The hottest research from various peer-reviewed journals – handpicked weekly by the ACC.org Editorial Board led by Kim A. Eagle, MD, MACC.
EVAPORATE: Findings Suggest Early and Substantial Benefits of Icosapent Ethyl in Patients With High Triglycerides
Compared with placebo, icosapent ethyl (IPE) significantly reduced multiple plaque components, including vulnerable (low attenuation) plaque in patients with elevated triglycerides and on statin therapy, according to findings from the EVAPORATE trial presented during ESC Congress 2020 and simultaneously published in European Heart Journal.
The study, led by Matthew J. Budoff, MD, FACC, enrolled 80 patients aged 30-85 years with known coronary atherosclerosis and on stable statin therapy. The primary endpoint was change in low-attenuation plaque volume at 18 months. All patients were randomized to receive either IPE (4 g/day) or placebo and had a multidetector computed tomography (MDCT) scan at nine months, followed by a final scan at 18 months.
Despite the small sample size, Budoff and colleagues noted demonstrated benefits of IPE on outcomes and plaque reduction as early as nine months, with increasing significance by 18 months. "To the best of our knowledge, this is the first elegant marriage of clinical trial results (REDUCE-IT) and imaging (EVAPORATE)," Budoff said. "These data highlight the early and substantial impact of IPE on the atherothrombotic burden in this at-risk population."
"EVAPORATE provides further confidence in the clinical findings from the REDUCE-IT clinical trial. Having mechanistic data like this to corroborate what we saw with the reduction of cardiovascular events in humans in the large randomized trial firmly establishes this therapeutic strategy as a cornerstone in preventive therapies," ACC.org Editor-in-Chief Kim A. Eagle, MD, MACC.
Budoff MJ, Bhatt DL, Kinninger A, et al. Eur Heart J 2020;Aug 29:[Epub ahead of print].
ELDERCARE-AF: Edoxaban Superior to Placebo in Preventing Stroke, SE in Elderly Japanese AFib Patients
Edoxaban (15 mg/once daily) was superior to placebo in preventing stroke or systemic embolism (SE) in very elderly Japanese patients with nonvalvular atrial fibrillation (AFib) who were not appropriate candidates for standard doses of oral anticoagulants, according to findings from the ELDERCARE-AF trial presented at ESC Congress 2020 and simultaneously published in the New England Journal of Medicine.
Researchers led by Ken Okumura, MD, PhD, randomly assigned a total of 984 Japanese patients (≥80 years of age) with nonvalvular AFib to either a once-daily 15-mg dose of edoxaban or placebo. The primary efficacy endpoint was the composite of stroke or systemic embolism. The primary safety endpoint was major bleeding.
Results found the annualized rate of stroke or systemic embolism was 2.3% in the edoxaban group and 6.7% in the placebo group. The rate of major bleeding was 3.3% in the edoxaban group and 1.8% in the placebo group. Patients in the edoxaban group also experienced more gastrointestinal bleeding (14 events vs. 5 events) than those in the placebo group. No substantial difference was observed in death from any cause between the two groups (9.9% in the edoxaban group and 10.2% in the placebo group).
One of the limitations to the trial was the larger number of patients who discontinued participation. Of the 303 who didn't finish the trial, 158 withdrew and 135 died. The number of patients who discontinued were similar across both groups. "Most patients who withdrew did so because of adverse events unrelated to bleeding or because they were no longer capable of participation, the authors said.
Additionally, because the trial only involved Japanese AFib patients, the results may not be applicable to other populations. For example, results from the ENGAGE AF-TIMI 48 found Asian AFib patients treated with the lower-dose regimen of edoxaban showed higher rates of stroke or SE and higher rates of overt bleeding of any kind than patients who were not East Asian.
"This study adds to the large body of knowledge suggesting benefit over risk of anticoagulating elderly patients with AFib," said ACC.org Editor in Chief Kim A. Eagle, MD, MACC. "Age alone should not stop the use of effective agents to prevent embolic stroke."
Okumura K, Akao M. Yoshida T, et al. N Engl J Med 2020;Aug 30:[Epub ahead of print].
Can a Smartwatch Record Multiple-Lead ECGs and Detect Changes in the ST Segment?
Agreement between ST-segment changes identified using a smartwatch ECG and standard ECGs, suggest smartwatch technology could be used for earlier detection of acute coronary syndromes (ACS), especially in high-risk patients, and possibly during major events when normal ECG technology is not available, according to new research presented at ESC Congress 2020 and published in JAMA Cardiology.
Researchers led by Carmen Anna Maria Spaccarotella, MD, et al., used a commercially available smartwatch to obtain multiple channel ECGs from 100 participants, 54 of whom had ST-elevation myocardial infarction, 27 of whom had non-ST-elevation myocardial infarction and 19 of whom were identified as "healthy." The watch was placed in different body positions to obtain nine bipolar ECG tracings and the results were compared with a simultaneous standard 12-lead ECG.
Overall results showed agreement between the smartwatch and standard ECG for the identification of a normal ECG (Cohen κ coefficient, 0.90; 95% CI, 0.78-1.00), ST-segment elevation changes (Cohen κ coefficient, 0.88; 95% CI, 0.78-0.97), and non–ST-segment elevation changes (Cohen κ coefficient, 0.85; 95% CI, 0.74-0.96). In addition to detecting changes in ST-segment, researchers also noted the smartwatch was able to detect the localization of ST alterations.
Limitations to the study's findings include the inability to detect ST-segment abnormalities by simply wearing the smartwatch on the wrist. Rather, the watch needed to be removed and placed on "appropriate chest and abdomen locations." In addition, interpretation of the ECG generated by the smartwatch must still be done by a cardiologist. Lastly, control participants in the study were healthy, but not matched by age or sex with the ST segment participants.
While further studies and data analysis are needed, the researchers noted their findings do suggest the possibility that smartwatches could be used under specific circumstances, including pandemics or catastrophes, to recognize ST-segment changes and "be of clinical and social relevance in individuals with chest pain."
Spaccarotella CMA, Polimeni A, Migliarino S, et al. JAMA Cardiol 2020:Aug 31:[Epub ahead of print].
ENABLE CHF-PC: QOL Not Improved With Early Palliative Care Telehealth Intervention
A 16-week palliative care telehealth intervention for patients with advanced heart failure (HF) did not improve quality of life or mood, but did improve pain intensity and interference, according to a study published in JAMA Internal Medicine.
ENABLE CHF-PC was a culturally based, early palliative care intervention to address the gaps in reaching rural, minority and underserved patients with the lowest access to palliative care services. Quality of life and mood were the primary outcomes of this single-blind, nurse-led psychoeducational intervention. Secondary outcomes were pain, global health and resource use.
Of the 415 participants with ACC stage C or D heart failure, 54.5% were African American, 26% lived in a rural area and 45.8% had a high-school education or less. A total of 208 participants were randomized to receive an in-person palliative care consultation, six weekly nurse-coach telephonic sessions and monthly follow-up for 48 weeks, and 207 participants were randomized to receive usual care.
Marie A. Bakitas, DNSc, NP-C, et al., reported that the early palliative care intervention did not demonstrate improved quality of life or mood in an advanced HF population that was majority African American and had baseline good quality of life. The mean Kansas City Cardiomyopathy Questionnaire (KCCQ) score at baseline was 52.6, and this score improved by 3.9 points in the intervention group and 2.3 points in the usual care group at week 16. Pain intensity and pain interference in daily life did demonstrate a clinically important improvement. Global health and resource use were not different between the groups.
"[This] trial raises a key question about the likely influence of baseline QOL as a key element in determining which populations might show the greatest benefit from the scarce palliative care specialty resource," write the authors. "Future analyses and studies will examine both the patient factors and intervention components to find the right palliative care dose, for the right patients, at the right time."
Bakitas MA, Dionne-Odom N, Ejem DB, et al. JAMA Inter Med 2020;July 27:[Epub ahead of print}.
Women Underrepresented Within CV Clinical Trial Leadership Roles
The underrepresentation of women in cardiovascular clinical trial leadership was highlighted in a research letter published in JAMA Internal Medicine.
Kara J. Denby, MD, et al., sought to describe representation of women within leadership committees of cardiovascular clinical trials and in lead authorship positions of ensuing trial publications. The authors examined data from 200 clinical trial results published in JAMA, The Lancet and New England Journal of Medicine from Jan. 1, 2014 to Dec. 31, 2018.
Of the 2,433 committee members from the 200 trials studied, 270 (11.1%)were women. Women represented a median of 10.1% of committees, and a mean of 5.4% to 6.3% of leadership committees. Of the 200 trials, 83 (41.5%) had no female investigators, 111 (55.5%) had no female physicians on their leadership committees and only 19 had leadership committees made up of more than 25% women. Women accounted for only 18.5 of 200 (9.3%) first authors and 20 (10%) last authors.
"Our findings provide additional evidence of gender disparities in scientific leadership," write the authors of the study. "Prior research suggests that research teams with gender heterogeneity may produce higher quality research. Greater visibility of women in clinical trial leaderships positions can enhance recruitment of female trial participants and attract more female investigators to cardiovascular clinical research."
Denby KJ, Szpakowski N, Silver J, et al. JAMA Intern Med 2020;Aug 31:[Epub ahead of print].
Keywords: ACC Publications, Cardiology Magazine, Aged, 80 and over, ST Elevation Myocardial Infarction, Atrial Fibrillation, Quality of Life, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Palliative Care, Acute Coronary Syndrome, Multidetector Computed Tomography, Authorship, Single-Blind Method, Vulnerable Populations, Global Health, Leadership
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