ESC 2010 Research Highlights : A slideshow presentation

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Key trials presented at the meeting include: AVERROES, SHIFT, ALPHA OMEGA Trial, EINSTEIN DVT, FUTURA OASIS-8, LESSON 1, PLATO genetic substudies,CURE/ACTIVE A, INNOVATE PCI, ATOLL, COPPS, RESPONSE and STAR-HEART

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ESC 2010 Research Highlights : A slideshow presentation

  1. 1. ESC 2010 research highlights:A slideshow presentation
  2. 2. ESC 2010 Research Highlights Key trials presented at the meeting include: AVERROES: Apixaban yields significant reductions in stroke, no increased bleeding. SHIFT: Adding HR-slowing agent ivabradine to HF meds cuts mortality, hospitalization. ALPHA OMEGA Trial: n-3 fatty acids fail to reduce cardiovascular events in post-MI patients. EINSTEIN DVT: Rivaroxaban almost superior to usual care in treatment of DVT. FUTURA OASIS-8: Standard-dose heparin recommended during PCI to avoid catheter thrombosis with fondaparinux. LESSON 1: Everolimus bests sirolimus in nonrandomized DES face-off. PLATO genetic substudies: No need for gene testing in PCI patients. CURE/ACTIVE A: No effect of loss-of-function clopidogrel gene on event rates in ACS or AF. INNOVATE PCI: Elinogrel, a new antiplatelet agent, passes initial hurdles. ATOLL: Study seen as supporting enoxaparin over standard heparin in primary PCI. COPPS: Colchicine halves incidence of postpericardiotomy syndrome. RESPONSE: Nurse program "reasonably successful" for ACS secondary prevention. STAR-HEART: Stem cells associated with improved long-term hemodynamics and reduced mortality in chronic heart failure
  3. 3. AVERROES (Apixaban versus Acetylsalicylic Acid toPrevent Strokes) Results: Patients with atrial fibrillation unable to take warfarin who were treated with the investigational oral factor Xa inhibitor apixaban (Pfizer/Bristol-Myers Squibb) had a significantly lower risk of stroke and systemic embolic events compared with patients treated with aspirin. Importantly, there were no observed increases in the risk of major bleeding, minor bleeding, or intracranial hemorrhage, among other end points, in those treated with apixaban. "As a proof of principle, its exciting, because these new drugs are so selective just on one factor, like factor Xa, whereas warfarin is much less selective, inhibiting around five factors, so it makes sense that bleeding tends to be lower in these new drugs," said Dr Harald Arnesen (Oslo University Hospital, Norway), the scheduled discussant during the late-breaking clinical-trials session. "The fact that the [bleeding] risks are quite similar to aspirin is really quite exciting." See AVERROES: Apixaban yields significant reductions in stroke, no increased bleeding for more information.
  4. 4. SHIFT (Systolic Heart Failure Treatment with the If InhibitorIvabradine Trial)Results: Patients with chronic systolic heart failure who added ivabradine (Procoralan, Servier) to the medications they werealready taking showed a significant 18% drop in the composite rate of cardiovascular death or heart-failure hospitalization,compared with a placebo control group, over a period of about two years."This is a very interesting study that tests a novel concept of heart-rate slowing as adjunctive therapy for heart failure," said DrClyde Yancy (Baylor University Medical Center, Dallas, TX), who was not involved with the trial. "But," he added, "sufficientquestions remain regarding who would benefit most from this approach."See SHIFT: Adding HR-slowing agent ivabradine to HF meds cuts mortality, hospitalization for more information.
  5. 5. ALPHA OMEGA Results: Low-dose supplementation with the n-3 fatty acids eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), or plant-derived alpha-linolenic acid (ALA) failed to reduce cardiovascular events in a large cohort of patients who had previously had an MI. The investigators, including trial leader Dr Daan Kromhout (Wageningen University, the Netherlands), say the negative findings are likely the result of the optimal medical therapy that patients in the trial were receiving following their index MI. All patients were treated with "state-of-the-art antihypertensive, antithrombotic, and lipid-modifying therapy," and this might explain the discrepancy with previous studies that suggested n-3 fatty acids, particularly EPA, might be cardioprotective following MI. See Alpha Omega Trial: n-3 fatty acids fail to reduce cardiovascular events in post-MI patients for more information.
  6. 6. EINSTEIN DVT Results: The oral factor Xa inhibitor rivaroxaban (Xarelto, Bayer/Johnson & Johnson) was found to be noninferior to standard medical therapy for the treatment of acute symptomatic deep vein thrombosis (DVT). Dr Harry R Buller (Academic Medical Center, Amsterdam, the Netherlands) said that rivaroxaban, an oral factor Xa inhibitor, was close to demonstrating superiority, although the trial was designed specifically to demonstrate noninferiority, because "the standard medical treatment is so good." But although usual care is effective, it is inconvenient, requiring initial subcutaneous injections of low-molecular-weight heparin followed by warfarin treatment, with its own attendant problems. See Rivaroxaban almost superior to usual care in treatment of DVT for more information.
  7. 7. Cardiologists of Tomorrow at ESC 2010 At this years Congress, the ESC debuted a special educational program for cardiologists-in-training, junior cardiologists under the age of 35, and first-time attendees of the ESC interested in refreshing their knowledge. The program was a partnership between the ESC, the 52 ESC national societies, and 28 ESC affiliate national societies. The "Cardiologists of Tomorrow" program consisted of 42 sessions on topics from treatment of hypertension to the genetic aspects of arrhythmias. The sessions included clinical seminars, special sessions, and regular symposia. Prof Fausto Pinto, chair of the ESC Congress Program Committee, awarded prizes to the following young investigators: Joanna Hammond from Brussels, Belgium (basic science), Andrew Ludman from London, UK (clinical science), Alexios Antonopoulos from Athens, Greece (coronary pathophysiology and microcirculation), Radoslaw Debiec from Leicester, UK (population sciences), Sasha Koul from Lund, Sweden (thrombosis), and Daurice Grossniklaus from Atlanta, GA, who won the Atie Immink ward in nursing. The state-of-the-art research awards in heart failure and CAD were awarded to Katrin Walenta from Homburg/Saar, Germany and Pascal Lim from Creteuil, France.
  8. 8. FUTURA/OASIS-8 (Fondaparinux Trial With UFH DuringRevascularization in Acute Coronary Syndromes)Results: ACS patients undergoing PCI being treated with fondaparinux as the main anticoagulant should receive standard-doseunfractionated heparin during the procedure to avoid catheter thromboses. Results of the trial showed no major advantages of low-dose heparin over standard-dose heparin in such patients, and neither dose increased major bleeding when compared with the historicalcontrol group of fondaparinux alone in the OASIS-5 trial."The trial has resolved this important issue with fondaparinux. It has shown that we can reduce the problem of catheter thrombosiswithout increasing major bleeding. This means that ACS patients on fondaparinux can undergo PCI safely with adjunctive [intravenous]IV heparin," said Dr Sanjit Jolly (McMaster University, Hamilton, ON), co-lead investigator of the trial, speaking at an ESC pressconference.See: FUTURA/OASIS-8: Standard-dose heparin recommended during PCI to avoid catheter thrombosis with fondaparinux for moreinformation.
  9. 9. LESSON I Results: Patients treated with everolimus-eluting stents showed a 17% relative risk reduction in the primary end point of death, MI, and TVR, compared with a patient cohort treated with sirolimus-eluting stents, only narrowly missing statistical significance (p=0.056). This nonrandomized comparison provides some of the strongest evidence yet that so-called "next-generation" drug-eluting stents (DES) may have an edge in terms of safety and efficacy over the first drug-eluting stent on the market. Dr Stephan Windecker (Bern University Hospital, Switzerland), who presented the results during a hot-line session at the ESC, noted that the study just missed its primary end point but showed statistically significant differences in rates of MI and stent thrombosis. Windecker added that the trial was not powered to look at the isolated clinical end points found to be statistically significant in this study, calling the findings "exploratory only." See LESSON I: Everolimus bests sirolimus in nonrandomized DES face-off. for more information.
  10. 10. PLATO genetic substudies Results: Two genetic substudies of the large pivotal trials of the new antiplatelet agents ticagrelor (Brilinta, AstraZeneca) and prasugrel (Effient, Lilly) confirm that neither agent seems to be affected by CYP2C19 loss-of-function alleles, which often indicate poor outcomes in patients taking clopidogrel. Nor was either drug affected by another genetic variation, in the ABCB1 gene, which affects absorption of clopidogrel. CURE/ACTIVE A Results: Loss-of-function CYP2C19 alleles did not have any effect with regard to safety or efficacy of clopidogrel (Plavix, Bristol-Myers Squibb/Sanofi-Aventis) in ACS and AF patients participating in the CURE and ACTIVE A trials, respectively, new results show. However, a gain-of-function CYP2C19 allele was associated with a greater benefit of clopidogrel in the CURE trial, but not the ACTIVE A trial. See New PLATO data: No need for gene testing in PCI patients and CURE ACTIVE: No effect of loss-of-function clopidogrel gene on event rates in ACS or AF for more information.
  11. 11. INNOVATE PCI Results: Treatment with oral and intravenous (IV) elinogrel (Novartis), a novel antiplatelet agent, had more rapid antiplatelet effects than clopidogrel (Plavix, Bristol Myers-Squibb/Sanofi- Aventis) in acute and chronic phases of therapy for patients undergoing nonurgent PCI in this phase 2 trial. "I think, at this point, were talking about potential advantages, remembering this is a phase 2 trial, with this drug," said lead investigator Dr Sunil Rao (Duke University Medical Center, Durham, NC). "Remember that, based on recent clinical-trial data, there is a suggestion that greater platelet inhibition is associated with better ischemic outcomes, but that comes with a cost of increased bleeding risk. The platelet trials suggest reversible platelet inhibition may mitigate some of those risks and further improve outcomes. So, in that sense, elinogrel has properties of reversible inhibition of the CYP12 receptor, so it might reduce bleeding risk in patients." See INNOVATE PCI: Elinogrel, a new antiplatelet agent, passes initial hurdles for more information.
  12. 12. ESC 2010 Poster Sessions 3360 Abstracts were selected for poster presentations and 112 for moderated poster presentations spread over four days at the ESC 2010 Congress. Topics included: cardiomyopathies, lipids, atrial fibrillation, antithrombotic agents, genetics and gene therapy, and the effects of culture and society on heart disease.
  13. 13. ATOLL (STEMI Treated With Primary Angioplasty andIntravenous Lovenox or Unfractionated Heparin)Results: About 900 patients undergoing PCI for acute STEMI were randomized to receive either IV enoxaparin orunfractionated heparin (UFH) with the procedure. The two groups subsequent 30-day rates of a complex composite primaryend point that included death and major bleeding were not significantly different, although the enoxaparin group showed afavorable trend. Also, the low-molecular-weight heparin (LMWH) roundly outperformed UFH for most of the trialsprospectively defined secondary end points, which generally were composites of serious clinical events.Featured discussant Dr Harvey White (Green Lane Hospital, Auckland, New Zealand) lauded ATOLL as "a contemporarytrial—in fact, a supercontemporary trial&mdash in terms of the use of radial access and the high rate of use of evidence-based therapies. Theyve shown that enoxaparin is safe and may have an important clinically relevant effect on ischemicend points in patients undergoing primary PCI." Still, he cautioned, "it missed its primary end point."See ATOLL seen as supporting enoxaparin over standard heparin in primary PCI for more information.
  14. 14. COPPS (Colchicine for the Prevention of thePostpericardiotomy Syndrome) Results: The first large-scale double-blind, placebo-controlled trial to test the efficacy of colchicine to prevent the development of postpericardiotomy syndrome (PPS) after heart surgery has shown that the drug is very effective, with only eight people needing to be treated to prevent one from developing the syndrome. See Colchicine halves incidence of postpericardiotomy syndrome for more information.
  15. 15. RESPONSE (Randomized Evaluation of SecondaryPrevention by Outpatient Nurse Specialists) Results: A program of appointments with outpatient nurse specialists was "reasonably successful" at lowering cardiovascular risk on top of high-level usual care in patients with acute coronary syndrome (ACS) in a randomized trial conducted in the Netherlands. Patients who saw the nurses four times over the six months after their event were more likely to achieve targets for systolic blood pressure, LDL cholesterol, and a healthy lifestyle, with a relative risk reduction of 16.9% (p=0.029) in the primary outcome— calculated 10-year mortality—after one year, compared with the usual-care group. They did not, however, fare better in terms of smoking cessation and or lose any more weight than those getting standard care. "I consider this trial extremely important," said American College of Cardiology president Dr Ralph Brindis (Kaiser Permanente, Oakland, CA), who attended the press conference on the hot-line sessions. "We have to figure out a better way of translating our science to the bedside. Here we have a trial that shows an effective way of better delivering care with things that we know work." See Nurse program provides good RESPONSE for ACS secondary prevention for more information.
  16. 16. STAR-heart Results: The largest clinical trial so far of intracoronary autologous stem-cell transplantation in patients with chronic heart failure has shown that such treatment was associated with multiple hemodynamic and functional benefits as well as a reduction in mortality, benefits that were maintained out to five years of follow-up. Results at three months, 12 months, and five years after bone-marrow-cell therapy showed significant improvement in left ventricular ejection fraction, cardiac index, exercise capacity, oxygen uptake, and left ventricular contractility. Controls, however, showed a deterioration in LV performance. "Our study suggests that, when administered as an alternative or in addition to conventional therapy, bone-marrow-cell therapy can improve quality of life, increase ventricular performance, and increase survival. Intracoronary therapy has been shown to be effective in acute myocardial infarction, and the STAR-heart study now indicates its efficacy in chronic heart failure," concluded presenter Dr Bodo-Eckehard Strauer (Heinrich-Heine University, Düsseldorf, Germany). See STAR-heart study: Stem cells associated with improved long-term hemodynamics and reduced mortality in chronic heart failure for more information.
  17. 17. Opinions from ESC Heartfelt with Dr Melissa Walton-Shirley STAR-heart study associates stem cells with improved hemodynamics and reduced mortality; PEARL-HF on reducing hyperkalemia in heart failure; SHIFT; Alpha Omega; HEBE III; and analysis of top news from ESC 2010 Novel antiplatelets; optimal heparin dosing in ISAR-REACT 3A; elinogrel, a new antiplatelet, passes test in INNOVATE PCI; ATOLL; LESSON-1; ART trial; and analysis of top news from ESC 2010 ANTIPAF: Olmesartan doesnt suppress paroxysmal atrial fib; AVERROES: Apixaban gives significant reductions in stroke; DANPACE; FUTURA/OASIS-8; and analysis of top news from ESC 2010 Trials and PIs with Dr Michael Gibson Heart failure and transplantation with Dr Ileana Piña Focus on exercise in older men and in women at ESC 2010 Private practice with Dr Seth Bilazarian Apixaban in AVERROES points the way to excellent alternatives to warfarin The Bob Harrington Show Episode #27: Elinogrel and INNOVATE PCI with Dr Sunil Rao Click here to view more opinions from ESC 2010
  18. 18. ESC Congress 2010: An Overview Spotlight on Coronary Artery Disease: From Genes to Outcomes In an ESC press release, Prof Fausto Pinto, outgoing chair of the Congress Program Committee, declared the meeting a great success. Attendance included: • 22 032 active participants • 4947 exhibitors • 571 accompanying persons • 556 members of the press The ESC Congress 2011 will be held in Paris on August 27-31, 2011. The spotlight will be: "Controversies in Cardiology."
  19. 19. For more information ESC Coverage on theheart.org http://www.theheart.org/coverage/esc-2010.do Medscape ESC 2010 http://www.medscape.com/viewcollection/31520 ESC Congress 2010 http://www.escardio.org/congresses/esc- 2010/Pages/welcome.aspx
  20. 20. Credits and disclosuresContributor Information Journalists:Shelley WoodManaging Editor, heartwire Lisa Nainggolan, theheart.orgtheheart.org London, UKKelowna, BC Disclosure: Lisa Nainggolan has disclosed no relevant financialDisclosure: Shelley Wood has disclosed no relevant relationshipsfinancial relationships. Sue Hughes, theheart.orgSteven Rourke London, UKManager, Editorial programming Disclosure: Sue Hughes has disclosed no relevant financialtheheart.org relationships.Montreal, QCDisclosure: Steven Rourke has disclosed no relevant Reed Miller, theheart.orgfinancial relationships. Bethesda, MD 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.
  21. 21. 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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