ESC Congress 2020 Hot Line Review

Slideshows

Billed as the largest online gathering of cardiovascular professionals the world has ever seen, the ESC Congress 2020 will feature the latest advances and research in across the field of cardiovascular medicine. With more than 5000 presentations planned across the weekend, coverage of the European Society of Cardiology’s virtual conference will consist of articles, exclusive video interviews, and podcasts with leading experts in their respective fields.

ESC Congress 2020

Dr. Gregory Weiss compiles thoughts and perspective on hot line trials presented at ESC Congress 2020.

ESC Congress 2020 Hot Line Reviews

Few agents have been as thoroughly studied for use in 

 patients in recent years as sacubitril/valsartan (Entresto). In recent years, major clinical trials have examined the agent in HFrEF and, now, the PARALLAX trial is offering greater insight into the effects of sacubitril/valsartan in patients with heart failure with preserved ejection fraction (HFpEF).

Presented by Burkert Pieske, MD, professor of medicine and director of cardiology at Charite University Medicine, at the European Society of Cardiology (ESC) Congress 2020, 

 detail the benefit of sacubitril/valsartan on NT-proBNP levels in HFpEF patients. While the study failed to meet its other primary end point, data from the trial offer greater insight into the mechanisms and effects of the agent in patients with heart failure.

For more insight into the use of sacubitril/valsartan and whether the clinical trial data is sufficient enough to prescribe the agent to patients, 

reached out to Pieske to take part in a special ESC 2020 House Call.

Videos

Lead investigator of the PARALLAX trial discusses whether he feels clinical data related to sacubitril/valsartan is strong enough to warrant prescribing it for HFpEF patients.

Burkert Pieske, MD: Sacubitril/Valsartan for HFpEF

For the first time in recent years, an analysis of REDUCE-IT was not included as part of the late-breaking sessions at a major cardiology conference, but that does not mean the European Society of Cardiology (ESC) Congress 2020 came and went without major data related to icosapent ethyl (Vascepa) from the landmark trial.

Among the more than 4000 pieces of data presented at 

 were a trio of studies assessing data from REDUCE-IT in an attempt to provide clinicians a more comprehensive overview of the effects of icosapent ethyl. A pair of these studies, one examining outcomes by baseline statin type and another assessing total ischemic events based on baseline LDL-C levels, were presented by the principal investigator of the original REDUCE-IT trial, Deepak Bhatt, MD, MPH.

In the following interview, Bhatt, who is also the executive director of interventional cardiovascular programs at Brigham and Women’s Hospital, discusses the results of both these analyses and an additional examining data from interim analyses conducted during the study.

These studies, “REDUCE-IT: total ischemic events reduced across the full range of baseline LDL cholesterol and other key subgroups,” “REDUCE-IT: accumulation of data across prespecified interim analyses to final results,” and “REDUCE-IT: outcomes by baseline statin type,” were all presented at 

Deepak Bhatt, MD, of Brigham and Women's Hospital, offers perspective on REDUCE-IT analyses and icosapent ethyl (Vascepa) data presented at ESC Congress 2020.

Deepak Bhatt, MD: Icosapent Ethyl and REDUCE-IT Data from ESC Congress 2020

For the past 2 years, the annual European Society of Cardiology (ESC) Congress has been headlined by major data related to SGLT2 inhibitors. In 2019, it was DAPA-HF and, in 2020, EMPEROR-Reduced, as well as DAPA-CKD, were among the most noteworthy studies presented.

Once seen as the less effective, oral option to GLP-1 receptor agonists for HbA1c control and weight loss, the way cardiologists regard the SGLT2 inhibitor class has undergone a fundamental shift. Now, after multiple major trials have examined use of the agents in those with and without type 2 diabetes, the class has gone from the domain of endocrinologists to cardiologists.

To gain a greater understanding about how cardiologists interpret this new data, 

 reached out to presenter of the EMPEROR-Reduced trial Milton Packer, MD, a cardiologist at Baylor Medical Center, to take part in a special edition ESC 2020 House Call. 


Milton Packer, MD, discusses how EMPEROR-Reduced data influences the way clinicians view the SGLT2 inhibitor class and its uses. 

Milton Packer, MD: The Evolution of the SGLT2 Inhibitor Class

This episode of the Practical Cardiology Podcast features an interview with Prof. Kausik Ray, Professor of Public Health at the School of Public Health, the Director of the Imperial Centre for Cardiovascular Disease Prevention and the Deputy Director of the Imperial Clinical Trial Unit at the Imperial College London. The subject of the current interview is the latest data from the ORION program examining inclisiran presented at the European Society of Cardiology (ESC) Congress 2020.

Currently under review for the treatment of primary 

 by both the European Medicines Association and the US Food and Drug Administration, the first-in-class investigational treatment for hyperlipidemia has the potential to drastically improve disease management for a number of patients.

During the conversation, Ray offers perspective and insights into a pair of analyses presented at the conference and also explains why he thinks physicians should be comfortable prescribing inclisiran to patients, once approved, based on clinical trial data associated with the agent.

Podcasts

A podcast featuring an interview with Prof. Kausik Ray centered around the latest inclisiran data presented at ESC Congress 2020. 

Prof. Kausik Ray: Inclisiran Data at ESC Congress 2020

Results of the EAST-AFNET 4 study are shedding new light on the beneficial effects of early rhythm control compared against usual care in patients with 

An analysis of more than 2500, results of the study suggest initiating a rhythm control intervention within the first year of an AF diagnosis could reduce risk of adverse cardiovascular events by 21% over a 5-year follow-up period.

“Rhythm control therapy initiated soon after diagnosis of atrial fibrillation reduces cardiovascular complications without increasing time spent in hospital and without safety concerns,” said principal investigator Professor Paulus Kirchhof, MD, of the University Heart and Vascular Centre UKE Hamburg, Germany, in a 

statement from the European Society of Cardiology (ESC)

. “These results have the potential to completely change clinical practice towards rhythm control therapy early after the diagnosis of atrial fibrillation.”

, EAST-AFNET 4 was designed to examine whether rhythm control therapy with antiarrhythmic drugs or ablation within the first year following diagnosis could improve outcomes associated with the disease. Conducted at 135 sites, the international, investigator-initiated, parallel-group, open, blinded-outcome-assessment trial randomized 2789 patients to undergo early rhythm control or usual care and was stopped for efficacy at the third interim analysis, which resulted in a median of 5.1 years of follow-up per patient.

Investigators chose a pair of primary efficacy outcomes for their analysis. The first was a composite of deaths from cardiovascular causes, stroke, or hospitalization with worsening heart failure or acute coronary syndrome. The second was the number of nights spent in the hospital per year. For safety, investigators chose a composite of death, stroke, or serious adverse events related to rhythm control therapy as the primary outcome.

For inclusion in the study, patients needed to be at least 18 years of age, have a previous transient ischemic attack or stroke, and meet at least 2 of the following criteria: age greater than 65 years, female sex, heart failure, hypertension, diabetes mellitus, severe coronary artery disease, chronic kidney disease, and left ventricular hypertrophy.

Upon analysis, the first primary outcome event occurred in 249 patients randomized to early rhythm control and 316 patients randomized to usual care (3.9 events per 100 person-years vs 5.0 events per 100 person-years, respectively). Based on these results, investigators determined patients randomized to early rhythm control reduced their risk of such an event by 21% (HR, 0.79; 95% CI, 0.66-0.94; 

=.05). The analysis also indicated the mean number of nights spent in the hospital did not differ significantly between the study groups with means of 5.8±21.9 and 5.1±15.5 days per year among the early rhythm control and placebo arms, respectively (

In regard to safety, results suggested the rate of primary safety outcome events did not differentiations significantly between the study arms. Investigators pointed out serious adverse events related to rhythm control therapy occurred in 4.9% of patients assigned to rhythm control and in 1.4% of patients assigned to usual care. Additionally, analysis of symptoms and left ventricular function at 2 years indicated no significant difference between the study arms.

This study, “EAST–AFNET 4: Effects of Early Rhythm Control Therapy in Patients with Atrial Fibrillation,” was presented at ESC Congress 2020 and simultaneously published as “

Early Rhythm-Control Therapy in Patients with Atrial Fibrillation

Articles

A study from ESC Congress 2020 details the effects of initiating rhythm control within the first year of an atrial fibrillation diagnosis. 

Early Rhythm Control Cuts Event Rate in Afib Patients

In what will come as a disappoint to many, results of IMPACT-AFib indicate an early education on stroke prevention did little to improve the rates of oral anticoagulant use among patients with 

 and an indication for oral anticoagulant use.

Results of the study, which were presented at the European Society of Cardiology 

, indicate an approach including patient- and provider-level educational intervention was not effective at increasing the proportion of patients using oral anticoagulant therapies.

“Among a population with a guideline indication for oral anticoagulant[s] for stroke prevention with atrial fibrillation, there was no statistically significant difference in rates of oral anticoagulant initiation at one year with a single education intervention,” said Sean Pokorney, MD, lead investigator and member of the Duke Clinical Research Institute, in a statement from the ESC.

In an effort to identify new methods of improving use of oral anticoagulants in patients with atrial fibrillation, Pokorney and a team of colleagues designed IMPACT-AFib to assess whether a patient- and provider-level intervention would improve use of oral anticoagulants in patients with a guideline-based indicated. For inclusion in the study, patients need to have a diagnosis of atrial fibrillation, a CHA2DS2-VASc score of 2 or greater, have no admission for bleeding 6 months prior to enrollment, not be prescribed an anticoagulant in the past 12 months, and be at least 30 years of age or older.

The primary outcome of the study was the difference in the proportion of patients using an oral anticoagulant over the course of the 12-month trial. The study also included multiple secondary end points such as proportion of days covered with an oral anticoagulant prescription, number of patients on an oral anticoagulant at the end of 1 year, and admissions for stroke or bleeding.

In total, the study enrolled more than 47,000 patients, but found the intervention failed to increase the proportion of patients using an oral anticoagulant during the trial. For more on the results of the trial and outcomes related to secondary end points, 

 reached out to Pokorney to take part in a special edition ESC 2020 House Call.

IMPACT-AFib Implementation of Stroke Prevention in Atrial Fibrillation

Lead investigator of IMPACT-AFib discusses the results of the study and how they inform clinicians on strategies to improve oral anticoagulant use. 

Sean Pokorney, MD: IMPACT-AFib and the Struggle to Improve Anticoagulant Adherence

After months of debate and speculation, the BRACE CORONA trial has drawn a firm conclusion: there is no benefit from discontinuing treatment with ACE inhibitors and ARBs in patients with coronavirus disease 2019 (COVID-19).

Presented at the European Society of Cardiology 

, BRACE CORONA provides insight into the effects of discontinuing ACEs/ARBs from a prospective, randomized trial, which had been lacking from previous data related to information from observational studies.

“This is the first randomized data assessing the role of continuing versus stopping ACE inhibitors and ARBs in patients with COVID-19,” said Renato Lopes, MD, of Duke Clinical Research Institute, in a statement from the ESC. “In patients hospitalized with COVID-19, suspending ACE inhibitors and ARBs for 30 days did not impact the number of days alive and out of hospital.”

After early research indicated ACE2 as the functional receptor for SARS-CoV-2, debate began over whether the discontinuation of ACEs/ARBs would result in benefit or contribute to worsening outcomes among patients hospitalized with COVID-19. With this in mind, Lopes and a team of colleagues designed the phase 4 study with a primary outcome of the number of days alive and out of the hospital at 30 days to provide an answer.

In total, 659 patients from 29 sites across Brazil were enrolled in the study. All patients included in the study had a history of chronic use of an ACE inhibitor or ARB and were hospitalized with COVID-19. Of note, patients using 3 or more antihypertensive agents, using sacubitril/valsartan, or who were hemodynamically unstable at presentation were excluded from the study.

Upon analysis, the mean number of days alive and out of the hospital was 21.9 days for patients who discontinued use of ACEs/ARBS and 22.9 days for patients who continued use of these agents (mean difference between groups: -1.1 days; 95% CI, -2.33 to 0.17). At 30 days, 91.8% of the patients in the discontinuation group were alive and out of the hospital at 30 days compared to 95% of patients in the group that continued use of the therapies—yielding mortality rates of 2.7% vs 2.8%, respectively.

For more on the results of BRACE CORONA and how these results can be applied to clinical practice, 

reached out to Lopes to take part in a special edition ESC 2020 House Call.

BRACE CORONA: Continuing vs. Suspending ACE Inhibitors and ARBs in COVID-19

Investigators found no benefit from the discontinuation of ACE inhibitors/ARBs in patients hospitalized with COVID-19 in a prospective, randomized, phase 4 trial. 

BRACE CORONA: No Benefit from Discontinuing ACEs/ARBs in Patients with COVID-19

New research from the Blood Pressure Lowering Treatment Trialists’ Collaboration (BPLTTC) is offering clinicians insight into the benefits of blood pressure-lowering therapy in patients with and without cardiovascular disease and with myriad of different 

Results of the study, which included data from nearly 50 clinical trials encompassing at least 1000 person-years of follow-up data each, investigators found blood pressure-lowering therapies were associated with a decrease in risk of cardiovascular disease events regardless of whether a patient had hypertension or a history of cardiovascular disease.

“The decision to prescribe blood pressure medication should not be based simply on a prior diagnosis of cardiovascular disease or an individual’s current blood pressure. Rather, blood pressure medication should be viewed as an effective tool for reducing cardiovascular risk when an individual’s probability of having a heart attack or stroke is elevated,” said study presenter Kazem Rahimi, MD, Deputy Director of George Institute for Global Health, in a statement from the European Society of Cardiology (ESC).

Presented at the ESC Congress 2020, the latest study from the BPLTTC is billed by investigators as the largest and most detailed study ever conducted examining the impact of blood pressure-lowering therapy across groups with differing blood pressures and histories of cardiovascular disease. In total, the trial included data from 48 randomized clinical trials and 348,854 participants.

For the purpose of the analysis, investigators classified patients into 2 groups based on whether they had a history of cardiovascular disease. These patients were then divided into 7 subgroups based on systolic blood pressure at study entry—these groups were defined as less 120, 120-129, 130-139, 140-149, 150-159, 160-169, and 170 mmHg or greater.

Upon analysis, which included a mean of 4 years of follow-up per patient, investigators found every 5 mmHg reduction in systolic blood pressure was associated with a 10% reduction in relative risk of major cardiovascular events by about 10%. Results also indicated each 5 mmHg reduction was associated with decreases of 13%, 7%, 14%, and 5% in the risk for stroke, ischemic heart disease, heart failure, and death from cardiovascular disease, respectively.

For more on the latest study from the BPLTTC, 

reached out the Rahimi to take part in an interview further exploring the design and results of the study.

BPLTTC - Blood Pressure Lowering for Prevention of Cardiovascular Events across Different Levels of Blood Pressure

The largest and most comprehensive look at blood pressure therapies and cardiovascular disease risk to date is providing an overview of the effects of antihypertensive therapy at varying levels of baseline blood pressure.

Blood Pressure Therapies Lower CVD Risk, Regardless of Disease History

New data from the HOME-PE study supports the use of HESTIA criteria as a triaging strategy for care of patients with acute 

Presented at the European Society of Cardiology (ESC) Congress 2020, results indicate use of HESTIA was non inferior to sPESI for the study’s primary end point, which was a composite of recurrent venous thromboembolism, major bleeding events, and death.

“These results support outpatient management of acute pulmonary embolism patients using either the Hestia method or the sPESI score with the option for physicians to override the decision. In hospitals organized for outpatient management, both triaging strategies enable more than a third of pulmonary embolism patients to be managed at home with a low rate of complications,” said Pierre-Marie Roy, MD, PhD, Department Head at the University Hospital of Angers, France, in a statement from the ESC.

Enrolling more than 1900 patients from 4 European countries, HOME-PE was the first prospective randomized study to compare a pair of resigning strategies for outpatient treatment of pulmonary embolism patients. Enrolled within 24 hours of a diagnosis, investigators hoped to draw a definitive conclusion on use of a pragmatic approach such as HESTIA for determining which patients could be managed with outpatient therapy at home. In total, 984 patients were randomized to a HESTIA approached and 986 were randomized to the sPESI group.

Among those in the HESTIA group, 39% were considered eligible for outpatient care, of which 3% were overruled by the physician-in-charge. Additionally, investigators found just 1% of those HESTIA determined were in need of hospitalization were eligible for outpatient. Among those in the sPESI group, 48% were considered eligible for outpatient care and 52% required further hospitalization. Of those considered eligible for outpatient care, 29% of these patients were overruled by the physician-in-charge. Additionally, 3% of the patients in need of further hospitalization according to sPESI were eligible for outpatient care. Final management rates between the 2 study arms were similar, as were the rates of adverse events in outpatients. Upon analysis, the primary outcome of the study occurred in 3.8% of the HESTIA group and 3.6% of the sPESI group (

reached out to Roy to take part in discussion related to the results of HOME-PE.

Hospitalization or Outpatient Management of Patients with Pulmonary Embolism: HESTIA versus simplified PESI

Results of HOME-PE suggest an approach using HESTIA was noninferior to sPESI for patients with acute pulmonary embolism. 

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