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Dr Ben Scirica presents
his top abstracts from
AHA 2016, including
ORION 1, MILANO-PILOT
and ATHENAHF
Benjamin Morgan Scirica MD Associate
Professor of Medicine, Harvard Medical
School and
PracticeUpdate Cardiology
Editorial Board member, recommended the
following papers presented at this year’s
AHA Scientific Sessions.
LBCT.01:
Big trials for big
questions
EUCLID – Effects of ticagrelor
compared with clopidogrel in
patients with peripheral artery
disease. MR Patel, FGR Fowkes,
JS Berger, et al
•
The EUCLID trial was designed
to test if long-term monother-
apy treatment with ticagrelor
would be superior to clopidogrel
at preventing cardiovascular
death, myocardial infarction, or
ischaemic stroke in patients with
symptomatic PAD.
PRECISION – Cardiovascular
outcomes with celecoxib vs
ibuprofen or naproxen: the
PRECISION trial.
SE Nissen
•
This is a very large trial comparing
cardiovascular outcomes with
three commonly used NSAIDs in
high-cardiovascular risk patients.
LBCT.03:
Insights from new
therapeutic trials for lipids
ORION 1 – Inhibition of PCSK9 synthe-
sis via RNA interference: 90 day data
fromOrion-1 – a multi-centre phase-2
randomized controlled trial.
KK Ray,
U Landmesser, LA Leiter, et al
•
ORION1 will provide information
on safety and efficacy of using
RNA interference quarterly or
biannually to target intracellular
PCSK9 production as a means to
lower LDL-C in a large patient
cohort.
GLAGOV – effect of evolocumab
on progression of coronary athero-
sclerosis in statin-treated patients:
a placebo-controlled intravascular
ultrasound trial.
SE Nissen
•
This trial is the first to assess the
effects of a PCSK9 inhibitor on the
regression or progression of coro-
nary atherosclerosis as assessed by
intravascular ultrasound.
MILANO-PILOT – impact of
infusion of an ApoA-I HDL mimetic
on regression of coronary
atherosclerosis in acute coronary
syndrome patients: The MILANO-
PILOT Study.
S Nicholls, S Nissen,
D Kallend, et al
•
This trial was designed to
evaluate whether infusions of a
HDL mimetic containing apia-I
Milano would promote regression
of coronary atherosclerosis.
LBCT.04: Guiding the
momentum to effect HF
outcomes – ironing out the
wrinkles
ATHENA HF – Aldosterone Targeted
NeuroHormonal CombinEd with
Natriuresis TherApy in Heart Failure
(ATHENA-HF) trial.
J Butler, MA
Konstam, M Felker, et al
•
This trial assesses the use of
high-dose spironolactone versus
standard of care in patients with
acute heart failure.
The analysis focused on the 7875 (57%) patients enrolled based
on prior lower extremity revascularisation. Patients could not be
enrolled within 30 days of their most recent revascularisation,
and patients with an indication for dual antiplatelet therapy
were excluded.
The primary efficacy endpoint was a composite of cardiovascular
death, myocardial infarction, or ischaemic stroke. The primary
safety endpoint was major bleeding.
Patients who had undergone prior revascularisation were a
mean age of 66 years, 73% were male, and median baseline
ankle-brachial index was 0.78.
After adjustment for baseline characteristics, patients enrolled
based on prior revascularisation experienced similar rates of the
primary composite endpoint (hazard ratio 1.10, 95%CI 0.98–1.23)
and statistically significantly higher rates of myocardial infarction
(hazard ratio 1.29, 95% CI 1.08–1.55, P = 0.005) and acute limb
ischaemia (hazard ratio 4.23, 95% CI 2.86–6.25, P < 0.001) than
patients enrolled based on ankle-brachial index criteria.
No differences in ticagrelor- versus clopidogrel-treated patients
were observed for the primary efficacy endpoint (11.4% vs
11.3%, hazard ratio 1.01, 95% CI 0.88–1.15); all-cause
mortality (9.2% vs 9.2%, hazard ratio 0.99, 95% CI 0.86–1.15);
acute limb ischaemia (2.5% vs 2.5%; hazard ratio 1.03, 95%
CI 0.78–1.36); or major bleeding (1.9% vs 1.8%; hazard ratio
1.15, 95% CI 0.83–1.59). The median duration of follow-up
was approximately 30 months.
Dr Jones said that after adjustment for baseline characteristics,
patients enrolled based on prior revascularisation for peripheral
artery disease experienced higher rates of myocardial infarction
and acute limb ischaemia with similar composite rates of
cardiovascular death, myocardial infarction, and stroke versus
patients enrolled based on the ankle-brachial index criterion.
No significant differences between ticagrelor and clopidogrel
were observed in reduction of cardiovascular or acute limb events.
The findings suggest that patients with prior revascularisation
have a substantial residual rate of cardiovascular and acute
limb events, despite high adherence to antiplatelet and statin
medications, and require further study.
The findings not only add context to knowledge of antiplatelet
monotherapy after revascularisation for peripheral artery
disease, but they also highlight the need for more trials of
antithrombotic agents after revascularisation.
Specifically, whether patients should be treated with one or two
antiplatelet agents, which agents should be used, the duration
of antiplatelet monotherapy or dual therapy, and whether
antithrombotics that utilise different mechanistic pathways
(for example, P2Y12 receptor antagonists, factor Xa inhibitors)
should be used in isolation or in combination for these complex
patients to reduce their long-term rates of cardiovascular events
and acute limb ischaemia have not been determined.
Finally, while the optimal antiplatelet medication regimen is
being studied and developed, the impact of disease presenta-
tion, anatomic burden of disease, and type of revascularisation
procedures need to be understood.
“While ticagrelor was no more effective in reducing risk than
clopidogrel,” Dr Schuyler Jones said, “we learned valuable in-
formation about this population, specifically, that patients with
a history of lower extremity revascularisation are at higher risk
of acute limb events and cardiovascular events.”
DECEMBER 2016
AHA 2016
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