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, Louisiana, from April 2 to April 5, 2011.

Key trials presented at the sessions included:

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 endpoint

STICH substudy: Viability testing didn't affect treatment outcomes

MAGELLAN: Rivaroxaban prevents VTE in medical patients but bleeding is 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 6 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 endpoint of mortality, but major strokes were higher in the TAVI-treated patients, both at 30 days and 1 year. In a combined endpoint of all stroke or transient ischemic attack (TIA), the difference between groups was statistically significant.

"These results indicate that TAVR [transcatheter aortic-valve replacement] 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: TAVI 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, and 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

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 noncoronary artery bypass graft (CABG)-related major bleeding at 30 days. Transradial access, however, did result in a 63% reduction in the risk for 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, Ontario, Canada). "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 Artery Favored Over Saphenous Vein Grafts for CABG

Spotlight on Health Information Technology

The Health Information Technology 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, North Carolina

Meaningful Use: Electronic Quality Reporting

Presented by Floyd Eisenberg, Washington, DC

STICH (Surgical Treatment for Ischemic Heart Failure)

Results: The 5-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 endpoint 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 endpoints.

"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, North Carolina).

See: STICH: No Mortality Benefit for CABG Over Medical Therapy

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 5 years, and such viability didn't influence the relative effectiveness of the 2 treatment strategies, either for all-cause mortality or the secondary endpoints of CV mortality and CV hospitalization.

During a press conference on the STICH presentations, interventionalist Dr. Ted Feldman (Evanston Hospital, Illinois), 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: 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 for 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, Ohio).

See: MAGELLAN: Rivaroxaban Prevents VTE, 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, Indiana

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, Birmingham, United Kingdom

Enhanced external counter pulsation improves endothelial function, inflammatory markers and depression. Deepak Hooda, et al, West Virginia University Heart Institute, Morgantown, West Virginia

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, Virginia

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, Pennsylvania

Influence of myocardial ischemia on outcomes in patients with systolic versus nonsystolic heart failure. Thomas E. Vanhecke, et al, William Beaumont Hospital, Royal Oak, Michigan

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, Illinois

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 lowering blood pressure than using a high (double) dose of an ARB alone, particularly if they have cardiovascular 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: Hypertension Therapy Should Be Guided by Underlying Disease

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

Results: One- and 2-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 2-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, Illinois). "We don't know if we get this from the clip. Perhaps patients can tolerate low levels of regurgitation long term. Perhaps not."

See: 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: PCI using a sirolimus-eluting stent and coronary artery bypass graft (CABG) surgery for unprotected left main coronary artery stenosis yield similar rates of major adverse cardiac or cerebrovascular events at 1 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, Georgia). "That is, we have a remarkable consistency across trials of equipoise with regard to the so-called hard endpoints -- 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

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, Ontario, Canada

Case II: Adolescent athlete with exertional syncope/chest pain

Presented by Wayne J Franklin, Houston, Texas

Case III: Collegiate athlete with ICD

Presented by Renee Sullivan, Iowa City, Iowa

Case IV: 20-Yyar-old with aortic disease wants to continue to swim at NCAA level

Presented by Sandeep Mangalmurti, Chicago, Illinois

Spotlight panelists included: Christine Lawless, Chicago, Illinois; Rachel Lampert, New Haven, Connecticut; Barry Maron, Minneapolis, Minnesota; Luigi Padeletti, Florence, Italy; Paul Thompson, Hartford, Connecticut; and Jeffrey Towbin, Cincinnati, Ohio.

RESOLUTE US

Results: The single-arm study shows the new Resolute stent to yield lower rates of restenosis at 1 year than historical controls made up of studies testing the predecessor stent, Endeavor, also made by Medtronic.

RESOLUTE AC

Results: At 2 years, rates of "patient-related outcomes" and "stent-related outcomes" were no different between patients randomly assigned to the Resolute or to the Xience everolimus-eluting stent, nor were rates of any major clinical events different between the 2 groups. Stent-thrombosis rates at 1 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: 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 1 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 endpoints, explained study investigator Dr. Julinda Mehilli (Technische Universität, Munich, Germany). Although many interventionalists already use DES in SVGs, most DES trials have excluded SVGs, and the only 2 previous randomized trials comparing DES and bare-metal stents in SVGs were very small and produced conflicting mortality results, said Mehilli.

See: DES 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 randomly assigned to dual antiplatelet therapy for 6 months or dual antiplatelet therapy for 1 year. Regarding the primary endpoint of target vessel failure, a composite of cardiac death, MI, or target vessel revascularization at 12 months, investigators observed no statistically significant difference between those treated for 6 months and those treated with for 1 year, suggesting that some patients can stop clopidogrel after just 6 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 6 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 6 Months

Opinions and Discussions

Heartfelt with Dr. Melissa Walton-Shirley

Improving DVT Prophylaxis and Other Stories From ACC 2011

Major Trials From ACC 2011 Affect Cardiology Interventions

TAVI vs Surgery -- Center Stage at ACC 2011

Ileana Pina Offers Insights on Heart Failure Studies

STICHing Results Together from ACC 2011

Optimal Practices for Heart Failure: What's the Latest?

For more information, see the following resources:

• ACC Scientific Sessions
• ACC 2011 on Medscape
• ACC 2011 coverage on theheart.org

Credits and Disclosures

Editor
Shelley Wood
Managing Editor, heartwire
theheart.org
Kelowna, British Columbia, Canada

Disclosure: Shelley Wood has disclosed no relevant financial relationships.

Contributor
Steven Rourke
Manager, Editorial programming
theheart.org
Montreal, Quebec, Canada

Disclosure: Steven Rourke has disclosed no relevant financial relationships.

Journalists
Lisa Nainggolan, theheart.org
London, United Kingdom
Disclosure: Lisa Nainggolan has disclosed no relevant financial relationships.

Sue Hughes, theheart.org
London, United Kingdom
Disclosure: Sue Hughes has disclosed no relevant financial relationships.

Reed Miller, theheart.org
Bethesda, Maryland
Disclosure: Reed Miller has disclosed no relevant financial relationships.

Michael O'Riordan, theheart.org
Toronto, Ontario, Canada
Disclosure: Michael O'Riordan has disclosed no relevant financial relationships.

Steve Stiles, theheart.org
Fremont, California
Disclosure: Steve Stiles has disclosed no relevant financial relationships.

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