Abstract: HomeCirculationVol. 132, No. 23Late-Breaking Clinical Trial Abstracts Free AccessResearch ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessResearch ArticlePDF/EPUBLate-Breaking Clinical Trial Abstracts Originally published8 Dec 2015https://doi.org/10.1161/CIR.0000000000000334Circulation. 2015;132:2267–22852015 Late-Breaking Clinical Trial AbstractsHeart Failure and CardiomyopathiesFailure is Not an Option: New Drugs and Systems of Care20102 A Randomized Trial of Liraglutide for High-Risk Heart Failure Patients With Reduced Ejection FractionKenneth B Margulies1, Kevin J Anstrom2, Margaret M Redfield3, Michael M Givertz4, Guilherme H Oliveira5, Robert Cole6, Doug Mann7, David J Whellan8, Michael S Kiernan9, G. Michael Felker10, Steven E McNulty10, Monica R Shah11, Adrian F Hernandez10, Eugene Braunwald12, Thomas P Cappola1; 1Medicine (Cardiology), Univ of Pennsylvania, Philadelphia, PA, 2Duke Clinical Rsch Institute, Duke Univ, Philadelphia, PA, 3Medicine (Cardiology), Mayo Clinic, Rochester, MN, 4Medicine (Cardiology), Brigham and Women's Hosp, Boston, MA, 5Medicine (Cardiovascular Medicine), UH Case Med Cntr, Cleveland, OH, 6Medicine (Cardiology), Emory Univ, Atlanda, GA, 7Medicine (Cardiovascular), Washington Univ in St. Louis, St. Louis, MO, 8Medicine (Cardiology), Thomas Jefferson Univ, Philadelphia, PA, 9Medicine (Cardiology), Tufts Univ, Boston, MA, 10Duke Clinical Rsch Institute, Duke Univ, Durham, NC, 11Cardiovascular Sciences, National Heart Lung and Blood Institute, Bethesda, MD, 12Cardiovascular Medicine, Brigham and Women's Hosp, Boston, MA,Background: The heart consumes more energy per gram than any other organ, and myocardial metabolic demands are further increased in the failing heart. As heart failure (HF) progresses, the myocardium develops defects in substrate utilization including reduced fatty acid utilization and insulin resistance that impair glucose uptake. Synthetic GLP-1 agonists improve insulin sensitivity and represent promising metabolic modulators for patients with HF. Methods: The Functional Impact of GLP-1 for Heart Failure Treatment (FIGHT) study is a randomized, double-blinded, placebo-controlled clinical trial in high-risk HF patients with reduced ejection fraction (LVEF ≤ 40%) and recent hospitalization. 300 subjects were randomized to treatment with either the GLP-1 agonist liraglutide or placebo delivered by daily SQ injection. FIGHT included patients with and without type-2 diabetes, and a randomized block design to assure equal allocation of diabetics and non-diabetics to the two treatment arms. The primary end point of FIGHT is a global rank endpoint in which all participants, regardless of treatment assignment, are ranked across three hierarchical groups: 1) time to death, 2) time to HF hospitalization, and 3) time-averaged proportional change in NT-proBNP (from baseline to 180 days). The principal secondary end points include change in cardiac structure and function (by echocardiography) from baseline to 180 days. Additional endpoints include functional status based on the six-minute walk distances at 30, 90, and 180 days, changes in symptoms, based on the KCCQ, from baseline to 180 days, and individual components of the primary endpoint at 30, 90 and 180 days after randomization. Results: Enrollment in FIGHT was completed in March 2015 and follow up and database finalization will be completed in September. Baseline characteristics of the 300 patients include (median (25th, 75th) or %): Age 61 years (51, 68); Female 21%; Black 38%; Ischemic heart disease 82%, Hypertension 79%; Diabetes 60%; NYHA II/III 29%/65%, and LVEF 23% (17, 27). Conclusion: FIGHT is the first multicenter trial of a GLP-1 receptor agonist in the treatment of high-risk HF with reduced ejection fraction and will determine if this intervention improves clinical status at 180 days.Author Disclosures: K.B. Margulies: Consultant/Advisory Board; Modest; Merck, Sharp and Dohme; Pfizer, Inc. K.J. Anstrom: Research Grant; Modest; AstraZeneca. Consultant/ Advisory Board; Modest; Pfizer, Abbot Vascular, AstraZeneca. M.M. Redfield: Honoraria; Modest; Heart Failure Society of America. Consultant/Advisory Board; Modest; Novartis (unpaid). Other; Modest; Anexion (Royalties). M.M. Givertz: Research Grant; Modest; Bristol Myers Squibb, Merck, Portola. Research Grant; Significant; AstraZeneca, Glaxo Smith Kline. Consultant/Advisory Board; Modest; Amgen, AstraZeneca, Bayer, Bristol- Myers Squibb, Gilead, Glaxo Smith Kline, Janssen, Merck, Pluristem Therapeutics, Inc., Sensible. Consultant/Advisory Board; Significant; Novartis. G.H. Oliveira: Research Grant; Significant; Frankino-Dodero Foundation. Speakers Bureau; Modest; Amgen, Novartis. Consultant/Advisory Board; Modest; Abiomed. R. Cole: None. D. Mann: None. D.J. Whellan: Research Grant; Significant; ResMed, Poszen. M.S. Kiernan: None. G. Felker: Research Grant; Significant; Roche Diagnostics, Novartis, Amgen, Otsuka, Singulex. Consultant/ Advisory Board; Modest; Trevena, Merck, Celladon. Consultant/Advisory Board; Significant; Novartis, Amgen. S.E. McNulty: None. M.R. Shah: None. A.F. Hernandez: Consultant/ Advisory Board; Modest; Novartis, Janssen, Bristol-Myers Squibb. E. Braunwald: Research Grant; Significant; AstraZeneca. Consultant/Advisory Board; Modest; Genzyme, Amorcyte, Medicines Co., CardioRentis, Sanofi-Aventis. Other; Modest; Eli Lilly (Lectures), Daichi Sankyo (Lectures), Menarini International (Lectures), Medscape (Lectures), Bayer (Lectures). T.P. Cappola: Consultant/Advisory Board; Modest; Teva Pharmaceuticals, Novartis.13362 Nitrate’s Effect on Activity Tolerance in Heart Failure With Preserved Ejection Fraction (NEAT-HFpEF)Margaret M Redfield1, Kevin J Anstrom2, James A Levine3, Barry Borlaug1, Horng Chen1, Martin M LeWinter4, Susan M Joseph5, Sanjiv J Shah6, Marc J Semigran7, G M Felker8, Robert T Cole9, Gordon Reeves10, Ryan J Tedford11, Wilson Tang12, Steven E McNulty2, Eric J Velazquez2, Monica R Shah13, Eugene Braunwald14, NHLBI Heart Failure Clinical Rsch Network; 1Cardiovascular Disease, Mayo Clinic & Foundation, Rochester, MN, 2Outcomes, Duke Clinical Rsch Institute, Durham, NC, 3Cardiovascular Disease, Mayo Clinic & Foundation, Scottsdale, AZ, 4Div of Cardiology, Univ of Vermont Med Cntr, Burlington, VT, 5Div of Cardiology, Washington Univ Sch of Medicine, St. Louis, MO, 6Div of Cardiology, Northwestern Univ, Chicago, IL, 7Div of Cardiology, Massachusetts General Hosp, Boston, MA, 8Div of Cardiology, Duke Univ Med Cntr, Durham, NC, 9Div of Cardiology, Emory Univ, Atlanta, GA, 10Div of Cardiology, Thomas Jefferson Univ, Philadelphia, PA, 11Div of Cardiology, Johns Hopkins Univ Sch of Medicine, Baltimore, MD, 12Cardiovascular Disease, The Cleveland Clinic Foundation, Cleveland, OH, 13NHLBI, NIH, Bethesda, MD, 14Div of Cardiology, Brigham & Women's, Boston, MA,Background: Exercise intolerance is a cardinal feature of heart failure (HF) with preserved ejection fraction (HFpEF) and perpetuates sedentary behavior, deconditioning and frailty. While nitrates are commonly prescribed for symptom relief in HFpEF, no study has tested their effect in HFpEF. Hypothesis: Isosorbide mononitrate (ISMN) will enhance activity tolerance in HFpEF and thus, daily activity as assessed by patient worn accelerometry devices (AXM). Methods: NEAT-HFpEF was a multi-center, randomized, double-blind, 12 wk crossover study of ambulatory HFpEF patients (n=110). Entry criteria included HF symptoms, EF ≥ 50% and objective clinical (HF hospitalization), biomarker (NT-proBNP) or echocardiographic evidence of HF. During each 6 wk phase of the crossover study, patients took no study drug for 2 weeks (Baseline/Washout), then 30 mg for one wk, 60 mg for one wk and 120 mg for two wks. The primary endpoint was average daily accelerometry units (ADAU) during 2 wks of 120 mg/day of ISMN versus placebo as assessed by hip worn, tri-axial AXM worn throughout the study. Secondary endpoints included alternate activity indices (hours active/day at 120 mg dose and ADAU during all doses (30-120 mg)), six minute walk distance (6MWD), quality of life (QOL) scores, NT-proBNP and dose response. Treatment effect (TE) analysis adjusted for phase, sequence, baseline values and random effect of each patient. Results: Baseline characteristics (median or %): Age (69 yrs), Female (57%), BMI (34.7 kg/m2), NYHA II (53%) or III (45%) symptoms, KCCQ QOL score (54), 6MWD (312 m).ISMN tended to decrease ADAU at the 120 mg dose (TE -381, p=0.06) and significantly decreased hours active/day during 120 mg (TE -0.3 hours, p=0.02) and ADAU during all doses, (TE -439, p=0.02). ADAU decreased progressively and significantly as the ISMN (but not placebo) dose increased. ISMN had no effect on 6MWD, QOL scores or NT-proBNP. Numerically more patients had side effects during ISMN. Conclusions: These findings do not support use of ISMN in HFpEF. Reduced activity during ISMN is of concern as decreased activity promotes frailty. Data on activity from patient worn devices provides unique, patient-centric information about the impact of HF therapies on patient’s lives.Author Disclosures: M.M. Redfield: None. K.J. Anstrom: Research Grant; Significant; NIH. J.A. Levine: Research Grant; Modest; Boeing. Consultant/Advisory Board; Modest; Kersh Health Risk Management, Gentag, SP Health. B. Borlaug: Research Grant; Significant; Mast Therapeutics, Medtronic. Consultant/Advisory Board; Significant; Merck, Amgen, AstraZeneca. H. Chen: None. M.M. LeWinter: Research Grant; Significant; NIH. S.M. Joseph: None. S.J. Shah: Research Grant; Significant; NIH, Actelion. Consultant/Advisory Board; Modest; AstraZeneca, Bayer, Alnylam. Consultant/Advisory Board; Significant; Novartis. M.J. Semigran: Other Research Support; Significant; St. Jude Medical. Consultant/Advisory Board; Significant; Broadview, Novartis. G.M. Felker: Research Grant; Significant; NIH, Roche Diagnostics, Novartis, Amgen, Otsuka, Singulex. Consultant/Advisory Board; Modest; Trevena, Merck, Celladon, Medtronic. Consultant/Advisory Board; Significant; Novartis, Amgen. R.T. Cole: None. G. Reeves: Employment; Significant; Thomas Jefferson University. Other Research Support; Significant; ResMed Foundation, Thoratec. R.J. Tedford: Other; Significant; Merck. W. Tang: Research Grant; Significant; National Institutes of Health. S.E. McNulty: None. E.J. Velazquez: None. M.R. Shah: None. E. Braunwald: None.16885 Oral sGC Stimulator Vericiguat in Patients With Worsening Chronic Heart Failure and Reduced Ejection Fraction - The SOluble guanylate Cyclase stimulatoR in heArT failurE patientS With REDUCED EF (SOCRATES-REDUCED) StudyMihai Gheorghiade1, Aldo P Maggioni2, Carolyn Lam3, Eliana Samano4, Elisabeth Kraigher-Krainer5, Gerasimos Filippatos6, Javed Butler7, Stephen J Greene8, Katharina Mueller9, Lothar Roessig9, Piotr Ponikowski10, Sanjiv Shah1, Scott D Solomon11, Burkert Pieske12; 1Dept of Medicine, Div of Cardiology, Northwestern Univ, Chicago, IL, 2ANMCO RESEARCH CENTER, ANMCO Rsch Cntr, Florence, Italy 3National Heart Cntr Singapore, National Heart Cntr Singapore, Singapore, Singapore 4Global Med Experts, Bayer S.A, Sao Paulo, Brazil 5Dept of Internal Medicine and Cardiology, Charité Univ Medicine Berlin , German Heart Cntr Berlin, Berlin, Germany 6Dept of Cardiology, Heart Failure, Athens Univ Hosp, Athens, Greece 7Cardiology, Stony Brook Univ, Stony Brook, NY, 8Dept of Medicine, Div of Cardiology, Duke Univ Med Cntr, Durham, NC, 9Global Development, Bayer Pharma AG, Wuppertal, Germany 10Dept of Cardiac Diseases, Med Univ, Wroclaw, Poland 11Cardiovascular Div, Brigham and Women's Hosp, Boston, MA, 12Dept of Internal Medicine and Cardiology, Charité Univ Medicine Berlin, Berlin, GermanyIntroduction: Worsening chronic heart failure (WCHF) is a major public health problem. The objective of this study was to determine the safety, efficacy, and optimal dose of vericiguat, a soluble guanylate cyclase stimulator, in patients with WCHF with reduced left ventricular ejection fraction (LVEF). Methods: The SOCRATES-REDUCED trial was a phase II, dose-finding study of stable patients with LVEF<45% within 4 weeks of a WCHF event. Patients were randomized to placebo or 1 of 4 target doses of vericiguat (1.25 mg, 2.5 mg, 5 mg, 10 mg) for 12 weeks. The primary end point was the change from baseline to week 12 in log-transformed NT-proBNP level. Primary analysis specified pooled comparison of the 3 highest dose vericiguat arms with placebo. Pre-specified secondary analyses included effects of individual vericiguat dose arms and testing for a vericiguat dose-response relationship. Results: Overall, 456 patients were randomized and 351 patients were eligible for primary end point analysis. In primary analysis, change in log-transformed NT-proBNP from baseline to week 12 was not significantly different between the pooled vericiguat group and placebo (ratio of geometric means 0.885, p=0.151). In secondary analysis, there was a dose-response relationship (p=0.017) and the 10 mg vericiguat arm showed greater reductions in log-transformed NT-proBNP than placebo at 12 weeks (ratio of geometric means 0.779, p=0.048). In the 10 mg vericiguat arm, LVEF increased at 12 weeks compared to placebo (+3.7% vs +1.5%, p=0.021). There were no significant differences in blood pressure and heart rate at 12 weeks between 10 mg vericiguat and placebo arms and adverse events were not increased. At 12 weeks, numerically fewer patients in the 5 mg (11 patients) and 10 mg vericiguat groups (10 patients) experienced cardiovascular death or HF hospitalization compared to placebo (18 patients). Conclusions: Although the primary analysis of the primary end point was not achieved, compared to placebo, patients receiving vericiguat 10mg daily experienced a greater reduction in NT-proBNP, greater improvement in LVEF, and fewer clinical events. As titrated in this study, vericiguat doses up to 10 mg daily were safe and did not meaningfully influence blood pressure and heart rate at 12 weeks.Author Disclosures: M. Gheorghiade: Consultant/Advisory Board; Modest; Abbott Laboratories, Astellas, AstraZeneca, Bayer HealthCare AG, CorThera, Cytokinetics, DebioPharm SA, Errekappa Terapeutici, GlaxoSmithKline, Ikaria, Johnson & Johnson, Medtronic, Merck, Novartis Pharma AG, Otsuka Pharmaceuticals, Palatin Technologies, Pericor Therapeutics, Protein Design Laboratories, Sanofi-Aventis, Sigma Tau, Solvay Pharmaceuticals, Takeda, Trevena Therapeutics. A.P. Maggioni: Research Grant; Modest; Cardiorentis, Bayer, Novartis, Servier. C. Lam: Research Grant; Modest; Medtronic, Vifor Pharma. Research Grant; Significant; Boston Scientific. Consultant/Advisory Board; Modest; Bayer, Novartis, Takeda, Merck, Astra Zeneca, Janssen Research&Development, LL. E. Samano: Employment; Modest; Bayer SA. E. Kraigher-Krainer: Consultant/Advisory Board; Modest; Bayer Healthcare. G. Filippatos: Research Grant; Modest; European Union. Consultant/Advisory Board; Modest; Bayer, Novartis, Cardiorentis. J. Butler: Research Grant; Modest; National Institutes of Health, European Union. Consultant/Advisory Board; Modest; Amgen, Bayer, Cardiocell, Novartis, Boehringer-Ingelheim, Trevena, Relypsa, Z Pharma, Pharmain, Zensun. S.J. Greene: None. K. Mueller: Employment; Modest; Bayer Pharma AG. L. Roessig: Employment; Significant; Bayer Pharma AG. P. Ponikowski: Consultant/Advisory Board; Modest; Bayer Pharma AG. S. Shah: Research Grant; Significant; NIH, Actelion. Consultant/Advisory Board; Modest; AstraZeneca, Bayer, Alnylam. Consultant/Advisory Board; Significant; Novartis. S.D. Solomon: Consultant/Advisory Board; Modest; Bayer. B. Pieske: Speakers Bureau; Modest; Bayer Healthcare, Novartis, Stealth Peptides, AstraZeneca. Consultant/Advisory Board; Modest; Stealth Peptides, Daiichi Sankyo, BMS. Consultant/Advisory Board; Significant; Bayer Healthcare, Novartis.Key Words: Clinical trials, Heart failure20282 Remote Patient Management After Discharge of Hospitalized Heart Failure Patients: The Better Effectiveness After Transition - Heart Failure StudyMichael K Ong1, Patrick S Romano2, Sarah Edgington1, Andrew D Auerbach3, Harriet U Aronow4, Jeanne T Black5, Teresa De Marco3, Jose J Escarce1, Lorraine Evangelista6, Theodore G Ganiats7, Barry Greenberg8, Sheldon Greenfield9, Sherrie H Kaplan9, Asher Kimchi10, Honghu Liu11, Dawn Lombardo12, Carol M Mangione1, Majid Sarrafzadeh13, Kathleen Tong14, Gregg C Fonarow1, BEAT-HF Rsch Group; 1Medicine, UCLA, Los Angeles, CA, 2Medicine and Pediatrics, UC Davis, Sacramento, CA, 3Medicine, UCSF, San Francisco, CA, 4Nursing, Cedars-Sinai Med Cntr, Los Angeles, CA, 5Resource and Outcomes Management, Cedars-Sinai Med Cntr, Los Angeles, CA, 6Nursing, UC Irvine, Orange, CA, 7Family Medicine and Community Health, Univ of Miami, Miami, FL, 8Medicine, UCSD, San Diego, CA, 9Medicine, UC Irvine, Irvine, CA, 10Medicine, Cedars-Sinai Med Cntr, Los Angeles, CA, 11Dentistry, UCLA, Los Angeles, CA, 12Medicine, UC Irvine, Orange, CA, 13Computer Science, UCLA, Los Angeles, CA, 14Medicine, UC Davis, Sacramento, CA,Introduction: Heart failure is a prevalent health problem associated with costly hospital readmissions. Transitional care programs have been shown to reduce readmissions but are costly to implement. Evidence regarding the effectiveness of telemonitoring in managing the care of this chronic condition is mixed. The Better Effectiveness After Transition - Heart Failure (BEAT-HF) study is a comparative effectiveness study designed to evaluate an intervention that combines a telephonic adaptation of care transition programs with telemonitoring. Hypothesis: a care transition intervention that includes pre-discharge education about heart failure and post-discharge telephone nurse coaching combined with home telemonitoring of weight, blood pressure, heart rate, and symptoms will reduce all-cause 180-day hospital readmissions for older adults hospitalized with heart failure. Methods: 1437 individuals admitted between October 2011 and September 2013 were enrolled in a multi-center, randomized controlled trial conducted at six academic health systems in California. Patients in the intervention group received intensive patient education using the 'teach-back' method and received instruction in using telemonitoring equipment. Following hospital discharge, they received up to nine scheduled health coaching telephone calls over 6 months from nurses located in a centralized call center. The nurses also called patients and patients' physicians in response to alerts generated by the telemonitoring system, based on predetermined parameters. Results: This presentation will report on the study primary outcome, readmission for any cause within 180 days, and on secondary outcomes including 30-day readmission, 30-day mortality, and 180-day mortality. Conclusions: BEAT-HF is one of the largest randomized controlled trials of telemonitoring in patients with heart failure, and the first explicitly to adapt the care transition approach and combine it with remote telemonitoring. The study population also includes patients with a wide range of demographic and socioeconomic characteristics.Author Disclosures: M.K. Ong: None. P.S. Romano: None. S. Edgington: None. A.D. Auerbach: None. H.U. Aronow: None. J.T. Black: None. T. De Marco: None. J.J. Escarce: None. L. Evangelista: None. T.G. Ganiats: None. B. Greenberg: None. S. Greenfield: None. S.H. Kaplan: None. A. Kimchi: None. H. Liu: None. D. Lombardo: None. C.M. Mangione: None. M. Sarrafzadeh: None. K. Tong: None. G.C. Fonarow: Consultant/Advisory Board; Modest; Medtronic, Amgen, Janssen, Bayer, Boston Scientific. Other; Modest; Abbott. Research Grant; Significant; NIH, PCORI, AHRQ. Consultant/Advisory Board; Significant; Novartis.Key Words: Heart failure, Transitions of care, Telemedicine24294 Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure (COSMIC-HF): Final Results from a Double-blind, Randomized, Placebo-controlled, Multicenter StudyJohn R Teerlink1, G Michael Felker2, John JV McMurray3, Scott D Solomon4, Maria Laura Monsalvo5, Jason Legg5, Fady I Malik6, Narimon Honarpour5, for the COSMIC-HF Investigators; 1San Francisco Veterans Affairs Medical Center and School of Medicine University of California, San Francisco, San Francisco, CA, 2Duke University School of Medicine, Durham, NC, 3University of Glasgow, Glasgow, United Kingdom, 4Brigham & Women’s Hospital and Harvard Medical School, Boston, MA, 5Amgen Inc., Thousand Oaks, CA, 6Cytokinetics, Inc., South San Francisco, CA.Background: Improving myocardial contractile function remains an attractive therapeutic target in patients with heart failure and reduced ejection fraction (HFrEF). Omecamtiv mecarbil (OM) is a novel selective cardiac myosin activator which when administered intravenously increases stroke volume by prolonging LV systolic ejection time (SET) without increasing heart rate or decreasing blood pressure. COSMIC-HF (NCT 01786512) was a Phase 2 study designed to select an oral modified-release formulation and dose of OM in patients with chronic HFrEF, and to characterize its pharmacokinetics (PK) and effects on cardiac function, as well as its safety and tolerability during 20 weeks of treatment. Methods: COSMIC-HF was a two-phase, multicenter, randomized, double-blind, placebo-controlled trial in outpatients with a history of optimally-treated chronic HF, LVEF ≤40%, and NT-proBNP ≥200 pg/mL (≥1200 pg/mL in patients with atrial fibrillation). Two cohorts were studied during the initial dose escalation phase; Cohort 1 was randomized 1:1:1:1 to 25 mg BID of one of three OM oral formulations or placebo for 7 days. Cohort 2 was randomized in the same manner to 50 mg BID. Based on PK, safety and tolerability, one formulation was advanced into the expansion phase, where patients were randomized 1:1:1 to receive the selected OM formulation in one of two treatment groups (25 mg BID or PK-based dose escalation to 50 mg BID) or placebo for 20 weeks. PK, echocardiographic and other clinical variables were assessed. Results: An oral formulation of OM was selected based on data from Cohorts 1 (n=49) and 2 (n=47) of the dose escalation phase (mean age 65 years, 21% female). The expansion phase completed enrollment and follow-up of 448 patients (mean age 63 years, 17% female). For the first time, the main results of COSMIC-HF, including Cmax/Ctrough (ng/ml), SET (msec), LV end-systolic dimension (mm), and adverse events will be presented. Conclusion: In addition to providing information on the PK of the selected oral formulation, COSMIC-HF will furnish some data addressing the hypothesis that oral administration of OM can increase SET and provide a sustained effect on cardiac performance in patients with chronic HFrEF.Author Disclosures: J.R. Teerlink: Research Grant; Modest; Cytokinetics, Bayer, Trevena. Research Grant; Significant; Amgen and Novartis. Consultant/Advisory Board; Modest; Cytokinetics, Bayer, Trevena. Consultant/Advisory Board; Significant; Amgen and Novartis. G. Felker: Research Grant; Significant; Amgen, Roche Diagnostics, Novartis, Otuska and NHLBI. Consultant/Advisory Board; Significant; served as a consultant for Amgen, Novartis, Roche Diagnostics, Singulex, Trevena, Celladon, Bristol Meyers Squibb, Merck and Medtronic. J.J. McMurray: Employment; Significant; Glasgow University has been paid by Cytokinetics/Amgen for his time spent working on the clinical trial program with omecamtiv mecarbil. Other; Modest; Travel accommodations costs paid by Cytokinetics/Amgen in relation to advisory board and clinical trial meetings about omecamtiv mecarbil. S.D. Solomon: Other Research Support; Modest; Amgen. Consultant/Advisory Board; Modest; Amgen. M.L. Monsalvo: Employment; Significant; employee and stockholder of Amgen. J. Legg: Employment; Significant; employee and stockholder of Amgen. F.I. Malik: Employment; Significant; Stockholder of Cytokinetics. N. Honarpour: Employment; Significant; employee and stockholder of Amgen.Prevention and RehabilitationDecreasing the Global Burden of Disease: Breakthroughs in Prevention15602 The Efficacy and Safety of Varenicline, a Selective Alpha4beta2 Nicotinic Receptor Partial Agonist, for Smoking Cessation in Patients Hospitalized With Acute Coronary Syndrome: A Randomized Controlled TrialMark J Eisenberg1, Sarah B Windle2, Nathalie Roy3, Wayne Old4, François Grondin5, Iqbal Bata6, Ayman Iskander7, Claude Lauzon8, Nalin Srivastava9, Adam Clarke10, Daniel Cassavar11, Danielle Dion12, Herbert Haught13, Shamir Mehta14, Jean-François Baril15, Charles Lambert16, Mina Madan17, Beth L Abramson18, Payam Dehghani19; 1Cardiology and Clinical Epidemiology, Jewish General Hosp / McGill Univ, Montreal, Canada 2Cntr for Clinical Epidemiology, Jewish General Hosp, Montreal, Canada 3Cardiology, CSSS Chicoutimi, Chicoutimi, Canada 4Cardiology, Sentara Cardiovascular Rsch Institute, Norfolk, VA, 5Cardiology, Clinique de Cardiologie de Lévis, Lévis, Canada 6Cardiology, Queen Elizabeth II Health Sciences Cntr, Halifax, Canada 7Cardiology, SJH Cardiology Associates and St. Joseph's Hosp, Liverpool, NY, 8Cardiology, CISSS - Chaudière-Appalaches, Thetford Mines, Canada 9Cardiology, Spartanburg Regional Med Cntr, Spartanburg, SC, 10Cardiology, Valley Regional Hosp, Kentville, Canada 11Cardiology, ProMedica Toledo Hosp, Toledo, OH, 12Cardiology, CISSS de Chaudière Appalaches - site Hôpital St-Georges, Saint-Georges, Canada 13Cardiology, Heart Cntr Rsch, Huntsville, AL, 14Cardiology, Hamilton Health Sciences, Hamilton, Canada, 15Cardiology, Dr. Georges-L.-Dumont Univ Hosp Cntr, Moncton, Canada, 16Cardiology, Florida Hosp Pepin Heart Institute, Tampa, FL, 17Cardiology, Sunnybrook Health Sciences Cntr, Toronto, Canada, 18Cardiology, St. Michaels Hosp / Univ of Toronto, Toronto, Canada, 19Cardiology, Prairie Vascular Rsch Network / Univ of Saskatchewan, Regina, CanadaBackground: Less than a third of smokers hospitalized with an acute coronary syndrome (ACS) remain abstinent following discharge. We assessed whether varenicline, begun in-hospital, is efficacious for smoking cessation following ACS. Methods: We conducted a multi-center, double-blind, randomized, placebo-controlled trial in which smokers hospitalized with an ACS were randomized to varenicline (1.0 mg twice daily) or matched placebo for 12 weeks. All patients received low-intensity counseling. The primary endpoint was point prevalence smoking abstinence assessed at 24 weeks by 7-day recall and biochemical validation using expired carbon monoxide. Results: A total of 302 patients were randomized in the US and Canada. Demographic, smoking, and clinical characteristics were well balanced between the two study arms. Patients were primarily male (75.2%) with a mean age of 55.0 ± 9.3 years. On average, patients had smoked 35.9 ± 11.6 years and were smoking a mean of 21.4 ± 10.6 cigarettes/day at the time of ACS. Scores on the Fagerström Test of Nicotine Dependence ranged from 0 to 10, with 80.4% of patients having scores ≥ 4 indicating moderate or severe dependence on nicotine. Patients presented with ST-segment elevation myocardial infarction (56.0%), non-ST segment elevation myocardial infarction (37.8%), and unstable angina (6.3%). At 24 weeks, patients randomized to varenicline had significantly higher rates of smoking abstinence and reduction than patients randomized to placebo. For the primary endpoint of point prevalence smoking cessation, 47.3% of varenicline patients were abstinent versus 32.5% of placebo patients (number needed to treat = 6.8). Continuous abstinence rates were 35.8% and 25.8%, respectively (number needed to treat = 10.0). Reduction ≥50% in number of cigarettes smoked/day were 67.4% and 55.6%, respectively (number needed to treat = 8.5). Adverse event rates within 30 days of study drug discontinuation were similar between groups (serious adverse events: varenicline 11.3%, placebo 11.3%; major adverse cardiovascular events: varenicline 4.0%, placebo 4.6%). Conclusions: Varenicline, initiated in-hospital following ACS, is efficacious for smoking cessation.Author Disclosures: M.J. Eisenberg: None. S.B. Windle: None. N. Roy: None. W. Old: None. F. Grondin: None. I. Bata: None. A. Iskander: None. C. Lauzon: None. N. Srivastava: None. A. Clarke: None. D. Cassavar: None. D. Dion: None. H. Haught: None. S. Mehta: None. J. Baril: None. C. Lambert: None. M. Madan: None. B.L. Abramson: None. P. Dehghani: None.Key Words: Smoking, Acute coronary syndromes, Clinical trials20189 Impact of a Comprehensive Lifestyle Peer-group-based Intervention on Cardiovascular Risk Factors: A Randomized Controlled TrialEmilia G. Pardo1, Juan Miguel Fernandez Alvira2, Marta Vilanova3, Domingo Haro4, Ramona Martínez5, Isabel Carvajal6, Vanesa Carral4, Carla Rodríguez7, Mercedes de Miguel1, Patricia Bodega1, Gloria Santos-Beneit1, José L Peñalvo8, Iñaki Marina9, Napoleón Pérez10, Marian DalRe11, Carmen Villar12, Teresa Robledo12, Rajesh Vedanthan13, Sameer Bansilal13, Valentin Fuster13; 1Scientific Dept, SHE Foundation, Madrid, Spain 2Dept of epidemiology, atherothrombosis and imaging, National Cntr for Cardiovascular Rsch (CNIC), Madrid, Spain 3Scientific Dept, SHE Foundation, Barcelona, Spain 4Dept of Pedagogy, SHE Foundation, Barcelona, Spain 5Coordination, SHE Foundation, Barcelona, Spain 6Director, SHE Foundation, Madrid, Spain 7Dept of Pedagogy, SHE Foundation, Madrid, Spain 8Friedman Sch of Nutrition Science and Policy, Tufts Univ, Boston, MA, 9Internal Medicine, Catalan Health Institute, Barcelona, Spain 10NAOS Strategy, Spanish Agency for Consumer Affairs, Food safety and Nutrition (AECOSAN), Madrid, Spain 11NAOS Strategy, Spanish Agency for Consumers Affairs, Food Safety and Nutrition (AECOSAN), Spain, Spain 12NAOS Strategy, Span