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“For decades, dietary guidelines have

focused on reducing total fat and saturated

fatty acid intake based on the presump-

tion that replacing saturated fatty acids

with carbohydrate and unsaturated fats will

lower LDL cholesterol and should therefore

reduce cardiovascular events,” she added.

She noted that much of the evidence

supporting this approach has been from

studies of Western populations character-

ized by nutritional excess.

Dr. Dehghan concluded, “PURE provided a

unique opportunity to study the impact of

diet on total mortality and cardiovascular

disease in diverse settings, some in which

overnutrition is common and others where

undernutrition is of greater concern.”

Results of PURE also showed that even rel-

atively moderate intake of fruit, vegetables,

and legumes, such as beans and lentils,

may lower risk of cardiovascular disease

and death.

“To our knowledge, this was the first

study to report on the associations of fruit,

vegetable, and legume intake with cardio-

vascular disease risk in countries at varying

economic levels and from different regions.

Previous research, and many dietary

guidelines in North America and Europe,

recommended daily intake of these foods

ranging from 400 to 800 g per day, but this

is unaffordable for many people in low- to

middle-income countries,” Dr. Mente said.

Dr. Mente and colleagues assessed asso-

ciations between fruit, vegetable, and

legume consumption at baseline and risk

of cardiovascular disease and mortality

after a median of 7.4 years of follow-up.

Looking at dietary components sepa-

rately, benefits were attributable to fruit and

legumes, with vegetable intake not signifi-

cantly associated with improved outcomes.

Specifically, compared with fewer than

three servings of fruit per week, more than

three daily was associated with an

18% reduced risk in noncardiovas-

cular mortality (hazard ratio 0.82:

95% confidence interval 0.70–0.97;

P = .0008), and 19% reduction in

total mortality (hazard ratio 0.81;

95% confidence interval 0.72–0.93;

P < .0001).

Regarding legumes, higher con-

sumption was associated with

significant reduction in both non-

cardiovascular mortality and total

mortality risk.

Finally, comparing vegetable

preparation, the study showed a

trend toward lower risk of cardio-

vascular disease and death with

raw vs cooked vegetable intake

“but raw vegetables are rarely

eaten in South Asia, Africa, and

Southeast Asia,” said Dr. Mente.

“Since dietary guidelines do not

differentiate between the benefits

of raw vs cooked vegetables, our

results indicated that recommenda-

tions should emphasize raw over

cooked vegetables.”

Dr. Mente concluded that the

findings “were robust, globally

applicable, and provided evidence

to inform nutrition policies. Many peo-

ple worldwide don’t consume an optimal

amount of fruit, vegetables, and legumes.

The PURE data added to substantial evi-

dence from many studies and extended

them globally.”

PracticeUpdate Editorial Team

apixaban vs warfarin with heparin in anti-

coagulation-naïve (<48 h of anticoagulation

therapy) patients scheduled for elective

cardioversion of predominantly new-on-

set non-valvular atrial fibrillation.

The study included 1500 patients with atrial

fibrillation who were randomized to apix-

aban or parenteral heparin with warfarin.

Apixaban was administered orally at a dose

of 5 mg twice a day (or 2.5 mg twice a

day when two of the following conditions

were met: age ≥80 years, weight ≤60 kg,

or serum creatinine ≥1.5 mg/dL).

At the discretion of the local investigator,

patients could also receive an initial 10 mg

or 5 mg loading dose of apixaban (for study

doses of 5 mg and 2.5 mg, respectively) if

cardioversion was immediate.

Rates of stroke, systemic embolism, death,

major bleeding, and clinically relevant non-

major bleeding were compared between

the two groups.

Patients treated with apixaban suffered

fewer strokes and similar bleeding to those

receiving usual care. No strokes occurred

in the 753 patients treated with apixaban vs

six strokes in the 747 patients who received

usual care (P = .01). No systemic embolic

events occurred in either group.

Major bleeds occurred in three and six

patients in the apixaban and usual care

groups, respectively. Clinically significant

nonmajor bleeding occurred in 11 and 13

patients, respectively. Two deaths occurred

in the apixaban group and one in the hep-

arin/warfarin group.

Of 753 patients in the apixaban group,

342 received a loading dose. No strokes

or systemic embolic events, one death,

one major bleed, and four clinically rel-

evant nonmajor bleeds occurred in this

subgroup.

The researchers noted that like the

other prospective cardioversion studies,

EMANATE was underpowered. However,

they concluded that their findings “support

the use of apixaban in patients with AFib

undergoing cardioversion.”

Jens Cosedis Nielsen, MD, PhD, of Aarhus

University, Aarhus, Denmark commented,

“EMANATE should be considered an

exploratory, not a conclusive trial. Conduct-

ing a 50,000-patient randomized clinical

trial to conclude noninferiority or superior-

ity of one oral anticoagulant is unrealistic.”

He added, “Randomized trials compar-

ing novel oral anticoagulants vs vitamin K

antagonists provide us with important data

on outcomes around direct current cardio-

version for both treatment regimens. I think

EMANATE was well conducted, and rand-

omized trials are the best instrument we

have to compare treatments.”

PracticeUpdate Editorial Team

© ESC Congress 2017 – European Society of Cardiology

ESC 2017

21

VOL. 2 • NO. 2 • 2017