The ESC 2012 congress in Munich presented key trials, revealing significant findings in cardiovascular research, such as the recommendation to drop aspirin for stent patients on oral anticoagulants, and the lack of survival benefit from intra-aortic balloon pumps in acute myocardial infarction. Other notable studies included the neutral performance of prasugrel in high-risk ACS patients and promising data on the MitraClip for mitral regurgitation. Additionally, lifestyle factors related to income and the importance of timely care in STEMI management were emphasized.

1. ESC 2012 research highlights:
A slideshow presentation

2. ESC 2012 Research Highlights
he European Society of Cardiology (ESC) 2012 Congress
took place in Munich, Germany from August 25 through August
29, 2012.
Key trials presented at the sessions include:
WOEST: Drop aspirin in stent patients on oral anticoagulants
ALTITUDE: Details on why the trial was stopped, including the
role of ischemic stroke
FAME II: FFR-guided PCI reduces urgent reinterventions, but
does not change mortality, MI
TRILOGY ACS: No win for prasugrel in high-risk patients with
ACS who are medically managed without revascularization
ACCESS EU: Encouraging registry data on the MitraClip
PURE: Healthy lifestyle factors and diet linked with income
GARY: TAVI in-hospital death, stroke rates stay low even as
use climbs
IABP SHOCK II: No survival benefit of balloon pump in AMI
with shock
PARAMOUNT: Dual-action agent shows promise in preserved-
EF heart failure
DeFACTO: Results encouraging for "virtual" FFR despite
missing target

3. WOEST
Drop aspirin in stent patients on oral anticoagulants
Results: Patients on oral anticoagulant therapy undergoing stenting
should be treated with clopidogrel but not aspirin, according to
results reported at the ESC 2012. The study showed a large
reduction in overall TIMI bleeding in patients receiving dual therapy
with oral anticoagulants and clopidogrel compared with those
receiving triple therapy including aspirin. And efficacy did not seem to
be compromised. If anything, there appeared to be lower rates of
ischemic events and a significant reduction in all-cause mortality.
"This is a huge deal," said Dr David Holmes (Mayo Clinic,
Rochester, MN). "How to treat AF patients undergoing stenting is a
huge clinical problem. These results have incredibly important clinical
implications. They are going to change guidelines overnight."
See: WOEST: Drop aspirin in stent patients on oral anticoagulants

4. ALTITUDE
Increase in ischemic stroke played role in decision to stop trial
Results: New data from the trial with the direct renin inhibitor
aliskiren (Tekturna, Novartis) in diabetic patients were released at
the ESC 2012, shedding more light on why the trial was halted
prematurely. The trial, which was studying the effects of aliskiren on
top of ACE-inhibitor or angiotensin-receptor-blocker (ARB) therapy in
diabetic patients with renal disease (glomerular filtration rate <60
mL/min per 1.73 m2 or microalbuminuria), was stopped late last year
by the data and safety monitoring board. The reason given was no
apparent benefit and an increase in adverse events, including
nonfatal stroke, renal complications, hyperkalemia, and hypotension.
Dr Hans-Henrik Parving (University of Copenhagen, Denmark) said
an increase in ischemic stroke was "prominent" in the decision to stop
the trial. At the time the decision was made, the increase in stroke
was significant in the aliskiren group, but as more data have come in,
this finding is no longer statistically significant, although they still
show a strong signal.
"There was a 25% relative increase in stroke risk in the aliskiren group, which is a warning signal that there could be harm
here, but it could also be a chance finding," said Parving. He stressed that an increased risk of stroke is converse to what
would be expected with a drug that lowers blood pressure and has not been seen in any studies of the drug in
hypertension. "It is a very peculiar finding. It is certainly unique to have a blood-pressure–lowering medication that
increases stroke risk."
See: ALTITUDE: New data on why trial halted

5. FAME II
FFR-guided PCI reduces urgent reinterventions, but does
not change mortality, MI
Results: Stable patients who got a stent to treat a functionally
significant coronary lesion were less likely to need an urgent
reintervention than those treated with medical therapy alone.
However, all the other outcomes, including mortality, were the
same with either therapy, so the significance of the trial's
findings remains controversial. The trial was stopped last
winter—over the objections of some outside observers—after
an interim analysis clearly showed that patients randomized to
PCI were much less likely to need an urgent revascularization
than patients randomized to optimal medical therapy.
Although FAME II did not show any mortality or MI benefit for PCI among stable coronary disease patients, the difference
in the need for urgent revascularizations is an important benefit, insists lead investigator Dr Bernard De Bruyne (OLV
Clinic, Aalst, Belgium). All of the urgent revascularizations were performed in patients fulfilling the criteria for acute
coronary syndrome, either with acute MI, ECG evidence of ischemia, or clear unstable angina. De Bruyne also pointed out
that a landmark analysis showed that PCI patients were more likely to die or have an MI than the medical-therapy-only
patients within the first week after randomization, but this trend reversed after eight days, "suggesting that over time, we
might witness the emergence of a significant difference."
See: FAME II: FFR-guided PCI reduces urgent reinterventions, but not change mortality, MI

6. TRILOGY ACS
No win for prasugrel (over clopidogrel) in high-risk patients
with ACS who are medically managed without
revascularization
Results: In one of the few studies to focus on high-risk patients
with acute coronary syndrome (ACS) who are medically
managed without revascularization, the newer antiplatelet agent
prasugrel (Effient, Lilly/Daiichi-Sanyo) has failed to show a
reduction in major cardiovascular events compared with
clopidogrel.
"This trial does not suggest a priori that prasugrel should be
used for medically managed patients, because the results are
neutral," said senior author Dr Magnus Ohman (Duke Clinical
Research Institute). But, he says, there was a surprising twist.
The study was a median of 17 months in length, longer than
most previous trials in ACS, he noted, and "the most striking
thing is that there appears to be a time-dependent treatment
effect."
See: No win for prasugrel in TRILOGY ACS

7. ACCESS EU
Encouraging registry data on MitraClip
Results: Encouraging new results with the MitraClip (Abbott,
Abbott Park, IL) in patients with mitral regurgitation who are
unsuitable for surgery have been presented from the largest
registry yet with the product. The new data come from the
ACCESS-EU registry, which included 567 patients from four
European countries (Denmark, Switzerland, Italy, and
Germany). There was a high implant success rate (99.6%), low
rate of procedural events, and meaningful improvements in
NYHA class, MR grade, quality of life, and walking distance
reported in this elderly, symptomatic, high-risk population with
multiple comorbidities.
"In expert hands, MitraClip is feasible and has an acceptable procedural risk in patients with comorbidities, but the word
'expert' needs to be reiterated," said designated discussant of the study Dr Simon Ray (Academic Health Science Centre,
Manchester, UK). He stressed that the procedure should be done only to improve symptoms. "There is no evidence that it
improves mortality, and there is no point improving MR grade if there is no symptomatic improvement. And as 25% to 35%
of patients derive little or no symptomatic benefit, patient selection is a key issue."
See: ACCESS EU: Encouraging registry data on MitraClip

8. PURE
Healthy lifestyle factors and diet linked with income
Results: In this newest analysis, energy from total fat, saturated fats,
and protein increased almost linearly with increasing incomes.
Carbohydrate intake, on the other hand, made up approximately 65%
of energy from diets in poor nations, with the percentage declining in
wealthier nations. The consumption of fruits and vegetables
increased among nations with a higher gross domestic product (GDP)
and wealth index, but this was offset by an increase in the amount of
energy obtained from total and saturated fats, as well as from protein.
In terms of physical activity, the researchers observed that the
amount of recreational physical activity increased with increasing
GDP and wealth, but this increase was offset by a reduction in the
amount of obligatory physical activity, such as activity required for
physical labor. Overall, the net result was a reduction of
approximately 2000 METS/minute/week, or 2.7 hours of brisk walking
every day, among countries with higher incomes.
Dr Salim Yusuf (McMaster University, Hamilton, ON), the lead researcher of the PURE study, said the study, which
describes an "epidemiological transition," might help shift global food policies so that countries subsidize the production of
fruits and vegetables rather than meat and dairy. In addition, the study highlights an insufficient policy approach when it
comes to increasing physical-activity levels.
See: Healthy lifestyle factors and diet linked with income: PURE

9. GARY
TAVI in-hospital death, stroke rates stay low even as use climbs
Results: Data collected in 2011 for the German Aortic Valve Registry (GARY) suggest that several forms of
transcatheter aortic-valve implantation (TAVI) were being used primarily in high-risk patients, just as the guidelines
recommend, researchers concluded at ESC 2012.
Although the in-hospital rate of cerebrovascular events was lowest for conventional surgery in absolute terms, it wasn't
significantly higher in the TAVI groups and stayed fairly low for those patients, "in the 3.5% range," said Dr Christian W
Hamm (Kerckhoff Heart and Thorax Centre, Bad Nauheim, Germany). Nor was the risk significant between the two main
categories of TAVI based on the catheter approach, transfemoral and transapical.
See: GARY: TAVI in-hospital death, stroke rates stay low even as use climbs

10. IABP SHOCK II
No survival benefit of balloon pump in AMI with shock
Results: Use of an intra-aortic balloon pump (IABP) offered no
mortality benefits at 30 days in the 600-patient IABP SHOCK II trial,
according the trial results presented in a hot-line session at ESC
2012. While use of the pump may make PCI safer by improving left
ventricular unloading, this did not translate into any survival benefit or
give a boost to any of the secondary end points in the study,
investigators observed.
"We were really surprised by the results," said Dr Holger Thiele
(University of Leipzig, Germany). "We thought we'd at least find
something positive in the secondary end points. Our assumption was
that the trial would be positive, but we have to live with the results.
That's why we need randomized trials."
See: IABP SHOCK II: No survival benefit of balloon pump in AMI with
shock

11. PARAMOUNT
Dual-action agent shows promise in preserved-EF heart
failure
Results: In a randomized comparison, in a phase 2 study of the
angiotensin-receptor/neprilysin inhibitor (ARNI) LCZ696
(Novartis) vs the angiotensin-receptor blocker (ARB) valsartan,
levels of a heart-failure severity biomarker dropped significantly
in patients with heart failure and preserved ejection fraction
(HF-PEF) who received the newer agent for 12 weeks,
compared with those who received the ARB. Systolic blood
pressure fell significantly more in patients receiving LCZ696.
And the drug was associated with significant improvements in
left atrial size and volume and in NYHA functional class at 36
weeks.
"LCZ696 was effective for the primary [natriuretic-peptide] end point in every single one of the subgroups tested," said
lead investigator, Dr Scott D Solomon (Brigham and Women's Hospital, Boston, MA). The subgroup analysis broke
patients out by age, normal vs elevated systolic blood pressure, low vs preserved left ventricular ejection fraction, with vs
without atrial fibrillation or poor renal function, and with vs without a prior HF admission. "But there was one subgroup in
which [LCZ696] was more effective." There was a significant interaction in patients with diabetes, added Solomon. "It
appeared to be even more efficacious in that subgroup, even though it was effective in every subgroup."
See: PARAMOUNT phase 2 study: Dual-action agent shows promise in preserved-EF heart failure

12. New European STEMI guidelines emphasize
care coordination
Summary: Authors of the new European Society of Cardiology (ESC)
guidelines for the management of patients with acute ST-elevation MI
(STEMI) hope their recommendations spur efforts to improve the speed
and efficiency of STEMI care in Europe.
The new guidelines are "much more demanding [than the 2008 guidelines]
in terms of delays," said Dr Gabriel Steg, chair of the task force that wrote
the new recommendations. The new standard for time from medical
contact to ECG is 10 minutes, and "the fact that you use primary PCI
should not lead to complacency about the delays. You should target 60
minutes." Two hours is the limit of acceptable delay for a patient
transferred from a non-PCI center to a PCI center, but the target should be
90 minutes, Steg said. If PCI within two hours of presentation appears to
be impossible, then fibrinolysis should be administered within 30 minutes.
See: New European STEMI guidelines emphasize care coordination

13. DeFACTO
Results encouraging for "virtual" FFR despite missing target
Results: Noninvasive fractional flow reserve calculated from
computed tomography angiography (FFRCT) did not achieve the
prespecified target for diagnostic accuracy in the Determination of
Fractional Flow Reserve by Anatomic Computed Tomographic
Angiography (DeFACTO) trial. Nevertheless, investigators are
optimistic that FFRCT can become an important tool for efficiently
identifying high-grade stenoses and determining the hemodynamic
significance of lesions.
In an editorial on the study, Dr Manesh Patel (Duke University,
Durham, NC) writes that FFRCT "represents a novel and important
innovation, with the possibility not only to diagnose but also to help
direct invasive treatment." Because FFRCT demonstrated only
"modest" specificity in DeFACTO, "at first glance, readers of the study
may consider FFRCT technology to be limited based on the results
presented," Patel acknowledges. "However, this would be a naive
conclusion, likely based on the published diagnostic performance of
noninvasive tests compared only with invasive angiography."
See: DeFACTO results encouraging for "virtual" FFR despite missing
target

14. For more information
Complete ESC 2012 coverage on
theheart.org
ESC Congress 2012
European Society of Cardiology

15. Credits and disclosures
Editor: Journalists:
Shelley Wood Sue Hughes, theheart.org
Managing Editor, heartwire London, UK
theheart.org Disclosure: Sue Hughes has disclosed no
Kelowna, BC relevant financial relationships.
Disclosure: Shelley Wood has disclosed
no relevant financial relationships. Reed Miller, theheart.org
State College, PA
Contributors:
Disclosure: Reed Miller has disclosed no
Steven Rourke
relevant financial relationships.
Editorial Director
theheart.org
Montreal, QC
Lisa Nainggolan, theheart.org
Disclosure: Steven Rourke has London, UK
disclosed no relevant financial Disclosure: Lisa Nainggolan has disclosed
relationships. no relevant financial relationships.
Maria Turner Michael O'Riordan, theheart.org
Montreal, QC Toronto, ON
Disclosure: Maria Turner has disclosed Disclosure: Michael O'Riordan has
no relevant financial relationships. disclosed no relevant financial
relationships.
Steve Stiles, theheart.org
Fremont, CA
Disclosure: Steve Stiles has disclosed no
relevant financial relationships.

16. More slideshows
EuroPCR 2012 research highlights
HRS 2012 research highlights
ACC 2012 research highlights

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