The rematch trial: Rationale, design, and end points

Annals of Thoracic Surgery

Volumn 67, Issue 3, 1999, Pages 723-730

  Rose, Eric A ^a   Moskowitz, Alan J ^a   Packer, Milton ^a   Sollano, Josephine A ^a   Williams, Deborah L ^a   Tierney, Anita R ^a   Heitjan, Daniel F ^a   Meier, Paul ^a   Ascheim, Deborah Davis ^a   Levitan, Ronald G ^a   Weinberg, Alan D ^a   Stevenson, Lynne Warner ^a,b   Shapiro, Peter A ^a,b   Lazar, Ronald M ^a   Watson, John T ^c   Goldstein, Daniel J ^a,b   Gelijns, Annetine C ^a  

^a Och Spine at New York Presbyterian Hospitals   (United States)

^b NewYork Presbyterian Hospital   (United States)

^c NATIONAL HEART LUNG AND BLOOD INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; CONGESTIVE HEART FAILURE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COST BENEFIT ANALYSIS; COST EFFECTIVENESS ANALYSIS; EVALUATION; FOLLOW UP; FUNCTIONAL ASSESSMENT; HEALTH CARE COST; HEART ASSIST DEVICE; HUMAN; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RISK BENEFIT ANALYSIS; SURVIVAL RATE; SURVIVAL TIME; TREATMENT INDICATION;

HEART FAILURE, CONGESTIVE; HEART TRANSPLANTATION; HEART-ASSIST DEVICES; HUMANS; MULTICENTER STUDIES; PATIENT SELECTION; RANDOMIZED CONTROLLED TRIALS; RESEARCH DESIGN;

EID: 0032909782     PISSN: 00034975     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0003-4975(99)00042-9     Document Type: Article

References (27)

1. Ho K, Pinsky JL, Kannel WB, Levy D. The epidemiology of heart failure: the Framingham Study. J Am Coll Cardiol 1993;22(4 Suppl A):6A-13A.
2. Schocken D.D., Arrieta M.I., Leaverton P.E., Ross E.A. Prevalence and mortality rate of congestive heart failure in the United States. J Am Coll Cardiol. 20:1992;301-306.
3. Effect of enalapril on survival in patients with reduced left ventricular ejection fractions and congestive heart failure. N Engl J Med. 325:1991;293-302.
4. Hosenpud J.D., Novick R.J., Bennett L.E., Keck B.M., Fiol B., Daily O.P. The Registry of the International Society for Heart and Lung Transplantation thirteenth official report-1996 . J Heart Lung Transplant. 15:1996;655-674.
5. Meyer K.B., Espindle D.M., DeGiacomo J.M., et al. Monitoring dialysis patients' health status. Am J Kidney Dis. 24:1994;267-279.
6. Pennington D.G., McBride L.R., Peigh P.S., et al. Eight years' experience with bridging to cardiac transplantation. J Thorac Cardiovasc Surg. 107:1994;472-481.
7. Frazier O.H., Rose E.A., Macmanus Q., et al. Multicenter clinical evaluation of the HeartMate 1000 IP left ventricular assist device. Ann Thorac Surg. 53:1992;1080-1090.
8. Catanese K.A., Goldstein D.J., Williams D.L., et al. Outpatient left ventricular assist device support a destination rather than a bridge . Ann Thorac Surg. 62:1996;646-653.
9. Farrar D., Hill J. Recovery of major organ function in patients awaiting heart transplantation with Thoratec ventricular assist devices. J Heart Lung Transplant. 13:1994;1125-1132.
10. Foray A., Williams D., Reemtsma K., et al. Assessment of submaximal exercise capacity in patients with left ventricular assist devices. Circulation. 94:(Suppl 2):1996;222-226.
11. Moskowitz A.J., Weinberg A.D., Oz M.C., Williams D.L. Quality of life with an implanted left ventricular assist device. Ann Thorac Surg. 64:1997;1764-1769.
12. Rose E.A., Goldstein D.J. Wearable long-term mechanical support for patients with end-stage heart disease a tenable goal . Ann Thorac Surg. 61:1996;399-402.
13. Funk M. Epidemiology of end-stage heart failure. Hogness J., VanAntwerp M. The artificial heart prototypes, policies, and patients . 1991;251-261 National Academy Press, Washington, DC.
14. Gelijns A.C., Richards A.F., Williams D.L., Oz M.L., Oliveira J., Moskowitz A.J. Evolving costs of long-term left ventricular assist device implantation. Ann Thorac Surg. 64:1997;1312-1319.
15. Moskowitz A., Reemtsma K., Rose E., Gelijns A. Clinical outcomes in surgery. Sabiston D.C. Jr. Textbook of surgery the biological basis of modern surgical practice . 1997;36-53 WB Saunders, Philadelphia.
16. Pocock S. Clinical trials a practical approach . 1983;Wiley, New York.
17. Grage T., Zelen M. The controlled randomized trial in the evaluation of cancer treatment - the dilemma and alternative designs. UICC Tech Rep Ser. 70:1980;23.
18. Howard G., Chambless L., Kronmal R. Assessing differences in clinical trials comparing surgical vs nonsurgical therapy. Using common (statistical) sense. JAMA. 278:1997;1432-1436.
19. Matts J., Lachin J. Properties of permuted-block randomization in clinical trials. Control Clin Trials. 9:1988;327-344.
20. Karrison T. Use of Irwin's restricted mean as an index for comparing survival in different treatment groups - interpretation and power considerations. Control Clin Trials. 18:1987;151-167.
21. Packer M., O'Connor C., Ghali J., et al. Effect of amlodipine on morbidity and mortality in severe chronic heart failure. Prospective randomized amlodipine survival evaluation study group. N Engl J Med. 335:1996;1107-1114.
22. Schoenfeld D. Sample-size formula for the proportional-hazards regression model. Biometrics. 39:1983;499-503.
23. Cahalin L.P., Mathier M.A., Semigran M.J., Dec G.W., DiSalvo T.G. The six-minute walk test predicts peak oxygen uptake and survival in patients with advanced heart failure. Chest. 110:1996;325-332.
24. Rector T., Cohn J., Group P.M.R. Assessment of patient outcome with the Minnesota Living With Heart Failure questionnaire reliability and validity during a randomized double-blind, controlled trial of pimodbendan . Am Heart J. 124:1992;1017-1025.
25. Jenkinson C., Coulter A., Wright L. Short form 36 (SF36) health survey questionnaire normative data for adults of working age . [see comments] BMJ. 306:1993;1437-1440.
26. EuroQoL - a new facility for the measurement of health-related quality of life. Health Policy. 16:1990;199-208.
27. Gersh B.J., Kronmal R.A., Schaff H.V., et al. Comparison of coronary artery bypass surgery and medical therapy in patients 65 years of age or older. A nonrandomized study from the Coronary Artery Surgery Study (CASS) registry. N Engl J Med. 313:1985;217-224.