A Comparison of the Effects of Carvedilol and Metoprolol on Well-Being, Morbidity, and Mortality (the "Patient Journey") in Patients With Heart Failure
A Report From the Carvedilol Or Metoprolol European Trial (COMET)
John G.F. Cleland, MD, FRCP, FESC, FACC*,*,
Andrew Charlesworth, PhD ,
Jacobus Lubsen, MD, PhD ,
Karl Swedberg, MD, PhD ,
Willem J. Remme, MD, PhD, FACC, FESC||,
Leif Erhardt, MD, FESC¶,
Andrea Di Lenarda, MD, FESC#,
Michel Komajda, MD**,
Marco Metra, MD,
Christian Torp-Pedersen, MD,
Philip A. Poole-Wilson, MD, FRCP, FESC, FMedSci for the COMET Investigators
* University of Hull, Kingston-upon-Hull, United Kingdom
Nottingham Clinical Research Group, Nottingham, United Kingdom
SOCAR Research SR, Nyon, Switzerland; Erasmus Medical Centre, Rotterdam, the Netherlands
Sahlgrenska University Hospital/Östra, Göteborg, Sweden
|| Sticares Cardiovascular Research Foundation, Rhoon, the Netherlands
¶ Malmo University Hospital, Malmo, Sweden
# Ospedale di Cattinara, Trieste, Italy
** La Pitié-Salpétrière Hospital, Paris, France
Università di Brescia, Brescia, Italy
Bispebjerg University Hospital, Copenhagen, Denmark
National Heart and Lung Institute, Imperial College, London, United Kingdom
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Figure 1 Distribution of patients’ scoring of well-being on a scale of 1 (very good) to 5 (very poor) according to age, gender, and investigator-determined New York Heart Association (NYHA) functional class.
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Figure 2 Cumulative amount of time spent in each health state during different follow-up periods expressed as a proportion of potential days follow-up, alive or dead. The difference between interventions was significant (p = 0.0068). For the base case, a score of 100% was assigned for each day alive and spent out of hospital if the patient reported being very well ("well-being" score 1) and was reduced by 20% for each decrement in the patient-reported score down to a lowest potential score of 20% ("well-being" score 5).
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Figure 3 Distribution of percentages of notional days of life lost using the "patient journey" score. The best possible score is 0% loss (surviving 4 years with best well-being state, without increased need for diuretic therapy, hospitalization, or death). Poor scores may reflect early death, persistently poor well-being, or prolonged periods of hospitalization, or any combination of such events. Data shown use the base-case set of scores for well-being. Note the shift to the left in scores among patients randomized to carvedilol compared to metoprolol (p = 0.0068).
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Figure 4 Comparison of percentage of days alive lost due to poor well-being in patients randomized to carvedilol or metoprolol using four different sets of scores. Note that patients receiving carvedilol lived longer, and therefore potential days lost to poor well-being while receiving carvedilol were higher than for metoprolol. "Base case" represents well-being scores of 100, 80, 60, 40, or 20. "Well-being" reflects the view that survival in a poor health state has low value (100, 90, 70, 30, 0). "Life" reflects the view that survival regardless of health state has high value (100, 90, 80, 70, 60). "NYHA" reflects scores derived from Glick et al. (14) (100, 86, 73, 66). AR = absolute reduction with a 1% difference reflecting about 200,000 days in study or about 15 days per patient; RR = relative reduction.
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Figure 5 Days lost, overall and by component of the "patient journey," in subgroups of patients according to gender (A), age (B), New York Heart Association (NYHA) functional class (C), and left ventricular ejection fraction (D).
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Figure 6 Overall days lost in subgroups of patients according to age, gender, New York Heart Association (NYHA) functional class, and left ventricular ejection fraction (LVEF) in patients randomized to carvedilol or metoprolol.
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