ESC Focus on Interventions & PC - 11C
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first formal interim analysis due to overwhelming efficacy
in favour of rivaroxaban plus aspirin that exceeded the
prespecified stopping boundary. The mean follow-up
was 23 months; maximum was 47 months. Follow-up
was 99.8% complete.
The primary outcome of CV death, stroke, or MI
occurred in 4.1% of patients assigned to vascular dose
2.5 mg BID rivaroxaban plus aspirin (HR vs aspirin-only
0.76; 95% CI, 0.66 to 0.86; P < .0001); 4.9% of those
receiving rivaroxaban alone (HR vs aspirin-only 0.90;
95% CI, 0.79 to 1.03; P = .12); and 5.4% of participants
in the aspirin-only arm (Figure 3). On the individual components, for the combination therapy, there was a consistent benefit for all three components with a 22% relative risk reduction in CV death (P = .02), 42% relative
risk reduction in stroke (P < .0001), and 14% relative risk
reduction in MI (P = NS). The 5-mg dose of rivaroxaban
alone had no additional benefit over aspirin on any of
the individual outcomes (CV death (-4%), stroke (-18%),
and MI (-11%; all P = NS).
Figure 3. COMPASS Primary Composite Outcome (Cardiovascular
Death, Stroke, Myocardial Infarction)
Rivaroroxaban + Aspirin vs Aspirin HR, 0.76, 95% CI, 0.66 to 0.86, P = < .0001
Rivaroroxaban vs Aspirin HR, 0.90, 95% CI, 0.79 to 1.03, P = .12
Cumulative Hazard Rate
0.10
Aspirin
0.08
Rivaroxaban
Rivaroxaban
+ Aspirin
0.06
0.04
0.02
0.0
0
1
Years
2
3
From The New England Journal of Medicine, Eikelboom JW et al, Rivaroxaban
with or without Aspirin in Stable Cardiovascular Disease, EPub 28 August 2017.
Copyright © 2017 Massachusetts Medical Society. Reprinted with permission
from Massachusetts Medical Society.
Secondary outcomes for the comparison of vascular
dose 2.5 mg BID rivaroxaban plus aspirin with aspirin
alone were significantly reduced for 1) the composite of
CHD death, ischaemic stroke, MI, and acute limb ischaemia
(P < .001); 2) the composite of CV death, ischaemic stroke,
MI, or acute limb ischaemia (P < .001), and 3) death from
any cause (P = .01).
In general major bleeding rates were low, and as
expected there were significantly (P < .0001) more ISTH
major bleeds (both definitions) in patients treated with
the combined therapy of vascular dose 2.5 mg BID riva-
roxaban plus aspirin compared with aspirin alone (3.1
vs 1.9% COMPASS definition, 2.3 vs 1.3% standard ISTH
definition; Table 1), however importantly there were no
significant increases in fatal (0.2 vs 0.1 %), intracranial
(both 0.2%), or critical organ bleeding (0.5 vs 0.3%).
The prespecified net clinical benefit for events with irreversible harm (composite of CV death, stroke, MI, fatal
bleeding, or symptomatic bleeding into a critical organ)
was reduced by 20% with vascular dose 2.5 mg BID
rivaroxaban plus aspirin compared to aspirin alone (HR,
0.80; 95% CI, 0.70 to 0.91; P < .001).
Table 1. Bleeding Event Comparison: ISTH COMPASS and Standard ISTH
Rivaroxaban +
Aspirin
n = 9,152
Aspirin
n = 9,126
n (%)
n (%)
HR
(95% CI)
ISTH major COMPASS
288
(3.1%)
179
(1.9%)
1.70
(1.40-2.05)
< .0001
ISTH major
206
(2.3%)
116
(1.3%)
1.78
(1.41-2.23)
< .0001
Event
Rivaroxaban +
Aspirin vs Aspirin
P
Serious adverse events were reported by 7.9% of the
participants in the rivaroxaban plus aspirin group, 7.7%
in the rivaroxaban-alone group, and 7.3% in the aspirinalone group. The findings for rivaroxaban plus aspirin
on both the primary outcome and on major bleeding
were consistent among subgroups defined according to
age, sex, geographic region, race or ethnic group, body
weight, renal function, and history of CV risk factors.
In summary, the dual pathway inhibition of rivaroxaban with the vascular does of 2.5 mg BID plus aspirin 100
mg QD, on top of effective secondary therapy, reduces
CV death, stroke, and MI. There is an increase in major
bleeding but without a significant increase in fatal,
intracranial, or critical organ bleeding. Importantly, the
dual pathway inhibition combination therapy provides
a significant net clinical benefit as well as a reduction
in all-cause mortality. Conversely, there is no significant
benefit of rivaroxaban alone. If used in 10% of persons
with chronic CAD or PAD patients worldwide, the combination dose of rivaroxaban and aspirin has the potential to prevent about 100,000 deaths and 200,000 to
300,000 vascular events each year, When the results
of the COMPASS trial are compared with other prevention approaches (lipid lowering, blood pressure lowering, and ACE inhibition) the effects of a dual inhibition
therapy of vascular dose 2.5 mg BID rivaroxaban plus
aspirin appears to be very impressive (Table 2), particularly as the benefits of the combination of rivaroxaban
and aspirin were on top of already proven therapies.
This peer-reviewed article was based on scientific-clinical content presented at the European Society of Cardiology (ESC) Congress 2017. The content of this article
was entirely developed by Content Ed Net Medicom, and the opinions expressed herein do not necessarily represent those of the European Society of Cardiology, nor
of Bayer AG. The development of this article was supported by Bayer AG. This material is intended for educational purposes. G.MA.GM.XA.10.2017.1852
Table of Contents for the Digital Edition of ESC Focus on Interventions & PC
Contents
ESC Focus on Interventions & PC - Cover1
ESC Focus on Interventions & PC - Cover2
ESC Focus on Interventions & PC - 1
ESC Focus on Interventions & PC - 2
ESC Focus on Interventions & PC - Contents
ESC Focus on Interventions & PC - 4
ESC Focus on Interventions & PC - 5
ESC Focus on Interventions & PC - 6
ESC Focus on Interventions & PC - 7
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ESC Focus on Interventions & PC - 9
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ESC Focus on Interventions & PC - 11
ESC Focus on Interventions & PC - 11A
ESC Focus on Interventions & PC - 11B
ESC Focus on Interventions & PC - 11C
ESC Focus on Interventions & PC - 11D
ESC Focus on Interventions & PC - 12
ESC Focus on Interventions & PC - 13
ESC Focus on Interventions & PC - 14
ESC Focus on Interventions & PC - 15
ESC Focus on Interventions & PC - 16
ESC Focus on Interventions & PC - 17
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ESC Focus on Interventions & PC - 19
ESC Focus on Interventions & PC - 20
ESC Focus on Interventions & PC - Cover3
ESC Focus on Interventions & PC - Cover4
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