AHA 2010 research highlights: A slideshow presentation

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http://www.theheart.org/editorial-program/1156073.do

The American Heart Association (AHA) 2010 Scientific Sessions took place in Chicago. Key trials presented at the sessions include: ADVANCE,RAFT,QRS EMPHASIS-HF,ASCEND HF,ROCKET AF,CLOSURE I,GRAVITAS,P-OM3,BASKET-PROVE,DEFINE,SYMPLICITY HTN,ASCOT CRP and ACT.

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AHA 2010 research highlights: A slideshow presentation

  1. 1. AHA 2010 research highlights:A slideshow presentation
  2. 2. AHA 2010 Research Highlights The American Heart Association (AHA) 2010 Scientific Sessions took place in Chicago, IL, November 13-17, 2010. Key trials presented at the sessions include: ADVANCE: New LVAD equivalent to HeartMate II, nonrandomized study shows RAFT: CRT shows survival benefit for class 2 and 3 HF patients with low EF and wide QRS EMPHASIS-HF: Eplerenone shows large benefits in milder heart failure ASCEND HF: Nesiritide safe but of limited dyspnea benefit in acute HF ROCKET AF: Rivaroxaban noninferior to warfarin, but superiority analyses at odds CLOSURE I: No overall benefit, no reduction in stroke or TIA with PFO closure GRAVITAS: No benefit of doubling dose in clopidogrel nonrespondersP-OM3: Omega-3 PUFA caps dont suppress paroxysmal AF in randomized trialBASKET-PROVE: DES as safe as bare-metal stents in larger coronary arteries, with less TVRDEFINE: Large effects on LDL and HDL cholesterol with CETP inhibitor anacetrapibSYMPLICITY HTN: Catheter-based renal denervation reduces BP in patients with resistant hypertension?ASCOT CRP: Analysis fuels debate over JUPITER-based CRP indication for statinsACT: No benefit of N-acetylcysteine to reduce contrast-induced nephropathy
  3. 3. ADVANCE (Evaluation of the HeartWare Left Ventricular AssistDevice for the Treatment of Advanced Heart Failure) Results: A novel left ventricular assist device (LVAD) developed by a small company called HeartWare (Framingham, MA) is a viable alternative to the only other widely used LVAD, Thoratecs HeartMate II, as a bridge to heart transplant, according to a new multicenter trial carried out in the US. The new device showed noninferiority when compared with patients in the INTERMACS national registry, most of whom had received the HeartMate II device. "The early results show this is at least as good as the other available devices, and we hope this will translate into clinical benefit, but this is only the beginning. Adverse reactions have been a major problem that has dogged the application of LVADs," said Sir Magdi Yacoub (Harefield Hospital, Middlesex, UK), discussant of the trial at the AHA. See ADVANCE: New LVAD equivalent to HeartMate II, nonrandomized study shows for more information.
  4. 4. RAFT (Resynchronization/Defibrillation for Ambulatory HeartFailure Trial) Results: Cardiac resynchronization therapy (CRT) provided a survival benefit beyond that of implantable cardioverter defibrillator (ICD) therapy alone in patients with moderate heart- failure symptoms, a wide QRS complex, and left ventricular systolic dysfunction. "This is a pretty important finding across a wide spectrum of patients. It will likely lead to revisions in the guidelines and changes in physician practice patterns, with more eligible patients being treated and benefiting from this important therapy," said Dr Gregg Fonarow (University of California, Los Angeles). See CRT is a lifeRAFT for class 2 and 3 HF patients with low EF and wide QRS for more information.
  5. 5. EMPHASIS-HF(A Comparison of Outcomes in Patients in New York Heart Association (NYHA) Class II Heart Failure When Treated WithEplerenone or Placebo in Addition to Standard Heart Failure Medicines)Results: The aldosterone antagonist eplerenone (Inspra, Pfizer) produced large reductions in both the risk of death and therisk of hospitalization compared with placebo in patients with systolic heart failure and mild symptoms."Before we recommend expanding the population to receive aldosterone antagonists, we need to learn how to use themwithout causing life-threatening hyperkalemia. This may be particularly true for patients with reduced renal function, diabetes,and advanced age," said the discussant of the study, Dr Lynne Warner Stevenson (Brigham and Womens Hospital,Boston, MA).See EMPHASIS-HF: Eplerenone shows large benefits in milder heart failure for more information.
  6. 6. ASCEND HF (A Study Testing the Effectiveness of Nesiritide inPatients With Acute Decompensated Heart Failure) Results: The IV vasodilator nesiritide (Natrecor, Scios/Johnson & Johnson), a mass-production version of a native natriuretic peptide, appears to be safe for use in acute decompensated heart failure but does not seem to have much more of an effect against acute dyspnea than conventional diuretics and vasodilators, both of which are less expensive. "We constantly put drugs on the market without doing the right outcome trials. If this outcome trial had been done earlier, clinicians and patients would have had a much better idea of the potentially very limited role of this treatment, but they also would have known that it was not harmful," said chair of the ASCEND-HF executive committee, Dr Robert Califf (Duke Clinical Research Institute, Durham, NC), speaking at a press conference at the AHA. See ASCEND-HF: Nesiritide safe but of limited dyspnea benefit in acute HF for more information.
  7. 7. AHA/ASA Distinguished scientists 2010 Every year, the AHA recognizes a select group of prominent scientists whose contributions to research have advanced the understanding of cardiovascular disease and stroke. Those named as 2010 AHA/ASA Distinguished Scientists include: Martin Chalfie, PhD, FAHA (Columbia University, New York, NY), Harlan M Krumholz, MD, SM, FAHA (Yale University School of Medicine, New Haven, CT), Michael H Criqui, MD, MPH, FAHA (University of California, San Diego School of Medicine, La Jolla, CA), and Helen H Hobbs, MD, FAHA (Howard Hughes Medical Institute, Chevy Chase, MD). Dr Hobbs gave the 2010 Distinguished Scientist Lecture entitled "Genetics and Cardiovascular Disease: Are We Getting to the Heart of the Matter?"
  8. 8. ROCKET AF (Randomized, Double-Blind Study Comparing Once-Daily Oral Rivaroxaban With Adjusted-Dose Oral Warfarin for the Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation) Results: The new oral factor Xa inhibitor rivaroxaban (Xarelto, Bayer/Johnson & Johnson) was noninferior to dose-adjusted warfarin with regard to all-cause stroke and non—central nervous system (CNS) embolism, but the question of superiority over warfarin is less clear. In the intention-to-treat superiority analysis, investigators failed to show the drug had an advantage, statistically, over warfarin for the prevention of thromboembolic events in patients with nonvalvular atrial fibrillation. In an on-treatment analysis addressing the superiority question, however, rivaroxaban significantly reduced the risk of stroke or non-CNS embolization by 21% compared with warfarin."If you take away only the conclusion of noninferiority, thats a step up," said Dr Douglas Zipes (Krannert Institute ofCardiology, Indianapolis, IN) speaking with heartwire. "Warfarin is a very difficult drug to use. Patients dont like therepeated INR checks, and its very difficult to maintain control. I have several patients with INRs all over the map, so tohave another substitute for that is welcome. However, the on-treatment analysis shows superiority over warfarin, and whilethats not the gold standard—call it the silver standard—Im very impressed with the results."See Off orbit? ROCKET AF: Rivaroxaban noninferior to warfarin, but superiority analyses at odds for more information.
  9. 9. CLOSURE I Results: There were no differences in the primary end point of stroke or TIA at two years, all-cause mortality at 30 days, and neurological mortality between 31 days and two years for patients randomized to patent foramen ovale (PFO) closure using the STARFlex closure device (NMT Medical) as well as six months of aspirin and clopidogrel (and an additional 18 months of aspirin) compared with patients who received best medical therapy—aspirin or warfarin or a combination. "It is now clear that the selection of patients for PFO closure should be refined, and we cannot now consider closing PFO in all patients who have stroke of unknown cause. The term cryptogenic strokes is probably unnecessarily cryptic to many physicians and patients . . . too vague," said trial discussant Dr Pierre Amarenco (Bichat Hospital, Paris, France). See CLOSURE I: No overall benefit, no reduction in stroke or TIA with PFO closure for more information.
  10. 10. GRAVITAS (Gauging Responsiveness With A VerifyNowAssay-Impact On Thrombosis And Safety) Results: Patients receiving drug-eluting stents who showed high residual platelet activity, according to platelet-function tests with the VerifyNow assay, fared no better on a double-dose of clopidogrel than patients who received the regular clopidogrel dose. "In post-PCI patients with low-risk clinical presentations, a treatment strategy of high-dose clopidogrel for high residual reactivity on platelet-function testing is not warranted," concluded lead investigator Dr Matthew Price (Scripps Clinic, La Jolla, CA), presenting the results to the media at the AHA 2010 Scientific Sessions. See GRAVITAS: No benefit of doubling dose in clopidogrel nonresponders for more information.
  11. 11. P-OM3 (Efficacy and Safety of Prescription Omega-3-Acid Ethyl Esters for the Prevention of Recurrent Symptomatic Atrial Fibrillation) Results: Taking prescription-only omega-3 polyunsaturated fatty-acid (PUFA) capsules (Lovaza, GlaxoSmithKline), even at the fairly high dose of 4 g/day for six months, didnt cut the risk of recurrence of symptomatic paroxysmal atrial fibrillation (AF). There was, however, "a reduction in average ventricular rate during the first AF recurrence, a reduction in triglyceride levels at week 24 that did not occur with placebo, and increased blood levels of the omega-3 fish oils eicosapentaenoic acid and docosahexaenoic acid compared with placebo patients," according to the studys authors."Many of our patients in fact do use fish-oil products, in various doses and in various preparations, in hope of preventingseveral cardiovascular end points. And there clearly has been equipoise in the area of atrial fibrillation, with as manystudies producing positive as those producing negative results," said lead investigator Dr Peter R Kowey (LankenauInstitute for Medical Research, Wynnewood, PA). The current study, he said, "is actually the first large randomized trial ofthis medication in a nonsurgical population."See See Omega-3 PUFA caps dont suppress paroxysmal AF in randomized trial for more information.
  12. 12. Poster sessions A total of 2103 posters were presented at the AHA 2010 Scientific Sessions. The eight poster winners were: Nuclear Cardiology and Outcomes, Incremental Value of Noninvasive Cardiac Imaging in Risk Prediction: Results from the SPARC Study, presented by Marcelo DiCarli Body Composition and Mortality in Patients With Coronary Heart Disease - The "Obesity Paradox," presented by Carl Lavie Hypoxia Inducible Factor-1a Dependent miR-210 is a Critical Regulator of Paracrine Activity in Preconditioned Mesenchymal Stem Cells for Angiogenic Growth Factor Expression, presented by Shazia DurraniEfficacy and Potency of Class 1 Antiarrhythmic Drugs for Suppression of Ca2+ Waves in Permeabilized Calsequestrin Null Myocytes,presented by Eleonora Savio GalimbertiThe Relationship of Rotors to Scar Border Zones and Dominant Frequency Domains in Human Ventricular Fibrillation, presented byStephane MasseVegetation Size Does Not Affect Stroke Risk in Infective Endocarditis After 5 Days of Effective Antimicrobial Therapy: An Analysis From theInternational Collaboration on Endocarditis-Prospective Cohort Study (ICE-PCS), presented by Stuart DickermanThe Endovascular Stent Graft Raises Vascular Stiffness and Changes Cardiac Structure within a Very Short Term, presented by YasuharuTakedaHealth Economics in the Platelet inhibition and Patient Outcomes (PLATO) Randomized Trial: Report on Within Trial Resource UsePatterns, presented by Magnus Janzon
  13. 13. BASKET-PROVE Results: Patients needing a coronary stent 3.0 mm in diameter or larger were randomized to either a first-generation sirolimus- eluting stent (Cypher Select, Cordis), a bare-metal cobalt- chromium stent (Vision, Abbott), or a second-generation everolimus-eluting stent (Xience V, Abbott Vascular). All patients were prescribed aspirin and clopidogrel for at least one year postimplant. The rates of the primary end point, a composite of death from cardiac causes or nonfatal MI at two years, were statistically similar for all three groups. There were no significant differences in the rates of late events or the rates of death, MI, or stent thrombosis, but there was a significant difference in non-MI TVR rates between the DES patients and bare-metal- stent patients. "[I]n contemporaneous stenting of large coronary arteries, late safety problems with drug-eluting stents could not be confirmed, and there was even a trend in the opposite direction," explained study investigator Dr Christoph Kaiser (University Hospital Basel, Switzerland). See BASKET-PROVE: DES as safe as bare-metal stents in larger coronary arteries, with less TVR for more information.
  14. 14. DEFINE (Determining the Efficacy and Tolerability ofCETP Inhibition with Anacetrapib) Results: The new cholesteryl ester transfer protein (CETP) inhibitor anacetrapib (Merck, Whitehouse Station, NJ) significantly decreased LDL-cholesterol levels by 36% and increased HDL-cholesterol levels by 138% when compared with placebo. Importantly, there was no increase in systolic blood pressure, an off-target effect that troubled torcetrapib, an earlier CETP inhibitor that was later pulled from clinical testing after a large morbidity and mortality trial revealed an increased risk of mortality and cardiovascular events. "Its game changer, but because we dont have hard clinical events, we cant say that its a home run," Dr Roger Blumenthal (Johns Hopkins Medical Institute, Baltimore, MD) told heartwire. "Still, in this short time, [76 weeks], we see a decrease in total events and total revascularizations, and we werent expecting that at all. We just wanted to see the safety of the drug. So, its really exciting." See DEFINE: Large effects on LDL and HDL cholesterol with CETP inhibitor anacetrapib for more information.
  15. 15. SYMPLICITY HTN-2 (Renal Denervation in Patients WithUncontrolled Hypertension) Results: A new technique, catheter-based renal denervation, used in patients with resistant hypertension resulted in significant reductions in blood pressure without any major complications. Severe, resistant hypertension that is uncontrolled despite patients taking five or more antihypertensive medications is a big unmet clinical need, with those affected being at increased risk of stroke and renal failure. "There is nowhere to go for these patients. We think with this novel approach we can bring many of them under control. Ive never seen BP falls as big as this from any other treatment process, which makes the possibility of cure realistic; it might be within reach. It has always been a dream of mine, to come up with a cure for hypertension," said Dr Murray D Esler (Baker IDI Heart and Diabetes Institute, Melbourne, Australia) in an interview with heartwire. See A revolutionary road for resistant hypertension? Renal denervation in Symplicity HTN-2 for more information.
  16. 16. ASCOT-CRP Results: The addition of high-sensitivity C-reactive protein (hs- CRP) measurements didnt much improve conventional risk assessments in patients with hypertension and other CV risk factors but normal or only modestly elevated LDL-cholesterol levels in a post hoc analysis of the ASCOT lipid-lowering arm. Moreover, among patients in the analysis who had been randomized to receive atorvastatin (Lipitor, Pfizer), a significant reduction in LDL-C corresponded to a significant drop in CV- event risk at six months. But a significant fall in hs-CRP levels did not predict a decrease in CV events. "These results do not support current proposals to measure CRP in the clinical setting, either to assign statins to individuals on the basis of an elevated CRP alone or to monitor CRP levels as an indicator of the efficacy of statin treatment," said ASCOT co-chair Dr Peter S Sever (Imperial College, London, UK). See ASCOT analysis fuels debate over JUPITER-based CRP indication for statins for more information.
  17. 17. ACT (Acetylcysteine for Contrast-Induced Nephropathy Trial) Results: The addition of N-acetylcysteine failed to reduce the risk of contrast-induced nephropathy in patients undergoing coronary and vascular angiography. "I would be comfortable saying that this is a definitive trial, and Id be comfortable saying that because if you look at the other high-quality trials, we reached exactly the same result," Dr Otavio Berwanger (Hospital do Coração, São Paulo, Brazil) told heartwire. "It would be extremely unlikely that another trial would be conducted, say a larger 20 000-patient trial, and would find a different result. One thing that is interesting with negative trials is that there is often a subgroup, maybe sicker patients, the elderly, that might have a different result. But here, it was very consistent." See ACT: No benefit of N-acetylcysteine to reduce contrast- induced nephropathy for more information.
  18. 18. Opinions from AHA Heartfelt with Dr Melissa Walton Shirley: The HDL ceiling: Cracked today by DEFINE and the CETP inhibitor anacetrapib Ready, set, go! Lets see how long it takes us to stop using N- acetylcysteinepost-ACT DES safety in BASKET-PROVE; ACT on contrast-induced nephropathy; dosing for clopidogrel nonresponders in GRAVITAS; TAMARIS on gene therapy Latest on atrial fibrillation with analysis of ROCKET AF ( and POM 3 (fish oil supplements); SMART-AV on cardiac resynchronization; PFO closure in CLOSURE I Take the thrombin-inhibitor exam: Automatically win a million dollars if you get 100% correct! Three decades worth of proof: Minnesota cities prove critics of smoking- cessation efforts wrong, wrong, WRONG! Results, analysis, and clinical implications of leading heart-failure trials at AHA 2010: Eplerenone in EMPHASIS-HF; CRT and RAFT; LVAD in ADVANCE; nesiritide in ASCEND-HF Gross pics of tobacco carnage: Reverse marketing or empty drama?Private practice with Dr Seth Bilazarian:GRAVITAS has immediate impact on my practiceNew horizons for atrial fibrillation as ROCKET AF (rivaroxaban) follows on the heels of RE-LY (dabigatran)Eplerenone, nesiritide, CRT, LVAD: Clinical implications of heart-failure trial results from AHA 2010Physician wages across specialties: Cardiologists earn $93 per hour (for now)Heart failure and transplantation with Dr Ileana Piña:Petitioning the Social Security Administration for compassionate disability for HF, transplant, and congenital heart-disease patients
  19. 19. AHA 2010 Over 23 500 people attended the AHA 2010 Scientific Sessions, which included: 1592 oral presentations, 2103 posters, and 16 late-breaking clinical trials. Sessions were grouped into 7 core themes: • Cardiovascular Imaging • Epidemiology and Prevention of Cardiovascular Disease: Physiology, Pharmacology and Lifestyle • Genetics, Genomics and Congenital Cardiovascular Disorders • Heart Rhythm Disorders and Resuscitation Science • Myocardium: Function and Failure • Catheter-Based and Surgical Interventions • Vascular Disease: Biology and Clinical Science The 2011 AHA Scientific Sessions will be held November 12- 16, 2011, at the Orange County Convention Center in Orlando, Florida.
  20. 20. For more information AHA site AHA 2010 Coverage on theheart.org Medscape coverage AHA 2010
  21. 21. Credits and disclosuresEditor: Journalists:Shelley Wood Lisa Nainggolan, theheart.orgManaging Editor, heartwire London, UKtheheart.org Disclosure: Lisa Nainggolan has disclosed no relevant financialKelowna, BC relationshipsDisclosure: Shelley Wood has disclosed no relevantfinancial relationships. Sue Hughes, theheart.org London, UKContributor: Disclosure: Sue Hughes has disclosed no relevant financialSteven Rourke relationships.Manager, Editorial programmingtheheart.org Montreal, QC Reed Miller, theheart.orgDisclosure: Steven Rourke has disclosed no Bethesda, MDrelevant financial relationships. Disclosure: Reed Miller has disclosed no relevant financial relationships. Michael ORiordan, theheart.org Toronto, ON Disclosure: Michael ORiordan has disclosed no relevant financial relationships. Steve Stiles, theheart.org Fremont, CA Disclosure: Steve Stiles has disclosed no relevant financial relationships.
  22. 22. More slideshows ESC 2010 research highlights: A slideshow presentation TCT 2010 research highlights: A slideshow presentation
  23. 23. 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.

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