ACC 2011 research highlights:

A slideshow presentation

ACC 2011 Research Highlights

The American College of Cardiology (ACC) 2011 Scientific Sessions took

place in New Orleans, LA, from April 2 through April 5, 2011.

Key trials presented at the sessions include:

PARTNER cohort A: Transcatheter valves noninferior to surgery

PARTNER cohort B cost analysis: TAVI cost-effective treatment in

surgery-ineligible patients

RIVAL: Radial RIVALs femoral access for invasive ACS treatment, but

doesn't beat it

STICH: "Hypothesis one" results support CABG in HF patients despite

missing primary end point

STICH substudy: Viability testing didn't affect treatment outcomes

MAGELLAN: Rivaroxaban prevents VTE in medical patients, but bleeding

an issue

OSCAR: Antihypertensive choice in elderly should be guided by underlying disease

EVEREST II: MitraClip less effective but safer than surgery

PRECOMBAT: PCI noninferior to CABG for left main disease, but questions linger

RESOLUTE: New zotarolimus stent data flesh out efficacy, safety

PLATINUM: Novel everolimus-eluting stent noninferior to Xience V stent

ISAR CABG: Drug-eluting stents reduce repeat revascularization in saphenous vein grafts

EXCELLENT: Some patients can stop DAPT after six months following drug-eluting-stent implantation

View our complete ACC coverage here.

PARTNER (Placement of Aortic Transcatheter Valve Trial) cohort A

Results: Transcatheter-valve implantation was just as good as

surgery in surgery-eligible patients for the primary end point of

mortality, but major strokes were higher in the TAVI-treated

patients, both at 30 days and one year. In a combined end point

of all stroke or transient ischemic attack (TIA), the difference

between groups was statistically significant.

"These results indicate that [transcatheter aortic-valve

replacement] TAVR is an acceptable alternative to AVR in

selected high-risk operable patients," concluded principal

investigator Dr Craig Smith (Columbia University, New York,

NY). "Future randomized studies should focus on lower-risk

patients who are candidates for operation."

See: PARTNER cohort A: Transcatheter valves noninferior to

surgery

PARTNER (Placement of Aortic Transcatheter Valve Trial) cohort B: cost analysis

Results: Transcatheter aortic-valve implantation is a cost-

effective treatment strategy in surgery-ineligible patients with

severe aortic disease, with incremental costs per life-year

gained within commonly accepted ranges for other

cardiovascular technologies, according to a cost-effectiveness

analysis presented at the American College of Cardiology 2011

Scientific Sessions.

"There is a lot of cost up front now to do this, with the facility,

the team, all the imaging techniques that we need to have, so

this is only going to be done in major centers that can assemble

teams like this, once the device gets approved," said Dr

Michael Crawford (University of California, San Francisco),

who is not affiliated with the PARTNER trial. "It's hoped that as

we gain experience with this technique, this up-front cost will

actually go down and the cost-effectiveness will actually get

better."

See: TAVI cost-effective treatment in surgery-ineligible patients:

PARTNER cohort B cost analysis

RIVAL (Radial vs Femoral Access for Coronary Intervention) trial

Results: A head-to-head comparison of radial vs femoral access

for the treatment of patients with acute coronary syndromes has

shown that treatment via the radial artery did not reduce the

rate of death, MI, stroke, or non-coronary artery bypass graft

(CABG)-related major bleeding at 30 days. Transradial access,

however, did result in a 63% reduction in the risk of large

vascular-access complications.

"Interventional cardiologists should feel reassured that both

radial and femoral procedures are safe and effective in the

current era," said lead investigator Dr Sanjit Jolly (McMaster

University, Hamilton, ON). "The second take-home point is that

experience and expertise do matter, and the more procedures

you do the better you get. Clinicians and patients may decide,

with similar PCI efficacy, to use radial access because of the

lower rates of vascular complications."

See: Radial RIVALs femoral access for invasive ACS treatment,

but doesn't beat it

Spotlight on Health Information Technology

he Health Information Technology (IT) Spotlight at the ACC 2011

Scientific Sessions took place on Sunday, April 3, 2011.

The session focused on opportunities and challenges in launching an

electronic health record (EHR).

Highlights included:

The James T Dove Lecture: Meaningful Use from the Perspective of the

Office of the National Coordinator for Health IT

Presented by Farzad Mostashari, Washington, DC

Meaningful use: Eligible providers and hospital compliance

Presented by James E Tcheng, Durham, NC

Meaningful use: Electronic quality reporting

Presented by Floyd Eisenberg, Washington, DC

STICH (Surgical Treatment for Ischemic Heart Failure)

Results: The five-year results of a randomized comparison of

medical therapy with or without bypass surgery for ischemic

heart disease in patients with LV systolic dysfunction found that

CABG did not beat medical therapy alone in the primary end

point of all-cause death. There was, however, a slight

advantage for CABG in cardiovascular-specific causes of death

and in some of the composite secondary end points.

"The take-home message for me is that the STICH trial

supports bypass surgery on top of best medical therapy vs

medical therapy alone to reduce cardiovascular morbidity and

mortality and that many patients who are now treated for heart

failure without ever being assessed for the potential of having

angiographic coronary disease should be evaluated for that,

because [coronary disease] does not present the same way in

every patient," said Dr Eric Velazquez (Duke Clinical Research

Institute, Durham, NC).

See: Docs say STICH "hypothesis one" supports CABG in HF

patients despite missing primary end point

STICH (Surgical Treatment for Ischemic Heart Failure): Viability substudy

Results: A substudy of STICH found that: overall, substantial

viable myocardium evident at baseline imaging had no

independent bearing on all-cause mortality over five years; and

such viability didn't influence the relative effectiveness of the

two treatment strategies, either for all-cause mortality or the

secondary end points of CV mortality and CV hospitalization.

During a press conference on the STICH presentations,

interventionalist Dr Ted Feldman (Evanston Hospital, IL), who

was not connected with the trial, said: "I don't take away from

this [study] that viability testing doesn't help. What I take away

is, if there's viability, I really want to be sure to revascularize.

But prior to seeing these results, I was inclined to say if there

isn't viability, [do not] revascularize. And the results of the trial

challenge that historic bias."

See: STICH substudy: Viability testing didn't affect treatment

outcomes

MAGELLAN (Venous Thromboembolic Event [VTE] Prophylaxis in Medically Ill Patients)

Results: Taking the new oral anticoagulant rivaroxaban (Xarelto,

Bayer/Johnson & Johnson) once daily for 35 days was

associated with a reduction in the risk of venous thrombosis,

compared with standard 10-day treatment with enoxaparin

(Lovenox, Sanofi-Aventis) by subcutaneous injection, in acutely

ill medical patients. But bleeding rates were significantly

increased with rivaroxaban, and the new factor Xa inhibitor did

not show a net clinical benefit across the whole population.

"The drug has been shown to be noninferior to standard

treatments in other settings, and this was what was seen in the

first part of this trial. Also, since the extended-treatment arm

compared the drug with placebo, it is not surprising that

bleeding complications were increased. A better comparison

would have been to extend treatment with enoxaparin or

warfarin," said Dr Roy Silverstein (Cleveland Clinic, OH).

See: MAGELLAN: Rivaroxaban prevents VTE in medical

patients, but bleeding an issue

Poster sessions

The Best Fellows-in-Training Poster Awards included:

Heterogeneous upregulation of apamin-sensitive currents (IKAS) in failing human ventricles.

Po-Cheng Chang et al, Indiana University School of Medicine, Indianapolis, IN

Is the gender-specific risk of ischemic stroke in atrial fibrillation related to differences in

anticoagulation?

Renee Sullivan et al, University of Iowa Hospitals and Clinics, and University of Birmingham, UK

Enhanced external counter pulsation improves endothelial function, inflammatory markers and

depression.

Deepak Hooda et al, West Virginia University Heart Institute, Morgantown, WV

Molecular Imaging demonstrates ID3 modulates B lymphocyte homing to atherosclerosis-prone regions of the aorta.

Michael Lipinski et al, University of Virginia Health System, Charlottesville, VA

Use Of 320-detector computed-tomography coronary angiography for evaluating patients with chest pain in the emergency department:

Impact on duration of stay and coronary artery disease detection.

David E Winchester et al, University of Florida, Gainesville

Reverse-use dependence of antiarrhythmic drugs: Role of late sodium current.

Chinmay Patel et al, Lankenau Medical Center and Lankenau Institute of Medical Research, Wynnewood, PA

Influence of myocardial ischemia on outcomes in patients with systolic versus nonsystolic heart failure.

Thomas E Vanhecke et al, William Beaumont Hospital, Royal Oak, MI

The correlation of fragmented QRS complexes on 12-lead ECG and myocardial infarct size determined by cardiac magnetic resonance

imaging.

Waddah Maskoun et al, Medical College of Wisconsin, Milwaukee, and Northwestern University Feinberg School of Medicine, Chicago, IL

OSCAR (Olmesartan and Calcium Antagonists Randomized Study)

Results: Treating elderly hypertensive patients with a

combination of an angiotensin receptor blocker (ARB) and a

calcium antagonist is better at reducing BP than using a high

(double) dose of an ARB alone, particularly if they have CV

disease, according to a new study.

"The OSCAR study provides the first evidence showing that a

standard dose of ARB plus CCB combination is superior to

high-dose ARB in reducing adverse events in elderly

hypertensive patients with cardiovascular disease," said study

investigator Dr Hisao Ogawa (Kumamoto University, Japan).

See: OSCAR: Antihypertensive choice in elderly should be

guided by underlying disease

EVEREST II (Pivotal Study of a Percutaneous Mitral Valve Repair System)

Results: One- and two-year results show that

percutaneous repair of the mitral valve with the

MitraClip (Abbott) device was significantly less

effective at reducing mitral regurgitation than

surgery, but the procedure was associated with

superior safety and similar improvements in

clinical outcomes.

"It looks as though the MitraClip might be an alternative strategy for reducing regurgitation in older people with lots of

comorbidities who are not good candidates for surgery. With the two-year data we have just seen, I would say the clip is

fine for an 80-year-old with heart failure, but a younger patient needs a 20-year fix, and we get this from surgery," said Dr

Robert Bonow (Northwestern University, Chicago, IL). "We don't know if we get this from the clip. Perhaps patients can

tolerate low levels of regurgitation long term. Perhaps not."

See: Latest from EVEREST II: MitraClip less effective but safer than surgery

PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease)

Results: Either PCI using a sirolimus-eluting stent or coronary

artery bypass graft (CABG) surgery for unprotected left main

coronary artery stenosis yield similar rates of major adverse

cardiac or cerebrovascular events at one year, although study

investigators acknowledge that the study was underpowered as

a result of unexpectedly low event rates.

"Overall, this trial is a modest advance on what we already

recognize from the existing—and limited—randomized data

and, more broadly, the observational data of left main PCI," said

Dr David Kandzari (Piedmont Heart Institute, Atlanta, GA).

"That is, we have a remarkable consistency across trials of

equipoise with regard to the so-called hard end points—death,

myocardial infarction, and stroke—and at the same time we

have seemingly consistent data showing that with existing drug-

eluting stents, at least first-generation drug-eluting stents,

repeat revascularization is still higher when compared with

bypass surgery."

See: PRECOMBAT: PCI noninferior to CABG for left main

disease, but questions linger

Real World Cases in Sports Cardiology

The Clinical Cardiology Spotlight at the ACC 2011 Scientific

Sessions focused on "Real-World Cases in Sports Cardiology."

Four cases were presented:

Case I: Abnormal ECG in a 17-year old from the major league

soccer screening program

Presented by Ira Smith, Toronto, ON

Case II: Adolescent athlete with exertional syncope/chest pain

Presented by Wayne J Franklin, Houston, TX

Case III: Collegiate athlete with ICD

Presented by Renee Sullivan, Iowa City, IA

Case IV: 20-Yyar-old with aortic disease wants to continue to

swim at NCAA level

Presented by Sandeep Mangalmurti, Chicago, IL

Spotlight panelists included: Christine Lawless, Chicago, IL;

Rachel Lampert, New Haven, CT; Barry Maron, Minneapolis,

MN; Luigi Padeletti, Florence, Italy; Paul Thompson, Hartford,

CT; and Jeffrey Towbin, Cincinnati, OH.

RESOLUTE

RESOLUTE US

Results: The single-arm study shows the new Resolute stent to

yield lower rates of restenosis at one year than historical

controls made up of studies testing the predecessor stent,

Endeavor, also made by Medtronic.

RESOLUTE AC

Results: At two years, rates of "patient-related outcomes" and

"stent-related outcomes" were no different between patients

randomized to the Resolute or to the Xience everolimus-eluting

stent, nor were rates of any major clinical events different

between the two groups. Stent-thrombosis rates at one year

were reportedly higher for Resolute stent than for the Xience.

"No matter how you look at these data, from effectiveness or

safety, they're very, very strong. They're as good as we've seen

with a next-generation drug-eluting stent, and it's also a platform

that physicians like using; they like using the driver platform,"

said Dr Martin Leon (Columbia University, New York, NY).

See: New Resolute zotarolimus stent data flesh out efficacy,

safety

PLATINUM (Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions)

Results: A novel everolimus-eluting stent containing a new

metallic alloy, platinum, as part of a modified design has been

shown to be noninferior to the widely used Xience V stent

(Abbott Vascular)—also known as Promus (Boston Scientific)—

in a pivotal trial presented during a late-breaking clinical-trials

session at the American College of Cardiology 2011 Scientific

Sessions.

"Our procedures continue to get safer; our equipment and

devices are getting better. New stents will have to be as safe as

approved devices, and when it comes to deciding which stent is

better than another, it will come down to nuanced aspects, and

these don't come to light until you are using these devices in

lots and lots of people, not in these small trials designed for

regulatory approval. This is the sort of information you get from

large registries and from feedback from operators," said Dr

Edward J McNulty (University of California, San Francisco).

See: Everolimus-eluting stent performs well in PLATINUM

ISAR CABG (Is Drug-Eluting Stenting Associated With Improved Results in Coronary Artery Bypass Grafts)

Results: Drug-eluting stents (DES) reduced repeat

revascularization compared with bare-metal stents in

saphenous vein grafts (SVGs) for high-risk patients with at least

one lesion in a previously implanted saphenous vein bypass

graft.

The ISAR-CABG trial was designed to compare DES and bare-

metal stents in SVGs with a large enough study population to

provide information on clinical end points, explained study

investigator Dr Julinda Mehilli (Technische Universität Munich,

Germany). Although many interventionalists already use DES in

SVGs, most drug-eluting-stent trials have excluded SVGs, and

the only two previous randomized trials of comparing DES and

bare-metal stents in SVGs were very small and produced

conflicting mortality results, said Mehilli.

See: ISAR CABG: Drug-eluting stents reduce repeat

revascularization in saphenous vein grafts

EXCELLENT (Efficacy of Xience/Promus Versus Cypher in Reducing Late Loss After Stenting)

Results: Patients with coronary artery disease were randomized

to dual antiplatelet therapy for six months or dual antiplatelet

therapy for one year. Regarding the primary end point of target

vessel failure (TVF), a composite of cardiac death, MI, or target

vessel revascularization at 12 months, investigators observed

no statistically significant difference between those treated for

six months and those treated with for one year, suggesting that

some patients can stop clopidogrel after just six months

following drug-eluting-stent implantation.

"The take-home message from our study is that, at least in low-

risk, nondiabetic patients treated with second-generation drug-

eluting stents, we can safely discontinue clopidogrel at about six

months, especially if the patient is at high risk for bleeding or is

anticipating some surgery," said lead investigator Dr Hyeon-

Cheol Gwon (Sungkyunkwan University School of Medicine,

Seoul, Korea) during a morning press conference announcing

the results.

See: EXCELLENT results for stopping DAPT at six months, but

others say bigger trials are needed

Opinions and review

Cutting-edge dialogues with Drs Tim Gardner and Mat Williams

Surgeons and interventionalists partner to ensure best care

Heart failure and transplantation with Dr Ileana Piña

STICH: Focusing on the "crossover" patients

Private practice with Dr Seth Bilazarian

Shaking up the DES arena with safer, more efficacious newcomers

Radial didn't beat its rival

PARTNER A: Evaluating "important but different hazards"

Clotblog with Dr Samuel Goldhaber

MAGELLAN trial passes "proof-of-principle" test

Heartfelt with Dr Melissa Walton-Shirley

MAGELLAN on VTE, EXCELLENT on antiplatelets and OSCAR on

antihypertensives

STICH, EVEREST, RIVAL, and top interventional trials from ACC 2011

TAVI vs surgery: Mortality data and cost-effectiveness in PARTNER A

and B

Discussing science, anecdote, and opinion: Up in arms after RIVAL?

ACC Day 1: Dr Ralph Brindis and the doctrine of cardiovascular

ecumenism

This week in cardiology from heartwire

#84: TAVI matches surgery in PARTNER cohort A; PARTNER B cost-

effectiveness; MAGELLAN on rivaroxaban in...

#83: Hot topics at ACC 2011; noninvasive CV imaging for subclinical

disease; Elizabeth Taylor and...

Trials and PIs

Rivaroxaban vs enoxaparin for the Prevention of Venous

Thromboembolism in Acutely Ill Medical Patients with...

PROTECTION-AMI with Dr Michael Lincoff

NAGOYA HEART Study with Dr Murohara

EXCELLENT with Dr Hyeon-Cheol Gwon

PRECOMBAT with Dr Seung-Jung Park

Surgical Treatment for Ischemic Heart Failure Trial with Dr Robert

Bonow

EVEREST II: Two-year outcomes with Dr Ted Feldman

TAVI vs SAVR in PARTNER with Dr Craig Smith

RIVAL with DrSanjit Jolly

REMEDIAL II with Dr Carlo Briguori

Surgical Treatment of Ischemic Heart Failure Trial with Dr Eric

Velazquez

RAPS with Dr Stephen Fremes

PARTNER (cohort B) with Dr Matthew Reynolds

For more information

ACC Scientific Sessions

ACC 2011 coverage on theheart.org

ACC 2011 on Medscape

Credits and disclosures

Editor:

Shelley Wood

Managing Editor, heartwire

Kelowna, BC

Disclosure: Shelley Wood has disclosed no relevant financial relationships.

Contributor:

Steven Rourke

Manager, Editorial Programming

theheart.org

Montreal, QC

Disclosure: Steven Rourke has disclosed no relevant financial relationships.

Journalists:

Lisa Nainggolan, theheart.org

London, UK

Disclosure: Lisa Nainggolan has disclosed no relevant financial

relationships.

Sue Hughes, theheart.org

London, UK

Disclosure: Sue Hughes has disclosed no relevant financial relationships.

Reed Miller, theheart.org

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

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