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.

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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.”

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

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Key Points:

• Contrast-induced nephropathy (CIN) is a clinical condition that refers a deterioration in kidney function after contrast exposure and is a known complication of coronary angiography
• Some studies suggest that strategies to replace nitric oxide in the body may be beneficial because nitric oxide is deficient in CIN; inorganic (dietary) nitrate is metabolized in the body to nitric oxide, and previous studies have shown protective effects on the kidneys
• The NITRATE-CIN trial examined the efficacy of inorganic nitrate for the prevention of CIN in patients with non-ST elevation ACS (NSTE-ACS) referred for invasive coronary angiography
• Compared to placebo, inorganic nitrate reduced CIN, improved kidney outcomes at three months, and reduced major adverse cardiac events (MACEs) at 12 months in patients at risk of kidney injury undergoing coronary angiography for acute coronary syndrome (ACS)

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Key Points

• Evidence suggests that catheter ablation for atrial fibrillation (AF) is associated with improved cardiovascular outcomes compared to medical therapy in patients with heart failure (HF). However, its use in a population exclusively with end-stage HF eligible for heart transplant is unknown.
• The CASTLE-HTx trial demonstrated a significant decrease in a composite end-point of all-cause mortality, worsening of HF requiring a high urgent transplantation, or implantation of a ventricular assist device as bridge to transplantation therapy with atrial fibrillation ablation compared to medical therapy.

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Key Points:

• The DICTATE-AHF trial explored early initiation of the SGLT2 inhibitor dapagliflozin in acute decompensated heart failure (ADHF) patients.
• The trial did not show a statistically significant improvement in diuretic efficiency with dapagliflozin compared to structured usual care.
• However, exploratory analyzes indicated that dapagliflozin improved decongestion and led to earlier hospital discharge without worsening safety outcomes.

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Key Points

• This trial randomizing patients with an indication for initial dual chamber (DDD) permanent pacemaker implantation (PPI) for sinus node dysfunction (SND) to a base rate of 60 beats per minute (BPM) with rate adaptive pacing (DDDR-60) or base rate of 40 BPM with non-rate adaptive pacing (DDD-40) found that there was no difference in the primary endpoint of atrial fibrillation (AF) lasting more than 6 minutes during 2 years of follow up.
• There was also no difference in the secondary endpoints of AF lasting more than 6 or 24 hours, progression to permanent or persistent AF, cardioversions for AF, all cause mortality, quality of life, or 6 minute walk test.
• However, rates of syncope were significantly higher in the DDD-40 group, as were the rates of crossover from the DDD-40 to the DDDR-60 group.
• These results indicate that minimizing atrial pacing in patients SND did non prevent AF but did lead to an increased risk of pre-syncope or syncope.

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Key Points:

• The RIGHT trial assessed the benefit of post-procedural anticoagulation (PPA) after primary percutaneous coronary intervention (PCI) in ST-segment elevation myocardial infarction (STEMI) patients.
• The trial found that overall, PPA did not result in a significant reduction in adverse outcomes compared to placebo in a low-to-intermediate risk population.
• There was a significant interaction between the type of anticoagulant used and the primary endpoint, with enoxaparin showing potential benefit while unfractionated heparin and bivalirudin did not.

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Key Points

• This trial randomizing patients at high bleeding and/or ischemic risk who had successfully completed 9-12 months of dual anti-platelet therapy (DAPT) following initial percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) to an additional 9 months of either continued DAPT or clopidogrel monotherapy plus placebo found that patients in the clopidogrel monotherapy arm had significantly lower rates of clinically relevant bleeding and major adverse cardiovascular and cerebral events (MACCE; defined as all-cause death, MI, stroke, and clinically indicated revascularization).
• These data indicate that among patients at high bleeding and/or ischemic risk who undergo PCI for ACS, after initial 9-12 months of DAPT, de-escalation to clopidogrel alone is superior to continuation of DAPT for 9 additional months in terms of both bleeding and ischemia.
• The exact duration of clopidogrel monotherapy following the initial 9-12 months of DAPT in these patients remains uncertain. When and if they should de-escalate to aspirin monotherapy or if they should remain on lifelong clopidogrel is an area of future research.

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Key Points

• This pragmatic trial randomizing patients to optical coherence tomography (OCT)-guided or intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) found that OCT was non-inferior to IVUS for a composite outcome of cardiovascular death, target vessel myocardial infarction, or ischemia-driven target vessel revascularization.
• These data indicate that OCT has similar outcomes compared with IVUS in PCI across a broad range of coronary lesions, though patients with chronic kidney disease and ST-elevation myocardial infarction (STEMI) were excluded.

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Key Points

• This metanalysis integrating data from ILUMIEN IV and OCTOBER Trials with 18 prior randomized trials found that intravascular imaging (IVI) with intravascular ultrasound (IVUS) or optical coherence tomography (OCT) was associated with a 31% reduction in target lesion failure (TLF) compared to angiography alone.
• In addition, there were statistically significant reductions in all-cause death, all myocardial infarction (MI), and target vessel revascularization (TVR), a novel finding.
• OCT and IVUS performed similarly compared against angiography and one another.
• These data indicate that IVI with either OCT or IVUS is associated with better long-term clinical outcomes compared to angiography alone. The authors plan to update the analysis with data from the OCTIVUS trial, also presented the same day at ESC.

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Key Points:

• Tertiary screening for chronic cardiovascular disease as a means to reduce morbidity, mortality, and economic burden on the healthcare system has been proposed.
• RED-CVD trial was the first cluster randomized trial, that investigated the diagnostic yield of a systematic multi-step early screening strategy for an aggregate of coronary artery disease, heart failure, and atrial fibrillation, compared with usual care among high-risk patients.
• Active screening of patients with type 2 diabetes or COPD more than doubles new diagnoses of cardiovascular disease compared with usual care.

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Key Points

• This trial randomizing patients with stable angina, unstable angina (UA), or non–ST-segment elevation myocardial infarction (NSTEMI) and a true bifurcation lesion to optical coherence tomography (OCT)-guided or angiography-guided percutaneous coronary intervention (PCI) found a significantly lower rate of major adverse cardiovascular events in the OCT arm at two years.
• Results were consistent for both left main (LM) and non-LM bifurcation PCI. Secondary outcomes numerically favored OCT but did not reach statistical significance. Contrast use and procedural time was higher in the OCT arm.
• These data support the routine use of OCT guidance for stable angina, UA, and NSTEMI involving bifurcation lesions, though patients with advanced kidney disease were excluded from this study.

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Key Points:

• The optimal duration of therapy for distal deep vein thrombosis (DVT) among patients with an active malignancy is unknown.
• ONCO-DVT was the first randomized controlled trial comparing 12-months to 3-months of Edoxaban in patients with an active malignancy and recently diagnosed distal DVT
• Treatment with Edoxaban for 12 months compared to 3 months reduced symptomatic recurrent venous thromboembolism (VTE) or VTE-related death events without significantly increasing major bleeding risk.

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Key Points

• This trial randomizing patients with diabetes and/or complex lesions to optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) or angiography-guided PCI found that post-PCI minimum stent area (MSA) was larger in the OCT arm, but there was no significant difference in the two-year rate of target vessel failure (TVF).
• Patients in the OCT arm experienced significantly fewer angiographic complications and stent thrombosis at two years with a trend towards lower mortality.
• These results indicate that among a high-risk cohort, OCT significantly increases the MSA while reducing peri-procedural complications and stent thrombosis at two years, but did not lead to reductions in TVF. COVID-19 might have contributed to lower observed TVF rates due to apprehension to seek care.

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Key Points:

• It is well known that patients with STEMI often have multivessel disease (MVD) and those with MVD have worse outcomes compared to patients without it.
• Current US and European guidelines support complete revascularization in a staged fashion but trials examining immediate versus staged percutaneous coronary intervention (PCI) are lacking.
• The MULTISTARS AMI trial demonstrated that immediate revascularization with PCI was associated with a reduction in non-fatal myocardial infarction and unplanned revascularization compared to staged revascularization at 1 year.

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Key Points:

• The FRAIL-AF trial is an open-label, randomized controlled trial that randomized frail adults (75 years or older) who were on VKA for atrial fibrillation to either continuing VKA or switching to a NOAC.
• The study found a relative 69% increased risk in bleeding events among patients who were switched from VKA to NOACs (p=0.001). This was driven primarily by a 77% increase in clinically relevant non-major bleeding, as there was no significant difference in major bleeding events.

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Key Points:

• Sudden cardiac death causes a fifth of all deaths in industrialized countries, but survival to hospital discharge remains low.
• Transfer to a specialized, cath-lab capable cardiac arrest center may expedite care of patients with an ischemic cause of arrest.
• This multicenter randomized trial compared transfer to a specialized cardiac arrest center with the nearest ED in patients with a resuscitated out-of-hospital cardiac arrest (OHCA). The primary endpoint was 30-day all-cause mortality.
• There were no differences in the primary endpoint of all-cause mortality between the two transportation strategies, nor any difference in the secondary endpoints of 3-month mortality and neurological outcome.

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Key Points:

• Transthyretin amyloid cardiomyopathy develops because of mis-folded proteins infiltrating the myocardium, leading to clinical heart failure. Currently, tafamidis is the only commercially approved medication and is the most expensive cardiovascular drug on the market.
• Acoramidis is a once-daily medication that stabilizes the transthyretin tetrameric protein, preventing its degradation and subsequent deposition into the myocardium.
• Acoramidis in ATTR-CM resulted in a statistically significant reduction in hospitalization for heart failure and mortality based on a hierarchical analysis of a composite outcome with an overall win ratio of 1.8 (p<0.0001) compared to placebo.

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Key Points:

• ADVENT was the first randomized controlled trial comparing pulsed field ablation (PFA) to conventional strategies for ablation (including either radiofrequency or cryothermal ablation).
• The success rate was 73.3% and 71.3% in the PFA and thermal groups, respectively. PFA met the prespecified criteria for noninferiority.
• PFA is as effective and safe as conventional thermal ablation for the treatment of paroxysmal atrial fibrillation.

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