Dissemination and Adoption of Comparative Effectiveness Research Findings When Findings Challenge Current Practices. Study Results

01/01/2013

The results of COMPANION were published in 2004 (Table 5.1) (Bristow et al., 2004). The CRT treatment group showed a statistically significant improvement of 17 percent in the combined end point over those who received OPT alone. The CRT-D treatment group showed a similar 17-percent improvement. While adding an ICD to CRT did not significantly improve the combined end point, it did reduce 12-month all-cause mortality (a secondary outcome) from
15 percent to 12 percent. It is worth noting that the OPT-only group had a 13-percent dropout rate (before an end point was reached), compared with only a 2-percent dropout in the two treatment groups. However, the treatment groups experienced initial procedure failure rates during implantation of the CRT and CRT-D devices of 13 percent and 9 percent, respectively. The results of this study imply a clear survival and quality-of-life benefit from adding CRT (with or without CRT-D) to OPT for patients who have HF with delayed ventricular conduction. The practice at the time was to use CRT for HF but withhold ICD devices in these patients given both safety concerns and a lack of proven benefit.

Table 5.1

Results of the COMPANION Trial

Outcome

Results

Primary outcome

OPT Alone

CRT + OPT

CRT-D + OPT

Death or hospitalization (any cause), 12-month rate

68%

56%*

56%*

Secondary outcomes

 

 

 

Death or hospitalization (cardiac cause), 12-month rate

60%

45%*

44%*

Death or hospitalization (HF), 12-month rate

45%

31%*

29%*

Mortality (any cause), 12-month rate

19%

15%

12%*

Change in six-minute walk distance at three and six months (meters)

9±84

1±93

33±99*

40±96*

44±109*

46±98*

Improvement in quality of life at three and six
months (Minnesota HF Scale)

9±12

12±23

24±27*

25±26*

24±28*

26±28*

Improvement in NYHA functional class

24%

38%

54%*

61%*

55%*

57%*

Other

 

 

 

Moderate or severe event associated with device implantation

 

 

10%

8%

Failure of initial device-implantation attempt

 

13%

9%

Sensitivity analysis: study withdrawal (prior to primary end point)

13%

2%

2%

Sensitivity analysis: mortality status unknown at end of study

4%

1%

1%

NOTE: Asterisks denote statistically significant differences compared with OPT alone.

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