ESC Focus on Interventions & PC - 11B

the incidence of CV death, MI, or stroke was highest
among patients with prior history of ischaemic events,
intermediate among patients with chronic atherosclerosis without a history of an ischaemic event, and lowest
in those with risk factors only.7 Event rates increase with
the number of symptomatic arterial disease locations
and with polyvascular disease.8 The REACH registry
also identified that, among individuals with diabetes,
the risk of a CV event increases in the presence of arterial disease and a history of prior events.9
Data from many sources indicate that there are
major differences between the populations included
in clinical trials and those participating in registries,
leaving clinicians at times sceptical about the applicability of the results in their own practice. Randomised
clinical trials (RCTs) recruit specific groups of patients
with defined characteristics, administer therapy in a
controlled condition, and monitor predefined outcomes
within limited time periods, conditions that are often
opposite those in real-world clinical situations. On the
other hand, registries often recruit a wider range of
patients, and therapies are administered in clinical practice according to current guidelines and local practices.
Longitudinal registries offer additional benefits as they
can monitor a variety of outcomes, and, over extended
periods of time, provide insight into the natural history of the patient population and disease, and identify
putative links between factors and patient outcomes.10-12
These differences can and often do affect outcomes, eg,
patients ineligible for RCTs have been shown to have
significantly worse mortality outcomes compared with
RCT participants (Figure 2).11
Figure 2. Randomised Clinical Trial Enrolment Eligibility in New
GRACE Study
RCT participants: 11,3%
RCT-eligible patients: 55.1%
RCT-ineligible patients: 33.6%
n = 8,469

Mortality Rate (%)

12
P = .001

11.4

8
7.1

P = .001

4
3.6

7.7

4.8
3.0

0
In-hospital Mortality

Post-discharge Mortality

RCT, randomised controlled trial.
Adapted from Steg P et al. Arch Int Med. 2007;167:68-73.

Role for Oral Anticoagulation in Chronic CAD
Patients
Despite success with aspirin, statins, angiotensin modulators, and β-blockers for CV prevention in CAD patients,
as many of 5% of patients remain unprotected,7 thus
there is a compelling need for secondary prevention
strategies. Rivaroxaban is a selective direct factor Xa
inhibitor that has been shown to reduce stroke and systemic embolism in patients with atrial fibrillation13 and
to reduce CV events and mortality in patients post ACS.14
John W. Eikelboom, MD, McMaster University,
Hamilton, Ontario, Canada, presented the primary results
from the COMPASS trial,15,16 a double-blind superiority
trial designed to determine the effect of rivaroxaban on
the incidence of CV death, stroke, or MI in patients with
chronic CAD and/or PADs when compared with aspirin
alone. CAD was defined as an MI within the past 20 years,
multivessel coronary disease, or prior multivessel PCI
or CABG.16 If < 65 years of age, patients with CAD were
required to have documentation of atherosclerosis involving at least 2 vascular beds or to have at least 2 additional
risk factors (current smoking, diabetes mellitus, estimated glomerular filtration rate < 60 mL/min, heart failure, or
non-lacunar ischaemic stroke ≥ 1 month earlier).
After screening and a run-in period (patients
received rivaroxaban placebo BID and 100 mg aspirin
QD), patients were randomly assigned to receive (1:1:1
ratio) rivaroxaban 2.5 mg BID plus 100 mg aspirin QD,
rivaroxaban 5 mg BID, or aspirin 100 mg QD. Twicedaily dosing was chosen to conform to the ATLAS study
design14 and to maintain constant drug levels over 24
hours. The primary outcome was the composite of CV
death, stroke, or MI. Secondary endpoints included
the composite of coronary heart disease (CHD) death,
ischaemic stroke, MI, acute limb ischaemia; CV death,
ischaemic stroke, MI, or acute limb ischaemia; mortality from any cause. The primary safety outcome was a
modification of the ISTH criteria17 for major bleeding
and included fatal bleeding, symptomatic bleeding in a
critical organ, bleeding into the surgical site requiring
reoperation, and bleeding leading to hospitalisation or
presentation to an acute care facility. These latter criteria were a modification to the standard ISTH recommended by regulators.
COMPASS was conducted in 602 centres in 33 countries.15 Participants were a mean age of 68 years; 22%
were women. All patients were receiving treatment with
statins, angiotensin-converting enzyme (ACE) inhibitors,
and/or β-blockers. Lipid-lowering agents were used by
90% of participants and ACE inhibitors or angiotensinreceptor blockers by 71%. About 91% of the participants
had CAD; 27% had PAD. The trial was stopped after the



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
ESC Focus on Interventions & PC - 8
ESC Focus on Interventions & PC - 9
ESC Focus on Interventions & PC - 10
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
ESC Focus on Interventions & PC - 18
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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