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Table 1 Trials (PROVE-IT [10], LIFE [11], HOPE [12]) data and observed or estimated indices of treatment effect according to the PISA method

From: A novel method for interpreting survival analysis data: description and test on three major clinical trials on cardiovascular prevention

 

PROVE-IT

LIFE

HOPE

Duration/t50%(months)

30/21

66/58

55/27

Outcome

4p-MACE

3p-MACE

3p-MACE

Rate comparator (%/year)

11.6

2.8

3.7

RRR [95%CI] (%)

16 [5–26]

13 [2–23]

22 [14–30]

ARR (%)

4.65

1.95

3.71

Time-Gain@2 years (m)

49.9

14.5

14.8

Time-Gain@T

73.2

72.0

96.4

f50% 2nd order coef.

0.0537

0.0116

0.0335

f50% 1st order coef.

0.856

0.3186

−0.186

R2value 0-t50

0.9899

0.9991

0.9995

R2value 0-T

0.9970

0.9990

0.9994

Time-Gain f50%@2 years (m)

51.5

14.3

14.8

Time-Gain f50%@6 years (m)

340.0

83.1

160.3

MoT/y+@2 years

487

1946

1871

MoT/y+@T

400.3

1032.9

692.2

Fit coef.

2757

11,459

109,635

Fit exp.

−0.554

−0.562

− 1.278

R2value 0-T

0.9579

0.9686

0.9990

eMoT/y+@2 years

474

1920

1888

eMoT/y+@6 years

258

1036

464

NNT/y+@2 years

20.3

81.1

78.0

NNT/y+@T

13.6

15.7

11.5

Fit coef.

2757

11,459

109,635

Fit exp.

−1.554

−1.562

−2.278

R2value

0.9901

0.9964

0.9994

eNNT/y+@2 years

19.8

80.0

78.6

eNNT/y+@6 years

3.6

12.7

6.4

  1. Estimated indices and functions are presented in italics. RRR relative risk reduction, ARR absolute risk reduction, T end of the study, Time-Gain@T the value of even-free months accumulated at the end of the study, f50% fit performed at 50% of the study follow-up length, MoT/y+ months of treatment per event-free years, eMoT/y+ MoT/y+ estimated through curve fitting performed on time interval from 6 months to the end of the follow-up, NNT/y+ number needed to treat per event-free years, eNNT/y+ NNT/y+ estimated through curve fitting performed on time interval from 6 months to the end of the follow-up
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Trials

ISSN: 1745-6215