http://www.theheart.org/editorial-program/1315215.do The American Heart Association (AHA) 2011 Scientific Sessions took place in Orlando, FL, from November 12 through November 16, 2011. Key trials presented at the sessions include: AIM-HIGH,SATURN,ATLAS,ELEVATE,PALLAS,TRACER,POWER,FAST, AF C-PORT E,FREEE,ADOPT and NHBLI.

1. AHA 2011 research highlights:
A slideshow presentation

2. AHA 2011 Research Highlights
The American Heart Association (AHA) 2011 Scientific Sessions
took place in Orlando, FL, from November 12 through November 16,
2011.
Key trials presented at the sessions include:
AIM-HIGH: Stopped early at three years due to unexplained increase
in ischemic stroke in the niacin group vs placebo; experts now say
trial should not have stopped
SATURN: High-dose statin therapy resulted in significant regression
of coronary atherosclerosis
ATLAS: Rivaroxaban 2.5 mg has shown promising results
ELEVATE: Clopidogrel 225 mg for patients with one loss-of-function
allele
PALLAS: Dronedarone a hazard in high-risk CV patients with permanent AF
TRACER: Novel thrombin blocker vorapaxar stumbles in ACS, ups bleeding risk
POWER: Phone and internet intervention achieves and maintains weight loss
FAST: Surgical ablation bests catheter ablation in treatment of drug-refractory AF
C-PORT E: Elective PCI doesn't require surgical backup
MI FREEE: Cutting copays for post-MI drugs helps outcomes, with no added cost to insurers
ADOPT: Extended apixaban no better than standard enoxaparin for VTE in medically ill
NHBLI: NHBLI-appointed expert panel recommends universal cholesterol screening for kids

3. AIM-HIGH
Stopped early at three years due to unexplained increase in
ischemic stroke in the niacin group vs placebo; experts
now say trial should not have stopped
Results: Final results of the AIM-HIGH trial appear to suggest
that the signal of increased ischemic stroke with niacin, which
was one of the reasons the study was stopped early, could have
been the play of chance, with the final p value for ischemic
stroke coming in at a nonsignificant 0.11. This has provoked a
backlash from researchers in the field against the National
Institutes of Health (NIH) sponsors of the study who made the
decision to terminate the trial.
"When the NIH stopped the trial, there was an increase in ischemic stroke of borderline significance," said lead investigator
Dr William Boden (University of Buffalo School of Medicine, NY). "I think they saw neutral outcome data, and because of
a potential ethical safety issue they decided to stop the trial. But there was no signal of an increase in fatal stroke or of all-
cause or cardiac mortality. And now that we have all the data, the effect is far from significant, and when we look just at
strokes that occurred when the patients were actually on treatment, we have 21 on niacin vs 18 on placebo. The earlier
numbers were clearly an aberration—just the play of chance."
See: AIM-HIGH: Results raise controversy over early stopping

4. SATURN
High-dose statin therapy resulted in significant regression
of coronary atherosclerosis
Results: High-dose statin therapy with atorvastatin or
rosuvastatin resulted in a significant regression of coronary
atherosclerosis in the SATURN trial, despite differential effects
on LDL- and HDL-cholesterol levels with the two most popular
lipid-lowering medications. Treatment with rosuvastatin 40 mg
resulted in lower LDL- and higher HDL-cholesterol levels than
atorvastatin 80 mg, but the effect on percent atheroma volume
(PAV) measured by intravascular ultrasound (IVUS) did not
significantly differ. Less than 5% of patients with stable coronary
disease are treated with maximum-dose statins, and this
remains one of the challenges in secondary prevention.
"We're very good at prescribing statins, we're just not so good at increasing the doses," said Dr Stephen Nicholls
(Cleveland Clinic, OH). "Safety is one of the elements of it, but the other element is that people question what the added
benefit is. The incremental LDL lowering is about 5% or 6% every time you double the dose. I think what we're seeing here
is very reassuring for patients. Over a 24-month period, patients with largely stable disease tolerated these agents very
well at these doses. They achieved very effective levels of LDL and HDL cholesterol, and if you're looking for benefit, I see
the removal of the disease from the artery wall that ultimately causes the clinical event as a very reassuring extra benefit
for the doses of these agents."
See: SATURN: Maximum doses of rosuvastatin and atorvastatin equally regress atherosclerosis

5. ATLAS
Rivaroxaban 2.5 mg has shown promising results, with a
reduction in overall and cardiovascular mortality vs placebo,
despite an increased risk of bleeding and ICH
Results: The lower of the two doses of the new oral anticoagulant
rivaroxaban tested in the ATLAS ACS 2 TIMI 51 trial has shown
promising results, with a reduction in overall and cardiovascular
mortality vs placebo, despite an increased risk of bleeding and
intracranial hemorrhage (ICH). The trial compared two doses of
rivaroxaban with placebo in ACS patients. All patients were taking
low-dose (75-100 mg) aspirin and 93% were also on clopidogrel.
Study treatment was started an average of 4.6 days after the ACS
event. Patients with a previous stroke or transient ischemic attack
(TIA) were excluded, as this group has been shown to have a
particularly high risk of ICH in previous trials of other antithrombotic
agents. The population was high risk, with half having had a STEMI.
Both rivaroxaban doses reduced the primary end point of cardiovascular death/MI/stroke, at the cost of increased bleeding rates. The 2.5-
mg twice-daily dose had the better benefit/risk balance, due to a lower bleeding risk than the 5-mg twice-daily dose.
"Thus, the addition of very low-dose anticoagulation with rivaroxaban may represent a new treatment strategy in patients with a recent
acute coronary syndrome," the ATLAS investigators conclude in the New England Journal of Medicine paper, published online to coincide
with the AHA presentation. "We have shown a 32% relative reduction in all-cause mortality with the 2.5-mg dose in the whole population
and a 36% reduction in those on dual antiplatelet therapy. This translates into one death prevented for every 56 patients treated for two
years. This is big news," said ATLAS investigator Dr Michael Gibson (Beth Israel Deaconess Hospital, Boston, MA).
See: ATLAS ACS 2: Low-dose rivaroxaban looks good in ACS

6. ELEVATE-TIMI 56
Tripling the maintenance dose of clopidogrel in stable
heart disease patients carrying one clopidogrel loss-of-
function allele achieved levels of platelet reactivity similar
to that seen with the standard dose in noncarriers
Results: The ELEVATE-TIMI 56 trial results show that tripling
the maintenance dose of clopidogrel to 225 mg daily in stable
heart disease patients carrying one clopidogrel loss-of-function
allele (CYP2C19*2) achieved levels of platelet reactivity similar
to that seen with the standard 75-mg dose in noncarriers. In
contrast, in patients with two loss-of-function alleles, doses as
high as 300 mg daily did not result in comparable degrees of
platelet inhibition.
"If I knew someone's genotype [indicated loss of function], I would feel uncomfortable treating them with standard doses of clopidogrel,"
said Dr Jessica Mega (Brigham and Women's Hospital, Boston, MA), adding that there are also other agents available, prasugrel and
ticagrelor, that have been shown to reduce events in "all-comers." That's despite the fact that ELEVATE did not look at effects on patient
outcomes. "It is important to understand that this is a pharmacodynamic study . . . but I think it gives us a great deal of insight into the
optimal ways of treating different patients with clopidogrel."
See: ELEVATE-TIMI 56: Clopidogrel 225 mg for patients with one loss-of-function allele

7. PALLAS
Dronedarone a hazard in high-CV-risk patients with
permanent AF
Results: The PALLAS data indicate that the dronedarone-
related CV events over a median follow-up of 3.5 months
consisted largely of stroke, heart failure, CV death, and
arrhythmic death. Those events contributed to significant
increases, by a factor of about two, in the trial's pair of co–
primary end points: stroke, MI, systemic embolism, or CV
death; and death or unplanned CV hospitalization. The
significant effect of dronedarone on those end points held
regardless of NYHA functional class or LVEF. The PALLAS
results were published in the New England Journal of Medicine,
coinciding with their presentation at AHA 2011.
"Our data show that dronedarone is hazardous in such patients," write the publication's authors, led by Dr Stuart J
Connolly (Population Health Research Institute and McMaster University, Hamilton, ON). "It is reasonable to conclude that
dronedarone should be avoided in patients with heart failure and other advanced cardiovascular disease, particularly when
they also have permanent atrial fibrillation."
See: PALLAS: Dronedarone a hazard in high-CV-risk patients with permanent AF

8. TRACER
Novel thrombin blocker vorapaxar stumbles in ACS, ups
bleeding risk
Results: In the international TRACER trial with >12 000 patients
with non-ST-elevation ACS who were mostly already on dual-
agent antiplatelet therapy, adding the investigational
antithrombotic agent vorapaxar to standard therapy
significantly raised the risk of major bleeding complications,
including intracranial hemorrhage (ICH), over two years. That
wasn't a complete surprise, as TRACER had been halted earlier
this year when an interim safety analysis saw a jump in ICH
among vorapaxar patients with a history of stroke.
"The magnitude of the increase [in bleeding] was not expected on the basis of preclinical and phase 2 data" for [protease-
activated receptor 1] PAR-1 blockade, which suggested no risk increase when added to aspirin and clopidogrel, TRACER
investigators write in the New England Journal of Medicine, where their report was published online to coincide with its
scheduled presentation here at the AHA sessions.
However, they continue, "The results from our study are consistent with previous evidence indicating that more potent
antithrombotic therapy incrementally increases the risk of bleeding."
See: TRACER: Novel thrombin blocker vorapaxar stumbles in ACS, ups bleeding risk

9. POWER
Phone and internet intervention achieves and maintains
weight loss
Results: The randomized, two-year POWER trial showed that a
weight-loss program conducted solely by telephone and via
internet was just as effective as a program attended in person,
with face-to-face coaching, at promoting meaningful weight loss
and helping to keep it off.
About half of the patients participating in either weight-loss
intervention lost at least 5% of their initial body weight (the
primary end point) within six months. The lost weight stayed off
after two years in about 40% of both groups. The degree of
weight loss achieved was similar to that of other weight-loss
studies.
"In contrast with the findings in most weight-loss trials, however, participants sustained weight loss to the end of the trial,"
according to lead author Dr Lawrence J Appel (Johns Hopkins University, Baltimore, MD).
See: POWER program: Phone, internet intervention achieves, maintains weight loss

10. FAST
Surgical ablation bests catheter ablation in treatment of
drug-refractory AF
Results: The FAST trial was a randomized comparison between
surgical ablation and radiofrequency catheter ablation for the
treatment of antiarrhythmic-drug–refractory atrial fibrillation. It
showed that the surgical approach is superior in achieving
freedom from arrhythmias at one year. The minimally invasive
surgical approach is not without its drawbacks, however, with
investigators reporting a significantly higher procedural adverse-
event rate in the surgical ablation arm compared with catheter
ablation. Of note, 67% of the patients included in the trial had
failed a previous catheter-ablation procedure, "which could
signify a predisposition to catheter-ablation failure."
"In this population of patients with atrial fibrillation with dilated left atrium and hypertension who had failed a prior catheter
ablation, we found that minimally invasive surgical ablation was superior to catheter ablation to achieve freedom from atrial
arrhythmias without antiarrhythmic drugs in follow-up to 12 months," said lead investigator Dr Lucas Boersma (St
Antonius Ziekenhuis, Nieuwegein, the Netherlands) during a press conference announcing the results. "Surgical ablation
was accompanied by a higher adverse-event rate than catheter ablation, and we think this is important for physicians and
patients when deciding which type of invasive therapy they need."
See: FAST: Surgical ablation bests catheter ablation in treatment of drug-refractory AF

11. C-PORT E
Elective PCI doesn't require surgical backup
Results: During a late-breaking clinical-trial session, findings
from the C-PORT E trial showed that patients who had elective
PCI at experienced US hospitals without on-site cardiac surgery
fared no worse than those who had the same procedure at
institutions with surgical backup. The mortality rate after six
weeks was almost the same for each group, at just under 1%.
"The key finding is that the patient-related medical outcomes, at least the short-term safety outcomes, of elective
angioplasty are the same, regardless of the hospital type," said Dr Thomas Aversano (Johns Hopkins Medical Institute,
Baltimore, MD). He added that his team will have data on how patients fared nine months after the procedure early next
year. And he stressed: "The purpose of the trial was not to expand the number of centers doing angioplasty but to give
healthcare policy makers—who can make rational decisions about access, quality, and cost of angioplasty care in their
state—some information on which to base their decision."
See: C-PORT E: Elective PCI doesn't require surgical backup

12. MI FREEE
Cutting copays for post-MI drugs helps outcomes, with no
added cost to insurers
Results: The 5855-patient MI FREEE study shows that patients
who had suffered an MI were significantly less likely to have
another major cardiac event if the costs of statins, beta
blockers, ACE inhibitors, and angiotensin-receptor blockers
were totally covered by insurance rather than if their insurance
company charged them a copay for their drugs. For the primary
outcome of revascularization plus major cardiac events
combined, the difference was not statistically significant. The
patients with no copay paid 26% less overall for their drugs than
the patients with copays. Over the three years of follow-up, the
people with no copay actually cost the insurance company
slightly less to care for than the people with one ($66 008 vs
$71 778; p=0.68).
"For essential medications—the meds we're talking about are highly evidence-based—we don't want people to stop using
those meds when the copays are a relatively small part of cost relative to costs of hospitalizations, or even death, that
result from not using the drugs," said study lead author Dr Niteesh Choudhry (Harvard University, Boston, MA). Not only
does eliminating copays not cost the insurance company more in the long run, it's also an easy change to implement,
Choudhry said. "Insurers that want to do this could do this tomorrow. It literally just means changing pharmacy
authorization codes. It doesn't mean deploying armies of nurse health coaches or anything like that."
See: Cutting copays for post-MI drugs helps outcomes, with no added cost to insurers

13. ADOPT
Extended apixaban no better than standard enoxaparin for
VTE in medically ill
Results: Results of the ADOPT trial demonstrate that
prolonging prophylaxis for venous thromboembolism in
medically ill patients with a 30-day course of the new oral
anticoagulant apixaban was not superior to a shorter six- to 14-
day course of subcutaneous enoxaparin—designed to
represent standard in-hospital VTE prevention.
"The ADOPT trial does not provide evidence to justify a policy of extended prophylaxis in a broad population of medically ill
patients after hospital discharge," said Dr Samuel Z Goldhaber (Brigham and Women's Hospital, Boston, MA) in a press
conference at the AHA meeting. However, the ADOPT findings, together with those from similar studies—such as the
MAGELLAN trial with rivaroxaban and EXCLAIM with enoxaparin—show that "it is clear that the risk of VTE increases
beyond the time of hospital discharge" in this patient population.
See: ADOPT: Extended apixaban no better than standard enoxaparin for VTE in medically il

14. NHBLI-appointed expert panel recommends universal
cholesterol screening for kids
Results: The Expert Panel on Integrated Guidelines for
Cardiovascular Health and Risk Reduction in Children and
Adolescents presented new guidelines at the AHA meeting.
They recommended that all children, regardless of family
history, undergo universal screening for elevated cholesterol
levels. The panel recommended that adolescents undergo lipid
screening for nonfasting non-HDL-cholesterol levels or a fasting
lipid panel between the ages of 9 and 11 years followed by
another full lipid screening test between 18 and 21 years of age.
They also recommend measuring fasting glucose levels to test
for diabetes in children 10 years of age (or at the onset of
puberty) who are overweight with other risk factors, including a
family history, for type 2 diabetes mellitus.
The Expert Panel was appointed by the National Health, Lung,
and Blood Institute (NHLBI) and endorsed by the American
Academy of Pediatrics (AAP).
"The goal of the expert panel was to develop comprehensive evidence-based guidelines that address the known risk factors
for cardiovascular disease to assist all primary pediatric care providers in both the promotion of cardiovascular health and the
identification and management of specific risk factors from infancy into young adult life," write panel chair Dr Stephen Daniels
(University of Colorado School of Medicine, Denver) and colleagues in Pediatrics.
See: NHBLI-appointed expert panel recommends universal cholesterol screening for kids

15. For more information
Complete AHA 2011 coverage on
theheart.org
AHA 2011 Scientific Sessions
American Heart Association

16. Credits and disclosures
Editor:
Shelley Wood
Managing Editor, heartwire
theheart.org
Kelowna, BC
Disclosure: Shelley Wood has disclosed no relevant financial relationships.
Contributors:
Steven Rourke
Manager, Editorial programming theheart.org
Montreal, QC
Disclosure: Steven Rourke has disclosed no relevant financial relationships.
Katherin Vasilopoulos
Montreal, QC
Disclosure: Katherin Vasilopoulos has disclosed no relevant financial
relationships.
Journalists:
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.

17. More slideshows
TCT 2011 research highlights
ESC 2011 research highlights
HRS 2011 research highlights
EuroPCR 2011 research highlights

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