Thrombosis Adviser at the European Society of Cardiology Congress 2020

Gerhard Hindricks, Tatjana Potpara and Isabelle Van Gelder discuss the new ESC guidelines for diagnosis and management of atrial fibrillation

Like many meetings planned for 2020, this year’s European Society of Cardiology (ESC) congress moved online. Although it was not possible for delegates to meet in person in Amsterdam, the sessions were still able to provide participants with the new data, expert discussion and clinical guidelines that they have come to expect. What’s more, this edition of the ESC congress was the largest ever, with over 100,000 people taking part from around the world.

As in previous years, many sessions focused on the prevention and treatment of thrombosis. Despite progress in our understanding of stroke, myocardial infarction (MI), limb ischaemia and venous thromboembolism (VTE), these events still devastate too many lives each year and we are always learning more about new ways to protect patients.

This year, recent progress in the management of atrial fibrillation (AF) and non-ST elevation acute coronary syndromes (NSTE-ACS) has been compiled into new ESC guidelines, which you can find online or read more about below.

Of course, one advantage of a digital congress is that it’s easier to catch up on what you might have missed. All sessions are available on-demand from the ESC website until at least the end of September and access is free.

Breaking News: Key updates from the guidelines

Atrial fibrillation 1

The management of AF in the new guidelines is based around the ABC pathway of Anticoagulation/Avoid stroke, Better symptom control and Co-morbidities/Cardiovascular (CV) risk factor management
The importance of patient protection is emphasized very prominently within this pathway, with the default position being stroke prevention unless the patient is at low risk for a stroke
Recommendations indicate that bleeding risk should not be a driver for decision-making. Patient risk factors beyond treatment choice are noted as being key to the risk of bleeding, and modifiable risk factors should be identified and addressed in all patients with AF
The guidelines now highlight the importance of including co-morbidities such as diabetes and renal impairment in the holistic management of patients with AF

Non-ST elevation acute coronary syndromes 2

A second antithrombotic such as rivaroxaban 2.5 mg twice daily (bid) should be considered for extended secondary prevention in patients with NSTE-ACS at high ischaemic risk and low bleeding risk
This extends last year’s recommendations on the management of chronic coronary syndromes from the chronic to the ACS setting, and reemphasizes that aspirin can no longer be assumed to provide adequate protection for the management of patients at moderate-to-high ischaemic risk

Atrial fibrillation: Taking the holistic view

High bleeding risk is not an excuse to withhold oral anticoagulation

In a session looking at the new ESC guidelines for the management of AF, Isabelle Van Gelder explains the importance of considering comorbidities in these patients

The new ESC guidelines represent a marked shift towards a more personalized and holistic view of AF management and now emphasize that stroke prevention should be the primary concern.1

There is now a class I recommendation for discussing the benefits and risks of treatment with patients and including their perceptions of treatment burden in the treatment decision.1

But to have these discussions with patients, the benefits and risks of different treatments first need to be established. To this end the guidelines also provide advice on the use of scores to assess stroke and bleeding risk in patients.1

Importantly, risk scores should be used as an aid to decision-making and not be relied on for decision-making. For example, while HAS-BLED should be considered to help address modifiable bleeding risk factors, estimated bleeding risk alone should not be used as a reason to withhold oral anticoagulation. Correspondingly, the default position is now to use anticoagulation unless patients have a low risk of stroke. Even then, patients with AF and low stroke risk should be reassessed within 4–6 months of index evaluation.1

What does protection look like and what does safety mean for patients with AF?

Professor Valeria Caso and Dr Manesh Patel discuss what protection looks like for patients

The Bayer-sponsored satellite symposium ‘A new decade for patients with Atrial Fibrillation: Protect the irreplaceable’ continued this focus on personalized and holistic treatment by focusing on the many different considerations needed to protect patients with AF.

In opening the session, Dr Manesh Patel explained that ‘protection is a driving force and many of our patients and communities are focused on ways in which we can protect those critical functions such as quality of life, neurologic cognition and functionality’. Dr Patel also drew parallels between the efforts to ‘flatten the curve’ during the COVID-19 pandemic and the need to supress the worldwide burden of stroke.

Another aspect of protection is adherence to treatment. Professor Valeria Caso highlighted the importance of explaining the importance of their treatment to the patient because they may not realize the irreversible impact of a stroke. She suggested that colleagues tell patients ‘I’m protecting you to be safe from stroke. Even the best-treated stroke will change your life – something in your brain will change’.

Professor Craig Coleman and Professor Peter Rossing focused on the importance of considering diabetes in patients with AF. Diabetes increases a patient’s risk of stroke, CV death, renal function decline and lower limb amputation and affects approximately 1 in 3 patients with AF. The audience also saw data showing that rivaroxaban was associated with a significant reduction in the risk of CV death compared with warfarin in a prespecified analysis of ROCKET AF and a significant reduction in the risk of major adverse limb events in a retrospective claims analysis of patients with AF and co-morbid diabetes.3-5 Professor Coleman also highlighted the diabetes-specific data supporting the advice from the 2019 update to the American Heart Association/American College of Cardiology/Heart Rhythm Society guidelines for the management of AF that ‘over time, non-vitamin K antagonist oral anticoagulants (NOACs; particularly dabigatran and rivaroxaban) may be associated with a lower risk of adverse renal outcomes than warfarin in patients with AF’.6

With the new ESC guidelines providing a class I recommendation that identification and management of co-morbidities should be an ‘integral part of treatment in AF patients’, understanding the effect of diabetes on outcomes in AF is of paramount importance.1

Professor Reinhold Kreutz summarizes the key studies showing the renal preservation effect associated with rivaroxaban compared with warfarin in patients with AF

Following this look at diabetes, Dr Christian Ruff led a discussion of renal impairment, another frequent co-morbidity in patients with AF. Professor Tatjana Potpara explained that chronic kidney disease (CKD) is an independent risk factor for stroke, intracranial bleeding and all-cause mortality in patients with AF. Importantly, renal function may also be impacted by anticoagulant choice and Professor Reinhold Kreutz explained the potential mechanisms by which exposure to vitamin K antagonists (VKAs) may accelerate renal decline.7-9

You can find more information on the impact of worsening renal function in patients with AF here.

To conclude the symposium, the panel returned to the topic of co-morbidities in patients with AF in a Q&A session. Dr Patel noted the moderate-to-high-risk population in ROCKET AF and how this can reassure clinicians:

’When we were doing ROCKET AF, we were thinking specifically of saying “can we test the higher risk population?” Because we think when clinicians see patients that are higher risk, they’ll feel comfortable applying that information to lower-risk patients, if they had to. We did not anticipate that we could study lower-risk patients and believe that would be effective for clinicians for higher-risk patients’.

New data in atrial fibrillation

Several new data sets focusing on real-world evidence with the NOACs were presented at ESC and highlighted the importance of appropriate dosing and choice of anticoagulant in patients with AF:

A retrospective cohort study in 15,608 German patients with AF receiving NOACs found that adherence to once-daily NOACs was significantly higher than adherence to twice-daily NOACs10
A Danish cohort study of 31,745 frail patients with AF showed that 52.1% of this population received no anticoagulation. Patients receiving standard doses of NOACs had the lowest risk of thromboembolic events compared with patients receiving reduced NOAC doses, VKAs or no anticoagulant. This supports the importance of dosing in line with the label and not reducing doses on the basis of age alone11
An analysis of the Taiwan National Insurance Database found that NOACs were associated with a lower risk of the composite endpoint of ischaemic stroke, intracranial haemorrhage, major bleeding or mortality than warfarin in 7362 very elderly (aged ≥90 years) high-risk patients with AF. The conclusions of this study are in line with ESC guidance that NOACs have a better benefit–risk profile than VKAs12
Similarly, an analysis of the 32,745 Japanese patients aged ≥75 years in the ANAFIE registry found that the incidence of stroke/systemic embolism and major bleeding was lower in patients receiving a NOAC compared with those receiving warfarin13
In 3517 Russian patients with AF and advanced CKD (15–29 ml/min/1.73 m2), rivaroxaban was associated with an improvement in renal function compared with warfarin14

Anticoagulation in patients with AF and coronary disease

AF and coronary atherosclerosis often overlap and the new guidelines for the management of AF and NSTE-ACS both provided recommendations for patients with AF who require concomitant antiplatelet therapy. Consistent with the 2019 chronic coronary syndrome guidelines, NOACs – at standard anticoagulant doses for AF unless there is a high bleeding risk – are now recommended over VKAs in patients with AF undergoing percutaneous coronary intervention (PCI) in both new guidelines.1,2,15

Furthermore, there is now increased clarity on the duration of triple therapy (i.e. aspirin + P2Y12 inhibitor + oral anticoagulation) with guidelines now recommending that, unless the risk of stent thrombosis outweighs bleeding risk, aspirin should now be stopped ≤1 week after the intervention. The P2Y12 inhibitor should then be stopped at 12 months.1,2

Continuing oral anticoagulation only after 12 months was supported by a new Swedish registry study, which found that this approach led to superior CV and bleeding outcomes in 2564 patients following coronary artery bypass grafting compared with antiplatelet with or without oral anticoagulation.16

Vascular protection: More should be done for moderate-to-high-risk patients

Recognizing the high risk of events across the continuum of coronary syndromes

Professor Dirk Sibbing explains how new antithrombotic regimens can be implemented when DAPT is stopped

Last year, the ESC recognized the continuing risk of major adverse CV events in patients with atherosclerotic disease by replacing their 2013 guidelines on stable coronary artery disease (CAD) with the new 2019 guidelines on chronic coronary syndromes.15 As well as this change in terminology, the guidelines included a new recommendation to consider adding a second antithrombotic such as rivaroxaban 2.5 mg bid in patients with moderate-to-high ischaemic risk and without high bleeding risk.2

With the new guidelines on NSTE-ACS making a similar recommendation, the ESC have recognized the high continuing risk post-ACS and provided a strong recommendation that aspirin is not enough for high-risk patients.2

The importance of following these new guidelines was highlighted by a new analysis of the international CLARIFY registry which evaluated the 5-year incidence of CV death, MI and stroke in 32,703 patients with chronic coronary syndromes.17 The investigators found that patients with CAD and either peripheral artery disease (PAD) or cerebrovascular disease had a significantly higher risk than patients with CAD alone. This increased risk was especially striking in patients who had diabetes, where disease in an additional vascular bed increased the 5-year risk of a CV death, MI and stroke from 9.8% to 15.5% (p<0.001).

Applying the guidelines to your patients

The high risk of events across the full continuum of atherosclerotic disease was discussed in the Bayer-sponsored symposium ‘Towards a new standard of care in coronary and peripheral artery disease: from trial results to guidelines and beyond’ which looked at four different patient cases.

Professor Jan Steffel demonstrates the net clinical benefit of rivaroxaban 2.5 mg bid plus aspirin in COMPASS

Professor Jan Steffel presented the first case and showed how a recent analysis of the net clinical benefit of rivaroxaban 2.5 mg bid plus aspirin in COMPASS supports his decision to use this dual pathway inhibition (DPI) to protect a 63-year-old woman at high risk of ischaemic events and low risk of bleeding.18 This analysis combined the most clinically severe efficacy and safety outcomes into a predefined composite outcome of CV death, stroke, MI, fatal bleeding and symptomatic bleeding into a critical organ. Rivaroxaban 2.5 mg bid plus aspirin demonstrated its protective effect by leading to a significant 20% relative reduction (p=0.0005) in the risk of this composite compared with aspirin alone.18

Professor Rob Welsh’s presentation also included data from a new analysis of the COMPASS study, this time focusing on long-term protection after a PCI. Professor Welsh presented the case of a 66-year-old woman with hypertension, dyslipidaemia and diabetes who had a non-ST-elevation myocardial infarction 20 months previously and received a PCI with stenting. The patient had been receiving dual antiplatelet therapy (DAPT) with aspirin and ticagrelor but was this still the most suitable regimen? Data from COMPASS demonstrated that the benefits of DPI with rivaroxaban 2.5 mg bid plus aspirin were consistent in patients with CAD irrespective of the time since PCI. Accordingly, and in line with ESC guidelines, the patient’s therapy was switched from DAPT to DPI for long-term protection.19

In the Q&A session, Professor Steffel summed up his advice for treating patients with CAD by explaining ‘If your patient is 3 or 4 years post-PCI, start [DPI] now. If they’re on DAPT now, you can already schedule them to move from DAPT to DPI’.

Dr Marc Bonaca highlights the high risk of events in patients with PAD following a revascularization

Transitioning from the case of a patient with a history of coronary intervention, Dr Marc Bonaca presented a patient with PAD and a recent endovascular intervention. As Dr Bonaca explained, ‘patients with PAD are most vulnerable in the acute post-revascularization setting’, so these patients have a special need for protection from life-changing events such as amputation. However, there were previously few proven preventative strategies for these patients until the recent VOYAGER PAD trial.20 Based on the results of VOYAGER PAD, Dr Bonaca’s patient was started on rivaroxaban 2.5 mg bid plus aspirin for long-term protection from CV and limb events with clopidogrel administered for the first 30 days.

The final case was presented by Professor Marianne Brodmann who continued the discussion of PAD. In this case, the patient was a 72-year-old woman who had received an endovascular revascularization 4 years ago and was now experiencing claudication. The patient also had multiple CV risk factors including CAD, diabetes, hypertension, CKD and smoking, and was therefore in clear need of extra protection from CV and limb events. DPI with rivaroxaban 2.5 mg bid plus aspirin was supported by numerous recent guidelines and, furthermore, the patient was reassured by the extra measures being taken to protect them15,21-23

New evidence highlighting the importance of vascular protection

Further data sets presented at ESC continued to provide evidence for the need of antithrombotic therapy in high-risk patients with atherosclerotic disease:

A subanalysis of VOYAGER PAD demonstrated the benefit of DPI in patients undergoing lower-extremity revascularization for PAD with or without concomitant CAD. Patients with CAD receiving DPI experienced a substantial reduction in the risk of stroke, MI and CV death compared with those receiving aspirin, while the benefit in patients without CAD was driven predominantly by protection from acute limb ischaemia24
Another subanalysis of VOYAGER PAD demonstrated a significant decrease in the risk of acute limb ischaemia associated with DPI compared with aspirin alone in patients undergoing lower-extremity revascularization for PAD. This benefit appeared early, was persistent over time and was unaffected by method of revascularization or background clopidogrel use25
Danish registry data showed that patients in routine clinical practice who would have met the enrolment criteria for VOYAGER PAD have an even higher risk of adverse outcomes than those included in the trial26
An integrated analysis of six phase 2 and phase 3 studies of patients with CAD/PAD (n=38,283) found that rivaroxaban 2.5 mg bid on a background of antiplatelet therapy significantly reduced ischaemic stroke and all stroke compared with standard of care. International Society on Thrombosis and Haemostasis major bleeding was significantly increased but there was no significant increase in critical site or fatal bleeding27
In COMPASS, neither the number of concomitant CV drugs taken by patients nor the number of co-morbidities affected the relative efficacy and safety of rivaroxaban 2.5 mg bid plus aspirin versus aspirin alone28
A retrospective cohort study using the US Optum Clinformatics® data set demonstrated that machine learning models can outperform existing risk scores such as the REACH score and the CHA2DS2-VASc score when predicting the risk of cardiac, limb and bleeding events in a heterogeneous population of patients with CAD/PAD29

Venous prevention: Implementation of guidelines in clinical practice

Finding opportunities for home treatment of patients with PE

Following new guidelines on the management of pulmonary embolism (PE) at ESC 2019, this year’s congress was focused on implementation of these guidelines and understanding of the wealth of recent data that informed them.

Professor Pierre-Marie Roy presents data from the HOME-PE study showing that one third of patients with PE may be suitable for home treatment

In particular, home treatment of patients with PE was a major topic with results from the HOME-PE study presented in a Hot Line session.30 This randomized study compared the simplified Pulmonary Embolism Severity Index (sPESI) score and the Hestia rule, two scores recommended for identification of patients with PE suitable for home treatment in the 2019 ESC guidelines. The Hestia rule was found to be non-inferior to sPESI and, although it identified fewer patients as suitable for outpatient care, it was less frequently overruled than sPESI by the treating physician, suggesting it had better applicability.30 Notably, both scores indicated that around one-third of patients with PE may be suitable for outpatient management.30

Additional data on home treatment of patients with PE was provided by a subanalysis of the HoT-PE study which evaluated the safety and efficacy of outpatient treatment in frail patients with low-risk PE treated with NOACs.31 The investigators concluded that frailty (i.e. age >75 years, creatinine clearance <50 ml/min or body mass index <18.5 kg/m2) was not in itself a reason to avoid early discharge and outcomes were similar to those in non-frail patients.31

Continuing to optimise clinical decision-making

To provide practical advice on implementation of guidelines and clinical data, the Bayer-sponsored symposium ‘Treatment challenges in VTE: Exploring solutions with rivaroxaban across three clinical scenarios’ focused on three patient cases and the factors that affect anticoagulant decisions.

Professor Stavros Konstantinides guides the audience through the ESC algorithm for determining risk in patients with PE

The first case was presented by Professor Stavros Konstantinides and this continued the debate over outpatient treatment of patients with PE. The patient in question was a 65-year-old man diagnosed with deep vein thrombosis (DVT) and PE. He was treated with rivaroxaban but there were questions on whether the patient could be discharged early.

The patient was haemodynamically stable and had no right ventricular disfunction, which would make him a candidate for early discharge based on the 2019 ESC guidelines.32 However, a formal risk analysis using the sPESI score said the patient was not a candidate for home treatment because of his history of cancer, despite receiving successful treatment 18 months ago and being well for the past year. Professor Konstantinides advised that ‘this apparent discrepancy can be resolved if we check criteria that explicitly were developed to judge whether a patient is a candidate for home treatment’. This means using the Hestia criteria, which defined the patient as a candidate for home treatment. Furthermore, as there were no other reasons to avoid home treatment, the patient was discharged 36 hours after admission.

In the next case, Professor Jeff Weitz looked at a 67-year-old man who was worried about recurrent PE following a first event after a recent flight. Professor Weitz explained that the key clinical characteristics that suggested to him that there may be a benefit from extended anticoagulation were that the patient was obese, male and had a PE provoked by a flight. Furthermore, recurrent VTE after PE is associated with a higher case fatality rate than VTE after DVT.32 Given that the patient had a low risk of bleeding and was concerned about a recurrent event, the decision was made to continue anticoagulation beyond 6 months.

Dr Alok Khorana highlights the improved treatment satisfaction identified in patients switched from LMWH/VKA to rivaroxaban in the COSIMO study

The final case was presented by Dr Alok Khorana who discussed the case of a 63-year-old woman who had a PE while being treated for non-small cell lung cancer. The patient was responding well to cancer treatment and felt well but they were receiving anticoagulant treatment with enoxaparin and expressed a desire to switch to an oral agent. Based on the results of the SELECT-D and COSIMO studies, the patient would be eligible for rivaroxaban and this would also be in line with recent guidelines for the treatment of cancer-associated thrombosis.33-37

You can read more about treating patients with cancer-associated thrombosis at
ThrombosisAdviser.com

References

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Updated date 10/10/2022

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Thrombosis Adviser at the European Society of Cardiology Congress 2020

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