Table 2.
Predicted and observed results in RE-LY and Medicare populations
| Outcome | Population* | Two-year Risk (%) | RR (95% CI) | RD (95% CI) | |||||
|---|---|---|---|---|---|---|---|---|---|
| Dabigatran | Warfarin | (ref: warfarin) | SDRR† | (ref: warfarin) | SDRD† | ||||
| Stroke/SE | Predicted | RE-LY | 2.22 | 3.59 | 0.62 (0.49, 0.78) | −1.37 (−2.04, −0.72) | |||
| Early | 2.48 | 3.39 | 0.74 (0.53, 1.00) | 0.88 | −0.92 (−1.86, −0.01) | 0.78 | |||
| Extended | 2.37 | 3.27 | 0.73 (0.53, 0.98) | 0.83 | −0.90 (−1.76, −0.06) | 0.86 | |||
| Observed | 1.95 | 3.01 | 0.65 (0.56, 0.75) | 0.67 | −1.06 (−1.41, −0.71) | 0.34 | |||
| Major bleeding | Predicted | RE-LY | 6.67 | 7.42 | 0.90 (0.75, 1.05) | −0.75 (−1.91, 0.34) | |||
| Early | 8.82 | 8.24 | 1.08 (0.85, 1.34) | 1.26 | 0.58 (−1.39, 2.56) | 1.15 | |||
| Extended | 8.43 | 7.81 | 1.09 (0.86, 1.35) | 1.33 | 0.62 (−1.24, 2.50) | 1.23 | |||
| Observed | 3.61 | 4.89 | 0.74 (0.66, 0.82) | 3.03 | −1.28 (−1.73, −0.82) | 1.94 | |||
| All-cause death | Predicted | RE-LY | 6.56 | 7.51 | 0.88 (0.76, 1.01) | −0.95 (−1.93, 0.04) | |||
| Early | 6.64 | 6.01 | 1.11 (0.87, 1.41) | 1.62 | 0.64 (−0.86, 2.17) | 1.72 | |||
| Extended | 5.99 | 5.44 | 1.11 (0.87, 1.39) | 1.66 | 0.55 (−0.80, 1.92) | 1.75 | |||
| Observed | 3.81 | 4.62 | 0.83 (0.74, 0.92) | 2.21 | −0.81 (−1.26, −0.36) | 1.68 | |||
Abbreviations: RR, risk ratio; RD, risk difference; SD, standardized difference.
*
Early: early post-market target population in 2010–2011; Extended: extended time window target population in 2010–2017; RE-LY: the RE-LY trial target population.
†
Relative to the predicted results in the RE-LY trial participants except for the observed results in the extended time window target population that are relative to the predicted results in the same extended time window target population.