patients’ arteries did not reduce the risk of death, heart attack or stroke within three months of a prior heart attack, according to research presented at the American College of Cardiology’s Annual Scientific Session. However, the findings suggest that the strategy may be beneficial with longer follow-up.

We did not see a statistically significant reduction in the primary endpoint of risk for death, a heart attack or a stroke at 90 days, or a reduction in risk for stroke at any time.”

C. Michael Gibson, MD, professor of medicine at Harvard Medical School and study’s lead author

However, in an exploratory analysis of outcomes, treated patients had fewer heart attacks and heart-attack deaths than patients in the control group at six months, he said.

“Although we missed our primary endpoint, our data support the hypothesis that HDL cholesterol plays a role in reducing subsequent coronary plaque disruption events like heart attack via enhanced cholesterol efflux attacks,” Gibson said.

People who have had a heart attack are at high risk for another one, especially during the next 90 days, Gibson said. This study was the first in which patients received an infusion of ApoA-I, a component of HDL (“good”) cholesterol, shortly after a heart attack, with the aim of stabilizing coronary plaque and reducing adverse cardiovascular events. The investigational drug CSL112 used in the study is a form of ApoA-I that’s extracted from human plasma, the liquid component of blood.

High levels of LDL cholesterol create a build-up of plaque in the arteries that carry blood to the heart, increasing risk for an arterial blockage that causes a heart attack. HDL cholesterol removes cholesterol from the arteries and carries it to the liver, which then excretes it. ApoA-I, the main component of HDL cholesterol, helps initiate the process of removing cholesterol from the body. A previous study showed that a single infusion of CSL112 reduced the amount of LDL cholesterol in arterial plaque by as much as 50%.

Other studies have shown that high levels of HDL cholesterol are associated with reduced heart attack risk. Recent research, however, suggests that the level of HDL cholesterol number may be less important for reducing heart attack risk than how well it performs at removing cholesterol, Gibson said.

“We know that in the setting of a heart attack, when the HDL cholesterol is good at getting a lot of cholesterol out of the arteries, that results in better outcomes for patients,” he said.

Gibson and his colleagues hypothesized that infusions of CSL112 given shortly after a heart attack might—by boosting the body’s ability to dispose of cholesterol—reduce patients’ risk for a repeat heart attack during the next crucial 90 days. The international AEGIS-II trial, conducted in 49 countries, was designed to test this hypothesis.

The study enrolled 18,219 patients (median age 65.5 years, 74% men and 84.5% White) who had been hospitalized for a heart attack and had multiple blockages in arteries carrying blood to the heart that elevated their risk for another heart attack. They also had other risk factors, including having had a previous heart attack, receiving drug treatment for diabetes or being 65 or older. Patients were randomly assigned to receive infusions of either CSL112 or a placebo for four weeks, with the first infusion given within five days of hospitalization.

The study’s primary endpoint was the time to the first occurrence of a major adverse cardiovascular event (MACE; i.e., heart attack, stroke or death due to heart disease or a stroke) at 90 days. Secondary endpoints included the time to the first occurrence of a MACE within six months and one year and of each specific event within 90 days, six months and one year.

At 90 days, patients treated with CSL112 had a 4.8% reduction in risk for death, heart attack or stroke compared with 5.2% for those treated with a placebo, a difference that was not statistically significant. In an exploratory analysis, however, patients treated with CSL112 were 14% less likely to have or die from a heart attack at 180 days. In addition, patients treated with CSL112 were 32% less likely to have a heart attack caused by a blood clot in a stent (a tiny mesh tube inserted into an artery to prevent it from becoming blocked) at 90 days and 29% less likely at 180 days.

Another potentially important finding, Gibson said, is that patients whose LDL cholesterol level was 100 mg/dL or higher at study entry experienced a 30% decrease in the primary endpoint, a statistically significant finding, whereas patients whose LDL cholesterol at study entry was less than 100 mg/dL saw no decrease in the primary endpoint.

“Baseline LDL modulated the treatment effect,” Gibson said.

“Overall, our findings are consistent with ApoA-I having a role in stabilizing heart blockages and reducing the risk of a blockage that ruptures and causing a heart attack further out than 90 days,” Gibson said. “It’s plausible that by giving ApoA-1 to clear the cholesterol out of the body and then treating the patient with cholesterol-lowering medications to keep LDL cholesterol levels low, we could see reductions in deaths and heart attacks that continue over time.”

Future research will focus on identifying high-risk patients who might benefit from this approach, he said.

An antiplatelet effect of CSL112 or a reduction of cholesterol in the arteries resulting from treatment with CSL112 could also explain the significant reduction in the number of heart attacks caused by a blood clot in a stent, he said. The reason strokes were not reduced may be that strokes can be caused by mechanisms other than the rupture of arterial blockages, he said.

A limitation of the study is that women, Black people and people of Asian heritage were underrepresented, which could reduce the findings’ generalizability, Gibson said.

The study was funded by CSL Behring, the manufacturer of CSL112.

This study was simultaneously published online in the New England Journal of Medicine at the time of presentation. The findings of the exploratory analysis were/will be published in the Journal of the American College of Cardiology.

Gibson will be available to the media in a press conference on Saturday, April 6, 2024, at 10:45 a.m. ET / 14:45 UTC in Room B203.

Gibson will present the study, “Patients With Acute Myocardial Infarction (ApoA-I Event Reducing In Ischemic Syndromes II (AEGIS-II) Trial): Primary Trial Results,” on Saturday, April 6, 2024, at 9:30 a.m. ET / 13:30 UTC in the Hall B-1 Main Tent.

Source:

American College of Cardiology

[ad_2]

Source link

April 8, 2024
Empagliflozin shows mixed results in heart attack patients

[ad_1]

Use of the sodium glucose cotransporter-2 (SGLT-2) inhibitor empagliflozin following a heart attack did not show a significant benefit in reducing overall heart failure hospitalizations or death from any cause, according to a study presented at the American College of Cardiology’s Annual Scientific Session. However, researchers said the drug may be helpful in reducing heart failure risks, including hospitalization, following a heart attack.

Despite falling short of its primary endpoint, results from the EMPACT-MI trial found that people who took empagliflozin had a significantly lower risk of certain outcomes directly related to heart failure, including first hospitalization for heart failure, total hospitalization for heart failure and a composite of heart failure hospitalization and death from heart failure, without any increased risk of adverse events.

We found that empagliflozin did not reduce mortality after a heart attack but did reduce the risk of heart failure after heart attack. To have a 25% to 30% reduction in heart failure hospitalizations is pretty clinically meaningful, but if you put it together with all-cause mortality, it was not a positive study for our primary endpoint.”

Javed Butler, MD, president of the Baylor Scott and White Research Institute in Dallas, distinguished professor of medicine at the University of Mississippi in Jackson, Mississippi, and study’s lead author

SGLT-2 inhibitors were initially approved to treat Type 2 diabetes by lowering blood sugar. As evidence has mounted pointing to their benefits in reducing heart failure and other forms of heart disease, researchers have sought to determine whether these drugs could help to prevent heart failure even in people without diabetes or chronic kidney disease.

A heart attack can damage the heart muscle in ways that sometimes lead to heart failure, a condition in which the heart becomes too weak or too stiff to effectively pump blood throughout the body. The EMPACT-MI trial was designed to determine whether SGLT-2 inhibitors could safely help to prevent heart failure and reduce mortality in people with a high risk of heart failure following a heart attack.

The study enrolled 6,522 people treated for acute myocardial infarction at 451 centers in 22 countries. Participants had no history of heart failure but had at least one heart failure risk factor in addition to signs of potential heart dysfunction as indicated by a newly lowered left ventricle ejection fraction to below 45% and/or signs or symptoms of congestion requiring treatment. About 32% had Type 2 diabetes. On average, participants were 64 years old and approximately 25% were women and 84% were White.

Within 14 days of being admitted to the hospital for a heart attack, half of the participants were randomly assigned to receive empagliflozin at a dose of 10 mg daily, while the other half received a placebo. Researchers tracked outcomes for a median of just under 18 months.

The study’s primary composite endpoint occurred in 8.2% of those who received empagliflozin and 9.1% of those receiving a placebo, a difference that was not statistically significant. There was also no difference in the rate of death from any cause, which occurred in 5.2% of those receiving empagliflozin and 5.5% of the control group.

All secondary endpoints related specifically to heart failure outcomes were significantly reduced among patients who received empagliflozin. For example, those receiving empagliflozin were 23% less likely to experience a first heart failure hospitalization and 33% less likely to experience any heart failure hospitalization—including recurrent hospitalizations—compared with those taking a placebo. The composite rate of total heart failure hospitalizations and death from heart failure was also 31% lower among those receiving empagliflozin.

Among patients who were not taking common heart failure therapies such as diuretics, angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor/neprilysin inhibitor (ARNI) at the time of their initial hospital discharge, those taking empagliflozin were significantly less likely to start such therapies within six months compared with those taking a placebo.

“In terms of heart failure outcomes, the data is not only strong, but it’s consistent with what we’ve found over the past 10 years in yet another population,” Butler said. “This finding is completely consistent in both direction and magnitude with other studies of SGLT-2 inhibitors in populations with diabetes and chronic kidney disease.”

While as a pragmatic trial design to simplify trial procedures and make it easier on both the participants and the sites, the study had limitations that may have influenced the findings, researchers said. For example, because outcomes were not adjudicated by independent reviewers, outpatient heart failure events were not formally captured as part of the primary endpoint. However, researchers said data on outpatient heart failure visits were collected as part of the study protocols for assessing adverse events. An analysis of these events showed outpatient visits for heart failure were substantially lower in participants who received empagliflozin compared with placebo.

Another limitation was the use of all-cause mortality as part of the primary endpoint, which meant that deaths unrelated to heart failure were included in the endpoint even though the study drug was unlikely to influence them. There were also some unusual circumstances that may have influenced rates of both hospitalization and death, including the COVID-19 pandemic and conflicts involving Russia, Ukraine and Israel, all countries that participated in the trial.

Finally, researchers said that the follow-up period may have been too short to fully capture any difference in mortality related to heart failure. Since people who developed heart failure following their heart attack typically did not begin to show heart failure symptoms until a few months later, any reductions in mortality would not be expected to emerge until after that.

“We just did not have long enough follow-up to see whether that heart failure prevention would lead to a benefit in mortality, but it’s a reasonable clinical thing to say that if you’re preventing heart failure, it’s a good thing,” Butler said.

The study was funded by Boehringer Ingelheim and Eli Lilly.

This study was simultaneously published online in the New England Journal of Medicine at the time of presentation.

Butler will be available to the media in a press conference on Saturday, April 6, 2024, at 10:45 a.m. ET / 14:45 UTC in Room B203.

Butler will present the study, “Empagliflozin After Acute Myocardial Infarction: Results of the EMPACT-MI Trial,” on Saturday, April 6, 2024, at 9:30 a.m. ET / 13:30 UTC in the Hall B-1 Main Tent.

Source:

American College of Cardiology

[ad_2]

Source link

April 8, 2024
Study provides insights on lung transplantation in advanced age candidates

[ad_1]

Data from the International Society for Heart and Lung Transplantation (ISHLT) indicates that the proportion of recipients aged 66 and above has risen to 19% by 2017. In the United States, the percentage of recipients aged 65 and above increased to over 30% by 2019. Despite age over 65 being characterized as a relative contraindication, there has been a steady rise in the age threshold considered for lung transplantation.

Jingyu Chen et al., at Wuxi Lung Transplant Center, Wuxi People’s Hospital Affiliated to Nanjing Medical University, China, conducted a retrospective cohort study. The study recruited 166 lung transplant recipients aged 65 and above from January 2016 to October 2020 at the largest lung transplant center in China. Subgroups included recipients aged 65-70 years (111 recipients) and those aged 70 and above (55 recipients). The main indication for lung transplantation in recipients over 65 was Group D restrictive lung disease.

A significantly higher percentage of coronary artery stenosis was observed in the group aged 70 and above (30.9% vs. 14.4% in the 65-70 group, P = 0.014). Kaplan-Meier estimates indicated that recipients with cardiac abnormalities had a significantly increased risk of mortality. After adjusting for potential confounders, cardiac abnormality was independently associated with an increased risk of post-lung transplantation mortality (HR 6.37, P = 0.0060).

The study demonstrated that lung transplantation can be performed in candidates with advanced age and can provide life-extending benefits. Recipients aged 70 and above had more frequent comorbidities, including cardiac disease and hypertension. A higher percentage of pulmonary infections requiring hospitalization was observed in the 70 and above group. The study also found a significantly higher proportion of coronary artery abnormalities in the 70 and above group compared to the 65-70 group.
The study’s findings provide several key observations regarding the outcomes of lung transplantation in recipients aged 65 and above. Bilateral transplantation is associated with improved long-term survival, while single lung transplantation offers a survival benefit within the first year post-transplant. The benefits of the transplantation type may be related to indications and comorbidities. The study’s experience supports that lung transplantation can be performed in advanced age candidates and provides life-extending benefits, which may help the global transplant community expand recipient access despite an increasing number of older recipients.

Source:

Journal reference:

Jiao, G., et al. (2022). Association of cardiac disease with the risk of post-lung transplantation mortality in Chinese recipients aged over 65 years. Frontiers of Medicine. doi.org/10.1007/s11684-022-0937-y.

[ad_2]

Source link

April 8, 2024