AHA 2012 Research Highlights

  • 1,312 views
Uploaded on

The American Heart Association (AHA) 2012 Scientific Sessions took place in Los Angeles, CA on November 3-7, 2012. Key trials presented at the sessions include: FREEDOM, TACT, UMPIRE, PHS II, OPERA …

The American Heart Association (AHA) 2012 Scientific Sessions took place in Los Angeles, CA on November 3-7, 2012. Key trials presented at the sessions include: FREEDOM, TACT, UMPIRE, PHS II, OPERA and FORWARD, ASPIRE, TRILOGY ACS/ARCTIC, MADIT-RIT, RELAX-AHF, POSEIDON / SCIPIO, PCSK9 studies, PCSK9, dal-OUTCOMES andLoDoCo.

  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Be the first to comment
No Downloads

Views

Total Views
1,312
On Slideshare
0
From Embeds
0
Number of Embeds
1

Actions

Shares
Downloads
24
Comments
0
Likes
2

Embeds 0

No embeds

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
    No notes for slide

Transcript

  • 1. AHA 2012 research highlights:A slideshow presentation
  • 2. AHA 2012 Research Highlights The American Heart Association (AHA) 2012 Scientific Sessions took place in Los Angeles, CA on November 3-7, 2012. Key trials presented at the sessions include: FREEDOM: CABG superior to PCI in diabetic patients with coronary disease TACT: Surprising, puzzling benefit from chelation therapy after MI UMPIRE: Fixed-dose combo improves adherence, lowers cholesterol and BP PHS II: No benefits of vitamins for preventing CVD OPERA and FORWARD: Death knell for fish oil in atrial fibrillationASPIRE: Aspirin good option for extended treatment of VTETRILOGY ACS/ARCTIC: Back to the drawing board for platelet monitoringMADIT-RIT: Simple programming change averts most inappropriate ICD therapyRELAX-AHF: Serelaxin reduces dyspnea, but questions surround mortality benefitPOSEIDON / SCIPIO: Two trials stand out among the mixed results of stem-cell trials presented at the Scientific SessionsPCSK9 studies: Two new PCSK9 MAbs for LDL-lowering look good in phase 2dal-OUTCOMES: Wrestling with why the CETP inhibitor failed to reduce outcomesLoDoCo: Cheap, widely available colchicine reduces events in secondary prevention
  • 3. FREEDOM CABG superior to PCI in diabetic patients with coronary disease Results: Patients with diabetes and multivessel coronary artery disease treated with CABG surgery had significantly lower rates of death from any cause, nonfatal MI, or nonfatal stroke when compared with diabetic patients treated with PCI, according to the long-awaited main results of the FREEDOM trial. The researchers believe the results have the potential to immediately alter clinical practice and potentially have an impact on the clinical guidelines for the management of patients with diabetes."I think the study is very convincing, and I think the guidelines will likely recognize that," said Dr David Williams (Brighamand Womens Hospital, Boston, MA), an interventional cardiologist not affiliated with the trial. "There have been trendsshowing this before, such as the BARI-2D study with similar information showing that surgery was definitely better thanmedicine. I think that if you look at the anatomy—and all coronary disease is not the same—the anatomy [of diabetics] isimposing, and I think most of these patients go to surgery anyway. But I think this provides meaningful information to helpus with these decisions."See:FREEDOM: CABG superior to PCI in diabetic patients with coronary disease
  • 4. TACT Surprising, puzzling benefit from chelation therapy after MI Results: A randomized, double-blind trial of chelation therapy has suggested that the alternative-medicine mainstay may modestly improve clinical outcomes in patients after an acute MI. Over a four-year follow-up, those who followed an arduous regimen involving up to 40 separate three-hour infusions of a standard chelation-therapy solution of multiple ingredients, compared with a placebo, showed an 18% drop in the trials primary end point. Adverse effects were mostly minimal. The difference in the end point—a composite of all-cause mortality, MI, stroke, coronary revascularization, and hospitalization for angina—barely reached the trials prespecified threshold for statistical significance.Dr E Magnus Ohman (Duke University, Durham, NC), who wasnt connected with the trial, agreed that the efficacydifference was only marginal but pointed to the trials subgroup analysis, which suggested that diabetics seemed to show asignificantly more pronounced benefit from chelation therapy than the population as a whole. "So theres a subgroup thatappears to have a very strong signal."See:TACT: Surprising, puzzling benefit from chelation therapy after MI
  • 5. UMPIRE Fixed-dose combo improves adherence, lowers cholesterol and BP Results: A fixed-dose combination tablet that includes aspirin, a statin, and two antihypertensive medications improves adherence to therapy and results in a significant reduction in LDL-cholesterol levels and blood pressure when compared with patients randomized to usual care. Overall, investigators observed a 33% increase in adherence over a 15-month period, suggesting that fixed-dose combination therapy might go a long way toward reducing cardiovascular events in this population of high-risk patients and those with established cardiovascular disease."I think the real potential benefit in UMPIRE is compliance, giving everybody a single pill that is easier to take, rather than ahandful of pills," said Dr Dariush Mozaffarian (Brigham and Womens Hospital, Boston, MA). "I think, on average, thatsactually a good idea. If people have indications for these medicines, why not combine them into a single pill and make iteasier for them to take? I think the polypill is a good idea for people who already have the indications."See:UMPIREs ruling: Fixed-dose combo improves adherence, lowers cholesterol and BP
  • 6. PHS II No benefits of vitamins for preventing CVD Results: The largest, randomized, double-blind trial to date has confirmed what smaller studies have suggested and what many physicians have long believed: a daily multivitamin does not reduce the risk of CVD. In an accompanying editorial, Dr Eva Lonn (McMaster University, Hamilton, ON) notes that over one-third of the US population takes some kind of daily multivitamin, swelling sales of dietary supplements to almost $24 billion in 2008. Regulations governing their approval and marketing, however, are less strict than for drugs. "This has allowed for claims of benefit in preventing or curing an amazingly diverse and ever- increasing variety of illnesses ranging from CVD to cancer,arthritis, infections, macular degeneration, Alzheimers disease, wrinkles, hair loss, decreased libido, and low sexualprowess. As a result," she argues, "many people with heart disease or risk factors continue to lead unhealthy lives yettake daily vitamins and supplements in the hope of mitigating future problems."See:Big bucks, no bang: PHS II shows no benefits of vitamins for preventing CVD
  • 7. OPERA and FORWARD Death knell for fish oil in atrial fibrillation Results: Short-term administration of fish oil to patients undergoing heart surgery did not reduce the incidence of postoperative atrial fibrillation (AF) according to the results of the OPERA trial. There was no difference between the active- treatment and placebo groups in terms of preventing postoperative AF, despite the fact that patients in this study were given fairly high doses of fish oil in the form of a prescription product. This assertion was borne out in a second trial, Fish Oil Research with Omega-3 for Atrial Fibrillation Recurrence Delay (FORWARD), performed in people with previous AF, to see whether 1 g per day of fish oil would prevent recurrences. It did not. "Every time weve had a major trial using omega-3s that was conducted as a primary purpose of the trial, weve come up short. Its very discouraging for the omega-3 story," said invited panel member Dr Peter Wilson (Emory University, Atlanta). See: OPERA does not sing praises for fish oil in AF
  • 8. ASPIRE Aspirin good option for extended treatment of VTE Results: People who have suffered a first episode of unprovoked venous thromboembolism (VTE) need to have initial therapy with heparin followed by warfarin or one of the newer anticoagulants for a few months, but thereafter there is debate as to what they should do. Results of a new study— together with findings from an almost identical trial reported last year, WARFASA—now suggest that 100 mg per day of aspirin is a good option for ongoing treatment in these patients."We are not advocating that patients should decide to stop anticoagulant therapy early as a result of these findings,"stresses senior author Dr John Simes (University of Sydney, Australia). "But in patients who are going to stop anyway,aspirin provides a moderately effective treatment compared with not having anything. We believe this is a cheap andrelatively safe therapy that should be considered to prevent further venous thromboembolic events, and not only is it ofbenefit in clinical terms, but it is cost saving."See:ASPIRE: Aspirin good option for extended treatment of VTE
  • 9. TRILOGY ACS and ARCTIC Back to the drawing board for platelet monitoring Results: The role of platelet-function monitoring has suffered another serious setback, with two new studies adding to several others that suggest no benefit of such an approach. The TRILOGY ACS substudy found no independent association of platelet function and ischemic outcomes in medically managed ACS patients. Meanwhile, the ARCTIC trial found no benefit of platelet-function testing and modification of treatment in patients receiving drug-eluting stents."The TRILOGY substudy tells us that this single marker measuring ADP-mediated platelet activation is not giving us thewhole picture," said senior TRILOGY investigator Dr E Magnus Ohman (Duke Clinical Research Institute, Durham, NC)."It is more complicated than that. There are six or seven different receptors on platelets, and we have just measuredone." Commenting on the ARCTIC study, he added: "I dont think this means that monitoring is not a viable strategy inselected patients, but we may need to do much more work to understand what affects platelet reactivity that is driven bycommon clinical characteristics."See:TRILOGY/ARCTIC: Back to the drawing board for platelet monitoring
  • 10. MADIT-RIT Simple programming change averts most inappropriate ICD therapy Results: A large randomized trial has identified specific programming criteria for implantable cardioverter defibrillator (ICD) devices that, compared with conventional programming, cut the risk of inappropriately delivered therapy by almost 80%. The alternate programming also led to a significant drop in mortality in the patients with primary-prevention ICDs by more than one-half over a follow-up averaging 1.4 years."It would have been very surprising to me if this had not been a positive study, but what we didnt have before was alarge, randomized clinical trial," said Dr Bruce L Wilkoff (Cleveland Clinic, OH). "This is a large randomized trial thatsupports absolutely all the studies that have come before it, with a large and clearly significant outcome. So I think this ishuge."See:MADIT-RIT: Simple programming change averts most inappropriate ICD therapy
  • 11. RELAX-AHF Serelaxin reduces dyspnea, but questions surround mortality benefit Results: A novel recombinant form of human relaxin 2 used in the treatment of acute heart failure (AHF) reduced shortness of breath as assessed using one of two dyspnea end points, according to the results of a new study. Investigators were also excited by the reduction in all-cause and cardiovascular mortality with serelaxin (Novartis Pharmaceuticals), as well as reductions in the signs and symptoms of congestion and worsening heart failure."In terms of its primary end point, breathlessness, I think there is little doubt that this agent was beneficial," said Dr JohnMcMurray (University of Glasgow, Scotland). "The totality of the evidence, the breathlessness measurement, the signs,the symptoms, and the use of other therapies, to me at least, quite clearly indicate that this drug is doing something goodin terms of relief of symptoms and congestion."See:RELAX-AHF: Serelaxin reduces dyspnea, but questions surround mortality benefit
  • 12. POSEIDON and SCIPIO POSEIDON: Allogeneic stem cells are safe in chronic ischemics; SCIPIO: Cardiac stem cells reverse heart failure Results: Results of the POSEIDON study indicate that myocardial injections of allogeneic mesenchymal stem cells (MSC) are safe and may eventually be an "off-the-shelf" therapy for chronic ischemic MI. As well, encouraging two-year follow-up results from SCIPIO, a small study of cardiac stem-cell (CSC) injections in patients with ischemic cardiomyopathy, showed that the CSC-treated patients had statistically significant improvements in mass of nonviable myocardial tissue and the percentages of viable tissue within the infarcted region. Minnesota Heart Failure Scores improved significantly in the CSC-treated patients while remaining almost flat in the control group."We come away from this [trial] with optimism and feel that weve helped to define the parameters around which cell therapy can andshould be used for ischemic cardiomyopathy," said lead POSEIDON investigator Dr Joshua Hare (University of Miami, FL)."We are just at the beginning of a dramatic revolution in cardiovascular medicine," said Dr Roberto Bolli (University of Louisville,KY). "Its amazing. We picked an arbitrary dose. We dont understand when the best time to give [the cells] is or if you can give themmultiple times to the same patient—which we probably can, but it hasnt been done so far—so were still learning how to use them,but the very first time with this totally new therapy we found such a dramatic improvement. This is very encouraging."See:POSEIDON: Allogeneic stem cells are safe in chronic ischemicsSCIPIO: Cardiac stem cells reverse heart failure
  • 13. PCSK9 studies New PCSK9 MAbs for LDL-lowering look good in phase 2 Results: New phase 2 studies with two anti-PCSK9 monoclonal antibodies all show large reductions in LDL cholesterol. The antibodies work by inhibiting the PCSK9 protein. This PCSK9 protein binds to LDL receptors, resulting in their degradation, so that fewer are available on liver cells to remove excess LDL-C from the blood. Moreover, traditional LDL-lowering therapies such as statins actually stimulate the production of PCSK9, which limits their own ability to lower LDL-C. By blocking the PCSK9 pathway, these antibodies upregulate the recycling of LDL receptors and therefore represent a potentially novel mechanism for lowering LDL.Dr Peter Wilson (Emory University School of Medicine, Atlanta) said the information presented today added data on anti-PCSK9 antibodies in another 450 to 500 patients. "We now have biologics now to treat hypercholesterolemia. The lipideffects with these antibodies are really quite good. They are very effective and extremely promising." But he added: "Alleyes will now be on safety and long-term outcomes."See:Two new PCSK9 MAbs for LDL-lowering look good in phase 2
  • 14. dal-OUTCOMES Wrestling with why the CETP inhibitor failed to reduce outcomes Results: Final results of the dal-OUTCOMES study, a phase 3 clinical trial testing the efficacy of the investigational cholesteryl ester transfer protein (CETP) inhibitor dalcetrapib (Hoffman-La Roche), have left investigators to wrestle with reasons that the drug failed to have an impact on clinical outcomes. Some experts believe the modest but clinically significant increase in blood pressure might have doomed the drug."It may be that when other risk factors are controlled as well as we currently can using many, if not all, of our evidence-based treatments, including statins, dual antiplatelet therapies, beta blockers, etc, that the risk thats modifiable by alteringHDL-cholesterol levels may not be significant," said Dr Gregory Schwartz (University of Colorado School of Medicine,Denver). He pointed out that even among patients in dal-OUTCOMES who achieved the highest HDL-cholesterol levels,approximately 70 mg/dL in about 10% of patients, there was no apparent decrease in risk compared with other patients inthe trial.See:dal-OUTCOMES: Wrestling with why the CETP inhibitor failed to reduce outcomes
  • 15. LoDoCo Cheap, widely available colchicine reduces events in secondary prevention Results: In this prospective, randomized, open, blinded end- point study testing the effectiveness of colchicine in secondary prevention, investigators showed that the drug reduced the risk of the primary end point—defined as ACS, out-of-hospital cardiac arrest, or noncardioembolic ischemic stroke—by 67%, driven largely by a reduction in non–stent-related ACS. Colchicine is an old drug commonly used to treat gout and familial Mediterranean fever. Dr Seth Bilazarian (Pentucket Medical Associates, Haverhill, MA) said he was very excited to see such positive results for an old standby. "Our familiarity and longtime use of this drug in gout makes this a very attractive treatment option." See: LoDoCo: Cheap, widely available colchicine reduces events in secondary prevention
  • 16. For more information Complete AHA 2012 coverage on theheart.org AHA 2012 Scientific Sessions American Heart Association
  • 17. Credits and disclosures Editor: Michael ORiordan, heartwire Shelley Wood theheart.org Managing Editor, heartwire Toronto, ON theheart.org Disclosure: Michael ORiordan has Kelowna, BC disclosed no relevant financial Disclosure: Shelley Wood has disclosed relationships. no relevant financial relationships. Steve Stiles, heartwire Journalists: theheart.org Sue Hughes, heartwire Fremont, CA theheart.org Disclosure: Steve Stiles has disclosed no London, UK Disclosure: Sue Hughes has disclosed relevant financial relationships. no relevant financial relationships. Contributors: Reed Miller, heartwire Steven Rourke theheart.org Editorial Director State College, PA theheart.org Disclosure: Reed Miller has disclosed Montreal, QC no relevant financial relationships. Disclosure: Steven Rourke has disclosed no relevant financial relationships. Lisa Nainggolan, heartwire theheart.org Maria Turner London, UK Montreal, QC Disclosure: Lisa Nainggolan has Disclosure: Maria Turner has disclosed no disclosed no relevant financial relevant financial relationships. relationships.
  • 18. More slideshows TCT 2012 research highlights ESC 2012 research highlights EuroPCR 2012 research highlights HRS 2012 research highlights ACC 2012 research highlights
  • 19. Become a member of http://www.theheart.org Become a fan on Facebook: http://www.facebook.com/theheartorg Follow us on Twitter: http://www.twitter.com/theheartorgtheheart.org is the leading online source of independent cardiology news.We are the top provider of news and opinions for over 100 000 physicians.