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to the aortic valve. One has to point out,
though, that the average age in this trial was
nearly 80 years and that the long-term use
over decades in younger patients is not as
defined. Also, the complication profile var-
ies by type of valve and is to be outlined
and considered by patients when deciding
which type of procedure to undergo.
Reference
1. Reardon MJ, Van Mieghem NM, Popma JJ, et al.
N Engl J Med
DOI:10.1056/NEJMoa1700456.
COMPARE-ACUTE
Some 3.5 years ago, the PRAMI trial re-rev-
olutionized our views of non-culprit lesion
intervention in the setting of a STEMI.
1
The mantra had been “culprit only,” but
the PRAMI trial indicated a 75% reduction
in major adverse cardiovascular events
(MACE) with “preventive” stenting of any
lesion greater than 50% in addition to the
culprit lesion. Several other trials revis-
ited this question, but here is another that
stands out: the COMPARE-ACUTE trial.
2
Unique about the trial is that all patients
underwent FFR of any lesion with at least
a 50% diameter stenosis, and about half
of these were significant in both groups;
that is, those who would be allowed to
have additional PCI based on the informa-
tion provided and those who would have
culprit-only intervention despite the infor-
mation provided. Strikingly, even though
no longer based on angiography findings
alone, the MACE reduction with this strategy
was again 75%. Similar to what was found in
PRAMI and any other study that had been
done in between, the main reduction is by
a lower number of future revascularizations,
which is intuitive. However, one may want to
consider the trend of a 50% lower MI rate
with the complete versus the culprit-only
approach. The effect size on this endpoint
was much stronger in PRAMI.
Overall, COMPARE-ACUTE is building
momentum for a complete revascularization
approach in STEMI patients, confirming
the PRAMI trial data. In an era of cost-
confinement, this seems most certainly a
very cost-effective approach. The risks of
multivessel intervention should still not be
forgotten; in this trial, more than two-thirds
of patients had just one more vessel to be
taken care of at the time of STEMI.
References
1. Wald DS, Morris JK, Wald NJ, et al.
N Engl J Med
2013; 369 (12):1115-1123.
2. Smits PC, Abdel-Wahab M, Neumann F-J, et al. N
Engl J Med
DOI: 10.1056/NEJMoa1701067.
EINSTEIN-CHOICE
The EINSTEIN-CHOICE trial compared
two doses of rivaroxaban, 10 mg per
day and rivaroxaban 20 mg per day, and
aspirin 100 mg per day for the duration
of 12 months in patients with a venous
thromboembolic event (VTE; 50% isolated
deep-vein thrombosis, 40% unprovoked)
who had completed recommended 6 to 12
months of treatment and were in equipoise
in regard to extended anticoagulation. The
primary endpoint of symptomatic recur-
rent fatal or nonfatal VTE was reduced by
approximately 70% in both rivaroxaban
groups (1.2% VTE occurrence with 10 mg
and 1.5% with 20 mg vs aspirin at 4.4% VTE
occurrence; HR = 0.26 for 10 mg rivarox-
aban vs aspirin and HR = 0.34 for 20 mg
vs aspirin; P < 0.001 for both comparisons).
1
There was no difference among prespeci-
fied subgroups, including type of prior VTE
event (provoked vs unprovoked) and dura-
tion of prior anticoagulation therapy. There
was a trend toward a higher rate of major
or clinically relevant non-major bleeding
in the rivaroxaban 20 mg per day group
compared with the aspirin group (3.3% vs
2.0%; HR, 1.59; P = 0.08); however, the rates
in individual safety endpoints did not dif-
fer, and the incidence of adverse events
was similar among the groups. While not
reaching statistical significance, there was
a signal for the elderly (>75 years of age)
and fragile in particular to do better with
rivaroxaban 10 mg per day than aspirin in
terms of bleeding.
Thus, in summary, the EINSTEIN-CHOICE
trial showed that patients with VTE ben-
efit from extended anticoagulation, and
rivaroxaban 10 mg per day seems to strike
the best balance in terms of efficacy and
safety compared with aspirin. These results
are also in line with the AMPLIFY-EXT trial
published 4 years ago, which showed that
extended (12-month) anticoagulation with
apixaban 2.5 mg per day or 5 mg per day is
safe and efficacious compared with placebo
for the prevention of recurrent VTE.
2
Obvi-
ously, an open question now is in regard
to the timing of stopping the therapy. Both,
EINSTEIN-CHOICE and AMPLIFY-EXT do
not show a solid plateau in the comparator
groups, suggesting that anticoagulationmay
need to continue beyond the time frame
specified in these trials.
References
1. Weitz JI, Lensing AWA, Prins MH, et al.
N Eng J
Med
DOI:10.1056/NEJMoa1700518.
2. Agnelli G, Buller HR, Cohen A, et al.
N Engl J
Med
2013;368(8):699-708.
Both, EINSTEIN-CHOICE
and AMPLIFY-EXT do
not show a solid plateau
in the comparator
groups, suggesting that
anticoagulation may need
to continue beyond the
time frame specified in
these trials.
ACC 2017
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