COMPASS trial

XARELTO® 2.5 mg with aspirin* significantly reduced a composite of CV death, MI, and stroke in patients with CAD/PAD5,6

*XARELTO® 2.5 mg twice daily plus aspirin 100 mg once daily.

Primary outcome: major cardiovascular events†

COMPASS trial: primary outcome for major cardiovascular events with XARELTO® (rivaroxaban) 2.5 mg BID + aspirin 100 mg
Secondary outcome:
all-cause mortality‡
HR=0.82 (95% CI: 0.71-0.96) 
XARELTO® 2.5 mg BID
+ aspirin 100 mg QD:

3.4% (313/9152)


vs


Aspirin 100 mg QD:
4.1% (378/9126)
†
Major cardiovascular events were a composite of cardiovascular death, myocardial infarction, and stroke.
‡
Not adjusted for multiplicity.
ARR = absolute risk reduction; BID = twice daily; CAD = coronary artery disease; CI = confidence interval; CV = cardiovascular; HR = hazard ratio; MACE = major adverse cardiovascular events; PAD = peripheral artery disease;
QD = once daily; RRR = relative risk reduction.

COMPASS trial

Safety profile in CAD/PAD1
Proven safety profile
Clinical endpoint

XARELTO® 2.5 mg BID

+ aspirin 100 mg QD

%/year | (n/N)

Placebo

(aspirin 100 mg QD)

%/year | (n/N)

HR

(95% CI)

Notes
Major bleeding*

1.6

(263/9134)

0.9

(144/9107)

1.8

(1.5, 2.3)

arrowMajor bleeding was increased; however, ~97% of patients taking XARELTO® 2.5 mg BID with aspirin 100 mg QD did not experience major bleeding vs 98.4% for placebo1
Fatal bleeding event

<0.1

(12/9134)

<0.1

(8/9107)

1.5

(0.6, 3.7)

arrowSimilar fatal bleeding rates vs aspirin
Symptomatic bleeding in critical organ (nonfatal)

0.3

(58/9134)

0.3

(43/9107)

1.4

(0.9, 2.0)

arrowSimilar critical organ bleeding rates vs aspirin
Bleeding into surgical site requiring reoperation (nonfatal, not in critical organ)

<0.1

(7/9134)

<0.1

(6/9107)

1.2

(0.4, 3.5)

arrowSimilar surgical site bleeding requiring reoperation rates vs aspirin
Bleeding leading to hospitalization (nonfatal, not in critical condition, not requiring reoperation)

1.1

(188/9134)

0.5

(91/9107)

2.1

(1.6, 2.7)

arrowBleeding events leading to hospitalization were increased; however, ~98% of patients taking XARELTO® did not experience 1 of these events vs 99% for placebo5

≤1%

of patients had fatal bleeding, nonfatal ICH, or critical organ bleeding1

*Major bleeding events within each subcategory were counted once per patient, but patients may have contributed events to multiple subcategories. These events occurred during treatment or within 2 days of stopping treatment in the safety analysis set.

BID = twice daily; CAD = coronary artery disease; CI = confidence interval; HR = hazard ratio; ICH = intracranial hemorrhage; ISTH = International Society on Thrombosis and Haemostasis; PAD = peripheral artery disease; QD = once daily.

Dosing

Reducing the risk of major CV events* in patients with CAD

XARELTO® (rivaroxaban) tablet 2.5 mg

2.5 mg

2.5 mg twice daily

With or without food, in combination with aspirin (75 mg-100 mg) once daily

No dose adjustment needed based on CrCl

Tablet shown not actual size.

*Major cardiovascular events were a composite of cardiovascular death, myocardial infarction, and stroke.

CAD = coronary artery disease; CrCl = creatinine clearance; CV = cardiovascular.

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REFERENCES: 1. XARELTO® (prescribing information). Titusville, NJ: Janssen Pharmaceuticals, Inc. 2. Eliquis® [prescribing information]. Princeton, NJ and New York, NY: Bristol-Myers Squibb Company and Pfizer Inc.; 2023. 3. Savaysa® [prescribing information). Basking Ridge, NJ: Daiichi Sankyo, Inc.; 2023. 4. Pradaxa® (prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; 2023. 5. Eikelboom JW, Connolly SJ, Bosch J, et al; COMPASS Investigators. Rivaroxaban with or without aspirin in stable cardiovascular disease. N Engl J Med. 2017;377(14):1319-1330. 6. Online supplement to: Eikelboom JW, Connolly SJ, Bosch J, et al; COMPASS Investigators. Rivaroxaban with or without aspirin in stable cardiovascular disease. N Engl J Med. 2017;377(14):1319-1330.