Saturday, September 23, 2023
Shelley Wood
Managing Editor, heartwire
theheart.org
Kelowna, British Columbia
Disclosure: Shelley Wood has disclosed no relevant financial relationships.
Steven Rourke
Manager, Editorial Programming
theheart.org
Montreal, Quebec
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.
The European Society of Cardiology (ESC) Congress 2010 took place in Stockholm, Sweden, from August 28 to September 1, 2010.
Key trials presented at the meeting include:
AVERROES: Apixaban yields significant reductions in stroke, no increased bleeding.
SHIFT: Adding heart rate-slowing agent ivabradine to heart failure medications cuts mortality, hospitalization.
Alpha Omega Trial: n-3 fatty acids fail to reduce cardiovascular events in post-myocardial infarction patients.
EINSTEIN DVT: Rivaroxaban almost superior to usual care in treatment of deep-vein thrombosis.
FUTURA OASIS-8: Standard-dose heparin recommended during percutaneous coronary interventions (PCI) to avoid catheter thrombosis with fondaparinux.
LESSON 1: Everolimus bests sirolimus in nonrandomized drug-eluting stents 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 acute coronary syndrome or atrial fibrillation.
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 secondary prevention of acute coronary prevention.
STAR-HEART: Stem cells associated with improved long-term hemodynamics and reduced mortality in chronic heart failure
AVERROES (Apixaban versus Acetylsalicylic Acid to Prevent 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 for stroke and systemic embolic events than patients treated with aspirin. Of note, no increases in the risk for major bleeding, minor bleeding, or intracranial hemorrhage, among other end points, were observed in patients treated with apixaban.
"As a proof of principle, it's 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, Oslo, 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.
SHIFT (Systolic Heart Failure Treatment with the If Inhibitor Ivabradine Trial)
Results: Patients with chronic systolic heart failure who added ivabradine (Procoralan®, Servier) to the medications they were already taking showed a significant 18% drop in the composite rate of cardiovascular death or hospitalization for heart failure compared with a placebo control group over a period of about 2 years.
"This is a very interesting study that tests a novel concept of heart-rate slowing as adjunctive therapy for heart failure," said Dr. Clyde Yancy (Baylor University Medical Center, Dallas, Texas), who was not involved with the trial. "But," he added, "sufficient questions 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.
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 a myocardial infarction (MI).
The investigators, including trial leader Dr. Daan Kromhout (Wageningen University, Wageningen, The Netherlands), say the negative findings are probably the result of the optimal medical therapy that patients in the trial were receiving after 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 after MI. See Alpha Omega Trial: n-3 fatty acids fail to reduce cardiovascular events in post-MI patients for more information.
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, which has its own attendant problems. See Rivaroxaban almost superior to usual care in treatment of DVT for more information.
Cardiologists of Tomorrow at ESC 2010
At this year's 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 among 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.
Professor 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, United Kingdom (clinical science); Alexios Antonopoulos from Athens, Greece (coronary pathophysiology and microcirculation); Radoslaw Debiec from Leicester, United Kingdom (population sciences); Sasha Koul from Lund, Sweden (thrombosis); and Daurice Grossniklaus from Atlanta, Georgia, who won the Atie Immink Award in Nursing. The state-of-the-art research awards in heart failure and coronary artery disease were awarded to Katrin Walenta from Homburg/Saar, Germany, and Pascal Lim from Creteuil, France.
Futura/Oasis-8 (Fondaparinux Trial With UFH During Revascularization in Acute Coronary Syndromes)
Results: Patients with acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI) being treated with fondaparinux as the main anticoagulant should receive standard-dose unfractionated 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 historical control 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 thrombosis without 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, Ontario), co-lead investigator of the trial, speaking at an ESC press conference. See FUTURA/OASIS-8: Standard-dose heparin recommended during PCI to avoid catheter thrombosis with fondaparinux for more information.
LESSON I (Long-term comparison of Everolimus-eluting and Sirolimus-eluting Stents for cOronary revascularization)
Results: Patients treated with everolimus-eluting stents showed a 17% relative risk reduction in the primary end point of death, MI, and target vessel revascularization, compared with a patient cohort treated with sirolimus-eluting stents, only narrowly missing statistical significance (P = .056). This nonrandomized comparison provides some of the strongest evidence yet that so-called next-generation drug-eluting stents 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, Bern, 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.
PLATO (A Study of Platelet Inhibition and Patient Outcomes) 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. In addition, neither drug was affected by another genetic variation, in the ABCB1 gene, which affects absorption of clopidogrel.
CURE (Clopidogrel in Unstable angina to prevent Recurrent Events)/ACTIVE A (Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events A)
Results: Loss-of-function CYP2C19 alleles had no effect with regard to safety or efficacy of clopidogrel (Plavix®, Bristol-Myers Squibb/Sanofi-Aventis) in patients with ACS and atrial fibrillation participating in the CURE and ACTIVE A trials, respectively. 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.
"There may be a case for genotype testing in the acute situation where patients are undergoing stenting, but the genetic data from both the CURE and PLATO trials suggest there is no difference between outcomes with clopidogrel in patients with loss-of-function alleles and those without such alleles in the chronic phase of treatment," commented designated discussant Dr. Robert Califf (Duke Clinical Research Institute, Durham, North Carolina). 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.
INNOVATE PCI (INtraveNous and Oral administration of elinogrel versus clopidogrel to eVAluate Tolerability and Efficacy in nonurgent Percutaneous Coronary Interventions patients)
Results: Treatment with oral and intravenous elinogrel (Novartis), a novel antiplatelet agent, had more rapid antiplatelet effects than clopidogrel (Plavix®, Bristol Myers-Squibb/Sanofi-Aventis) in short- and long-term phases of therapy for patients undergoing nonurgent PCI in this phase 2 trial.
"I think, at this point, we're 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, North Carolina). "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.
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.
ATOLL (STEMI Treated With Primary Angioplasty and Intravenous Lovenox or Unfractionated Heparin)
Results: About 900 patients undergoing PCI for acute ST-segment elevation MI were randomly assigned to receive intravenous enoxaparin or unfractionated heparin with the procedure. The two groups' subsequent 30-day rates of a complex composite primary end point that included death and major bleeding were not significantly different, although the enoxaparin group showed a favorable trend. Also, the low-molecular-weight heparin roundly outperformed unfractionated heparin for most of the trial's prospectively 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 contemporary trial -- in fact, a supercontemporary trial -- in terms of the use of radial access and the high rate of use of evidence-based therapies. They've shown that enoxaparin is safe and may have an important clinically relevant effect on ischemic end 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.
COPPS (Colchicine for the Prevention of the Postpericardiotomy Syndrome)
Results: The first large-scale double-blind, placebo-controlled trial to test the efficacy of colchicine to prevent the development of postpericardiotomy syndrome after heart surgery has shown that the drug is very effective: Only 8 patients needed to be treated to prevent 1 from developing the syndrome.
"Colchicine halves the risk of postpericardiotomy syndrome following cardiac surgery, and not only is it efficacious but it is safe," said lead author of the study, Dr. Massimo Imazio (Maria Vittoria Hospital, Turin, Italy), who presented the findings. See Colchicine halves incidence of postpericardiotomy syndrome for more information.
RESPONSE (Randomized Evaluation of Secondary Prevention 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 ACS in a randomized trial conducted in The Netherlands. Patients who saw the nurses 4 times over the 6 months after their event were more likely to achieve targets for systolic blood pressure, low-density lipoprotein cholesterol, and a healthy lifestyle, with a relative risk reduction of 16.9% (P = .029) in the primary outcome -- calculated 10-year mortality -- after 1 year, compared with the usual-care group. They did not, however, fare better in terms of smoking cessation 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, California), 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.
STAR-heart (Stem Cells Associated With Improved Long-Term Hemodynamics and Reduced Mortality in Chronic Heart Failure)
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. These benefits were maintained through 5 years of follow-up. Results at 3 months, 12 months, and 5 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 left ventricular 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.
Opinions from ESC
Day in Review
Ileana Piña
ESC Congress 2010
Spotlight on Coronary Artery Disease: From Genes to Outcomes
In an ESC press release, Professor Fausto Pinto, outgoing chair of the Congress Program Committee, declared the meeting a great success.
Attendance included:
The ESC Congress 2011 will be held in Paris on August 27-31, 2011. The spotlight will be "Controversies in Cardiology."
Shelley Wood
Managing Editor, heartwire
theheart.org
Kelowna, British Columbia
Disclosure: Shelley Wood has disclosed no relevant financial relationships.
Steven Rourke
Manager, Editorial Programming
theheart.org
Montreal, Quebec
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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