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Xarelto^® Tailored Protection for Your Cardio-Vascular Patients1

Prevention of atherothrombotic events in chronic CAD

Xarelto is indicated for the prevention of atherothrombotic events in adults with coronary artery disease (CAD) at high risk of ischaemic events.

It’s time to give your high-risk patients a new standard of care

Despite current guideline-recommended secondary prevention therapies, patients with chronic CAD remain at high residual risk of major CV events2-5.

Patients with chronic CAD remain at high residual risk of major CV events

CAD, coronary disease; CV, cardiovascular; MI , myocardial infarction.
* Based on an incidence rate of 5–10% in those treated with aspirin alone or clopidogrel plus aspirin.

High ischaemic risk defined as:11

Diffuse multivessel CAD with at least one of the following:

Diabetes mellitus requiring medication
Recurrent MI
PAD
CKD with eGFR 15-59 ml/min/1.73 m2

CAD, coronary artery disease; CKD, chronic kidney disease; eGFR, estimated glomerular filtration rate; ESC, European Society of Cardiology; MI, myocardial infarction; PAD, peripheral artery disease.

COMPASS – a landmark study for patients with chronic CAD or PAD*

Trial stopped early for efficacy^‡,7

Trial design:6-9

Primary endpoints

Efficacy: Major adverse CV events (MACE, defined as the combination of CV death, MI and stroke)6-8
Safety: Major bleeding^† (including fatal bleeding, symptomatic bleeding into a critical organ or area, surgical site bleeding leading to reoperation, or any bleed leading to hospital visit or admission)6-8

The trial was stopped early for efficacy after a mean follow up of 23 months^‡,6

BID, twice daily; CAD, coronary artery disease; CV, cardiovascular; ISTH, International Society on Thrombosis and Haemostasis; MACE, major adverse cardiovascular events; MI , myocardial infarction; OD, once daily; PAD, peripheral artery disease.
* Xarelto 5mg BID was not approved for clinical use. ^†Based on modified ISTH bleeding criteria with a broader definition of major bleeding. ^‡The planned follow-up period was 3–4 years.

Isn’t life the outcome that matters most for your patients with CAD?

Superior reduction in all-cause mortality and MACE vs aspirin alone7

Xarelto vascular dose plus aspirin for patients with chronic CAD vs aspirin alone

* Primary endpoint; included cardiovascular death, myocardial infarction and stroke.

† Secondary endpoint in CAD population.

^‡RRR was calculated as 1-HR

Protect your patients with a reassuring safety profile

Generally manageable bleeding, with no significant increase in the most serious types vs aspirin alone6

BID, twice daily; CAD, coronary artery disease; ICH , intracranial haemorrhage; OD, once daily. ^¶Proportion of patients experiencing bleeding events were calculated as percentages from the number of events and the number of patients in each treatment group. * Primary safety endpoint. Based on a modified version of the ISTH bleeding criteria10 with a broader definition for major bleeding events defined as fatal bleeding, symptomatic bleeding into a critical organ or area (e.g. intracranial), surgical site bleeding requiring reoperation or bleeding events requiring hospital admission with or without an overnight stay. Reported sites of major bleeding included gastrointestinal, intracranial, skin or injection site, and urinary. ^†If a participant had more than one event of major bleeding, only the most serious bleeding event was counted in these analyses. ^‡Non-fatal, symptomatic.

All about the COMPASS trial

The Xarelto COMPASS Trial: Rationale and results

PP-XAR-ALL-1790-1

References

Xarelto (rivaroxaban) Summary of Product Characteristics. Xarelto (rivaroxaban) Summary of Product Characteristics. Return to content
Cholesterol Treatment Trialists’ (CTT) Collaboration, et al. Lancet. 2015;385:1397–1405 Cholesterol Treatment Trialists’ (CTT) Collaboration, et al. Lancet. 2015;385:1397–1405 Return to content
The Heart Outcomes Prevention Evaluation Study Investigators, et al. N Engl J Med. 2000;342:145–153 The Heart Outcomes Prevention Evaluation Study Investigators, et al. N Engl J Med. 2000;342:145–153 Return to content
Marso SP, et al. N Engl J Med. 2016;375:311–322. Marso SP, et al. N Engl J Med. 2016;375:311–322. Return to content
Bhatt DL, et al. J Am Coll Cardiol. 2007;49:1982–1928. Bhatt DL, et al. J Am Coll Cardiol. 2007;49:1982–1928. Return to content
Eikelboom JW, et al. N Engl J Med. 2017;377:1319–1330. Eikelboom JW, et al. N Engl J Med. 2017;377:1319–1330. Return to content
Connolly SJ, et al. Lancet. 2018;391:205–218. Connolly SJ, et al. Lancet. 2018;391:205–218. Return to content
Anand SS, et al. Lancet. 2018;391:219–229. Anand SS, et al. Lancet. 2018;391:219–229. Return to content
Bosch J, et al. Can J Cardiol. 2017;33:1027–1035. Bosch J, et al. Can J Cardiol. 2017;33:1027–1035. Return to content
Schulman S, et al. J Thromb Haemost. 2005;3:692–694. Return to content
Knuuti J, et al. Eur Heart J. 2019;ehz425. doi:10.1093/eurheartj/ehz425 Return to content

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Xarelto^® Tailored Protection for Your Cardio-Vascular Patients1

Prevention of atherothrombotic events in chronic CAD