Xarelto®
Tailored Protection for
Your Cardio-Vascular Patients1

NEW – INDICATED FOR CAD OR SYMPTOMATIC PAD

Prevention of Atherothrombotic Events in Chronic Coronary or Symptomatic Peripheral Artery Disease

Xarelto is indicated for the prevention of atherothrombotic events in adults with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events.1

COMPASS – a Landmark Study for Patients with Chronic CAD or PAD

Trial design:2-5

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COMPASS trial design
Primary endpoints
  • Efficacy: Major adverse CV events (MACE, defined as the combination of CV death, MI MI
    Myocardial infarction (= MI). This is commonly known as a heart attack. This is usually caused by a blood clot that stops the blood flowing to part of the heart muscle. As a result, the heart muscle becomes damaged.
    and stroke)2-4
  • Safety: Major bleedingd (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)2-4

The trial was stopped early for efficacy after a mean follow up of 23 monthse,2

CAD, coronary artery disease; PAD, peripheral artery disease; MACE, major adverse cardiovascular events; CV, cardiovascular; MI, myocardial infarction; OD, once daily; BID, twice daily; aPatients treated according to local standard of care. bThe Xarelto 5 mg BID arm did not show any significant difference in the primary efficacy endpoint vs aspirin alone.2-4 c≤30 days of the required pre-specified number of events having occurred. dBased on modified ISTH bleeding criteria with a broader definition of major bleeding. eThe planned follow-up period was 3–4 years.5

Xarelto Vascular Dose Plus Aspirin – Improving Standard of Care

Superior reduction in major vascular events2

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COMPASS trial superior reduction in major vascular events

CV, cardiovascular; MI MI
Myocardial infarction (= MI). This is commonly known as a heart attack. This is usually caused by a blood clot that stops the blood flowing to part of the heart muscle. As a result, the heart muscle becomes damaged.
, myocardial infarction; RRR RRR
Relative risk reduction (= RRR). Proportion of the control group experiencing a given outcome minus the proportion of the treatment group experiencing the outcome, divided by the proportion of the control group experiencing the outcome.
, relative risk reduction; OD, once daily; BID, twice daily.

Safety Profile
Xarelto Vascular Dose Plus Aspirin

Generally manageable bleeding, with no significant increase in the most serious types vs aspirin alone2

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Similar rates of the most serious types of bleeding to aspirin alone

Similar rates of the most serious types of bleeding to aspirin alone

 

Safety profile
  • Bleeding rate of 3.1% for Xarelto vascular dose plus aspirin vs 1.9% for aspirin alone (p<0.001)b,c,3-5
  • No significant increase in the most serious types of bleeding (fatal bleeding, ICH ICH
    Intracranial haemorrhage (= ICH). This is bleeding within the skull.
    and critical organ bleeding) vs aspirin alone3-5

ICH, intracranial haemorrhage; RRR RRR
Relative risk reduction (= RRR). Proportion of the control group experiencing a given outcome minus the proportion of the treatment group experiencing the outcome, divided by the proportion of the control group experiencing the outcome.
, relative risk reduction; OD, once daily; BID, twice daily; ISTH, International Society on Thrombosis Thrombosis
Formation of a clot inside a blood vessel.
and Haemostasis. bBased on modified ISTH bleeding criteria with a broader definition of major bleeding. Reported sites of major bleeding included gastrointestinal, intracranial, skin or injection site, and urinary. cIf a participant had more than one event of major bleeding, only the most serious bleeding event was counted in these analyses. dNon-fatal, symptomatic.

COMPASS Explainer Video

The Xarelto COMPASS Trial: Rationale and Results

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