News
Electronically Delivered Nudges Increase Influenza Vaccination Uptake: The NUDGE-FLU Trial
Key Points
- Despite the proven benefits of annual influenza (flu) vaccination among patients with cardiovascular disease (CVD), uptake remains suboptimal.
- The NUDGE-FLU implementation trial randomized all Danish citizens ages 65 and older with access to the official Danish electronic letter system to usual care (no letter) or one of 9 active arms utilizing electronic letters (E-letter) with a different nudging strategy for flu vaccination. One of the nudges specifically mentioned the potential cardio benefits of the vaccine. The primary endpoint was receipt of the flu vaccine.
- Electronically delivered letters highlighting potential cardiovascular benefits of influenza vaccination or sent again as a reminder significantly increased vaccination uptake across Denmark, and they especially effective in those who had not been vaccinated the previous season.
- This is likely one of the largest randomized implementation trials in history; while the magnitude of effect was not very large, this study demonstrated that an automated, inexpensive and scalable intervention can help make modest but real gains in public health.
RAPID HF: Rate-adaptive atrial pacing for HFpEF not ready for prime time
Key Points
- Over half of the patients with HFpEF suffer from exercise intolerance, which may be often due to inability to augment heart rate (HR). As such, rate-adaptive atrial pacing may offer an innovative approach to improve their quality of life.
- In the single center RAPID-HF trial, 29 patients with HFpEF received a transvenous pacemaker and were randomized to to atrial rate responsive pacing or no pacing first for 4 weeks, followed by a 4-week washout period and then crossover for an additional 4 weeks.
- Despite a statistically and clinically significant increase in mean HR during exercise between the pacer-on phase or a pacer-off phase, there was no statistically significant improvement in the primary outcome of the trial, oxygen consumption (VO2) at the anaerobic threshold, nor in any of the secondary endpoints. As such, the RAPID-HF trial does not support the use of rate-adaptive atrial pacing to treat patients with HFpEF and chronotropic incompetence
PCDS Statin: Automated reminders increase statin use in ASCVD patients
Key Points
- Despite guideline recommendations, both statin use overall and high intensity statin (HIS) use specifically remains low in patients with established atherosclerotic cardiovascular disease (ASCVD). Both therapeutic inertia (TI) and concerns for statin associated side effects (SASE) have been identified as contributors to under-prescribing.
- In this cluster randomized controlled trial performed in the Department of Veterans Affairs (VA), clinicians at the intervention sites received individualized electronic reminders created using natural language processing (NLP) and structured chart data that included information on the patient’s statin use, SASE, ASCVD history, and statin fill history. Those in the control sites, usual care, had access to a patient dashboard displaying compliance with statin therapy..
- Centrally processed individualized statin specific reminders, when compared to usual care, lead to a modest yet statistically significant increase in HIS use and statin adherence in VA patients with ASCVD.
ACCESS: Eliminating chronic disease medication co-payments for low income elderly adults improved adherence but did not change clinical outcomes
Key Points
- Cost related medication non-adherence is a common problem among patients with cardiovascular disease and is associated with poor clinical outcomes. Whether eliminating co-payments for a large number of medications meant to treat a broad set of chronic diseases would translate into improved clinical outcomes is unknown.
- ACCESS was a randomized controlled trial in Canada in which the copayment of 15 medication classes commonly used to reduce cardiovascular events was waived in the intervention group and the cost was unchanged in the control group.
- Copayment elimination did not reduced the primary composite outcome of death, myocardial infarction, stroke, coronary revascularization, or cardiovascular-related hospitalization over 3 years of follow up. Adherence to statins was significantly higher in the intervention group.
Using Causal A.I. to Translate Polygenic Risk for Coronary Artery Disease into Clinically Actionable Information: How much does LDL or SBP need to be lowered to overcome inherited polygenic risk?
Key Points:
- Polygenic scores (PGS) give insights into a patient’s inherited risk for coronary artery disease (CAD) but it is unclear how this information should inform clinical care.
- Participants in this study had their lifetime risk of major coronary events (MCS) estimated by a PGS and were then divided into deciles based on that risk. A causal AI algorithm that integrated data from Mendelian randomization studies as well as randomized trials was used to estimate the reduction in LDL or systolic blood pressure (SBP) needed in each decile to reduce their risk to that of the participants with the average PGS. These estimated were then validated against the observed events in each group.
- This study found that most patients could overcome their polygenic risk for CAD with small lifetime reductions in LDL and systolic blood pressure (SBP), however the later in life that therapy is initiated, the more that lipids and blood pressure needed to be lowered to achieve the same effect.
Minimally invasive thoracoscopically-guided right mini thoracotomy for mitral valve repair is a safe and effective alternative to conventional sternotomy
Key points :
- Mitral valve surgery via sternotomy is associated with significant disadvantages, including an increased risk of bleeding, difficult valve access due to the incision’s location, and a 2-3% risk of wound infections that can result in significant morbidity and mortality.
- Recovery from sternotomy can take up to 3 months, during which patients must significantly limit their activity to reduce the risk of complications, which can prolong recovery and limit their ability to return to usual activities.
- Minimally invasive approaches to mitral valve surgery have been shown to be safe and effective, with lower rates of morbidity and mortality than conventional sternotomy, including in high-risk patients such as the elderly.
- Emerging evidence suggests that minimally invasive surgery may be less costly than conventional sternotomy, with cost savings driven by reduced hospital stay and the need for blood transfusion. The UK Mini Mitral trial aims to assess whether minimally invasive surgery is associated with improvements in physical functioning, a return to usual activities, and cost-effectiveness compared to conventional surgery.
BETTER CARE-HF: EHR-embedded alert increased MRA prescription in AMBULATORY HFrEF patients
Key Points
- Many patients with heart failure with reduced ejection fraction (HFrEF) are not on optimal guideline directed medical therapy (GDMT), especially mineralocorticoid receptor antagonists (MRAs), despite their strong evidence base in improving clinical outcomes. GDMT under-prescribing is a cause of potentially preventable morbidity and mortality.
- It is unknown whether electronic clinical decision support (CDS) is able to improve MRA prescribing, and if so, what type of CDS is most effective.
- This was a pragmatic, cluster-randomized trial trial that included HFrEF patients, no active prescription of MRA, and an outpatient cardiologist in a large health system. Patients were cluster-randomized by cardiologist (60 per arm) into: automated EHR alerts automated EHR message and usual care.
- Patients randomized to the intra-visit BPA arm resulted in a significantly higher MRA prescription rate as compared to the monthly message or usual care.
- An automated, patient specific, visit based alert in the electronic medical record can increase appropriate GDMT prescription for HFrEF patients.
TAVR at 3 years showed durable benefits vs surgery: the Evolut Low Risk Trial
Key Points
- Both transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) procedures offer options for intervention in patients with aortic stenosis
- High-surgical risk has guided the use of a transcatheter approach, but data on its application in patients at low-surgical risk remains an area to be fully explored
- An update to the outcomes at 3-year follow up of the Evolut Low Risk Trial provide reassurance that TAVR is as safe as SAVR with respect to all-cause mortality or disabling stroke in low surgical risk patients
TRILUMINATE: Tri-Clip reduces tricuspid regurgitation and improves quality of life at one year
Key Points:
- There have been limited data examining the safety and efficacy of transcatheter tricuspid repair systems.
- In the TRILUMINATE study, Tri-Clip was compared against medical therapy in patients with severe symptomatic TR.
- Tri-Clip implantation reduced severity of TR and improved quality of life. Tri-Clip was safe and resulted in only a 1.7% rate of major adverse events.
FLAME: FlowTriever use for PE associated with decreased in-hospital adverse outcomes
Key Points:
- Mortality in high-risk PE remains unacceptably high (25%) despite advances in medical and interventional therapies.
- The FLAME study was a prospective, multi-center non-randomized observational study to describe the outcomes of patients undergoing mechanical thrombectomy and other modern therapies and generate evidence in high-risk PE. The primary outcome was a composite of all-cause mortality, bailout to alternate thrombus removal strategy, clinical deterioration, and major bleeding.
- Compared with a pre-established performance goal of 32%, patients treated with Flowtriever had a significant reduction in the primary endpoint. There was also significant reduction in in-hospital mortality (1.9% compared to 28.5%). There was no increase in adverse events in the FlowTriever group.
- Randomized evidence will be required to follow-up this observational study, but FlowTriever appears to be a safe, effective treatment which may reduce mortality in high-risk PE.
Intravascular Imaging-Guiding PCI in Complex Coronary Lesions Linked to Better Outcomes: The RENOVATE-COMPLEX-PCI Study
Key Points:
- Intravascular imaging-guided PCI shows promise in improving outcomes for patients with complex coronary artery lesions, with a 36% reduction on the primary outcome (composite of cardiac death, target vessel myocardial infarction, and clinically-driven target vessel revascularization; HR: 0.64; p = 0.008) compared with the angiography guided PCI group.
- RENOVATE-COMPLEX PCI trial highlights the potential benefits of utilizing intravascular imaging devices during PCI procedures, especially on complex coronary artery lesions.
- Ongoing medical research is crucial in advancing medical treatments and improving patient care, as demonstrated by the RENOVATE-COMPLEX PCI trial.
TARGET Trial: On-site CT-FFR Feasible and Effective in stable CAD
Key points:
- The TARGET trial is the first randomized trial designed to assess the impact of an on-site CT-FFR strategy using machine learning compared to standard care in patients with new onset stable chest pain with an intermediate-to-high pretest of coronary artery disease probability found to have intermediate stenosis on CCTA.
- Utilization of on-site CT-FFR compared to standard care with stress testing reduced the proportion of patients referred for invasive coronary angiography who did not have obstructive coronary artery disease or require intervention within 90 days. In addition, the on-site CT-FFR strategy increased revascularization overall but did not improve quality of life, symptoms of angina, or clinical outcomes.
- On-site CT-FFR measurement was based on a deep learning algorithm, which has been shown to perform equally well as computational fluid dynamics CT-FFR in identifying hemodynamically significant stenosis.
- The TARGET trial provides support for the use of on-site CT-FFR in the management of intermediate-to-high risk patients with stable chest pain and is expected to further consolidate the role of CCTA as a “gatekeeper” of the Cath lab.
BIOVASC Trial: Immediate complete revascularization non-inferior to staged complete in MVD ACS patients
Key Points:
- Complete revascularization is recommended in patients with multivessel CAD who present with ACS without cardiogenic shock, but the optimal timing of non-culprit lesion revascularization is unknown.
- The BIOVASC study was a randomized, open-label, non-inferiority clinical trial which sought to determine whether an immediate complete revascularization strategy was inferior to a staged complete revascularization strategy in patients with ACS and multivessel disease (MVD). The primary outcome was a composite of all-cause death, MI, unscheduled ischemia-driven revascularization, or cerebrovascular events at 1 year.
- At one year of follow-up, immediate complete revascularization was non-inferior to staged complete revascularization for the primary composite outcome. Patients who underwent immediate complete revascularization had fewer MIs and required fewer unplanned revascularizations.
HALO – Baxdrostat Fails to Beat Placebo for Blood Pressure Reduction in Uncontrolled Hypertension
Key Points
- Baxdrostat, a highly selective aldosterone synthase inhibitor, reduced systolic blood pressure as compared with placebo among patients with resistant hypertension in the BrigHTN trial. Efficacy and safety data are needed for individuals with uncontrolled hypertension.
- In this randomized, double-blind, placebo-controlled, phase 2 clinical trial, treatment with baxdrostat did not meet primary endpoint of statistically significant change from baseline in mean seated SBP versus placebo in patients with uncontrolled hypertension
Evolocumab Effect on Plaque Characteristics in Stable CAD Patients
Key Points
- The YELLOW III study aimed to assess the effect of 26 weeks of evolocumab on plaque morphology using intravascular imaging (OCT and NIRS/IVUS) and peripheral blood mononuclear cell (PBMC) gene expression analysis in patients with stable CAD on maximally tolerated statin therapy.
- In patients with stable CAD on maximally tolerated statins, more intensive lipid lowering with addition of evolocumab for 26 weeks resulted in significant and substantial increase in the minimum FCT by OCT, reduction in NIRS maxLCBI4mm and reduction in atheroma volume by IVUS in angiographically non-obstructive lesions.
- The prevalence of high-risk vulnerable TCFA lesions was reduced from 48% to 13%.
- This is the first multimodality imaging report in stable patients with non-obstructive lesions and lower levels of LDL-C at baseline.
BrigHTN: Baxdrostat, an aldosterone synthase inhibitor, showed dose-related reductions in blood pressure and safely and effectively lowers blood pressure in patients with resistant hypertension
Key Points
- In a Phase 2 randomized trial, baxdrostat, a highly potent and selective aldosterone synthase inhibitor, had dose-related reductions in blood pressurein patients with resistant hypertension compared to placebo, without any serious adverse events.
FRESH –First-in-Class Aminopeptidase-A Inhibitor Firibastat Fails in Resistant Hypertension
Key Points
- Hypertension remains a major public health threat contributing significantly to rates of ischemic heart disease and strokes worldwide despite a wide array of antihypertensives available
- A new antihypertensive agent, firibastat, is a first-in-class prodrug that acts through the inhibition of amiopeptidase A to block the conversion of angiotensin II to angiotensin III resulting in a decrease in blood pressure
- Firibastat failed to demonstrate efficacy to decrease blood pressure in patients with difficult-to-treat/resistant hypertension and was associated with allergic skin reactions.
PRECISION –Dual Endothelin Receptor Antagonist Aprocitentan Superior to Placebo in Resistant Hypertension
Key Points
- Despite the many drug classes available to treat hypertension, the prevalence of resistant hypertension (hypertension requiring at least 3 blood pressure medications of different classes) points to significant pathways not yet explored or addressed by current therapeutics
- Dual endothelin receptor antagonist (ERA), aprocitentan, offers a new pathway to the treatment of hypertension, pertinent to those prone to developing resistant hypertension including Black patients, patients with obesity or obstructive sleep apnea
- Aprocitentan lowered both office and 24-hour ambulatory blood pressures compared to placebo after 4 weeks of treatment, maintaining its effect over 48 weeks. It was, however, associated with fluid retention/edema which was clinically manageable with diuretic therapy.
RAPID – Self-Administered Etripamil Improves PSVT Conversion to Sinus Rhythm
Key Points
-The RAPID study achieved its primary efficacy endpoint of terminating PSVT with self-administered Etripamil using a symptom-based optimal repeat dosing.
-Pooled analysis with the NODE-301 study showed that self-administered etripamil showed a significant reduction in emergency department utilization and medical intervention.
-This Phase III trial showed a favorable safety and tolerability profile of etripamil consistent with prior etripamil trials.
NOVA – No significant difference in rate of post-op AF with botulinum toxin vs placebo
Key Points:
-In a Phase II, dose-ranging trial of epicardial fat pad injection of botulinum toxin type A (AGN-151607) there was no significant differences in the rates of post-operative atrial fibrillation (POAF).
-Subgroup analyses suggest a lower rate of POAF and rehospitalization in patients >65 years of age who received the 125 U dose of AGN-151607, and those undergoing isolated CABG.
-The mechanism of POAF within the first 30 days may be related to both direct autonomic influences and decreased inflammation.