ESC Congress 2017 In Review – Focus on Arrhythmias - 8

Late-Breaking Clinical Trials

Figure 1. Primary Outcome: OAC Status Over 1 Year
100

Proportion of Patients on Oral Anticoagulation (%)

[NCT02082548] indicating that a customised, multilevel
educational intervention, with appropriate monitoring
and follow-up, increases the use of OAC in patients with
AF, compared with usual care.
IMPACT-AF [Vinereanu D et al. Lancet. 2017] is a
prospective, cluster-randomised, controlled trial in
adult patients with AF, a CHA2DS2-VASc score ≥ 2, and
no absolute contraindication for OAC. Clusters (48
sites; 5 middle-income countries) were randomised in
a 1:1 ratio to receive a quality-improvement educational
intervention (interventional group) or usual care (control group). The educational component targeted the
patient and their family as well as health care providers. A monitoring and feedback component was developed to identify patients not being treated with OAC
and review opportunities for them to start/restart medication and to identify patients were are at high risk for
not staying on medications and intervene to prevent
discontinuation.
The diagnosis of AF was confirmed by a 12-lead ECG
and/or rhythm strip, or reports of 2 ECGs 2 weeks apart
showing AF. Patients with a mechanical prosthetic valve
were excluded as were those who were clinically unstable, had a life expectancy of < 6 months, were unable
to provide consent or to have 1 year of follow-up, or
had an absolute contraindication to OAC. The primary
outcome was the change in the proportion of patients
treated with OAC from baseline to 1 year. Secondary
clinical outcomes were death, stroke, and bleeding.
A total of 2,281 participants (1,187 in the intervention group; 1,094 controls) were enrolled. Patients were
a mean age of 70 years, 47% were women, and the
mean CHA2DS2-VASc score was 3.6. At baseline, 34%
of patients were not on an OAC; 78% of these were on
antiplatelet agents. The 3 main reasons for not being
on baseline anticoagulants were patient preference or
refusal (26%), physician determination that the risks
outweighed the benefits (15%), and concomitant antiplatelet therapy (13%). At 12 months there was a 9.1%
absolute greater increase in OAC use in the intervention
group (Figure 1).

Intervention group
Control group

90
80
70
60
50
40
30

Change from baseline to 1 year of 12% in the intervention group and 3% in the
control group, 1-year adjusted odds ratio 3.28 (95% CI, 1.67-6.44; P = .0002)

20
10
0

Intervention group
Control group

Baseline
68% (804/1184)
64% (703/1092)

6 Months
79% (934/1184)
67% (734/1092)

12 Months
80% (943/1184)
67% (732/1092)

Reprinted from Lancet. Vinereanu D et al. A multifaceted intervention to
improve treatment with oral anticoagulants in atrial fibrillation (IMPACT-AF):
an international, cluster-randomised trial. doi: 10.1016/S0140-6736(17)32165-7.
Copyright 2017. With permission from Elsevier.

The results were consistent across subgroups and
particularly important for patients who were on aspirin
at baseline (OR, 5.07; 95% CI, 2.09 to 12.28; P = .01).
Among patients who were not on OAC at baseline, 48%
of those in the intervention group were on OAC at 1 year,
compared with 18% in the control group (OR, 4.60; 95%
CI, 2.20 to 9.63; P < .0001). There were no differences in
the secondary outcomes of mortality, major bleeding,
clinical relevant nonmajor bleeding, or the composite of
stroke, systemic embolism, and major bleeding. A nominally significant decrease was noted in stroke (HR/OR,
0.48; 95% CI, 0.23 to 0.99; P = .043); however, the study
was not powered for this outcome.
In this study, a customised, multifaceted, and multilevel intervention involving education of patients with
AF and their providers, with regular monitoring and
feedback, resulted in a significant increase in the proportion of patients treated with OACs and a favourable
trend in stroke reduction.

Sign up to receive My ESC News

Don't miss the key dates and deadlines
for all ESC scientific meetings
https://escol.escardio.org/MyESC

8

October 2017

medicom-publishers.com/mcr
https://escol.escardio.org/MyESC http://www.medicom-publishers.com/mcr
Table of Contents for the Digital Edition of ESC Congress 2017 In Review – Focus on Arrhythmias
