ESC Congress 2017 In Review – Focus on Arrhythmias - 11
ESC Congress 2017
Late-Breaking Science
In Review
Arrhythmias
Results From RE-DUAL PCI
Written by Nicola Parry
Christopher P. Cannon, MD, Harvard Medical School, Baim
Institute for Clinical Research, Boston, Massachusetts,
USA, reported data from the RE-DUAL PCI trial, showing
that dual antithrombotic therapy with dabigatran and a
P2Y12 inhibitor reduced bleeding when compared to triple
therapy with warfarin in patients with atrial fibrillation (AF)
undergoing percutaneous coronary intervention (PCI).
According to Dr Cannon, although triple antithrombotic therapy comprising warfarin plus dual antiplatelet
therapy is standard care after PCI for patients with AF,
this triple combination leaves these individuals at high
risk for bleeding events. The WOEST trial suggested
that removing aspirin from the triple-therapy regimen
could be done safely [Dewilde WJ et al. Lancet. 2013]. Dr
Cannon and colleagues conducted the RE-DUAL PCI trial
to investigate the efficacy and safety of dual therapy with
dabigatran and a P2Y12 inhibitor in AF patients after PCI
[Cannon CP et al. N Engl J Med. 2017].
This multicentre, open-label trial randomised 2,725
patients with AF who had undergone PCI to receive
either triple therapy (warfarin, plus a P2Y12 inhibitor
[clopidogrel or ticagrelor] and aspirin) or dual therapy
(dabigatran [110 mg or 150 mg BID] plus a P2Y12 inhibitor
[clopidogrel or ticagrelor]).
The study's primary endpoint was time to first ISTH
major or clinically relevant nonmajor bleeding (CRNM).
Compared with the triple-therapy regimen, treatment with dabigatran 110 mg with a P2Y12 inhibitor
reduced by almost 50% the incidence of major or CRNM
bleeds at 14 months (15.4% vs 26.9%; HR, 0.52; 95% CI,
0.42 to 0.63, P < .001 for noninferiority, P < .001 for superiority; Figure 1). Dr Cannon noted that this was con-
sistent with an absolute risk reduction (ARR) of 11.5%.
Dual therapy using dabigatran 150 mg was also associated with fewer bleeds (20.2% vs 25.7%; HR, 0.72; 95%
CI, 0.58 to 0.88; P < .001 for noninferiority, P = .002 for
superiority; Figure 1), representing a 5.5% ARR.
Compared with the triple-therapy regimen, both
dual-therapy groups also had lower rates of intracranial
haemorrhage, with a 0.7% ARR (HR, 0.3; 95% CI, 0.08
to 1.07; P = .064) using dabigatran 110 mg, and a 0.9%
ARR (HR, 0.12; 95% CI, 0.02 to 0.98; P = .047) using
dabigatran 150 mg.
The investigators also performed a prespecified analysis of thrombotic events that occurred during the trial,
evaluating the effect of dual versus triple therapy on
the incidence of a composite of death, thromboembolic
events (myocardial infarction, stroke, or systemic embolism), or unplanned revascularisation. Combining the 2
dabigatran dose groups, they found that dual therapy
met the threshold for noninferiority for the composite
endpoint (incidence, 13.7% vs 13.4%; HR, 1.04; 95% CI,
0.84 to 1.29; P = .005 for noninferiority). In the patients
treated with 110-mg dual therapy, the incidence of death,
thromboembolic events, or unplanned revascularisation
was 15.2% versus 13.4% in the triple-therapy group (HR,
1.13; 95% CI, 0.90 to 1.43; P = .30). In the patients treated with 150-mg dual therapy, the incidence was 11.8%
versus 12.8% in the triple-therapy group (HR, 0.89; 95%
CI, 0.67 to 1.19; P = .44).
Dr Cannon concluded that these dabigatran dualtherapy regimens, using doses approved worldwide for
stroke prevention, offer clinicians 2 additional options
for managing AF patients following PCI.
Figure 1. Rates of Major Bleeding or Clinically Relevant Nonmajor Bleeding in RE-DUAL
Probability of Event (%)
35
35
HR, 0.52 (95% CI, 0.42-0.63)
Noninferiority P < .0001
P < .0001
30
HR, 0.72 (95% CI, 0.58-0.88)
Noninferiority P < .0001
P < .002
30
25
25
20
20
15
15
10
Warfarin
triple therapy
10
Warfarin
triple therapy
5
Dabigatran 110 mg
dual therapy
5
Dabigatran 150 mg
dual therapy
0
0
90
180
270
360
450
540
Time to First Event (days)
630
750
0
0
90
180
270
360
450
540
630
750
Time to First Event (days)
From The New England Journal of Medicine, Cannon CP et al, Dual Antithrombotic Therapy with Dabigatran after PCI in Atrial Fibrillation. EPub 28 August 2017.
Copyright © 2017 Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society.
Official Peer-Reviewed Highlights From ESC Congress 2017
11
Table of Contents for the Digital Edition of ESC Congress 2017 In Review – Focus on Arrhythmias
Contents
ESC Congress 2017 In Review – Focus on Arrhythmias - Cover1
ESC Congress 2017 In Review – Focus on Arrhythmias - Cover2
ESC Congress 2017 In Review – Focus on Arrhythmias - 1
ESC Congress 2017 In Review – Focus on Arrhythmias - 2
ESC Congress 2017 In Review – Focus on Arrhythmias - Contents
ESC Congress 2017 In Review – Focus on Arrhythmias - 4
ESC Congress 2017 In Review – Focus on Arrhythmias - 5
ESC Congress 2017 In Review – Focus on Arrhythmias - 6
ESC Congress 2017 In Review – Focus on Arrhythmias - 7
ESC Congress 2017 In Review – Focus on Arrhythmias - 8
ESC Congress 2017 In Review – Focus on Arrhythmias - 9
ESC Congress 2017 In Review – Focus on Arrhythmias - 9A
ESC Congress 2017 In Review – Focus on Arrhythmias - 9B
ESC Congress 2017 In Review – Focus on Arrhythmias - 10
ESC Congress 2017 In Review – Focus on Arrhythmias - 11
ESC Congress 2017 In Review – Focus on Arrhythmias - 12
ESC Congress 2017 In Review – Focus on Arrhythmias - 13
ESC Congress 2017 In Review – Focus on Arrhythmias - 14
ESC Congress 2017 In Review – Focus on Arrhythmias - 15
ESC Congress 2017 In Review – Focus on Arrhythmias - 16
ESC Congress 2017 In Review – Focus on Arrhythmias - 17
ESC Congress 2017 In Review – Focus on Arrhythmias - 18
ESC Congress 2017 In Review – Focus on Arrhythmias - Cover3
ESC Congress 2017 In Review – Focus on Arrhythmias - Cover4
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