http://www.theheart.org/editorial-program/1156073.do The American Heart Association (AHA) 2010 Scientific Sessions took place in Chicago. Key trials presented at the sessions include: ADVANCE,RAFT,QRS EMPHASIS-HF,ASCEND HF,ROCKET AF,CLOSURE I,GRAVITAS,P-OM3,BASKET-PROVE,DEFINE,SYMPLICITY HTN,ASCOT CRP and ACT.

1. AHA 2010 research highlights:
A slideshow presentation

2. AHA 2010 Research Highlights
The American Heart Association (AHA) 2010 Scientific Sessions took
place in Chicago, IL, November 13-17, 2010.
Key trials presented at the sessions include:
ADVANCE: New LVAD equivalent to HeartMate II, nonrandomized study
shows
RAFT: CRT shows survival benefit for class 2 and 3 HF patients with low
EF and wide QRS
EMPHASIS-HF: Eplerenone shows large benefits in milder heart failure
ASCEND HF: Nesiritide safe but of limited dyspnea benefit in acute HF
ROCKET AF: Rivaroxaban noninferior to warfarin, but superiority
analyses at odds
CLOSURE I: No overall benefit, no reduction in stroke or TIA with PFO
closure
GRAVITAS: No benefit of doubling dose in clopidogrel nonresponders
P-OM3: Omega-3 PUFA caps don't suppress paroxysmal AF in randomized trial
BASKET-PROVE: DES as safe as bare-metal stents in larger coronary arteries, with less TVR
DEFINE: Large effects on LDL and HDL cholesterol with CETP inhibitor anacetrapib
SYMPLICITY HTN: Catheter-based renal denervation reduces BP in patients with resistant hypertension?
ASCOT CRP: Analysis fuels debate over JUPITER-based CRP indication for statins
ACT: No benefit of N-acetylcysteine to reduce contrast-induced nephropathy

3. ADVANCE (Evaluation of the HeartWare Left Ventricular Assist
Device for the Treatment of Advanced Heart Failure)
Results: A novel left ventricular assist device (LVAD) developed
by a small company called HeartWare (Framingham, MA) is a
viable alternative to the only other widely used LVAD,
Thoratec's HeartMate II, as a bridge to heart transplant,
according to a new multicenter trial carried out in the US. The
new device showed noninferiority when compared with patients
in the INTERMACS national registry, most of whom had
received the HeartMate II device.
"The early results show this is at least as good as the other
available devices, and we hope this will translate into clinical
benefit, but this is only the beginning. Adverse reactions have
been a major problem that has dogged the application of
LVADs," said Sir Magdi Yacoub (Harefield Hospital, Middlesex,
UK), discussant of the trial at the AHA.
See ADVANCE: New LVAD equivalent to HeartMate II,
nonrandomized study shows for more information.

4. RAFT (Resynchronization/Defibrillation for Ambulatory Heart
Failure Trial)
Results: Cardiac resynchronization therapy (CRT) provided a
survival benefit beyond that of implantable cardioverter
defibrillator (ICD) therapy alone in patients with moderate heart-
failure symptoms, a wide QRS complex, and left ventricular
systolic dysfunction.
"This is a pretty important finding across a wide spectrum of
patients. It will likely lead to revisions in the guidelines and
changes in physician practice patterns, with more eligible
patients being treated and benefiting from this important
therapy," said Dr Gregg Fonarow (University of California, Los
Angeles).
See CRT is a lifeRAFT for class 2 and 3 HF patients with low
EF and wide QRS for more information.

5. EMPHASIS-HF
(A Comparison of Outcomes in Patients in New York Heart Association (NYHA) Class II Heart Failure When Treated With
Eplerenone or Placebo in Addition to Standard Heart Failure Medicines)
Results: The aldosterone antagonist eplerenone (Inspra, Pfizer) produced large reductions in both the risk of death and the
risk of hospitalization compared with placebo in patients with systolic heart failure and mild symptoms.
"Before we recommend expanding the population to receive aldosterone antagonists, we need to learn how to use them
without causing life-threatening hyperkalemia. This may be particularly true for patients with reduced renal function, diabetes,
and advanced age," said the discussant of the study, Dr Lynne Warner Stevenson (Brigham and Women's Hospital,
Boston, MA).
See EMPHASIS-HF: Eplerenone shows large benefits in milder heart failure for more information.

6. ASCEND HF (A Study Testing the Effectiveness of Nesiritide in
Patients With Acute Decompensated Heart Failure)
Results: The IV vasodilator nesiritide (Natrecor, Scios/Johnson &
Johnson), a mass-production version of a native natriuretic peptide,
appears to be safe for use in acute decompensated heart failure but
does not seem to have much more of an effect against acute dyspnea
than conventional diuretics and vasodilators, both of which are less
expensive.
"We constantly put drugs on the market without doing the right
outcome trials. If this outcome trial had been done earlier, clinicians
and patients would have had a much better idea of the potentially very
limited role of this treatment, but they also would have known that it
was not harmful," said chair of the ASCEND-HF executive committee,
Dr Robert Califf (Duke Clinical Research Institute, Durham, NC),
speaking at a press conference at the AHA.
See ASCEND-HF: Nesiritide safe but of limited dyspnea benefit in
acute HF for more information.

7. AHA/ASA Distinguished scientists 2010
Every year, the AHA recognizes a select group of prominent
scientists whose contributions to research have advanced the
understanding of cardiovascular disease and stroke.
Those named as 2010 AHA/ASA Distinguished Scientists
include: Martin Chalfie, PhD, FAHA (Columbia University, New
York, NY), Harlan M Krumholz, MD, SM, FAHA (Yale
University School of Medicine, New Haven, CT), Michael H
Criqui, MD, MPH, FAHA (University of California, San Diego
School of Medicine, La Jolla, CA), and Helen H Hobbs, MD,
FAHA (Howard Hughes Medical Institute, Chevy Chase, MD).
Dr Hobbs gave the 2010 Distinguished Scientist Lecture entitled
"Genetics and Cardiovascular Disease: Are We Getting to the
Heart of the Matter?"

8. ROCKET AF
(Randomized, Double-Blind Study Comparing Once-Daily Oral
Rivaroxaban With Adjusted-Dose Oral Warfarin for the
Prevention of Stroke in Subjects With Non-Valvular Atrial
Fibrillation)
Results: The new oral factor Xa inhibitor rivaroxaban (Xarelto,
Bayer/Johnson & Johnson) was noninferior to dose-adjusted
warfarin with regard to all-cause stroke and non—central
nervous system (CNS) embolism, but the question of superiority
over warfarin is less clear. In the intention-to-treat superiority
analysis, investigators failed to show the drug had an
advantage, statistically, over warfarin for the prevention of
thromboembolic events in patients with nonvalvular atrial
fibrillation. In an on-treatment analysis addressing the
superiority question, however, rivaroxaban significantly reduced
the risk of stroke or non-CNS embolization by 21% compared
with warfarin.
"If you take away only the conclusion of noninferiority, that's a step up," said Dr Douglas Zipes (Krannert Institute of
Cardiology, Indianapolis, IN) speaking with heartwire. "Warfarin is a very difficult drug to use. Patients don't like the
repeated INR checks, and it's very difficult to maintain control. I have several patients with INRs all over the map, so to
have another substitute for that is welcome. However, the on-treatment analysis shows superiority over warfarin, and while
that's not the gold standard—call it the silver standard—I'm very impressed with the results."
See Off orbit? ROCKET AF: Rivaroxaban noninferior to warfarin, but superiority analyses at odds for more information.

9. CLOSURE I
Results: There were no differences in the primary end point of
stroke or TIA at two years, all-cause mortality at 30 days, and
neurological mortality between 31 days and two years for
patients randomized to patent foramen ovale (PFO) closure
using the STARFlex closure device (NMT Medical) as well as
six months of aspirin and clopidogrel (and an additional 18
months of aspirin) compared with patients who received best
medical therapy—aspirin or warfarin or a combination.
"It is now clear that the selection of patients for PFO closure
should be refined, and we cannot now consider closing PFO in
all patients who have stroke of unknown cause. The term
cryptogenic strokes is probably unnecessarily cryptic to many
physicians and patients . . . too vague," said trial discussant Dr
Pierre Amarenco (Bichat Hospital, Paris, France).
See CLOSURE I: No overall benefit, no reduction in stroke or
TIA with PFO closure
for more information.

10. GRAVITAS (Gauging Responsiveness With A VerifyNow
Assay-Impact On Thrombosis And Safety)
Results: Patients receiving drug-eluting stents who showed high
residual platelet activity, according to platelet-function tests with the
VerifyNow assay, fared no better on a double-dose of clopidogrel
than patients who received the regular clopidogrel dose.
"In post-PCI patients with low-risk clinical presentations, a
treatment strategy of high-dose clopidogrel for high residual
reactivity on platelet-function testing is not warranted," concluded
lead investigator Dr Matthew Price (Scripps Clinic, La Jolla, CA),
presenting the results to the media at the AHA 2010 Scientific
Sessions.
See GRAVITAS: No benefit of doubling dose in clopidogrel
nonresponders for more information.

11. P-OM3
(Efficacy and Safety of Prescription Omega-3-Acid Ethyl Esters
for the Prevention of Recurrent Symptomatic Atrial Fibrillation)
Results: Taking prescription-only omega-3 polyunsaturated
fatty-acid (PUFA) capsules (Lovaza, GlaxoSmithKline), even at
the fairly high dose of 4 g/day for six months, didn't cut the risk
of recurrence of symptomatic paroxysmal atrial fibrillation (AF).
There was, however, "a reduction in average ventricular rate
during the first AF recurrence, a reduction in triglyceride levels
at week 24 that did not occur with placebo, and increased blood
levels of the omega-3 fish oils eicosapentaenoic acid and
docosahexaenoic acid compared with placebo patients,"
according to the study's authors.
"Many of our patients in fact do use fish-oil products, in various doses and in various preparations, in hope of preventing
several cardiovascular end points. And there clearly has been equipoise in the area of atrial fibrillation, with as many
studies producing positive as those producing negative results," said lead investigator Dr Peter R Kowey (Lankenau
Institute for Medical Research, Wynnewood, PA). The current study, he said, "is actually the first large randomized trial of
this medication in a nonsurgical population."
See See Omega-3 PUFA caps don't suppress paroxysmal AF in randomized trial for more information.

12. Poster sessions
A total of 2103 posters were presented at the AHA 2010 Scientific Sessions.
The eight poster winners were:
Nuclear Cardiology and Outcomes, Incremental Value of Noninvasive Cardiac
Imaging in Risk Prediction: Results from the SPARC Study, presented by Marcelo
DiCarli
Body Composition and Mortality in Patients With Coronary Heart Disease - The
"Obesity Paradox," presented by Carl Lavie
Hypoxia Inducible Factor-1a Dependent miR-210 is a Critical Regulator of Paracrine
Activity in Preconditioned Mesenchymal Stem Cells for Angiogenic Growth Factor
Expression, presented by Shazia Durrani
Efficacy and Potency of Class 1 Antiarrhythmic Drugs for Suppression of Ca2+ Waves in Permeabilized Calsequestrin Null Myocytes,
presented by Eleonora Savio Galimberti
The Relationship of Rotors to Scar Border Zones and Dominant Frequency Domains in Human Ventricular Fibrillation, presented by
Stephane Masse
Vegetation Size Does Not Affect Stroke Risk in Infective Endocarditis After 5 Days of Effective Antimicrobial Therapy: An Analysis From the
International Collaboration on Endocarditis-Prospective Cohort Study (ICE-PCS), presented by Stuart Dickerman
The Endovascular Stent Graft Raises Vascular Stiffness and Changes Cardiac Structure within a Very Short Term, presented by Yasuharu
Takeda
Health Economics in the Platelet inhibition and Patient Outcomes (PLATO) Randomized Trial: Report on Within Trial Resource Use
Patterns, presented by Magnus Janzon

13. BASKET-PROVE
Results: Patients needing a coronary stent 3.0 mm in diameter
or larger were randomized to either a first-generation sirolimus-
eluting stent (Cypher Select, Cordis), a bare-metal cobalt-
chromium stent (Vision, Abbott), or a second-generation
everolimus-eluting stent (Xience V, Abbott Vascular). All patients
were prescribed aspirin and clopidogrel for at least one year
postimplant. The rates of the primary end point, a composite of
death from cardiac causes or nonfatal MI at two years, were
statistically similar for all three groups. There were no significant
differences in the rates of late events or the rates of death, MI,
or stent thrombosis, but there was a significant difference in
non-MI TVR rates between the DES patients and bare-metal-
stent patients.
"[I]n contemporaneous stenting of large coronary arteries, late
safety problems with drug-eluting stents could not be confirmed,
and there was even a trend in the opposite direction," explained
study investigator Dr Christoph Kaiser (University Hospital
Basel, Switzerland).
See BASKET-PROVE: DES as safe as bare-metal stents in
larger coronary arteries, with less TVR for more information.

14. DEFINE (Determining the Efficacy and Tolerability of
CETP Inhibition with Anacetrapib)
Results: The new cholesteryl ester transfer protein (CETP)
inhibitor anacetrapib (Merck, Whitehouse Station, NJ)
significantly decreased LDL-cholesterol levels by 36% and
increased HDL-cholesterol levels by 138% when compared with
placebo. Importantly, there was no increase in systolic blood
pressure, an off-target effect that troubled torcetrapib, an earlier
CETP inhibitor that was later pulled from clinical testing after a
large morbidity and mortality trial revealed an increased risk of
mortality and cardiovascular events.
"It's game changer, but because we don't have hard clinical
events, we can't say that it's a home run," Dr Roger
Blumenthal (Johns Hopkins Medical Institute, Baltimore, MD)
told heartwire. "Still, in this short time, [76 weeks], we see a
decrease in total events and total revascularizations, and we
weren't expecting that at all. We just wanted to see the safety of
the drug. So, it's really exciting."
See DEFINE: Large effects on LDL and HDL cholesterol with
CETP inhibitor anacetrapib for more information.

15. SYMPLICITY HTN-2 (Renal Denervation in Patients With
Uncontrolled Hypertension)
Results: A new technique, catheter-based renal denervation,
used in patients with resistant hypertension resulted in
significant reductions in blood pressure without any major
complications. Severe, resistant hypertension that is
uncontrolled despite patients taking five or more
antihypertensive medications is a big unmet clinical need, with
those affected being at increased risk of stroke and renal
failure.
"There is nowhere to go for these patients. We think with this
novel approach we can bring many of them under control. I've
never seen BP falls as big as this from any other treatment
process, which makes the possibility of cure realistic; it might be
within reach. It has always been a dream of mine, to come up
with a cure for hypertension," said Dr Murray D Esler (Baker
IDI Heart and Diabetes Institute, Melbourne, Australia) in an
interview with heartwire.
See A revolutionary road for resistant hypertension? Renal
denervation in Symplicity HTN-2 for more information.

16. ASCOT-CRP
Results: The addition of high-sensitivity C-reactive protein (hs-
CRP) measurements didn't much improve conventional risk
assessments in patients with hypertension and other CV risk
factors but normal or only modestly elevated LDL-cholesterol
levels in a post hoc analysis of the ASCOT lipid-lowering arm.
Moreover, among patients in the analysis who had been
randomized to receive atorvastatin (Lipitor, Pfizer), a significant
reduction in LDL-C corresponded to a significant drop in CV-
event risk at six months. But a significant fall in hs-CRP levels
did not predict a decrease in CV events.
"These results do not support current proposals to measure
CRP in the clinical setting, either to assign statins to individuals
on the basis of an elevated CRP alone or to monitor CRP levels
as an indicator of the efficacy of statin treatment," said ASCOT
co-chair Dr Peter S Sever (Imperial College, London, UK).
See ASCOT analysis fuels debate over JUPITER-based CRP
indication for statins for more information.

17. ACT (Acetylcysteine for Contrast-Induced Nephropathy Trial)
Results: The addition of N-acetylcysteine failed to reduce the
risk of contrast-induced nephropathy in patients undergoing
coronary and vascular angiography.
"I would be comfortable saying that this is a definitive trial, and
I'd be comfortable saying that because if you look at the other
high-quality trials, we reached exactly the same result," Dr
Otavio Berwanger (Hospital do Coração, São Paulo, Brazil)
told heartwire. "It would be extremely unlikely that another trial
would be conducted, say a larger 20 000-patient trial, and would
find a different result. One thing that is interesting with negative
trials is that there is often a subgroup, maybe sicker patients,
the elderly, that might have a different result. But here, it was
very consistent."
See ACT: No benefit of N-acetylcysteine to reduce contrast-
induced nephropathy for more information.

18. Opinions from AHA
Heartfelt with Dr Melissa Walton Shirley:
The HDL ceiling: Cracked today by DEFINE and the CETP inhibitor
anacetrapib
Ready, set, go! Let's see how long it takes us to stop using N-
acetylcysteinepost-ACT
DES safety in BASKET-PROVE; ACT on contrast-induced nephropathy;
dosing for clopidogrel nonresponders in GRAVITAS; TAMARIS on gene
therapy
Latest on atrial fibrillation with analysis of ROCKET AF ( and POM 3 (fish
oil supplements); SMART-AV on cardiac resynchronization; PFO closure
in CLOSURE I
Take the thrombin-inhibitor exam: Automatically win a million dollars if you
get 100% correct!
Three decades worth of proof: Minnesota cities prove critics of smoking-
cessation efforts wrong, wrong, WRONG!
Results, analysis, and clinical implications of leading heart-failure trials at
AHA 2010: Eplerenone in EMPHASIS-HF; CRT and RAFT; LVAD in
ADVANCE; nesiritide in ASCEND-HF
Gross pics of tobacco carnage: Reverse marketing or empty drama?
Private practice with Dr Seth Bilazarian:
GRAVITAS has immediate impact on my practice
New horizons for atrial fibrillation as ROCKET AF (rivaroxaban) follows on the heels of RE-LY (dabigatran)
Eplerenone, nesiritide, CRT, LVAD: Clinical implications of heart-failure trial results from AHA 2010
Physician wages across specialties: Cardiologists earn $93 per hour (for now)
Heart failure and transplantation with Dr Ileana Piña:
Petitioning the Social Security Administration for compassionate disability for HF, transplant, and congenital heart-disease patients

19. AHA 2010
Over 23 500 people attended the AHA 2010 Scientific
Sessions, which included: 1592 oral presentations, 2103
posters, and 16 late-breaking clinical trials.
Sessions were grouped into 7 core themes:
• Cardiovascular Imaging
• Epidemiology and Prevention of Cardiovascular Disease:
Physiology, Pharmacology and Lifestyle
• Genetics, Genomics and Congenital Cardiovascular Disorders
• Heart Rhythm Disorders and Resuscitation Science
• Myocardium: Function and Failure
• Catheter-Based and Surgical Interventions
• Vascular Disease: Biology and Clinical Science
The 2011 AHA Scientific Sessions will be held November 12-
16, 2011, at the Orange County Convention Center in Orlando,
Florida.

20. For more information
AHA site
AHA 2010 Coverage on theheart.org
Medscape coverage AHA 2010

21. Credits and disclosures
Editor: Journalists:
Shelley Wood Lisa Nainggolan, theheart.org
Managing Editor, heartwire London, UK
theheart.org Disclosure: Lisa Nainggolan has disclosed no relevant financial
Kelowna, BC relationships
Disclosure: Shelley Wood has disclosed no relevant
financial relationships. Sue Hughes, theheart.org
London, UK
Contributor: Disclosure: Sue Hughes has disclosed no relevant financial
Steven Rourke relationships.
Manager, Editorial programming
theheart.org Montreal, QC Reed Miller, theheart.org
Disclosure: Steven Rourke has disclosed no Bethesda, MD
relevant financial relationships. 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.

22. More slideshows
ESC 2010 research highlights: A slideshow
presentation
TCT 2010 research highlights: A slideshow
presentation

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