Key Points:

• The original STOP-DAPT trial randomized patients to receive either 12 months of dual antiplatelet therapy after percutaneous coronary intervention or one month of dual antiplatelet therapy followed by clopidogrel monotherapy, and found significantly less cardiovascular and bleeding events in the shorter DAPT group.
• As only 38% of the participants of the original STOP-DAPT 2 trial had acute coronary syndrome (ACS), STOP-DAPT 2 ACS was designed to assess the outcomes of a shorter DAPT duration in patients with ACS.
• After pooling patients from STOP-DAPT 2 and STOP-DAPT 2 ACS, one month of DAPT failed to meet noninferiority when compared to 12 months for a composite outcome of cardiovascular and bleeding events.
• Participants who received one month of DAPT had a trend toward higher cardiovascular events yet lower bleeding events, as would be expected.

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Key Points:

• • Prior observational and small randomized studies suggested that influenza vaccine may reduce future cardiovascular events in patients with known coronary artery disease.
  • The Influenza vaccination After Myocardial Infarction (IAMI) study is a double-blind, randomized controlled trial that tested whether influenza vaccination early after admission with myocardial infarction or high-risk coronary artery disease reduces cardiovascular events.
  • Late-breaking research presented in a Hot Line session today at ESC Congress 2021 showed that influenza vaccination reduces the risk of all-cause death, myocardial infarction, or stent thrombosis at 12 months in hospitalized patients with cardiovascular disease.
  • According to study authors, these findings suggest that influenza vaccination is underutilized in the cardiovascular disease population and should be considered as part of in-hospital treatment after myocardial infarction.

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Key Points:

• The STEP Study was a multicenter, randomized, controlled trial which was conducted in 42 clinical centers in China. Patients aged 60 – 80 years with hypertension were randomized to a systolic blood-pressure target of 110 to less than 130 mm Hg (intensive treatment) or a target of 130 to less than 150 mm Hg (standard treatment).
• The results of the trial mostly favored intensive treatment, including better outcomes with respect to rates of stroke, acute coronary syndrome, acute decompensated heart failure, coronary revascularization, atrial fibrillation and death from cardiovascular causes in the intensive as compared to the control group.
• The results for safety and renal outcomes did not differ significantly between the two groups, except for the incidence of hypotension, which was higher in the intensive-treatment group.
• The trial’s principal investigator, Dr. Jun Cai, wrote in an exclusive interview: “We suggested that in older patients treated for hypertension, the target of systolic blood pressure (SBP) should be below 130 mm H​g​ for better ​cardiovascular [outcomes]. The results of STEP could be generalized to and benefit more than 100 million persons in China, and we believe​ our result will provide important evidence for ​the development of future hypertension guidelines and bring ​progress in​ public health​ in the near future”.

The prevalence of arterial hypertension continues to rise worldwide, mainly due to arterial stiffening because of an aging global population. The impacts of chronic blood pressure elevation are enormous since hypertension is a major risk factor not only for cardiovascular morbidity and mortality but also for cognitive decline and autonomy loss later in life. The ideal targets for management of older adults with hypertension is increasingly discussed, and the STEP Study presented by Principal investigator Professor Jun Cai of the Chinese Academy of Medical Sciences, Beijing, China at today’s ESC Congress 2021 sought to provide additional evidence that would guide clinicians in optimal blood pressure management for elderly adults. Currently, optimal blood pressure targets are uncertain. During Dr. Cai’s presentation this morning he pointed out that several recent trials that focus on this topic have diverging findings regarding benefits of intensive blood pressure management as well as the risks. As a result, blood pressure target guidelines differ all over the world and by institution.

To clarify the optimal blood pressure target goals, Dr. Cai’s group launched the STEP trail – a prospective, multicenter, randomized, controlled trial which aimed to determine if intensive hypertension treatment (systolic blood-pressure [SBP] target, 110 to <130 mm Hg) would reduce cardiovascular risk to a greater extent than standard treatment (target, 130 to <150 mm Hg) in Chinese patients 60 to 80 years ​of age with hypertension over a planned 4-year period.

Beginning in January 2017, a total of 8,511 patients were enrolled in the study from 42 clinical sites in China. All participants had a SBP of 140–190 mmHg during three screening visits or were taking antihypertensive medication. Patients with prior stroke were excluded. After randomization, all patients were scheduled for follow up at 1, 2, and 3 months, and every 3 months thereafter until month 48 or until the end of study. Antihypertensive medications were provided to the patients. Office blood pressure monitoring was all conducted on a standardized, validated monitor, by a trained physician or nurse, measured three times with 1-minute intervals, and participants were required to rest for at least 5 minutes prior to measurement.

Though medication titrations were based off in-office blood pressure measurements, this trial was unique in that patients also received validated and automated home blood pressure monitors. The blood-pressure monitor was paired to the smartphone-based app with a Bluetooth function. The app was used to collect home blood-pressure readings obtained by the patient and then to upload the readings to a data-recording center. All the patients were required to obtain home blood- pressure readings at least 1 day per week during follow-up. Patients were not enrolled in the trial unless they could use the app or had a family member who could use it on their behalf. The details of the effects of the app-based management are not presented in the current study.

The primary outcome was a composite of stroke, acute coronary syndrome (which included acute myocardial infarction and hospitalization for unstable angina), acute decompensated heart failure, coronary revascularization, atrial fibrillation, or death from cardiovascular causes. Secondary outcomes included the components of the primary endpoint, death from any cause, major adverse cardiac events, and renal outcomes (a decrease in renal function or the development of end-stage renal disease).

The results of the study, published today in the New England Journal of Medicine, showed that baseline characteristics were evenly matched between the intensive and standard treatment groups, though importantly >75% of patients were aged 60-69 years in both groups. During the median follow up period of 3.34 years, the average decrease in SBP from baseline was 19.4 mmHg in the intensive treatment group and 10.1 mmHg in the standard treatment group. Average SBP reached 126.7 mmHg and 135.9 mmHg in the intensive and standard groups, respectively, with an average between-group difference of 9.2 mmHg. A total of 196 primary outcome events occurred in the standard treatment group (4.6%) compared to 147 events in the intensive treatment group (3.5%), with a relative risk reduction of 26% (hazard ratio with intensive treatment 0.74; 95% confidence interval [CI] 0.60–0.92). Dr. Cai wrote in an email interview, “Th​e results showed ​that t​he risk of adverse cardiovascular events was reduced by 26% with intensive treatment, and ​the results f​or safety (except for hypotension) and renal outcomes did not differ significantly between the two group​s.”​ The results for most of the secondary outcomes were also more favorable in the intensive-treatment group than in the standard-treatment group, including a 33% lower relative risk of  stroke (95%CI 0.47–0.97) and a 33% lower relative risk of acute coronary syndrome (95%CI 0.47– 0.94) in the intensive as compared to standard blood pressure control groups.

During the ESC Congress live release this morning, commentator Dr. Bryan Williams (University College London – London, United Kingdom of Great Britain and Northern Ireland) points out that the study population was relatively low risk, with very few patients with cardiovascular or renal disease and none with prior stroke because of exclusion criteria. He notes the impressive findings of the study included reduction in several important cardiovascular outcomes in the intensive group, which was extremely well tolerated as indicated by the few adverse events in this study arm. He makes the point, however, that older adults are a rather heterogenous group due to wide spectrums of comorbidities, frailty, and cognitive function among the elderly. He therefore remarked that this study indicates that clinicians may need to be more aggressive with blood pressure targets in certain groups, though the risk versus benefit of intensive blood pressure lowering may differ according to each patient.

Key points:

• The Amulet IDE is an open-label clinical trial that randomized 1,878 patients with non-valvular atrial fibrillation to receive either the novel Amulet device or the first-generation Watchman device, to compare the efficacy and safety of the two percutaneous left atrial appendage occlusion (LAAO) devices.

• The Amulet device was found to be superior to first-generation Watchman in effectively occluding the LAA (residual jet ≤5 mm at 45 days, 98.9% vs 96-8%, p=0.0025) and non-inferior with regard to procedure-related complications, major bleeding or all-cause death at 12 months (safety), and ischemic stroke or systemic embolism at 18 months (efficacy).

• Despite the difference in antithrombotic regimens used with the two devices (aspirin + warfarin for Watchman, versus aspirin + clopidogrel or aspirin + direct oral anticoagulant for Amulet), both the rates of bleeding and device-related thrombus were similar in the two arms.

• On August 14th, 2021, the Amulet percutaneous LAAO device received FDA approval.
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Key Points:

• In the LOOP trial, patients at high risk of stroke were randomized to either implantable loop recorder (ILR) versus usual care.
• The primary endpoint was time to stroke or arterial embolism, and secondary outcomes included a) combined ischemic stroke, systemic arterial embolism, and TIA, b) combined stroke, systemic arterial embolism, and CV death, and c) all-cause mortality. Other outcomes of interest included atrial fibrillation (AF) diagnosis and oral anticoagulant use.

• The use of ILR resulted in a three-fold increase in AF detection and initiation of anticoagulation, but there was no observed reduction in the primary endpoint of stroke or systemic arterial embolism.
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Key Points:

• The Salt Substitute and Stroke (SSaSS) study compared the effect of the consumption of a reduced sodium salt substitute to regular salt on stroke, cardiovascular events, and mortality.
• The trial, which was conducted in 600 villages in China, enrolled 35 participants from each village for a total of 20,995 participants.
• During almost 5 years of follow up, participants who consumed salt substitutes had significantly lower rates of all stroke, major adverse cardiac events, and total mortality. There was no evidence of harm with salt substitutes, and no significant increase in hyperkalemia.

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Key Points:

• Carotid artery stenting and carotid endarterectomy have both been employed to treat severely stenosed carotid arteries, a known risk factor for disabling stroke.
• In ACST-2, patient with severe carotid artery stenosis were randomized in a 1:1 fashion to receive either carotid artery stenting or carotid endarterectomy.
• Serious complications from either procedure were comparably rare. At 5 years, the nonprocedural stroke rate was 2.5% for both carotid artery stenting and endarterectomy.

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Key Points:

• Patients with high bleeding risk who were treated with PCI with an Ultimaster stent were randomized to either standard care dual antiplatelet therapy (DAPT) or abbreviated DAPT starting after 30 days of DAPT post PCI. Standard DAPT was defined as an additional 2 or 5 month duration (with or without anticoagulation, respectively) followed by single antiplatelet therapy (SAPT) for up to 11 months following randomization. Abbreviated DAPT was defined as immediate DAPT discontinuation followed by SAPT for 11 months (or 5 months if anticoagulation was indicated).
• The three primary endpoints included the following outcomes at 1 year: a) net adverse clinical events (NACE), b) major adverse cardiac and cerebral events (MACCE), and c) major or clinically relevant non-major bleeding (MCB).
• Treatment with abbreviated DAPT was noninferior to standard DAPT for NACE and MACCE. Abbreviated DAPT resulted in lower major or nonmajor bleeding.

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Key Points:

• In patients with resuscitated out-of-hospital cardiac arrest (OHCA) of potential cardiac etiology with either shockable or non-shockable arrest rhythm, performing immediate nonselective coronary angiography did not reduce 30-day all-cause mortality compared with delayed, selective angiography.
• Of those undergoing immediate angiography, a culprit lesion was identified in 38.1% of patients, compared with 43% of patients undergoing delayed selective angiography.

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Key Points:

• Patients undergoing coronary angiography were randomized to undergo fractional flow reserve pressure wiring of all lesions with >30% stenosis amenable to stenting versus coronary angiography alone.
• After enrollment of 1,100 patients and one year of follow up there was no difference in the primary outcome of total hospital cost or quality of life and angina status.
• While there were no differences in any of the prespecified secondary outcomes, including death, stroke and unplanned revascularization, almost 15% of patients undergoing coronary angiography alone required further testing to determine lesion significance.

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Key points:

• The APAF-CRT trial was a two-phase trial conducted among patients with permanent atrial fibrillation (AF) and narrow QRS (<110 ms) with ≥1 heart failure hospitalizations but considered unsuitable for AF ablation. The goal of this study was to compare two rate control strategies, and understand whether atrioventricular junction (AVJ) ablation followed by cardiac resynchronization therapy (CRT) is superior to pharmacological rate control.

• In 2018, the results from the first phase (APAF-CRT Morbidity) found that AVJ ablation + CRT significantly reduced the composite outcome of death due to heart failure (HF), heart failure hospitalizations (HHF) or worsening HF at 16 months, compared to pharmacological rate control.

• Now, the second phase of the trial (APAF-CRT Mortality) also found that AVJ ablation + CRT was associated with a 27% absolute reduction in all-cause mortality at 4 years of follow-up, compared to pharmacological rate control. Continue reading →

Key Points:                                         

• DECAAF-1 showed that higher volumes of atrial tissue fibrosis on cardiac MRI were associated with higher rates of atrial arrhythmia recurrence after catheter ablation.

• Patients were randomized to undergo MRI-guided ablation in addition to pulmonary vein isolation verses conventional pulmonary vein isolation and followed for 12-18 months to assess for atrial arrhythmia recurrence.

• MRI-guided ablation did not decrease rates of atrial arrhythmia recurrence, and was found to have higher adverse events, including stroke.

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Key Points:

• ENVISAGE-TAVI AF is a large, multinational, randomized-control trial investigate the safety and efficacy of edoxaban versus warfarin for those with atrial fibrillation undergoing TAVI.
• Edoxaban was noninferior to warfarin in the primary efficacy endpoint, a composite of adverse clinical events.
• Edoxaban  had higher rates of major bleeding, driven mostly by gastrointestinal (GI) bleeds. In patients requiring dose adjustment, however, no increase in bleeding events was seen.

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Key Points:                                  

• Finerenone is a nonsteroidal mineralocorticoid antagonist that has been shown to decrease adverse cardiovascular outcomes in patients with advanced diabetic kidney disease (DKD).

• FIGARO-DKD is a randomized, placebo-controlled trial assessing the cardiovascular effects of finerenone on patients with mild to moderate DKD.

• Finerenone was associated with fewer cardiovascular events, including a 30% decrease in heart failure hospitalization, as well as less progression to advanced CKD.

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KEY POINTS:

· CardioMEMS, a wireless, battery-free pressure sensor implanted in the pulmonary artery that transmits real-time pressure data, is an established means of remote, longitudinal clinical assessment for ambulatory patients with symptomatic heart failure syndromes

· The benefits of CardioMEMS in patients across the spectrum of heart failure syndrome classes was previously unknown

· GUIDE-HF shows that the benefits of hemodynamic guided management extends to a larger group of heart failure patients including patients with New York Heart Association Class II-IV heart failure, those without prior heart failure hospitalization, and among patients with all ejection fractions

Heart failure is a chronic, progressive condition that typically worsens over time. As a result it is one of the leading causes of hospitalization in the United States, resulting in almost one million hospitalizations in this country annually. Pulmonary artery congestion is the cause of many associated symptoms and therefore has been a long-standing target of therapeutic intervention. One such tool is the CardioMEMS HF System (Abbot, Atlanta, GA), a wireless, battery-free sensor that is implanted into the pulmonary artery to transmit pulmonary artery pressures. The device allows clinicians to

titrate heart failure medications according to the data received from the device, thereby allowing optimal control over fluid levels and ideally preventing heart failure hospitalizations for pulmonary congestion. Previously, the CardioMEMS device had been approved in Europe and the US on the basis of the results of the CHAMPION Trial, which demonstrated that active heart failure management guided by remotely obtained PA pressures using CardioMEMS reduced heart failure hospitalizations and improved health-related quality of life only in patients with more advanced heart syndromes, defined as patients with New York Heart Association (NYHA) Class III heart failure with

an admission for heart failure in the previous year. Notably this improvement was seen in patients irrespective of ejection fraction, therefore providing clinicians with possible therapeutic targets across the spectrum of heart failure syndromes.

The haemodynamic-GUIDEed management of Heart Failure (GUIDE-HF) trial, presented August 27th, 2021 in a Hot Line Session at ESC Congress sought to determine whether other types of patients might benefit from this pulmonary artery pressure monitoring device. Specifically, they evaluated whether haemodynamic-guided management using CardioMEMS could reduce heart failure events and mortality in patients with heart failure across the range of symptom severity (NYHA functional class II–IV), including those with elevated biomarkers but without a recent heart failure hospitalization. Furthermore, whether remote monitoring of pulmonary artery pressures could lead to timely intervention that might actually improve mortality is unknown.

The GUIDE-HF Trail was a multicenter, single-blind study conducted at 118 centers in the USA and Canada. Following successful implantation of a pulmonary artery pressure monitor, 1,000 patients with both preserved and reduced ejection fractions, NYHA functional class II–IV chronic heart failure, and either a recent heart failure hospitalization or elevated natriuretic peptides (based on a-priori thresholds) were randomly assigned (1:1) to either haemodynamic-guided heart failure management based on transmitted pulmonary artery pressures or to a control group who did not have pulmonary artery pressure data available. Though patients were blinded to the treatment allocation investigators were not. However, investigators did not have access to pulmonary artery pressure data for control patients. The primary endpoint was

a composite of all-cause mortality and total heart failure events (including heart failure hospitalizations and urgent heart failure hospital visits) at 12 months assessed in all randomly assigned patients. A pre-COVID-19 impact analysis for the primary and secondary outcomes was prespecified. The details of the study’s methods were published in the American Heart Journal in August 2019 and further information can be found at ClinicalTrials.gov (NCT03387813).

The trial’s results showed that though the primary endpoint was not met for the overall analysis (HR 0.88, 95% CI 0.74-1.05, p=0.16), the primary endpoint was met in the pre-COVID-19 impact analysis alone (HR 0.81, 95% CI 0.66-1.00, p=0.049). Furthermore

there was a highly significant 28% reduction in heart failure hospitalizations for patients with CardioMEMS devices in the pre-COVID-19 impact analysis (HR 0.72, 95% CI 0.57-0.92, p=0.007). This data is consistent with results previously reported in the CHAMPION trial, which enrolled only NYHA Class III patients with a previous heart failure hospitalization. Overall, there was a consistent signal for benefit for hemodynamic guided monitoring for patients of all subgroups regardless of NYHA Class, ejection fraction, sex, biomarkers, heart failure hospitalization in prior year, age, race, or etiology of heart failure. Notably there were only 54 NYHA class IV patients enrolled in the study and results for this population were inconsistent.

The trial’s lead investigator, Dr. Lindenfeld, points out during the GUIDE-HF press presentation that this trial’s novel finding is that it shows significant reduction in heart failure hospitalizations for patients with NYHA class II symptoms with a prior heart failure hospitalization or elevated biomarkers, NYHA class III patients even without a prior heart failure hospitalizations though with elevated biomarkers, and for patients with all ejection fractions. Furthermore, the findings have important implications for patients with heart failure with preserved ejection fractions as few therapies have shown benefit for this group.

The associated manuscript for this study is published today in The Lancet https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)01754-2/fulltext.

KEY POINTS:

• Implantable Cardioverter Defibrillators (ICDs) are indicated for post-myocardial infarction patients with severely reduced left ventricular systolic function, however, less is known about patients with moderately reduced LVEF.
• SMART-MI randomized post-myocardial infarction (MI) patients with moderate reduction in LVEF to receive an implantable cardiac monitor or continue with standard of care.
• In the Implantable Cardiac Monitor (ICM) group, arrhythmias were detected three times as often, and led to a higher number of therapies delivered to terminate such arrhythmias.

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Key Points:

• • Patients with chronic heart failure with preserved ejection fraction (HFpEF, defined here as EF>40%) with or without diabetes were treated with empagliflozin, a sodium-glucose cotransporter-2 (SGLT-2) inhibitor, in addition to standard of care therapy. The control arm was treated with standard of care alone.
  • Treatment with empagliflozin led to a significant reduction in the primary endpoint (time to first event of adjudicated cardiovascular death or heart failure hospitalization [HHF]) as well as both secondary endpoints (first and recurrent HHF and slope of change of eGFR). There was no effect on all-cause mortality.
  • The benefit of empagliflozin was seen across all pre-specified subgroups, including patients with or without diabetes.

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