ESC Congress 2017 In Review – Focus on CAD&ACS - 14

Late-Breaking Science

any subgroup, although there was a borderline significantly higher event rate in the heparin versus bivalirudin
group (P = .051) for females.
The investigators concluded that there were no
significant differences between bivalirudin and heparin therapy with respect to mortality, re-infarction, or
major bleeding events in patients with STEMI or NSTEMI
undergoing PCI.

Virtual Histology Imaging Fails
to Detect Benefit of Adding
Evolocumab to Statin Therapy to
Alter Plaque Composition
Written by Phil Vinall

The PCSK9 inhibitor evolocumab lowers LDL-C, induces
plaque regression on intravascular ultrasound (IVUS),
and reduces cardiovascular events in statin-treated
patients with atherosclerotic cardiovascular disease. Its
impact on plaque composition is unknown, however.
The GLAGOV trial [NCT01813422] compared the
effects of evolocumab (420 mg) or placebo administered
monthly for 78 weeks on the progression of coronary
atherosclerosis as measured by serial IVUS in patients
with angiographic coronary artery disease treated with
optimal statin therapy. Stephen J. Nicholls, MBBS, PhD,
South Australian Health and Medical Research Institute,
Adelaide, Australia, presented the results of a prespecified exploratory analysis from the GLAGOV trial that
evaluated the effect of evolocumab on plaque components in the patients who had ultrasound imaging that
enabled virtual histology (VH) analysis.
The substudy comprised 331 patients (evolocumab,
n	 =	 164;	 placebo,	 n	 =	 167).	 Participants	 (>	 70%	 men)	
were a mean age of about 59 years; about 17% had diabetes and about 26% were smokers. Almost 60% of the
patients were on high-intensity statin therapy; the rest
were on a moderate-intensity statin. The primary endpoint was the absolute change in dense calcium volume
from baseline to week 78. Secondary endpoints were
the changes in volume occupied by necrotic, fibrofatty,
and fibrotic components.
Compared with baseline, at week 78 evolocumab
was associated with changes in LDL-C (-62.8%), HDL-C
(+11.6%), triglycerides (-11.5%), and lipoprotein(a) (-22.7%)
that remained significant after adjustment for changes
in the placebo group (P < .001 for each, except HDL-C
P = .02). Using conventional measures of IVUS-derived
plaque burden, compared with baseline, there was a significant benefit for evolocumab combined with a statin
compared with placebo and statin monotherapy in both
percent (-1.20%) and total atheroma volume (-3.6 mm3;
both P < .0001).

14

October 2017

For the primary endpoint of change from baseline
in normalised dense calcium volume based on VH,
there was a statistically significant difference in both
groups compared with baseline; however, the difference
between the 2 treatments was not significant.
On the secondary outcomes, there were significant
reductions from baseline in both fibrofatty and fibrous
volume for both treatment groups, again with no significant between group difference. There was no change in
the size of the necrotic core with either therapy.
When combined with optimal statin therapy, evolocumab produces robust lowering of LDL-C and plaque
regression by conventional IVUS. However, VH imaging
failed to detect any difference between evolocumab
combination therapy and statin monotherapy for individual plaque components. The utility of VH imaging in
drug development to assess the effect of anti-atherosclerotic therapies remains uncertain.

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 had 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 consistent with
an absolute risk reduction (ARR) of 11.5%. Dual therapy
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Table of Contents for the Digital Edition of ESC Congress 2017 In Review – Focus on CAD&ACS

Contents
ESC Congress 2017 In Review – Focus on CAD&ACS - Cover1
ESC Congress 2017 In Review – Focus on CAD&ACS - Cover2
ESC Congress 2017 In Review – Focus on CAD&ACS - 1
ESC Congress 2017 In Review – Focus on CAD&ACS - 2
ESC Congress 2017 In Review – Focus on CAD&ACS - Contents
ESC Congress 2017 In Review – Focus on CAD&ACS - 4
ESC Congress 2017 In Review – Focus on CAD&ACS - 5
ESC Congress 2017 In Review – Focus on CAD&ACS - 6
ESC Congress 2017 In Review – Focus on CAD&ACS - 7
ESC Congress 2017 In Review – Focus on CAD&ACS - 8
ESC Congress 2017 In Review – Focus on CAD&ACS - 9
ESC Congress 2017 In Review – Focus on CAD&ACS - 10
ESC Congress 2017 In Review – Focus on CAD&ACS - 11
ESC Congress 2017 In Review – Focus on CAD&ACS - 11A
ESC Congress 2017 In Review – Focus on CAD&ACS - 11B
ESC Congress 2017 In Review – Focus on CAD&ACS - 11B
ESC Congress 2017 In Review – Focus on CAD&ACS - 11C
ESC Congress 2017 In Review – Focus on CAD&ACS - 12
ESC Congress 2017 In Review – Focus on CAD&ACS - 13
ESC Congress 2017 In Review – Focus on CAD&ACS - 14
ESC Congress 2017 In Review – Focus on CAD&ACS - 15
ESC Congress 2017 In Review – Focus on CAD&ACS - 16
ESC Congress 2017 In Review – Focus on CAD&ACS - 17
ESC Congress 2017 In Review – Focus on CAD&ACS - 18
ESC Congress 2017 In Review – Focus on CAD&ACS - 19
ESC Congress 2017 In Review – Focus on CAD&ACS - 20
ESC Congress 2017 In Review – Focus on CAD&ACS - Cover3
ESC Congress 2017 In Review – Focus on CAD&ACS - Cover4
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