ESC Congress 2017 In Review -- Main Edition - 13

ESC Congress 2017

The population was further enriched for risk in that
patients aged < 65 years who had also multivessel coronary disease or at least 2 additional risk factors (diabetes mellitus, smoking, renal dysfunction, heart failure, or
nonlacunar stroke).
The primary outcome was a composite of CV death,
stroke, or MI. Secondary endpoints included the composite of ischaemic stroke, MI, acute limb ischaemia (ALI),
or death from coronary heart disease; the composite of
ischaemic stroke, MI, ALI, or CV death; and death from
any cause. The main safety outcome was a modification
of the ISTH criteria for major bleeding and the net clinical benefit was a composite of the primary outcome and
fatal or critical organ bleeding.
Between March 2013 and May 2016, 27,395 patients
from 602 centres in 33 countries were randomised (1:1:1)
to treatment with rivaroxaban 2.5 mg BID plus aspirin
100 mg QD, rivaroxaban 5 mg BID, or aspirin 100 mg daily. At baseline, patients were a mean age of 68.2 years
(22% women); 91% had CAD and 27% had PAD. The trial
was stopped at the first formal analysis, as overwhelming
efficacy in favour of rivaroxaban plus aspirin was noted.
Mean follow-up was 23 months and maximum follow-up
was 47 months.
Compared with aspirin alone, rivaroxaban 2.5 mg BID
plus aspirin 100 mg QD significantly reduced the composite
rate of CV death, stroke, and MI by 24% (4.1% vs 5.4%; HR,
0.76; 95% CI, 0.66 to 0.86; P ≤ .001). The rivaroxaban 5 mg
BID alone arm did not significantly reduce the primary endpoint (Figure 1). Benefits of the rivaroxaban 2.5 mg BID plus
aspirin arm versus aspirin alone were generally consistent
across the components of the primary endpoint.
The secondary composite outcomes were significantly improved with the combination therapy (all P ≤ .01)
compared with aspirin alone. There was a trend towards

Cumulative Risk of Cardiovascular Death,
Stroke, or Myocardial Infarction

Figure 1. Primary Outcome: Cardiovascular Death, Stroke, or Myocardial
Infarction
Rivaroxaban + aspirin vs aspirin HR, 0.76; 95% CI, 0.66-0.86; P = < .001
Rivaroxaban vs aspirin HR, 0.90; 95% CI, 0.79-1.03; P = .12

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lower mortality with the rivaroxaban 2.5 mg plus aspirin
arm versus aspirin alone (3.4% vs 4.1%; P = .01), however
this did not meet the threshold P value for significance of
.0025.
Both rivaroxaban arms caused more major bleeds than
aspirin alone. The aspirin plus rivaroxaban 2.5 mg arm
increased major bleeding by 70% (3.1% vs 1.9%; HR, 1.70;
95% CI, 1.40 to 2.05; P < .001) while the rivaroxaban only
arm increased major bleeding by 51% (P < .001). Rates of
fatal bleeding or symptomatic intracranial haemorrhage
were low and were not significantly increased with rivaroxaban plus aspirin versus aspirin (HR, 1.23; P = .40); there
was a trend toward an increase with rivaroxaban 5 mg
alone compared with aspirin (HR, 1.59; P = .05). Both rivaroxaban arms increased bleeding leading to transfusion
versus aspirin alone (HR, 1.97; P < .001 for rivaroxaban
2.5 mg; HR, 1.50; P = .03 for rivaroxaban 5 mg).
Overall with rivaroxaban 2.5 mg twice daily added to
aspirin versus aspirin alone over a median of 23 months
there was a 1.3% absolute reduction in the primary
endpoint versus a 1.2% increase in major bleeding. The
prespecified net clinical benefit weighing only fatal or
critical organ bleeding against the primary composite
efficacy outcome was superior for rivaroxaban 2.5 mg
with aspirin compared with aspirin alone (4.7% vs 5.9%;
HR, 0.80; 95% CI, 0.70 to 0.91; P < .001).
The COMPASS trial demonstrated that in high-risk
patients with CAD and/or PAD rivaroxaban 2.5 mg BID
plus aspirin 100 mg QD reduces the composite of CV
death, stroke, or MI compared with aspirin alone while
rivaroxaban 5 mg BID monotherapy does not. Major
bleeding is increased with rivaroxaban with aspirin or
alone but without a significant increase in fatal, intracranial or critical organ bleeding.

Risk Factor Driven Treatment
Is Beneficial in Early Persistent
Atrial Fibrillation and Heart
Failure
Written by Brian Hoyle

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Aspirin
Rivaroxaban
Rivaroxaban + Aspirin

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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.

A therapeutic approach that aggressively treats risk
factors, including lifestyle changes, is feasible and effective in improving and maintaining sinus rhythm in heart
failure (HF) patients in the early stages of persistent
atrial fibrillation (AF).
Findings of the [NCT00877643] were presented
by Isabelle C. Van Gelder, MD, PhD, Netherlands Heart
Institute and the University of Groningen, Groningen,
The Netherlands.
The prospective, randomised, open-label RACE 3 superiority trial conducted at 14 centres in the Netherlands

Official Peer-Reviewed Highlights From ESC Congress 2017

Table of Contents for the Digital Edition of ESC Congress 2017 In Review -- Main Edition