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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-ITLIFEHOPE
Duration/t50%(months)30/2166/5855/27
Outcome4p-MACE3p-MACE3p-MACE
Rate comparator (%/year)11.62.83.7
RRR [95%CI] (%)16 [5–26]13 [2–23]22 [14–30]
ARR (%)4.651.953.71
Time-Gain@2 years (m)49.914.514.8
Time-Gain@T73.272.096.4
f50% 2nd order coef.0.05370.01160.0335
f50% 1st order coef.0.8560.3186−0.186
R2value 0-t500.98990.99910.9995
R2value 0-T0.99700.99900.9994
Time-Gain f50%@2 years (m)51.514.314.8
Time-Gain f50%@6 years (m)340.083.1160.3
MoT/y+@2 years48719461871
MoT/y+@T400.31032.9692.2
Fit coef.275711,459109,635
Fit exp.−0.554−0.562− 1.278
R2value 0-T0.95790.96860.9990
eMoT/y+@2 years47419201888
eMoT/y+@6 years2581036464
NNT/y+@2 years20.381.178.0
NNT/y+@T13.615.711.5
Fit coef.275711,459109,635
Fit exp.−1.554−1.562−2.278
R2value0.99010.99640.9994
eNNT/y+@2 years19.880.078.6
eNNT/y+@6 years3.612.76.4
  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