Edoxaban Monotherapy Associated with Better Net Clinical Benefit than Edoxaban Plus Single Antiplatelet in Patients with AF and Stable CAD: EPIC-CAD

Key Points:

  • In patients with stable coronary artery disease and atrial fibrillation, multiple society guidelines recommend the use of monotherapy with oral anticoagulants after an early period of dual antithrombotic therapy. However, randomized trial evidence supporting this practice is limited.
  • In this open-label, randomized clinical trial, 1040 patients who had chronic coronary artery disease and atrial fibrillation were randomized to receiving either standard-dose edoxaban monotherapy or standard-dose edoxaban plus a single antiplatelet agent. 
  • Edoxaban monotherapy was found to be superior to dual antithrombotic therapy for net clinical events of death, stroke, myocardial infarction, systemic embolization, unplanned urgent revascularization, or major or clinically relevant nonmajor bleeding at 12 months.

Continue reading

STEEER-AF: A Structured Educational Program for Clinicians Improved Adherence to Guideline Recommendation in AF

Key Points:

  • Adherence to guideline recommendations for AF management is suboptimal.
  • STEEER-AF, the first randomized trial conducted by the ESC, assigned treatment centers across Europe to a short, targeted, and structured educational program or their usual education activities.  The outcome was patient level receipt of guideline-concordant care.
  • Exposure to the educational program was associated with a significant improvement in adherence to rhythm control, but not stroke prevention, guideline recommendations.
  • This trial demonstrated the feasibility and efficacy of using educational initiatives to target implementation gaps in cardiology. 

Continue reading

IVORY FINALE: Low-Dose IL-2 Reduces Arterial Inflammation after ACS

Key Points:

  • While inflammation is critical to the pathogenesis of atherosclerosis, few available anti-inflammatory treatments have been tested in ACS.
  • In IVORY FINALE, low-dose interleukin 2 (IL-2) was compared to placebo in ACS. The primary endpoint was change in arterial inflammation, as measured by PET scan. Safety and tolerability were also assessed.
  • In the primary analysis, IL-2 resulted in a significant reduction in arterial inflammation in the index vessel on PET. Over a median of 2.6 years of follow-up, IL-2 also decreased MACE compared to placebo.

Continue reading

QUADRO – Quadruple Polypill More Effective In Lowering Blood Pressure Than Taking Three Separate Medications in Resistant Hypertension

Key Points:

  • Treatment of resistant hypertension often involves at least three or more medications, but non-adherence increases as the number of pills increases.
  • In the QUADRO trial, adding bisoprolol to a combination of perindopril, indapamide, and amlodipine in a single polypill significantly reduced blood pressure in patients with resistant hypertension over an 8-week period.

Continue reading

A Single Combined Measure Of hsCRP, LDL-C, And Lp(A) Predicts Incident CV Events Over 30 Years Among Women’s Health Study Participants

Key Points:

  • While drug trials evaluate the short-term cardiovascular risk associated with elevated, blood biomarkers, little is known about the long term (20-30 year) risk conferred by these biomarkers, alone or in combination.
  • This epidemiological study evaluated the association between baseline levels of hsCRP, LDL-C, and Lp(a) of ~28,000 initially healthy participants in the Women’s Health Study with incident cardiovascular events over 30 years of follow-up.
  • Each of the measures were independently associated with an increased adjusted hazard of incident cardiovascular events, and each biomarker provided additive information. Women in the highest quintile of all three biomarkers had the highest risk.
  • These data indicate that a single combined measure at one point in time can have predictive value beyond the traditional 10-year risk score. Since all three are potentially modifiable, these findings might have significant implications for how we prevent heart disease. 

Continue reading

ASSURE DES: No Difference In Ischemic Events If Aspirin Is Interrupted Or Continued In Patients With DES Undergoing Non-Cardiac Surgery

Key Points:

  • Anti-platelet therapy after coronary drug eluting stent (DES) placement reduces the risk of future ischemic events, but the risk of in-stent thrombosis with temporary interruption of anti-platelets decreases over time.
  • Holding aspirin for non-cardiac surgery more than one year after DES placement could lower peri-operative bleeding risk, but whether this is outweighed by the ischemic risk remains uncertain. 
  • ASSURE DES randomized patients with prior DES undergoing non-cardiac surgery to continuation or interruption of aspirin, and found no difference in major ischemic or bleeding events, but the lower than expected event rates left the study underpowered.

Continue reading

Morning vs. evening dosing of blood pressure meds: No differences in outcomes or safety for either community-dwelling adults or frail nursing home residents

Key Points:

  • Blood pressure follows a circadian rhythm, peaking after waking and dipping during sleep. While elevated nocturnal pressures are associated with adverse cardiovascular events, it is uncertain whether taking anti-hypertensive medication in the evening improves outcomes.
  • BedMed and BedMed-Frail were pragmatic trials that randomized community-dwelling adults and nursing home residents, respectively, to their once-daily anti-hypertensives either before bed or in the morning.
  • There were  no differences in major cardiovascular or safety events between the two groups in either trial.

Continue reading

NOTION-3: Revascularization in Patients Undergoing TAVI Associated with Lower Risk of MACE vs Conservative Treatment

Key Points:

  1. The NOTION-3 trial found that FFR-guided revascularization with PCI in TAVI patients with coronary artery disease significantly reduced the composite endpoint of all-cause mortality, myocardial infarction, and urgent revascularization compared to conservative management.
  2. The reduction in the composite endpoint was mainly driven by significantly lower rates of myocardial infarction and urgent revascularization in the PCI group compared to the conservative group.
  3. The trial provides evidence that severe AS patients with CAD can benefit from PCI revascularization with TAVI.

Continue reading

TAVI Superior to Surgical Aortic Valve Replacement in Women: RHEIA Trial

Key Points:

  • The RHEIA trial found that TAVI was superior to surgical aortic valve replacement (SAVR) in women with severe aortic stenosis, significantly reducing the composite endpoint of all-cause mortality, stroke, and rehospitalization for valve-related symptoms or worsening heart failure.
  • The reduction in the primary endpoint was primarily driven by a significant decrease in rehospitalizations for valve- or procedure-related symptoms in the TAVI group compared to the SAVR group.
  • TAVI demonstrated clear advantages over SAVR, suggesting that TAVI could be the preferred therapy for women with severe symptomatic aortic stenosis.

Continue reading

SWEDEGRAFT Trial: No Advantage of No-Touch vs Conventional Vein Harvesting in Coronary Artery Bypass Surgery

Key Points:

  • The SWEDEGRAFT study is a prospective, binational multicenter, open-label, registry-based trial in patients undergoing first isolated non-emergent coronary artery bypass grafting (CABG), randomized 1:1 to no-touch or conventional open skeletonized vein harvesting technique, with a planned enrollment of 900 patients. 
  • The SWEDEGRAFT trial found no significant difference in vein graft failure or clinical outcomes between no-touch and conventional vein harvesting techniques in coronary artery bypass grafting (CABG).
  • Patients undergoing no-touch harvesting experienced higher rates of leg wound complications compared to those who underwent conventional harvesting.

Continue reading

Transcatheter Mitral-valve Repair Lowers Hospitalization or CV Death vs Medical Therapy Alone in HF with Moderate to Severe MR: RESHAPE-HF2 Trial

Key Points:

  • The Mitral Transcatheter Edge-to-Edge Repair (M-TEER) procedure with the MitraClip device has shown in the previous COAPT trial to reduce heart failure hospitalizations and mortality in patients with heart failure and severe functional mitral regurgitation (FMR).
  • The RESHAPE-HF2 trial demonstrated that M-TEER, when added to standard care, significantly reduces heart failure hospitalizations compared to optimal standard of care alone in patients with FMR but did not significantly reduce mortality. M-TEER also substantially improved quality of life scores in heart failure patients as compared to optimal standard of care alone.
  • RESHAPE-HF2 provides further evidence of the benefits of M-TEER in patients with reduced ejection fraction and FMR. 

Continue reading

Continuation of Anticoagulation Non-Inferior to Interruption during TAVI: POPular PAUSE TAVI Trial.

Key Points:

  • Many patients who undergo transcatheter aortic-valve implantation (TAVI) have an indication for oral anticoagulation. However, there is uncertainty over the safety and efficacy of continuing anticoagulation versus holding periprocedural anticoagulation during TAVI.
  • In this international, international, open-label, randomized, noninferiority trial clinical trial, 869 patients undergoing TAVI who were also receiving long-term anticoagulants were randomized to either continuation strategy or interruption strategy of their anticoagulation.
  • Continuation of anticoagulation was found to be non-inferior to interruption of anticoagulation for composite outcomes of death, stroke, myocardial infarction, major vascular complications, or major bleeding within 30 days after TAVI.

Continue reading

Pooled Analysis Showed Semaglutide Reduced Combined CV death or Worsening HF and Worsening HF alone but No Significant Effect on CV Death

Key Points:

  • Heart failure with mildly reduced or preserved ejection fraction (hereafter referred to as HFpEF) is the most common type of heart failure and is associated with a high risk of adverse clinical events, especially in patients with overweight, obesity, or type 2 diabetes.
  • Whether semaglutide reduces heart failure (HF) events in patients with HFpEF remains an unresolved and important clinical question.
  • This study aimed to investigate whether semaglutide reduces the risk of adverse HF events by conducting a pooled, patient-level analysis of participants with HFpEF from the SELECT, FLOW, STEP-HFpEF, and STEP-HFpEF DM trials.

Continue reading

Transcatheter Edge-To-Edge Repair Is Non-Inferior To Surgery In Patients With Secondary Mitral Regurgitation: MATTERHORN Trial

Key Points:

  1. The MATTERHORN trial found that the transcatheter edge-to-edge repair (TEER) procedure was non-inferior to surgical mitral valve repair in reducing functional mitral regurgitation in heart failure patients with depressed left ventricular ejection fraction.
  2. Both TEER and surgical groups showed similar outcomes in terms of the primary composite efficacy endpoint, and both had low rates of severe MR recurrence at 1 year.
  3. The TEER group had significantly fewer safety events compared to the surgical group, highlighting its potential as a safer alternative for patients at high risk for surgery.

Continue reading

T-TEER Significantly Reduced the Severity of Secondary Tricuspid Regurgitation and Improved Quality of Life. TRI-FR Trial

Key Points:

  1. The TRI.FR trial found that tricuspid transcatheter edge-to-edge repair (T-TEER) together with optimal medical therapy significantly improved the clinical outcomes and reduced tricuspid regurgitation severity compared to optimal medical therapy alone.
  2. Patient-reported outcomes, including quality of life, were significantly better in the T-TEER group than in the control group.
  3. The trial underscores the importance of a multidisciplinary approach to treating tricuspid regurgitation, integrating T-TEER with guideline-directed medical management.

Continue reading

ABYSS – Beta Blocker Interruption in Post-Myocardial Infarction Patients

Key Points:

  • In the ABYSS trial, 3700 patients who had a left ventricular ejection fraction ≥ 40% and were > 6 months post myocardial infarction were randomized to receive beta blocker continuation vs. beta blocker interruption
  • The authors found higher rates of the primary endpoint, the composite of death, MI, stroke and cardiovascular hospitalization, among patients who had interruption of their beta blocker, especially if those individuals had a history of hypertension
  • Beta blocker interruption had no impact on quality of life and not surprisingly, resulted in higher blood pressures and heart rates

  Continue reading

Vitrusiran Reduces Risk of Death and CV Events in Patients with ATTR-CM

Key Points:

  • ATTR amyloid cardiomyopathy, resulting from accumulation of TTR amyloid protein in the heart, leads to progressive heart failure, complicated by arrhythmias, with a significant increase in worsened quality of life, hospitalization, and death
  • This study tested the efficacy and safety of vutrisiran, a novel subcutaneously (SQ) administered RNAi therapeutic, dosed quarterly, to treat ATTR amyloid cardiomyopathy
  • Vutrisiran demonstrated statistically significant improvement over standard therapy (tafamadis, SGLT2i inhibitors, and diuretics) on both primary and secondary outcomes, including mortality, disease progression, and quality of life
  • The authors argue these results support vutrisiran as a reasonable new standard-of-care for ATTR amyloid cardiomyopathy patients, either as first-line for new diagnosis, or alternative vs add-on therapy in treated patients with progressive disease

Continue reading

ARAMIS: Anakinra is safe but does not reduce complications of acute myocarditis

Key Points:

  • While myocarditis is an inflammatory condition, there have not yet been trials demonstrating the benefit of anti-inflammatory therapies in the treatment of acute myocarditis.
  • In the ARAMIS study, subcutaneous anakinra was compared with placebo in patients with acute myocarditis diagnosed on CMR presenting with chest pain and troponin elevation. The primary endpoint was number of days alive free from myocarditis complications.
  • Anakinra use did not result in a significant change in number of days free from myocarditis complications but was well-tolerated and safe.

Continue reading

PUSH-AHF: Natriuresis-guided diuresis approach increases natriuresis and diuresis without improving all-cause mortality or HF hospitalization

Key Points:

  • Diuretic requirement Is a major contributor to hospital length-of-stay for HF admissions, but the optimal strategy of diuretic optimization has not yet been established. Spot urinary sodium measurement and subsequent natriuresis-guided diuretic adjustment may refine diuretic dosage in the setting of insufficient diuretic response.
  • In the PUSH-AHF study, natriuresis-guided therapy was compared with standard of care in patients hospitalized with acute HF. The two primary endpoints were a) natriuresis over 24 hours and b) first occurrence of all-cause mortality or heart failure rehospitalization after 180 days.
  • Natriuresis-guided therapy resulted in significantly increased natriuresis over 24 hours without a significant difference in time to all-cause mortality or heart failure rehospitalization.

The duration of acute HF hospitalization is often driven by diuresis requirement, but the optimal strategy of in-hospital diuresis has not yet been established. For those with insufficient diuretic response, assessment of urinary sodium may help monitor diuretic response and guide further therapy. In a breaking presentation at the 2023 ESC Congress today, Dr. Jozine ter Maaten (University Medical Centre Groningen ) and her team presented their study: “PUSH-AHF: Natriuresis guided therapy in acute heart failure.”

The PUSH-AHF trial (NCT04606927) was a randomized, open-label single-center trial of adult patients with a primary inpatient diagnosis of acute heart failure with an intravenous diuretic requirement that compared natriuresis-guided therapy with standard of care diuresis. Natriuresis-guided therapy was dictated by spot urinary sodium measurements; a spot sodium <70 mmol/L indicated insufficient response and resulted in diuretic therapy adjustment.  Key exclusion criteria were non-cardiac dyspnea or severe renal impairment requiring dialysis. The two primary outcomes were total natriuresis after 24 hours and first occurrence of all-cause mortality or heart failure rehospitalization after 180 days.

A total of 310 patients were 1:1 randomized to either natriuresis-guided therapy or standard of care. The median age was 74, and 45% were women. Participants receiving natriuresis-guided therapy had a significant increase in natriuresis at 24 hours (409±178 vs 345±202 mmol, p=0.0061).  However, there were no significant differences in time to all-cause mortality or heart failure rehospitalization after 180 days (HR 0.92, 95% CI 0.62-1.38, p=0.698). The secondary endpoints of 48-hour natriuresis and both 24- and 48-hour diuresis were all increased in the intervention arm (all p<0.02). There was no difference in hospital length-of-stay between the two groups. Natriuresis-guided therapy was safe and well-tolerated.

When discussing the clinical implications of the study at the ESC Congress press conference, Dr. ter Maaten stated: “The results of the PUSH-AHF trial are directly implementable to improve decongestive treatment as spot urinary sodium values are easy to obtain, inexpensive and widely available…natriuresis guided therapy was safe and is a first step to a personalized treatment approach in patients with acute heart failure.”

SGLT2 inhibitors not linked with improved survival in hospitalized COVID-19 patients

Key Points:

  • In hospitalized COVID-19 patients, treatments targeting the virus’s pathobiology (e.g. dysregulated immune response, inflammation, etc.) has been shown to improve outcomes
  • Sodium glucose co-transporter 2 (SGLT2) inhibitors affect similar pathobiology and may lead to organ protection in acute illness, but their role in hospitalized COVID-19 patients is uncertain
  • In this meta-analysis, SGLT2 inhibitors did not demonstrate decreased 28-day all-cause mortality compared with usual care or placebo in hospitalized COVID-19 patients

Continue reading