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Clinical Review Report: Rivaroxaban (Xarelto): Bayer Inc. Indication: In combination with 75 mg to 100 mg acetylsalicylic acid, for the prevention of stroke, myocardial infarction, and cardiovascular death, and for the prevention of acute limb ischemia and mortality in patients with coronary artery disease with or without peripheral artery disease [Internet] Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2019 Jan.

Cover of Clinical Review Report: Rivaroxaban (Xarelto)

Clinical Review Report: Rivaroxaban (Xarelto): Bayer Inc. Indication: In combination with 75 mg to 100 mg acetylsalicylic acid, for the prevention of stroke, myocardial infarction, and cardiovascular death, and for the prevention of acute limb ischemia and mortality in patients with coronary artery disease with or without peripheral artery disease [Internet]

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Appendix 5Additional Data

Background

This data comes from a separate publication of subgroup data from COMPASS.14 This paper reported major adverse limb events (MALEs) in COMPASS participants with peripheral arterial disease (PAD) (n = 6,391). These participants could also have coronary artery disease (CAD). The data could not be located in the Clinical Study Report and were only available in the publication.

MALEs were a composite of acute or chronic limb ischemia and major vascular amputations. While the subgroup analysis of participants with PAD was specified in the protocol, the definition of MALEs and the analysis methodology were not found in the protocol. The analysis was not included in the adjustment for multiple comparisons and, therefore, the results should be interpreted with this in mind.

Results

Table 13Major Adverse Limb Events in Participants With PAD

COMPASS
Major Adverse Limb EventsRivaroxaban/ASA (n = 2139)ASA (n = 2123)
N (%)32 (1.5)56 (2.6)
HR (95% CI)0.57 (0.37 to 0.88)
P value0.01

ASA = acetylsalicylic acid; CI = confidence interval; HR = hazard ratio.

Source: Anand 2018.14

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Bookshelf ID: NBK541910
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