Mode of death and hospitalization from the second follow-up serial infusions of nesiritide (FUSION II) trial and comparison of clinical events committee adjudicated versus investigator reported outcomes

American Journal of Cardiology

Volumn 108, Issue 10, 2011, Pages 1449-1457

  O'Connor, Christopher M ^a,b   Fiuzat, Mona ^a   Lindenfeld, Joann ^c   Miller, Alan ^d   Lombardi, Carlo ^e   Carson, Peter ^f   Shaw, Linda K ^b   Wang, Li Joy ^g   Connolly, Patricia ^b   Mills, Roger ^g   Yancy, Clyde ^h   Mahaffey, Kenneth ^a,b  

^a DUKE UNIVERSITY   (United States)

^b DUKE CLINICAL RESEARCH INSTITUTE   (United States)

^c UNIVERSITY OF COLORADO   (United States)

^d UNIVERSITY OF FLORIDA   (United States)

^e UNIVERSITY OF BRESCIA   (Italy)

^f VETERANS AFFAIRS MEDICAL CENTER   (United States)

^g Ortho McNeil Pharmaceutical Incorporated   (United States)

^h NORTHWESTERN UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

NESIRITIDE;

ADULT; AGED; ARTICLE; CAUSE OF DEATH; COMPARATIVE STUDY; DISEASE SEVERITY; FEMALE; HEART DISEASE; HEART FAILURE; HOSPITALIZATION; HUMAN; KIDNEY DYSFUNCTION; MAJOR CLINICAL STUDY; MALE; OUTCOME ASSESSMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC);

AGED; CAUSE OF DEATH; CLINICAL TRIALS DATA MONITORING COMMITTEES; DOUBLE-BLIND METHOD; FEMALE; HEART FAILURE; HOSPITALIZATION; HUMANS; INFUSION PUMPS; MALE; MIDDLE AGED; NATRIURETIC AGENTS; NATRIURETIC PEPTIDE, BRAIN; PROSPECTIVE STUDIES; RENAL INSUFFICIENCY; RESEARCH PERSONNEL;

EID: 80255122714     PISSN: 00029149     EISSN: 18791913     Source Type: Journal    
DOI: 10.1016/j.amjcard.2011.06.065     Document Type: Article

References (27)

1. C.W. Yancy, H. Krum, B.M. Massie, M.A. Silver, L.W. Stevenson, M. Cheng, S.S. Kim, R. Evans FUSION II Investigators The Second Follow-Up Serial Infusions of Nesiritide (FUSION II) trial for advanced heart failure: study rationale and design Am Heart J 153 2007 478 484 (Pubitemid 46442809)
2. C.W. Yancy, H. Krum, B.M. Massie, M.A. Silver, L.W. Stevenson, M. Cheng, S.S. Kim, R. Evans FUSION II Investigators Safety and efficacy of outpatient nesiritide in patients with advanced heart failure: results of the Second Follow-Up Serial Infusions of Nesiritide (FUSION II) trial Circ Heart Fail 1 2008 9 16
3. J.R. Landis, and G.G. Koch The measurement of observer agreement for categorical data Biometrics 33 1977 159 174 (Pubitemid 8054849)
4. CONSENSUS Trial Study Group Effects of enalapril on mortality in severe congestive heart failure Results of the Cooperative North Scandinavian Enalapril Survival Study (CONSENSUS) N Engl J Med 316 1987 1429 1435
5. ESCAPE Investigators and Study Coordinators Evaluation study of congestive heart failure and pulmonary artery catheterization effectiveness: the ESCAPE trial JAMA 294 2005 1625 1633
6. J.G. Rogers, M. Fiuzat, G. Tassisa, and C.M. O'Connor Mode of death in advanced HF: data from the ESCAPE trial [abstract] J Card Fail 15 2009 S86
7. E.A. Rose, A.C. Gelijns, A.J. Moskowitz, D.F. Heitjan, L.W. Stevenson, W. Dembitsky, J.W. Long, D.D. Ascheim, A.R. Tierney, R.G. Levitan, J.T. Watson, P. Meier, N.S. Ronan, P.A. Shapiro, R.M. Lazar, L.W. Miller, L. Gupta, O.H. Frazier, P. Desvigne-Nickens, M.C. Oz, V.L. Poirier Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) Study Group Long-term mechanical left ventricular assistance for end-stage heart failure N Engl J Med 345 2001 1435 1443
8. C.M. O'Connor, P.E. Carson, A.B. Miller, M.L. Pressler, R.N. Belkin, G.W. Neuberg, D.J. Frid, A.B. Cropp, S. Anderson, J.H. Wertheimer, and D.L. DeMets Effect of amlodipine on mode of death among patients with advanced heart failure in the PRAISE trial Am J Cardiol 82 1998 881 887 (Pubitemid 28467363)
9. M. Packer, C.M. O'Connor, J.K. Ghali, M.L. Pressler, P.E. Carson, R.N. Belkin, A.B. Miller, G.W. Neuberg, D. Frid, J.H. Wertheimer, A.B. Cropp, D.L. DeMets Prospective Randomized Amlodipine Survival Evaluation Study Group Effect of amlodipine on morbidity and mortality in severe chronic heart failure N Engl J Med 335 1996 1107 1114 (Pubitemid 26330964)
10. C.M. O'Connor, A.B. Miller, J.E. Blair, M.A. Konstam, P. Wedge, M.C. Bahit, P. Carson, M. Haass, P.J. Hauptman, M. Metra, R.M. Oren, R. Patten, I. Pia, S. Roth, J.D. Sackner-Bernstein, B. Traver, T. Cook, M. Gheorghiade Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study With Tolvaptan (EVEREST) Investigators Causes of death and rehospitalization in patients hospitalized with worsening heart failure and reduced left ventricular ejection fraction: results from Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study With Tolvaptan (EVEREST) program Am Heart J 159 2010 841 849
11. M.A. Konstam, M. Gheorghiade, J.C. Burnett Jr, L. Grinfeld, A.P. Maggioni, K. Swedberg, J.E. Udelson, F. Zannad, T. Cook, J. Ouyang, C. Zimmer, C. Orlandi Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study With Tolvaptan (EVEREST) Investigators Effects of oral tolvaptan in patients hospitalized for worsening heart failure: the EVEREST outcome trial JAMA 297 2007 1319 1331 (Pubitemid 46513233)
12. R.M. Califf, K.F. Adams, W.J. McKenna, M. Gheorghiade, B.F. Uretsky, S.E. McNulty, H. Darius, K. Schulman, F. Zannad, E. Handberg-Thurmond, F.E. Harrell Jr, W. Wheeler, J. Soler-Soler, and K. Swedberg A randomized controlled trial of epoprostenol therapy for severe congestive heart failure: the Flolan International Randomized Survival Trial (FIRST) Am Heart J 134 1997 44 54 (Pubitemid 27329022)
13. M. Packer, A.J. Coats, M.B. Fowler, H.A. Katus, H. Krum, P. Mohacsi, J.L. Rouleau, M. Tendera, A. Castaigne, E.B. Roecker, M.K. Schultz, D.L. DeMets Carvedilol Prospective Randomized Cumulative Survival Study Group Effect of carvedilol on survival in severe chronic heart failure N Engl J Med 344 2001 1651 1658 (Pubitemid 32479962)
14. M. Packer, M.B. Fowler, E.B. Roecker, A.J. Coats, H.A. Katus, H. Krum, P. Mohacsi, J.L. Rouleau, M. Tendera, C. Staiger, T.L. Holcslaw, I. Amann-Zalan, D.L. DeMets Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) Study Group Effect of carvedilol on the morbidity of patients with severe chronic heart failure: results of the Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) study Circulation 106 2002 2194 2199 (Pubitemid 35222212)
15. P. Carson, I. Anand, C. O'Connor, B. Jaski, J. Steinberg, A. Lwin, J. Lindenfeld, J. Ghali, J.H. Barnet, A.M. Feldman, and M.R. Bristow Mode of death in advanced heart failure: the Comparison of Medical, Pacing, and Defibrillation Therapies in Heart Failure (COMPANION) trial J Am Coll Cardiol 46 2005 2329 2334 (Pubitemid 41785506)
16. M.R. Bristow, L.A. Saxon, J. Boehmer, S. Krueger, D.A. Kass, T. De Marco, P. Carson, L. DiCarlo, D. DeMets, B.G. White, D.W. DeVries, A.M. Feldman Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Investigators Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure N Engl J Med 350 2004 2140 2150
17. I.S. Anand, P. Carson, E. Galle, R. Song, J. Boehmer, J.K. Ghali, B. Jaski, J. Lindenfeld, C. O'Connor, J.S. Steinberg, J. Leigh, P. Yong, M.R. Kosorok, A.M. Feldman, D. DeMets, and M.R. Bristow Cardiac resynchronization therapy reduces the risk of hospitalizations in patients with advanced heart failure: results from the Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure (COMPANION) trial Circulation 119 2009 969 977
18. P. Carson, M. Fiuzat, C. O'Connor, I. Anand, J. Plehn, J.A. Lindenfeld, M. Silver, M. White, A. Miller, G. Davis, A.D. Robertson, M. Bristow, and S. Gottlieb Determination of hospitalization type by investigator case report form or adjudication committee in a large heart failure clinical trial (Beta-Blocker Evaluation of Survival Trial [BEST]) Am Heart J 160 2010 649 654
19. Beta-Blocker Evaluation of Survival Trial Investigators A trial of the beta-blocker bucindolol in patients with advanced chronic heart failure N Engl J Med 344 2001 1659 1667
20. B. Pitt, F. Zannad, W.J. Remme, R. Cody, A. Castaigne, A. Perez, J. Palensky, J. Wittes Randomized Aldactone Evaluation Study Investigators The effect of spironolactone on morbidity and mortality in patients with severe heart failure N Engl J Med 341 1999 709 717 (Pubitemid 29407370)
21. B.M. Massie, C.M. O'Connor, M. Metra, P. Ponikowski, J.R. Teerlink, G. Cotter, B.D. Weatherley, J.G. Cleland, M.M. Givertz, A. Voors, P. DeLucca, G.A. Mansoor, C.M. Salerno, D.M. Bloomfield, H.C. Dittrich PROTECT Investigators and Committees Rolofylline, an adenosine A1-receptor antagonist, in acute heart failure N Engl J Med 363 2010 1419 1428
22. K.W. Mahaffey, R.A. Harrington, M. Akkerhuis, N.S. Kleiman, L.G. Berdan, B.S. Crenshaw, B.E. Tardiff, C.B. Granger, I. DeJong, M. Bhapkar, P. Widimsky, R. Corbalon, K.L. Lee, J.W. Deckers, M.L. Simoons, E.J. Topol, R.M. Califf PURSUIT Investigators Disagreements between central clinical events committee and site investigator assessments of myocardial infarction endpoints in an international clinical trial: review of the PURSUIT study Curr Control Trials Cardiovasc Med 2 2001 187 194 (Pubitemid 32780806)
23. K.W. Mahaffey, R.A. Harrington, M. Akkerhuis, N.S. Kleiman, L.G. Berdan, B.S. Crenshaw, B.E. Tardiff, C.B. Granger, I. DeJong, M. Bhapkar, P. Widimsky, R. Corbalon, K.L. Lee, J.W. Deckers, M.L. Simoons, E.J. Topol, R.M. Califf PURSUIT Investigators Systematic adjudication of myocardial infarction end-points in an international clinical trial Curr Control Trials Cardiovasc Med 2 2001 180 186 (Pubitemid 32780805)
24. M. Packer, R.M. Califf, M.A. Konstam, H. Krum, J.J. McMurray, J.L. Rouleau, and K. Swedberg Comparison of omapatrilat and enalapril in patients with chronic heart failure: the Omapatrilat Versus Enalapril Randomized Trial of Utility in Reducing Events (OVERTURE) Circulation 106 2002 920 926 (Pubitemid 34925324)
25. S.D. Solomon, D. Wang, P. Finn, H. Skali, L. Zornoff, J.J. McMurray, K. Swedberg, S. Yusuf, C.B. Granger, E.L. Michelson, S. Pocock, and M.A. Pfeffer Effect of candesartan on cause-specific mortality in heart failure patients: the Candesartan in Heart failure Assessment of Reduction in Mortality and morbidity (CHARM) program Circulation 110 2004 2180 2183 (Pubitemid 39372498)
26. Effect of metoprolol CR/XL in chronic heart failure: Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure (MERIT-HF) Lancet 353 1999 2001 2007
27. Pogue J, Walter SD, Yusuf S. Evaluating the benefit of event adjudication of cardiovascular outcomes in large simple RCTs. Clin Trials 2009;6:239-251.