acc 2012 research highlights: a slideshow presentation
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http://www.theheart.org/article/1379569.do The American College of Cardiology (ACC) 2012 Scientific Sessions took place in Chicago, IL, from March 24 through March 27, 2012. Key trials presented at the sessions include: TRA 2°P – TIMI 50,PARTNER A, STAMPEDE, ROMICAT, ACRIN PA, EINSTEIN PE, ASCERT, ISSUE 3, C-PORTE E, CORONARY, CABG and Mendelian RCT.TRANSCRIPT
ACC 2012 research highlights:
A slideshow presentation
ACC 2012 Research Highlights
The American College of Cardiology (ACC) 2012 Scientific
Sessions took place in Chicago, IL, from March 24 through March
27, 2012.
Key trials presented at the sessions include:
TRA 2°P – TIMI 50: Possible future for vorapaxar in patients with
prior MI
PARTNER A: Paravalvular leaks linked with higher mortality at two
years in TAVI trial
STAMPEDE: Bariatric surgery betters standard diabetes treatment in
the obese
ROMICAT II and ACRIN PA: CT-first ACS strategy matches current
practice and safely discharges more patients
EINSTEIN PE: Rivaroxaban equals standard therapy, halves major bleeding
ASCERT: CABG, PCI analysis: Lower mortality with surgery
ISSUE 3: DDD pacing can help suppress asystolic neurally mediated syncope
C-PORTE E: Nine-month results: Elective PCI doesn't need surgery safety net
CORONARY: Off-pump and on-pump CABG give similar short-term outcomes
Mendelian RCT: Lowering LDL early in life has the potential to reduce coronary heart disease
TRA 2°P – TIMI 50
Possible future for vorapaxar in patients with prior MI
Results: Full results of the TRA 2°P TIMI-50 study suggest
that the novel antiplatelet agent vorapaxar (Merck) appears to
have a net clinical benefit in selected secondary-prevention
patients. Patients who did best on the drug were those with a
prior MI without a history of stroke or transient ischemic attack
(TIA) and who weighed over 60 kg. But many observers
expressed concerns about the bleeding risk with the drug, with
suggestions that it may not be suitable for general availability.
The top-line results of the trial, announced earlier this year,
reported that vorapaxar, which blocks the protease-activated
receptor 1 (PAR-1) on the platelet, was successful in reducing
the primary ischemic end point of the study, but at the cost of
increased bleeding, including intracranial hemorrhage (ICH).
"There are definitely some important—even practice-changing—messages from this trial. The most compelling benefits
were seen in the subgroup of patients with previous MI, where we saw a 20% reduction in the primary end point of
cardiovascular death/MI/stroke," said lead study investigator David Morrow (Brigham and Women's Hospital, Boston,
MA).
See: TRA 2°P-TIMI 50: Future possible for vorapaxar in patients with prior MI?
PARTNER A
Paravalvular leaks linked with higher mortality at two years
in TAVI trial
Results: Paravalvular leaks—a phenomenon virtually unheard
of in the surgical valve-replacement era—were truly propelled
into the limelight at the ACC 2012 Scientific Sessions, with the
presentation of two-year results from the PARTNER A
transcatheter aortic-valve intervention (TAVI) trial. At two years,
rates of death from any cause were not statistically different
between transcatheter aortic-valve replacement (TAVR) and
surgical valve replacement, but paravalvular regurgitation was
more common after TAVR than surgery. And strikingly, even
mild paravalvular regurgitation was associated with increased
late mortality.
"This is an important observation, but I would put it in perspective. If you look at overall mortality between surgery and
TAVR, the rates are identical, and in no subgroup is overall mortality different," said Dr Martin Leon (Columbia University,
NY). "We're thinking paravalvular leak can be treated or prevented, and there's clear evidence that there was valve
undersizing in PARTNER that we think can be corrected using postdilatation if done selectively and carefully. If you can
reduce the incidence of paravalvular leak down to 'none or trace,' you could potentially reduce mortality by half."
See: PARTNER A: Paravalvular leaks linked with higher mortality at two years
STAMPEDE
Bariatric surgery betters standard diabetes treatment in the
obese
Results: 150 obese patients (BMI 27–43 kg/m2) with
uncontrolled type 2 diabetes were enrolled in the trial and were
randomly assigned to medical therapy, Roux-en-Y gastric
bypass (RYGB), or sleeve gastrectomy. Mean age was 49
years, and mean HbA1c was 9.2%. The main study outcome of
HbA1c ≤6.0% after 12 months of treatment was met by 12% of
the medical-therapy group, 42% of the RYGB group (p=0.002
vs medical therapy), and 37% of the sleeve-gastrectomy group
(p=0.008 vs medical therapy). Although glycemic control
improved in all three groups, improvements were significantly
greater in the surgical groups, as was weight loss and
improvement in insulin resistance.
"There was quite a large difference between the surgical and medical group in terms of the success rate," said Dr Philip
Schauer (Cleveland Clinic, OH). "All of the gastric-bypass patients who reached HbA1c ≤6.0% did so without any
medication; they were weaned off all the antidiabetics, including insulin, to reach that target." They were also able to
reduce cardiovascular-medication use, he noted. "That's as close to a definition of remission that you can get. And the
sleeve-gastrectomy group was pretty close as well."
See: STAMPEDE: Bariatric surgery betters standard diabetes treatment in the obese
Legends of Cardiovascular Medicine Lecture Series: Eugene Braunwald
At this year's Legends of CV Medicine Lecture Series, the
cardiovascular legend Dr Eugene Braunwald delivered the
Simon Dack lecture.
2012 Simon Dack Lecture
The Treatment of Acute Myocardial Infarction — Into the
Second Century Eugene Braunwald, MD, MACC
See: ACC 2012 Opening Session: To Epcot with Braunwald
ROMICAT II/ACRIN PA
CT-first ACS strategy matches current practice and safely
discharges more patients
Results: The coronary computed-tomography angiography
(CCTA)-based strategy for screening chest-pain patients in the
emergency department is safe and reduces overall patient time
in the hospital but costs about the same overall as the current
standard approach, the Rule Out Myocardial Infarction Using
Computer Assisted Tomography II (ROMICAT II) results
show. CCTA screening also allows more patients not suffering
acute coronary syndrome (ACS) to be discharged safely than
standard screening practice, according the results of ACRIN-
PA.
"The reason we do all of this testing is because we want to drive the miss rate below 1%. The reason we want to drive the
miss rate below 1% is obvious, but what is not obvious is that there are gobs and gobs and gobs of clinical studies of 10
000 to 20 000 that show that when we use clinical judgment alone, we stink. We can use judgment to drive the miss rate
down to about 5%, but going from that 5% to less than 1% cannot possibly be done just with clinical judgment," said
ACRIN-PA coinvestigator and emergency physician Dr Judd Hollander (University of Pennsylvania).
See: ROMICAT II: CT-first ACS strategy matches current practice
CCTA-first ER strategy safely discharges more patients: ACRIN/PA
EINSTEIN PE
Rivaroxaban equals standard therapy, halves major
bleeding
Results: The new oral anticoagulant rivaroxaban (Xarelto,
Bayer) is at least as effective as the standard therapy of
injected low-molecular-weight heparin (LMWH) followed by
warfarin for the treatment of pulmonary embolism (PE),
according to the results of the EINSTEIN PE study reported at
the American College of Cardiology 2012 Scientific
Sessions and simultaneously published online in the New
England Journal of Medicine.
"We want to make life easier," said Dr Harry Büller, noting that many physicians and patients hate the monitoring that is
required with warfarin and similar agents. "Pulmonary embolism is a disease that occurs in all ages, and therefore having a
strategy with a pill and no monitoring is, I believe, a small revolution."
See: EINSTEIN PE: Rivaroxaban equals standard therapy, halves major bleeding
ASCERT
CABG, PCI analysis: Lower mortality with surgery
Results: Adjusted four-year all-cause mortality was about 20%
lower after CABG than after PCI in an observational study of
about 190 000 patients in the US who underwent nonemergent
revascularization for two- or three-vessel coronary disease.
Mortality at one year was similar for the two procedures.
Based on patients >65 years of age taken from two huge
society-sponsored databases, the analysis used several
methods to control for risk levels and other influences on
outcomes. It found the long-term advantage for CABG was
independent of age, sex, diabetes, renal function, and lung
disease and was evident "even among patients whose
propensity scores were most consistent with selection for PCI,"
write the study authors.
"That was one of the major surprises in the study. We really thought we'd find subsets of patients that would benefit from
surgery and other subsets that would benefit from percutaneous intervention," said surgeon Dr Fred H Edwards
(University of Florida, Jacksonville), co–principal investigator of the trial with Weintraub. "And much to our surprise, all of
the subsets showed a survival advantage for surgery."
See: ASCERT CABG, PCI analysis: Lower mortality with surgery
ISSUE-3
DDD pacing can help suppress asystolic neurally mediated
syncope
Results: Contrary to previous clinical trials that suggested
otherwise, pacemaker therapy can cut the risk of fainting spells
in patients with demonstrated asystolic neurally mediated
syncope (NMS), according to the authors of a randomized,
controlled trial.
Pacing therapy succeeded in their trial, but not the others, at
least partly because the study differed in requiring patients to
have demonstrated asystolic NMS at implantable loop-recorder
(ILR) screening, said principal investigator Dr Michele Brignole
(Ospedali del Tigullio, Lavagna, Italy) when presenting the
results of the third International Study on Syncope of
Uncertain Etiology (ISSUE-3). The trial was conducted at 29
centers in Canada and Western Europe.
"The point is that in these patients, there has been no [treatment] with proven efficacy for this form [of syncope] before this
trial," said Dr Michele Bignole (Ospedali del Tigullio, Lavagna, Italy). With the results of ISSUE-3, according to Bignole,
"the efficacy of pacing is established" without the need for replication in further trials.
See: ISSUE-3: DDD pacing can help suppress asystolic neurally mediated syncope
The Heart of Innovation Featured Learning DestinationTM
The Heart of Innovation explored the evolution of the standard
of care for coronary artery disease and heart failure caused by
valvular disease through the lenses of four main areas:
personalized medicine, technobiology, minimally invasive
therapies, and physician-patient engagement.
Topics covered included:
• Insights into how genetic research is rapidly transforming ways
to prevent, diagnose, and treat patients.
• How revolutionary ideas like growing heart valves are being
transformed into real possibilities, thanks to strides in stem-cell
research.
• How innovations like mobile apps are changing the
relationship between cardiologists and patients.
• The newest minimally invasive techniques, implantable
devices, multimodality imaging, dose reduction solutions, and
robotic surgical tools.
As part of the presentation, the Thought Leader Theater featured presentations and panel discussions from world-
renowned physicians, scientists, and academics on topics from these four areas.
See: The Heart of Innovation Featured Learning DestinationTM
Thought leader theatre schedule:
C-PORT E
Nine-month results: Elective PCI doesn't need surgery
safety net
Results: Nine-month clinical outcomes from a randomized trial
comparing elective PCI at centers without vs with on-site
cardiac surgery suggest, like the previously reported six-week
mortality results, that patients fare about the same regardless of
whether PCI has the surgical safety net. The composite rates of
death from any cause, Q-wave MI (QMI), and target-vessel
revascularization (TVR) at nine months were 12.1% without on-
site surgery and 11.2% with backup surgery in the noninferiority
trial, called Cardiovascular Patient Outcomes Research
Team Non-Primary PCI (C-PORT E). Previously reported six-
week mortality had been 0.9% and 1.0% respectively, which
also met the trial's criterion for noninferiority.
"In C-PORT, we didn't perceive angioplasty as a procedure that occurs [just] in the cardiac cath lab. We thought of it as a
strategy of care for coronary artery disease, with the hospital component of that strategy implemented in the emergency
room, the cardiac cath lab, the coronary care unit [CCU], and in any step-down unit to which the patient may be
transferred," said Dr Thomas Aversano (Johns Hopkins Medical Institute, Baltimore, MD).
See: C-PORT E: Nine-month results: Elective PCI doesn't need surgery safety net
CORONARY
Off-pump and on-pump CABG give similar short-term
outcomes
Results: The largest study ever to compare off-pump and on-
pump CABG has shown no significant difference in 30-day
results for the primary end point. Some differences in secondary
end points may drive decisions on an individual basis until long-
term results are available, suggests the lead author.
"Our study should settle the current controversy surrounding
off-pump surgery," said lead investigator Dr André Lamy
(McMaster University, Hamilton, ON). "The recent results
suggesting worse outcomes with this approach were probably
due to inexperienced surgeons. As off-pump is more technically
challenging, you need to be more experienced for this
approach, but if the surgeon is comfortable with off-pump, the
results seem to be good."
See: CORONARY: Off-pump and on-pump CABG give similar
short-term outcomes
Mendelian RCT
Lowering LDL early in life has the potential to reduce
coronary heart disease
Results: Lowering LDL early in life has the potential to reduce
coronary heart disease to a far greater extent than starting
treatment later in life—the current standard practice—a
"Mendelian" randomized, controlled trial suggest. To estimate
the clinical benefit of lowering LDL early in life, study
investigators used nine single nucleotide polymorphisms
(SNPs) from six genes associated with lower LDL as a proxy for
a treatment that lowers LDL beginning at birth. Results showed
that all nine SNPs were associated with a consistent 54%
reduction in the risk of the primary end point (a composite of CV
death, MI, and coronary revascularization) for each 1-mmol/L
(38.7 mg/dL) lower lifetime exposure to LDL cholesterol.
"We are not suggesting that everyone take statins from childhood; rather, that lowering LDL through more attention to
healthy diet and exercise from a young age could make a big difference to public health," commented lead author Dr Brian
Ference (Wayne State University School of Medicine, Detroit, MI).
See: Start lowering LDL in childhood, new study suggests
For more information
Complete ACC 2012 coverage on
theheart.org
ACC 2012 Scientific Sessions
American College of Cardiology
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Managing Editor, heartwire
theheart.org
Kelowna, BC
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Manager, Editorial programming
theheart.org
Montreal, QC
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Maria Turner
Montreal, QC
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Journalists:
Sue Hughes, theheart.org
London, UK
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Reed Miller, theheart.org
State College, PA
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relevant financial relationships.
Lisa Nainggolan, theheart.org
London, UK
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Michael O'Riordan, theheart.org
Toronto, ON
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relationships.
Steve Stiles, theheart.org
Fremont, CA
Disclosure: Steve Stiles has disclosed no
relevant financial relationships.
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