Vascular Adviser Podcast Vascular Adviser Team

How do new insights from the XARENO study impact
treatment options for patients with AF and advanced CKD?

In this episode, Dr Manesh Patel and Dr Peter Rossing expand upon the XARENO 2-year outcomes data presented at the ACC 2023 congress. The experts provide cardiology and endocrinology perspectives into how these results add to the wealth of randomized clinical trial and real-world data to determine the treatment options for patients with AF and advanced CKD.

The views and opinions expressed throughout this podcast are those of the speakers based on their expertise and do not necessarily reflect those of Bayer. The Bayer product rivaroxaban is discussed during this episode.

Rivaroxaban is indicated for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischaemic attack.

Further details:
• The ACC 2023 presentation of the 2-year XARENO data can be accessed here:
https://www.abstractsonline.com/pp8/#!/10674/presentation/19112
• The 1-year results from the XARENO study can be found here
https://www.ahajournals.org/doi/10.1161/circ.142.suppl_3.13927, here
https://www.researchgate.net/profile/Kai-Hahn2/publication/360217368_ACC22_XARENO_Poster_Final/links/6268ee8e8e6d637bd101
b8d0/ACC22-XARENO-Poster-Final.pdf and here
https://www.jacc.org/doi/abs/10.1016/S0735-1097%2822%2901192-5
• The XARENO study design is available here:
https://journals.viamedica.pl/kardiologia_polska/article/view/86346
• Access the ROCKET AF manuscript here:
https://www.nejm.org/doi/full/10.1056/nejmoa1009638
• The 2020 ESC guidelines for AF treatment can be accessed here:
https://www.escardio.org/Guidelines/Clinical-Practice-Guidelines/Atrial-FibrillationManagement
• AF treatment guidelines published by the AHA/ACC/AHS in 2019 can be found here:
230313-XARENO 2 year outcomes podcast shownotes-draft3 4
https://www.ahajournals.org/doi/10.1161/CIR.0000000000000665
• For anticoagulant dosing information, see the European labels for apixaban
(http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-
_Product_Information/human/002148/WC500107728.pdf), dabigatran
(http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-
_Product_Information/human/000829/WC500041059.pdf), edoxaban
(http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-
_Product_Information/human/002629/WC500189045.pdf), rivaroxaban
(https://www.ema.europa.eu/documents/product-information/xarelto-epar-productinformation_en.pdf) and warfarin (https://www.medicines.org.uk/emc/product/3064/smpc)

MA-M_RIV-ALL-1368-2 & MA-M_RIV-ALL-1370-2

This podcast is a follow-up to Bayer’s symposium at ESC 2022, ‘The beginning of the end for NOACs? The extra mile’.

In this episode, Dr Manesh Patel and Professor Rupert Bauersachs expand on the discussions from the symposium, providing further insight into the management of frail patients with AF and VTE. The experts also provide their perspectives on the treatment of paediatric patients with VTE and patients with cancer-associated thrombosis, evaluating the available evidence to guide decision-making for these particularly vulnerable patients.

The views and opinions expressed throughout this podcast are those of the speakers based on their expertise and do not necessarily reflect those of Bayer.

Further details:
• The EINSTEIN programme publications can be found here for EINSTEIN PE (https://www.nejm.org/doi/full/10.1056/NEJMoa1113572), EINSTEIN DVT (https://www.nejm.org/doi/full/10.1056/NEJMoa1007903), EINSTEIN Pooled (https://thrombosisjournal.biomedcentral.com/articles/10.1186/1477-9560-11-21), EINSTEIN CHOICE (https://www.nejm.org/doi/full/10.1056/nejmoa1700518) and EINSTEIN JUNIOR (https://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(19)30219-4/fulltext)
• Real-world evidence published by Craig Coleman on the efficacy and safety of rivaroxaban versus warfarin in frail patients with VTE can be accessed here: https://www.amjmed.com/article/S0002-9343(18)30202-X/fulltext
• The XALIA study publication can be found here: https://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(15)00257-4/fulltext
• The findings from the XANTUS trial are available here: https://academic.oup.com/eurheartj/article/37/14/1145/2466063
• Access the ROCKET AF manuscript here: https://www.nejm.org/doi/full/10.1056/nejmoa1009638
• The elderly subgroup analysis of ROCKET AF can be found here: https://www.ahajournals.org/doi/10.1161/circulationaha.113.005008
• Findings from the SAFIR trial can be accessed here: https://heart.bmj.com/content/107/17/1376
• Find the edoxaban phase II trial paper here: https://www.thieme-connect.com/products/ejournals/abstract/10.1160/TH10-01-0066
• Read the SELECT-D study paper here: https://ascopubs.org/doi/10.1200/JCO.2018.78.8034
• Information on the OSCAR trials can be found here for the UK (https://clinicaltrials.gov/ct2/show/NCT05112666, https://abstracts.isth.org/abstract/comparison-of-effectiveness-and-safety-of-direct-oral-anticoagulant-versus-low-molecular-weight-heparin-treatment-for-venous-thromboembolism-in-patients-with-active-cancer-the-oscar-uk-study/) and the US (https://clinicaltrials.gov/ct2/show/NCT04979780, https://www.sciencedirect.com/science/article/pii/S0006497121040908)
• Details on the Mayo Clinic prospective cohort study are available here: https://www.mayoclinicproceedings.org/article/S0025-6196(21)00435-3/fulltext
• Support for the proportion of patients not receiving anticoagulation can be accessed here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4278389/#CIT0011
• For anticoagulant dosing information, see the European labels for apixaban (http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002148/WC500107728.pdf), dabigatran (http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000829/WC500041059.pdf), edoxaban (http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002629/WC500189045.pdf), rivaroxaban (https://www.ema.europa.eu/documents/product-information/xarelto-epar-product-information_en.pdf) and warfarin (https://www.medicines.org.uk/emc/product/3064/smpc)

Audio: MA-M_RIV-ALL-1236-1
Shownotes: MA-M_RIV-ALL-1237-1

In this episode, Professor Jan Beyer-Westendorf and Professor Rupert Bauersachs discuss
the latest real-world evidence for the extended treatment of patients with venous
thromboembolism (VTE). They focus on data published from the all-comer Dresden NOAC
Registry, which provides important insights on the adherence patterns of patients with VTE
on anticoagulation treatment beyond 12 months. Our experts also discuss the FIRST and
SWIVTER registries, and how their findings highlight the importance of patient preference in
maintaining patient persistence with extended treatment in order for patients to gain the full
benefits of their treatment.
The views and opinions expressed throughout this podcast are those of the speakers based
on their expertise and do not necessarily reflect those of Bayer.

• You can read the most up to date CHEST guidelines here:
https://journal.chestnet.org/article/S0012-3692(21)01507-5/fulltext
• The Dresden NOAC Registry showed high persistence of patients with VTE on
rivaroxaban, these results can be viewed here:
https://www.thrombosisresearch.com/article/S0049-3848(21)00515-6/fulltext
• EINSTEIN CHOICE investigated the extended treatment of VTE patients with
rivaroxaban versus aspirin, results from the trial can be found here:
https://www.nejm.org/doi/full/10.1056/nejmoa1700518
• The FIRST registry is the largest real-world evidence registry for rivaroxaban to date,
read about its findings on treatment adherence here:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8606029/
• Read more about the insights from the SWIVTER registry here: https://www.thiemeconnect.com/products/ejournals/abstract/10.1160/TH16-03-0209
• The EINSTEIN EXTENSION study our experts discuss in this podcast can be found here:
https://www.nejm.org/doi/full/10.1056/nejmoa1007903
Extended treatment VTE podcast-draft1 4
• The pooled results from the EINSTEIN PE and EINSTEIN DVT studies are available
here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3850944/
• For anticoagulant dosing information, see the European labels for apixaban (Eliquis)
(http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-
_Product_Information/human/002148/WC500107728.pdf), dabigatran (Pradaxa)
(http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-
_Product_Information/human/000829/WC500041059.pdf), edoxaban (Lixiana)
(http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-
_Product_Information/human/002629/WC500189045.pdf), rivaroxaban (Xarelto)
(https://www.ema.europa.eu/documents/product-information/xarelto-epar-productinformation_en.pdf) and warfarin (https://www.medicines.org.uk/emc/product/3064/smpc)

Recording approval: PP-XAR-ALL-2638-1
Shownotes approval: PP-XAR-ALL-2639-1

In this podcast, Dr Manesh Patel, Professor Reinhold Kreutz and Dr Andrew Steele discuss the results of the XARENO study and its implications for patients with AF and chronic kidney disease. This group of experts share their insights on how cardiologists and nephrologists can work most effectively together in multi-disciplinary teams to provide optimal care for these patients.
The views and opinions expressed throughout this podcast are those of the speakers based on their expertise and do not necessarily reflect those of Bayer AG.

Further details:
• The paper on the rationale and design of the XARENO study can be found here: https://journals.viamedica.pl/kardiologia_polska/article/view/86346
• The XARENO abstract presented at ACC 2022 is available here: https://www.jacc.org/doi/10.1016/S0735-1097%2822%2901192-5
• The results of XARENO presented at AHA 2020 can be accessed here: https://www.ahajournals.org/doi/10.1161/circ.142.suppl_3.13927
• Further information on the XARENO trial can be found on the clinicaltrials.gov page here: https://clinicaltrials.gov/ct2/show/study/NCT02663076
• The paper on the ANTENNA study can be found here: https://www.sciencedirect.com/science/article/pii/S0167527322001905
• The 2021 ESC guidelines for the diagnosis and management of atrial fibrillation featuring the ABC pathway for AF treatment are available here: https://academic.oup.com/eurheartj/article/42/5/373/5899003
• Find the 2019 AHA/ACC/HRS focused update of the 2014 AHA/ACC/HRS guidelines for the management of patients with atrial fibrillation here: https://www.ahajournals.org/doi/10.1161/CIR.0000000000000665
• The EHRA practical guide on the use of NOACs in patients with atrial fibrillation can be accessed here: https://academic.oup.com/europace/article/23/10/1612/6247378
• For anticoagulant dosing information, see the European labels for apixaban (http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002148/WC500107728.pdf), dabigatran (http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000829/WC500041059.pdf), edoxaban (http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002629/WC500189045.pdf), rivaroxaban (https://www.ema.europa.eu/documents/product-information/xarelto-epar-product-information_en.pdf) and warfarin (https://www.medicines.org.uk/emc/product/3064/smpc) and the Canadian label for rivaroxaban (https://pdf.hres.ca/dpd_pm/00059600.PDF)

Shownotes: MA-M_RIV-ALL-1212-1
Recording: MA-M_RIV-ALL-1205-1

In this episode, Professor Jan Beyer-Westendorf and Dr Cecilia Becattini discuss the treatment of vulnerable patients with venous thromboembolism. In particular, they focus on the treatment of patients who have received the devastating diagnosis of pulmonary embolism. Other specific patient groups are also discussed, including patients who are considered vulnerable and therefore carry a significant additional burden, even beyond the heavy load afforded by a VTE diagnosis. These include frail patients, children and those who are also navigating a cancer diagnosis and treatment. Practical guidance for the treatment of these patients is discussed, based upon a hierarchy of risk and the options available to physicians at each point along the spectrum, from intensive care admission to home treatment.
The views and opinions expressed throughout this podcast are those of the speakers based on their expertise and do not necessarily reflect those of Bayer.

Further details:
• Further details on the HoT-PE study of rivaroxaban for the home treatment of PE can be found here: https://academic.oup.com/eurheartj/article/41/4/509/5497670
• Further details on the EINSTEIN-Junior phase III clinical trial of rivaroxaban for the treatment and prevention of VTE in paediatric patients can be found here: https://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(19)30219-4/fulltext
• An overview of the CALLISTO program of studies of rivaroxaban in patients with cancer-associated thrombosis can be found here: https://onlinelibrary.wiley.com/doi/10.1002/rth2.12327
• Further details on studies within the CALLISTO program can be found through the following links:
– CASSINI: https://www.nejm.org/doi/full/10.1056/NEJMoa1814630
– CASTA-DIVA: https://journal.chestnet.org/article/S0012-3692(21)04079-4/fulltext
– SELECT-D: https://ascopubs.org/doi/10.1200/JCO.2018.78.8034
– COSIMO: https://www.thrombosisresearch.com/article/S0049-3848(21)00381-9/fulltext
• The 2019 European Society of Cardiology guidelines for the diagnosis and management of acute pulmonary embolism, developed in collaboration with the European Respiratory Society, can be found here: https://academic.oup.com/eurheartj/article-lookup/doi/10.1093/eurheartj/ehz405
• The American College of Chest Physicians guidelines for antithrombotic therapy for VTE disease can be found here: https://journal.chestnet.org/article/S0012-3692(15)00335-9/fulltext
• The summary of product characteristics for rivaroxaban can be found here: https://www.medicines.org.uk/emc/product/2793/smpc#gref
• The summary of product characteristics for apixaban can be found here: https://www.medicines.org.uk/emc/product/2878/smpc#gref
• The summary of product characteristics for edoxaban can be found here: https://www.medicines.org.uk/emc/product/6905/smpc#gref
• The summary of product characteristics for dabigatran can be found here: https://www.medicines.org.uk/emc/product/4703/smpc#gref

Recording approval code: PP-XAR-ALL-2606
Shownotes approval code: PP-XAR-ALL-2607

This podcast is a follow-up to Bayer’s symposium at EHRA 2022 ‘What if? Protecting your patients with AF from stroke, no matter their journey.’

In this discussion, Professor John Camm and Professor Keith Fox provide further insight as to why patients with AF undergoing PCI need such close attention when choosing an antithrombotic regimen. They also explore additional considerations for the management of patients with AF undergoing elective PCI. Finally, the experts provide their perspectives on how patients with AF undergoing catheter ablation can be best protected from cardioembolic stroke.

The views and opinions expressed throughout this podcast are those of the speakers based on their expertise and do not necessarily reflect those of Bayer.

Further details:
• Read the 2020 ESC guidelines for the management of atrial fibrillation here:
https://academic.oup.com/eurheartj/article/42/5/373/5899003
• The 2020 ESC guidelines for the management of acute coronary syndromes can be found here: https://academic.oup.com/eurheartj/article/42/14/1289/5898842
• Find the 2019 AHA/ACC/HRS focused update of the 2014 AHA/ACC/HRS guidelines for the management of patients with atrial fibrillation here:
https://www.ahajournals.org/doi/10.1161/CIR.0000000000000665
• The EHRA practical guide on the use of NOACs in patients with atrial fibrillation can be accessed here: https://academic.oup.com/europace/article/23/10/1612/6247378
• The papers for the trials investigating NOACs in patients with AF undergoing PCI can be found here for rivaroxaban (https://www.nejm.org/doi/full/10.1056/nejmoa1611594),
apixaban (https://www.nejm.org/doi/full/10.1056/NEJMoa1817083), edoxaban
(https://www.sciencedirect.com/science/article/abs/pii/S0140673619318720) and dabigatran (https://www.nejm.org/doi/full/10.1056/nejmoa1708454)
• The findings from the Japanese study of rivaroxaban monotherapy versus rivaroxaban plus clopidogrel, the AFIRE trial, is available here:
https://www.nejm.org/doi/full/10.1056/nejmoa1904143
• Data from the COMPASS trial can be accessed here:
https://www.nejm.org/doi/full/10.1056/nejmoa1709118
• For anticoagulant dosing information, see the European labels for apixaban
(http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-
_Product_Information/human/002148/WC500107728.pdf), dabigatran
(http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-
_Product_Information/human/000829/WC500041059.pdf), edoxaban
(http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-
_Product_Information/human/002629/WC500189045.pdf), rivaroxaban
(https://www.ema.europa.eu/documents/product-information/xarelto-epar-productinformation_en.pdf) and warfarin (https://www.medicines.org.uk/emc/product/3064/smpc)
• For antiplatelet dosing information, see the European labels for clopidogrel
(https://www.ema.europa.eu/en/documents/product-information/plavix-epar-productinformation_en.pdf), prasugrel (https://www.ema.europa.eu/en/documents/productinformation/efient-epar-product-information_en.pdf) and ticagrelor
(https://www.ema.europa.eu/en/documents/product-information/brilique-epar-productinformation_en.pdf)
• The European label for pantoprazole can be accessed here:
https://www.ema.europa.eu/en/documents/product-information/pantoloc-control-eparproduct-information_en.pdf

Show notes: MA-M_RIV-ALL-1173-1
Recording: MA-M_RIV-ALL-1172-1