http://www.theheart.org/editorial-program/1119685.do Key trials presented at the meeting include: AVERROES, SHIFT, ALPHA OMEGA Trial, EINSTEIN DVT, FUTURA OASIS-8, LESSON 1, PLATO genetic substudies,CURE/ACTIVE A, INNOVATE PCI, ATOLL, COPPS, RESPONSE and STAR-HEART

1. ESC 2010 research highlights:
A slideshow presentation

2. ESC 2010 Research Highlights
Key trials presented at the meeting include:
AVERROES: Apixaban yields significant reductions in stroke, no
increased bleeding.
SHIFT: Adding HR-slowing agent ivabradine to HF meds cuts mortality,
hospitalization.
ALPHA OMEGA Trial: n-3 fatty acids fail to reduce cardiovascular events
in post-MI patients.
EINSTEIN DVT: Rivaroxaban almost superior to usual care in treatment of
DVT.
FUTURA OASIS-8: Standard-dose heparin recommended during PCI to
avoid catheter thrombosis with fondaparinux.
LESSON 1: Everolimus bests sirolimus in nonrandomized DES face-off.
PLATO genetic substudies: No need for gene testing in PCI patients.
CURE/ACTIVE A: No effect of loss-of-function clopidogrel gene on event
rates in ACS or AF.
INNOVATE PCI: Elinogrel, a new antiplatelet agent, passes initial hurdles.
ATOLL: Study seen as supporting enoxaparin over standard heparin in
primary PCI.
COPPS: Colchicine halves incidence of postpericardiotomy syndrome.
RESPONSE: Nurse program "reasonably successful" for ACS secondary
prevention.
STAR-HEART: Stem cells associated with improved long-term
hemodynamics and reduced mortality in chronic heart failure

3. AVERROES (Apixaban versus Acetylsalicylic Acid to
Prevent Strokes)
Results: Patients with atrial fibrillation unable to take warfarin
who were treated with the investigational oral factor Xa inhibitor
apixaban (Pfizer/Bristol-Myers Squibb) had a significantly lower
risk of stroke and systemic embolic events compared with
patients treated with aspirin. Importantly, there were no
observed increases in the risk of major bleeding, minor
bleeding, or intracranial hemorrhage, among other end points,
in those treated with apixaban.
"As a proof of principle, it's exciting, because these new drugs
are so selective just on one factor, like factor Xa, whereas
warfarin is much less selective, inhibiting around five factors, so
it makes sense that bleeding tends to be lower in these new
drugs," said Dr Harald Arnesen (Oslo University Hospital,
Norway), the scheduled discussant during the late-breaking
clinical-trials session. "The fact that the [bleeding] risks are
quite similar to aspirin is really quite exciting."
See AVERROES: Apixaban yields significant reductions in
stroke, no increased bleeding for more information.

4. SHIFT (Systolic Heart Failure Treatment with the If Inhibitor
Ivabradine Trial)
Results: Patients with chronic systolic heart failure who added ivabradine (Procoralan, Servier) to the medications they were
already taking showed a significant 18% drop in the composite rate of cardiovascular death or heart-failure hospitalization,
compared with a placebo control group, over a period of about two years.
"This is a very interesting study that tests a novel concept of heart-rate slowing as adjunctive therapy for heart failure," said Dr
Clyde Yancy (Baylor University Medical Center, Dallas, TX), who was not involved with the trial. "But," he added, "sufficient
questions remain regarding who would benefit most from this approach."
See SHIFT: Adding HR-slowing agent ivabradine to HF meds cuts mortality, hospitalization for more information.

5. ALPHA OMEGA
Results: Low-dose supplementation with the n-3 fatty acids
eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), or
plant-derived alpha-linolenic acid (ALA) failed to reduce
cardiovascular events in a large cohort of patients who had
previously had an MI.
The investigators, including trial leader Dr Daan Kromhout
(Wageningen University, the Netherlands), say the negative
findings are likely the result of the optimal medical therapy that
patients in the trial were receiving following their index MI. All
patients were treated with "state-of-the-art antihypertensive,
antithrombotic, and lipid-modifying therapy," and this might
explain the discrepancy with previous studies that suggested n-3
fatty acids, particularly EPA, might be cardioprotective following
MI.
See Alpha Omega Trial: n-3 fatty acids fail to reduce
cardiovascular events in post-MI patients for more information.

6. EINSTEIN DVT
Results: The oral factor Xa inhibitor rivaroxaban (Xarelto,
Bayer/Johnson & Johnson) was found to be noninferior to
standard medical therapy for the treatment of acute symptomatic
deep vein thrombosis (DVT).
Dr Harry R Buller (Academic Medical Center, Amsterdam, the
Netherlands) said that rivaroxaban, an oral factor Xa inhibitor,
was close to demonstrating superiority, although the trial was
designed specifically to demonstrate noninferiority, because "the
standard medical treatment is so good." But although usual care
is effective, it is inconvenient, requiring initial subcutaneous
injections of low-molecular-weight heparin followed by
warfarin treatment, with its own attendant problems.
See Rivaroxaban almost superior to usual care in treatment of
DVT for more information.

7. Cardiologists of Tomorrow at ESC 2010
At this year's Congress, the ESC debuted a special educational
program for cardiologists-in-training, junior cardiologists under
the age of 35, and first-time attendees of the ESC interested in
refreshing their knowledge.
The program was a partnership between the ESC, the 52 ESC
national societies, and 28 ESC affiliate national societies. The
"Cardiologists of Tomorrow" program consisted of 42 sessions
on topics from treatment of hypertension to the genetic aspects
of arrhythmias. The sessions included clinical seminars, special
sessions, and regular symposia.
Prof Fausto Pinto, chair of the ESC Congress Program
Committee, awarded prizes to the following young investigators:
Joanna Hammond from Brussels, Belgium (basic science),
Andrew Ludman from London, UK (clinical science), Alexios
Antonopoulos from Athens, Greece (coronary pathophysiology
and microcirculation), Radoslaw Debiec from Leicester, UK
(population sciences), Sasha Koul from Lund, Sweden
(thrombosis), and Daurice Grossniklaus from Atlanta, GA, who
won the Atie Immink ward in nursing. The state-of-the-art
research awards in heart failure and CAD were awarded to
Katrin Walenta from Homburg/Saar, Germany and Pascal Lim
from Creteuil, France.

8. FUTURA/OASIS-8 (Fondaparinux Trial With UFH During
Revascularization in Acute Coronary Syndromes)
Results: ACS patients undergoing PCI being treated with fondaparinux as the main anticoagulant should receive standard-dose
unfractionated heparin during the procedure to avoid catheter thromboses. Results of the trial showed no major advantages of low-
dose heparin over standard-dose heparin in such patients, and neither dose increased major bleeding when compared with the historical
control group of fondaparinux alone in the OASIS-5 trial.
"The trial has resolved this important issue with fondaparinux. It has shown that we can reduce the problem of catheter thrombosis
without increasing major bleeding. This means that ACS patients on fondaparinux can undergo PCI safely with adjunctive [intravenous]
IV heparin," said Dr Sanjit Jolly (McMaster University, Hamilton, ON), co-lead investigator of the trial, speaking at an ESC press
conference.
See: FUTURA/OASIS-8: Standard-dose heparin recommended during PCI to avoid catheter thrombosis with fondaparinux for more
information.

9. LESSON I
Results: Patients treated with everolimus-eluting stents showed
a 17% relative risk reduction in the primary end point of death,
MI, and TVR, compared with a patient cohort treated with
sirolimus-eluting stents, only narrowly missing statistical
significance (p=0.056). This nonrandomized comparison
provides some of the strongest evidence yet that so-called
"next-generation" drug-eluting stents (DES) may have an edge
in terms of safety and efficacy over the first drug-eluting stent
on the market.
Dr Stephan Windecker (Bern University Hospital, Switzerland),
who presented the results during a hot-line session at the ESC,
noted that the study just missed its primary end point but
showed statistically significant differences in rates of MI and
stent thrombosis. Windecker added that the trial was not
powered to look at the isolated clinical end points found to be
statistically significant in this study, calling the findings
"exploratory only."
See LESSON I: Everolimus bests sirolimus in nonrandomized
DES face-off. for more information.

10. PLATO genetic substudies
Results: Two genetic substudies of the large pivotal trials of the
new antiplatelet agents ticagrelor (Brilinta, AstraZeneca) and
prasugrel (Effient, Lilly) confirm that neither agent seems to be
affected by CYP2C19 loss-of-function alleles, which often indicate
poor outcomes in patients taking clopidogrel. Nor was either drug
affected by another genetic variation, in the ABCB1 gene, which
affects absorption of clopidogrel.
CURE/ACTIVE A Results: Loss-of-function CYP2C19 alleles did
not have any effect with regard to safety or efficacy of clopidogrel
(Plavix, Bristol-Myers Squibb/Sanofi-Aventis) in ACS and AF
patients participating in the CURE and ACTIVE A trials,
respectively, new results show. However, a gain-of-function
CYP2C19 allele was associated with a greater benefit of
clopidogrel in the CURE trial, but not the ACTIVE A trial.
See New PLATO data: No need for gene testing in PCI patients
and CURE ACTIVE: No effect of loss-of-function clopidogrel gene
on event rates in ACS or AF for more information.

11. INNOVATE PCI
Results: Treatment with oral and intravenous (IV) elinogrel
(Novartis), a novel antiplatelet agent, had more rapid antiplatelet
effects than clopidogrel (Plavix, Bristol Myers-Squibb/Sanofi-
Aventis) in acute and chronic phases of therapy for patients
undergoing nonurgent PCI in this phase 2 trial.
"I think, at this point, we're talking about potential advantages,
remembering this is a phase 2 trial, with this drug," said lead
investigator Dr Sunil Rao (Duke University Medical Center, Durham,
NC). "Remember that, based on recent clinical-trial data, there is a
suggestion that greater platelet inhibition is associated with better
ischemic outcomes, but that comes with a cost of increased bleeding
risk. The platelet trials suggest reversible platelet inhibition may
mitigate some of those risks and further improve outcomes. So, in
that sense, elinogrel has properties of reversible inhibition of the
CYP12 receptor, so it might reduce bleeding risk in patients."
See INNOVATE PCI: Elinogrel, a new antiplatelet agent, passes
initial hurdles for more information.

12. ESC 2010 Poster Sessions
3360 Abstracts were selected for poster presentations and 112 for
moderated poster presentations spread over four days at the ESC 2010
Congress.
Topics included: cardiomyopathies, lipids, atrial fibrillation, antithrombotic
agents, genetics and gene therapy, and the effects of culture and society
on heart disease.

13. ATOLL (STEMI Treated With Primary Angioplasty and
Intravenous Lovenox or Unfractionated Heparin)
Results: About 900 patients undergoing PCI for acute STEMI were randomized to receive either IV enoxaparin or
unfractionated heparin (UFH) with the procedure. The two groups' subsequent 30-day rates of a complex composite primary
end point that included death and major bleeding were not significantly different, although the enoxaparin group showed a
favorable trend. Also, the low-molecular-weight heparin (LMWH) roundly outperformed UFH for most of the trial's
prospectively defined secondary end points, which generally were composites of serious clinical events.
Featured discussant Dr Harvey White (Green Lane Hospital, Auckland, New Zealand) lauded ATOLL as "a contemporary
trial—in fact, a supercontemporary trial&mdash in terms of the use of radial access and the high rate of use of evidence-
based therapies. They've shown that enoxaparin is safe and may have an important clinically relevant effect on ischemic
end points in patients undergoing primary PCI." Still, he cautioned, "it missed its primary end point."
See ATOLL seen as supporting enoxaparin over standard heparin in primary PCI for more information.

14. COPPS (Colchicine for the Prevention of the
Postpericardiotomy Syndrome)
Results: The first large-scale double-blind, placebo-controlled
trial to test the efficacy of colchicine to prevent the
development of postpericardiotomy syndrome (PPS) after
heart surgery has shown that the drug is very effective, with
only eight people needing to be treated to prevent one from
developing the syndrome.
See Colchicine halves incidence of postpericardiotomy
syndrome for more information.

15. RESPONSE (Randomized Evaluation of Secondary
Prevention by Outpatient Nurse Specialists)
Results: A program of appointments with outpatient nurse
specialists was "reasonably successful" at lowering
cardiovascular risk on top of high-level usual care in patients
with acute coronary syndrome (ACS) in a randomized trial
conducted in the Netherlands. Patients who saw the nurses
four times over the six months after their event were more
likely to achieve targets for systolic blood pressure, LDL
cholesterol, and a healthy lifestyle, with a relative risk
reduction of 16.9% (p=0.029) in the primary outcome—
calculated 10-year mortality—after one year, compared with
the usual-care group. They did not, however, fare better in
terms of smoking cessation and or lose any more weight than
those getting standard care.
"I consider this trial extremely important," said American
College of Cardiology president Dr Ralph Brindis (Kaiser
Permanente, Oakland, CA), who attended the press
conference on the hot-line sessions. "We have to figure out a
better way of translating our science to the bedside. Here we
have a trial that shows an effective way of better delivering
care with things that we know work."
See Nurse program provides good RESPONSE for ACS
secondary prevention for more information.

16. STAR-heart
Results: The largest clinical trial so far of intracoronary
autologous stem-cell transplantation in patients with chronic
heart failure has shown that such treatment was associated
with multiple hemodynamic and functional benefits as well as a
reduction in mortality, benefits that were maintained out to five
years of follow-up. Results at three months, 12 months, and
five years after bone-marrow-cell therapy showed significant
improvement in left ventricular ejection fraction, cardiac index,
exercise capacity, oxygen uptake, and left ventricular
contractility. Controls, however, showed a deterioration in LV
performance.
"Our study suggests that, when administered as an alternative
or in addition to conventional therapy, bone-marrow-cell
therapy can improve quality of life, increase ventricular
performance, and increase survival. Intracoronary therapy has
been shown to be effective in acute myocardial infarction, and
the STAR-heart study now indicates its efficacy in chronic
heart failure," concluded presenter Dr Bodo-Eckehard
Strauer (Heinrich-Heine University, Düsseldorf, Germany).
See STAR-heart study: Stem cells associated with improved
long-term hemodynamics and reduced mortality in chronic
heart failure for more information.

17. Opinions from ESC
Heartfelt with Dr Melissa Walton-Shirley
STAR-heart study associates stem cells with improved hemodynamics
and reduced mortality; PEARL-HF on reducing hyperkalemia in heart
failure; SHIFT; Alpha Omega; HEBE III; and analysis of top news from
ESC 2010
Novel antiplatelets; optimal heparin dosing in ISAR-REACT 3A;
elinogrel, a new antiplatelet, passes test in INNOVATE PCI; ATOLL;
LESSON-1; ART trial; and analysis of top news from ESC 2010
ANTIPAF: Olmesartan doesn't suppress paroxysmal atrial fib;
AVERROES: Apixaban gives significant reductions in stroke; DANPACE;
FUTURA/OASIS-8; and analysis of top news from ESC 2010
Trials and PIs with Dr Michael Gibson
Heart failure and transplantation with Dr Ileana Piña
Focus on exercise in older men and in women at ESC 2010
Private practice with Dr Seth Bilazarian
Apixaban in AVERROES points the way to excellent alternatives to
warfarin
The Bob Harrington Show
Episode #27: Elinogrel and INNOVATE PCI with Dr Sunil Rao
Click here to view more opinions from ESC 2010

18. ESC Congress 2010: An Overview
Spotlight on Coronary Artery Disease: From Genes to
Outcomes
In an ESC press release, Prof Fausto Pinto, outgoing chair of
the Congress Program Committee, declared the meeting a
great success.
Attendance included: • 22 032 active participants
• 4947 exhibitors
• 571 accompanying persons
• 556 members of the press
The ESC Congress 2011 will be held in Paris on August 27-31,
2011. The spotlight will be: "Controversies in Cardiology."

19. For more information
ESC Coverage on theheart.org
http://www.theheart.org/coverage/esc-2010.do
Medscape ESC 2010
http://www.medscape.com/viewcollection/31520
ESC Congress 2010
http://www.escardio.org/congresses/esc-
2010/Pages/welcome.aspx

20. Credits and disclosures
Contributor Information Journalists:
Shelley Wood
Managing Editor, heartwire Lisa Nainggolan, theheart.org
theheart.org London, UK
Kelowna, BC Disclosure: Lisa Nainggolan has disclosed no relevant financial
Disclosure: Shelley Wood has disclosed no relevant relationships
financial relationships.
Sue Hughes, theheart.org
Steven Rourke London, UK
Manager, Editorial programming Disclosure: Sue Hughes has disclosed no relevant financial
theheart.org relationships.
Montreal, QC
Disclosure: Steven Rourke has disclosed no relevant Reed Miller, theheart.org
financial relationships. Bethesda, MD
Disclosure: Reed Miller has disclosed no relevant financial
relationships.
Michael O'Riordan, theheart.org
Toronto, ON
Disclosure: Michael O'Riordan has disclosed no relevant financial
relationships.
Steve Stiles, theheart.org
Fremont, CA
Disclosure: Steve Stiles has disclosed no relevant financial
relationships.

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