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

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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

Disclosure: Lisa Nainggolan has disclosed

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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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