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ThrombosisAdviser at the European Society of Cardiology Congress 2019

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The European Society of Cardiology (ESC) congress is the largest cardiovascular congress in the world. This year’s event also included the World Congress of Cardiology and attracted over 30,000 delegates, who gathered at the Paris Expo Porte de Versailles to participate in a programme of over 500 different sessions across the full spectrum of cardiovascular medicine.

 

This year, thrombosis was again a cornerstone of the programme, and delegates were able to learn about new data, developments in management strategies and updated practice guidance to help them protect their patients from the devastating consequences of thrombotic events.

 

A highlight of ESC is the publication of new guidelines, which combine recent advances in medical science with ongoing practical experience to support clinicians with their daily clinical decision-making. 2019 is an important year for anyone who treats patients with thrombotic conditions, with the release of new clinical practice guidelines for: Chronic Coronary SyndromesDiabetes, Pre-Diabetes and Cardiovascular Diseases; and Acute Pulmonary Embolism, (See Breaking News below).

 

Whether you missed out on ESC this year or simply want a closer look at the data away from the lively congress hall, this newsletter will provide you with all you need in the fields of atrial fibrillation (AF), venous thromboembolism (VTE) and vascular protection.

 

Further reading

 

BREAKING NEWS

Key updates from the guidelines

Chronic Coronary Syndromes:

  • Rivaroxaban vascular dose (2.5 mg twice daily [bid]) plus aspirin low dose once daily (od) should be considered in the treatment of patients with chronic coronary syndromes at high risk of further events and low risk of bleeding

 

Diabetes, Pre-Diabetes and Cardiovascular Diseases:

  • Rivaroxaban vascular dose (2.5 mg bid) plus aspirin low dose od may be considered in patients with diabetes mellitus and symptomatic lower-extremity peripheral artery disease (PAD)

 

Acute Pulmonary Embolism:

  • Non-vitamin K antagonist oral anticoagulants (NOACs) are now the first-line anticoagulant in patients with acute pulmonary embolism (PE)
  • In patients with PE and cancer, edoxaban or rivaroxaban should be considered as an alternative to low molecular weight heparin (LMWH) unless the patient has gastrointestinal cancer
  • Extended anticoagulation should be considered for patients with PE and a persistent risk factor (other than antiphospholipid syndrome) or with PE provoked by a minor transient/reversible risk factor
  • A reduced dose of apixaban 2.5 mg bid or rivaroxaban 10 mg od should be considered after the first 6 months of anticoagulation

Atrial fibrillation: The importance of diabetes and renal impairment

When we think about our patients with AF, it is important to remember why we prescribe anticoagulants in the first place – to protect our patients from the devastating consequences of stroke. However, protection is more than efficacy and safety, and safety is more than just bleeding risk. We also need to think about the other factors that can influence that protection, such as preserving renal function, and considering co-morbidities, dosing and adherence.

 

The Bayer-sponsored satellite symposium entitled The bigger picture in stroke prevention and anticoagulation: Think Beyond Atrial Fibrillation’ focused on the key and interlinked topics of renal impairment and diabetes. Patients with renal impairment are at significantly increased risk of stroke, bleeding and mortality, and co-morbid diabetes further increases this risk.

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The link between AFdiabetes and kidney function in the daily management and protection of patients with AF
AF, atrial fibrillation; CKD, chronic kidney disease

Exciting recent real-world evidence from the German RELOADED study was also presented at ESC, Significantly fewer patients receiving Factor Xa inhibitors in this study progressed to end-stage renal disease compared with those receiving a vitamin K antagonist (VKA). Furthermore, a significant reduction of acute kidney injury with rivaroxaban vs VKA in AF patients who have diabetes was also detected in this study. This finding was echoed by data from the real-world CALLIPER study, which used US claims data to look at worsening renal function in patients who had AF and stage 3/4 chronic kidney disease (CKD). The data showed that acute kidney injury, kidney failure or progression to stage 5 CKD were significantly reduced with rivaroxaban 15 mg compared with warfarin; this effect was maintained in patients who also had diabetes.

 

This accumulating evidence, suggesting that rivaroxaban may preserve renal function compared with VKAs, led to some fascinating discussions in a series of practical tutorials with experts closely linked to the management of patients with diabetes or renal impairment, including a nephrologist, a diabetologist, a pharmacist and a pharmacologist.

 

Professor Peter Rossing, a diabetologist from the Steno Center in Copenhagen, Denmark, highlighted the importance of ‘looking out for’ AF in patients with diabetes and CKD because of the increased risks of kidney and heart problems. Interestingly, a separate analysis of the US MarketScan data also indicated that rivaroxaban was associated with lower risks of major adverse cardiovascular events (MACE) and major adverse limb events versus warfarin in patients with non-valvular AF and diabetes.

 

These interesting topics were discussed further in the interactive hub session entitled ‘The bigger picture in stroke prevention: integrating AF, kidney disease and diabetes to optimize patient care’. In this session Dr Manesh Patel and Dr Christian Ruff discussed the management of two patients, highlighting the importance of individualizing care needs to optimize protection.

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Dr Manesh Patel and Dr Christian Ruff discuss a patient case

All of the sessions emphasized the importance of considering protection in its broadest sense, and this was summed up by Professor John Camm when he said that ‘we have to take a holistic approach to patient care’.

 

New data from the prospective SAFIR-AC registry compared the risk of bleeding in 1903 patients aged >80 years with AF receiving rivaroxaban or VKA. In this challenging population, rivaroxaban was associated with significantly fewer major bleeds and significantly fewer intracranial haemorrhages compared with VKA.

 

What’s new in the ESC diabetes guidelines?

VKAs or NOACs (e.g. apixaban, dabigatran, edoxaban or rivaroxaban) are recommended in patients with AF and diabetes aged >65 years with a CHA2DS2-VASc score ≥2; it is recommended to give preference to NOACs.

Vascular protection: Supporting practical implementation

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Three thousand delegates watch the presentation of the new ESC guidelines

The new ESC guidelines on Chronic Coronary Syndromes were presented on Sunday 1 September to a full auditorium. ESC Chronic Coronary Syndromes and Diabetes, Pre-Diabetes and Cardiovascular Diseases guidelines now include recommendations on the use of rivaroxaban 2.5 mg bid plus aspirin in patients with coronary artery disease (CAD). The Chronic Coronary Syndromes guidelines recommend that the addition of a second antithrombotic drug to aspirin therapy for long-term secondary prevention should be considered in patients with a high risk of ischaemic events and without a high risk of bleeding, and may be considered in patients with a moderately increased risk of ischaemic events and without a high risk of bleeding.

 

You can read the full Chronic Coronary Syndromes, and Diabetes, Pre-Diabetes and Cardiovascular Diseases guidelines online.

CAD sympo

Professors John Eikelboom, Rob Welsh, Keith Fox, Gilles Montalescot and Gabriel Steg discuss the identification of patients suitable for intensified antithrombotic therapy

With new guidelines comes a need for interpretation, and expert faculty were on hand throughout the congress to provide their views on how to apply the guidelines in clinical practice. In opening a satellite symposium, Professor Keith Fox reminded the audience that it was up to them to look at the evidence to make their treatment decisions when it came to applying guidelines. This was followed by a presentation from Professor Gabriel Steg, who referred to recent data from the REACH registry to re-emphasize that, in patients with CAD, the risk of ischaemic events increases at a greater rate than the risk of serious bleeding as the number of risk factors increases.

CAD sympo

2019 ESC guidelines for the management of chronic coronary syndromes
CI, confidence interval; CV, cardiovascular; HF, heart failure; MI, myocardial infarction; PAD, peripheral artery disease

The symposium also included a series of cases to show participants how to identify high-benefit patients, and this theme was continued across a series of Experts on the Spot sessions and practical tutorials. To reflect the heterogeneity of the chronic coronary syndromes population, the cases were diverse. However, all the cases had one thing in common – a high continuing risk of ischaemic events associated with co-morbidities such as diabetes, heart failure and renal impairment or disease in multiple vascular beds – patients identified in both the ESC guidelines and the recent COMPASS risk stratification publication.

CAD sympo

Professors John Eikelboom and Rob Welsh discuss the management of a patient with CAD and diabetes
CAD, coronary artery disease

CLARIFY at ESC 2019

New data from the CLARIFY registry was shown in two oral presentations. CLARIFY is an international observational longitudinal registry that recruited 32,703 patients with CAD and followed them for 5 years. In one analysis, the final follow-up data were presented and reiterated the high continuing risk of ischaemic events in patients with CAD despite guideline-recommended treatment, and the need to do more to protect these patients.

Venous prevention: Changing practice in the management of pulmonary embolism

Acknowledging the high-quality randomized controlled trials that have been conducted since the 2014 guidelines, the 2019 ESC Acute Pulmonary Embolism guidelines for the treatment of PE provide much-needed clarity in several subgroups of patients with VTE.

VTE sympo

Professor Stavros Konstantinides explains how NOACs have changed practice in patients with cancer-associated thrombosis
NOAC, non-vitamin K antagonist oral anticoagulant

In a major change to the guidelines for the treatment of patients with PE and cancer, the NOACs rivaroxaban or edoxaban are now recommended as an alternative to LMWH, with the exception of patients with gastrointestinal cancer (Class IIa). This advance was a key topic of discussion in a satellite symposium. Professor Jeffrey Weitz built on the guidelines and explained that physicians need to consider four things when selecting the patients with cancer-associated thrombosis who should be treated with a NOAC – tumour type, additional risk factors, drug–drug interactions and patient preference.

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Professor Jeffrey Weitz’s four considerations when identifying patients with cancer-associated thrombosis who are suitable for treatment with a NOAC
CYP3A4, cytochrome P450 3A4; GI, gastrointestinal; NOAC, non-vitamin K antagonist oral anticoagulant

Another key update in the 2019 ESC Acute Pulmonary Embolism guidelines was that in patients without cancer who require extended oral anticoagulation after suffering a PE, a reduced dose of the NOACs apixaban (2.5 mg bid) or rivaroxaban (10 mg od) after 6 months of therapeutic anticoagulation (Class IIa, Level A) is recommended. In a lively practical tutorial session, Dr Peter Verhamme and Dr David Jiménez used a series of cases to provide a practical approach to applying this new advice. Both stressed the importance of adequate patient risk assessment and stratification, as per the updates ESC guidelines, to steer decision-making with regard to doses used in extended anticoagulation therapy.

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Dr David Jiménez and Dr Peter Verhamme deliver a practical tutorial on the new PE guidelines
PE, pulmonary embolism

In the practical tutorial, Dr Jiménez also discussed new guidelines on early discharge and home treatment, which now have an upgraded recommendation (Class IIa, Level A) that patients with acute low-risk PE should be considered for early discharge and continuation of treatment at home if proper outpatient care and anticoagulation can be provided. This guideline update was based on supporting evidence from trials such as EINSTEIN PE and HoT-PE. After discussion of these trial results, Dr Jiménez concluded that use of rivaroxaban may simplify outpatient therapy of patients with low-risk PE, with shorter stays assisting in alleviating the burdens associated with hospitalization. Home treatment has the potential to improve patient quality of life, with physicians and patients assured of effective antithrombotic protection from life-changing thromboembolic events.

 

For more details on these guidelines read the full publication.