ESC Congress 2017 In Review -- Main Edition - 21

ESC Congress 2017

These data suggest that future guidelines should
consider lower LDL-C levels than are currently recommended for patients with atherosclerotic CVD, patients
and healthcare providers should be reassured that very
low LDLs levels are safe, and laboratories should not
consider a very low LDL-C abnormal.

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 2725
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).

In Review

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 consistent 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
40

40

HR, 0.52 (95% CI, 0.42-0.63)
Noninferiority P < .0001
P < .0001

Probability of Event (%)

35

HR, 0.72 (95% CI, 0.58-0.88)
Noninferiority P < .0001
P < .002

35

30

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

21



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

Contents
ESC Congress 2017 In Review -- Main Edition - Cover1
ESC Congress 2017 In Review -- Main Edition - Cover2
ESC Congress 2017 In Review -- Main Edition - 1
ESC Congress 2017 In Review -- Main Edition - 2
ESC Congress 2017 In Review -- Main Edition - Contents
ESC Congress 2017 In Review -- Main Edition - 4
ESC Congress 2017 In Review -- Main Edition - 5
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ESC Congress 2017 In Review -- Main Edition - 15
ESC Congress 2017 In Review -- Main Edition - 15A
ESC Congress 2017 In Review -- Main Edition - 15B
ESC Congress 2017 In Review -- Main Edition - 15C
ESC Congress 2017 In Review -- Main Edition - 15D
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ESC Congress 2017 In Review -- Main Edition - Cover3
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