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:
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Managing Editor, heartwire
Kelowna, BC
Disclosure: Shelley Wood has disclosed no relevant financial relationships.
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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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