Journal of Cardiac Failure
Volume 14, Issue 5 , Pages 368-372 , June 2008

A Global Ranking Approach to End Points in Trials of Mechanical Circulatory Support Devices

  • G. Michael Felker, MD, MHS

      Affiliations

    • Duke Clinical Research Institute
    • Division of Cardiovascular Medicine, Duke University School of Medicine, Durham, NC
    • Corresponding Author InformationReprint requests: G. Michael Felker, MD, MHS, Duke Clinical Research Institute, 2400 Pratt St, Room 0311 Terrace Level, Durham, NC 27705.
  • ,
  • Kevin J. Anstrom, PhD

      Affiliations

    • Duke Clinical Research Institute
  • ,
  • Joseph G. Rogers, MD

      Affiliations

    • Duke Clinical Research Institute
    • Division of Cardiovascular Medicine, Duke University School of Medicine, Durham, NC

Received 2 October 2007 ,Revised 21 December 2007 ,Accepted 15 January 2008.

References 

  1. Baughman KL, Jarcho JA. Bridge to life—cardiac mechanical support. N Engl J Med. 2007;357:846–849
  2. Rose EA, Gelijns AC, Moskowitz AJ, Heitjan DF, Stevenson LW, Dembitsky WP, et al. Long term use of left-ventricular assist device for end-stage heart failure. N Engl J Med. 2001;345:1435–1443
  3. Rogers JG, Butler J, Lansman SL, Gass A, Portner PM, Pasque MK, et al. Chronic mechanical circulatory support for inotrope-dependent heart failure patients who are not transplant candidates: results of the INTrEPID Trial. J Am Coll Cardiol. 2007;50:741–747
  4. Miller LW, Pagani FD, Russell SD, John R, Boyle AJ, Aaronson KD, et al. Use of a continuous-flow device in patients awaiting heart transplantation. N Engl J Med. 2007;357:885–896
  5. Stevenson LW, Couper G. On the fledgling field of mechanical circulatory support. J Am Coll Cardiol. 2007;50:748–751
  6. Neaton JD, Normand SL, Gelijns A, Starling RC, Mann DL, Konstam MA. Designs for mechanical circulatory support device studies. J Card Fail. 2007;13:63–74
  7. Neaton JD, Gray G, Zuckerman BD, Konstam MA. Key issues in end point selection for heart failure trials: composite end points. J Card Fail. 2005;11:567–575
  8. Yusuf S, Negassa A. Choice of clinical outcomes in randomized trials of heart failure therapies: disease-specific or overall outcomes?. Am Heart J. 2002;143:22–28
  9. O'Brien PC. Procedures for comparing samples with multiple endpoints. Biometrics. 1984;40:1079–1087
  10. Califf RM, Harrelson-Woodlief L, Topol EJ. Left ventricular ejection fraction may not be useful as an end point of thrombolytic therapy comparative trials. Circulation. 1990;82:1847–1853
  11. Temkin NR, Anderson GD, Winn HR, Ellenbogen RG, Britz GW, Schuster J, et al. Magnesium sulfate for neuroprotection after traumatic brain injury: a randomised controlled trial. Lancet Neurol. 2007;6:29–38
  12. Lachin JM. Worst-rank score analysis with informatively missing observations in clinical trials. Control Clin Trials. 1999;20:408–422
  13. Normand SL, Rector TS, Neaton JD, Pina IL, Lazar RM, Proestel SE, et al. Clinical and analytical considerations in the study of health status in device trials for heart failure. J Card Fail. 2005;11:396–403
  14. Moye LA, Davis BR, Hawkins CM. Analysis of a clinical trial involving a combined mortality and adherence dependent interval censored endpoint. Stat Med. 1992;11:1705–1717
  15. Finkelstein DM, Schoenfeld DA. Combining mortality and longitudinal measures in clinical trials. Stat Med. 1999;18:1341–1354
  16. McMahon RP, Harrell FE. Power calculation for clinical trials when the outcome is a composite ranking of survival and a nonfatal outcome. Control Clin Trials. 2000;21:305–312
  17. Maas AI, Murray GD. Magnesium for neuroprotection after traumatic brain injury. Lancet Neurol. 2007;6:20–21

 All decisions regarding this manuscript were made by a guest editor.Dr Felker is supported in part by NIH K23 HL072357.

PII: S1071-9164(08)00027-4

doi: 10.1016/j.cardfail.2008.01.009

Journal of Cardiac Failure
Volume 14, Issue 5 , Pages 368-372 , June 2008