Table 2.
Sensitivity analysis of primary and secondary endpoints.
| M-H Fixed Effects RR and 95% CI after the Removal of: | ||||||
|---|---|---|---|---|---|---|
| Endpoint | None | TITAX-AMI | TIDE | TITANIC-XV | BASE-ACS | TIDES-ACS |
| Total (all RCTs)—1-year follow-up | ||||||
| MACE | 1.01 [0.81, 1.26] | 1.06 [0.83, 1.36] | 0.96 [0.75, 1.23] | 0.98 [0.78, 1.24] | 0.99 [0.76, 1.29] | 1.07 [0.82, 1.40] |
| CD or MI | 0.55 [0.39, 0.77] | 0.57 [0.39, 0.82] | 0.52 [0.36, 0.74] | 0.55 [0.39, 0.77] | 0.53 [0.36, 0.79] | 0.60 [0.40, 0.91] |
| Non-fatal MI | 0.52 [0.36, 0.76] | 0.51 [0.33, 0.78] | 0.48 [0.31, 0.73] | 0.52 [0.35, 0.76] | 0.60 [0.38, 0.93] | 0.51 [0.32, 0.82] |
| CD | 0.66 [0.33, 1.31] | 0.77 [0.37, 1.61] | 0.66 [0.33, 1.31] | 0.66 [0.33, 1.31] | 0.30 [0.11, 0.81] | 1.11 [0.43, 2.85] |
| Clinically driven TLR | 1.62 [1.20, 2.18] | 1.56 [1.13, 2.15] | 1.60 [1.15, 2.24] | 1.58 [1.16, 2.14] | 1.74 [1.22, 2.47] | 1.63 [1.14, 2.33] |
| Probable or definite ST | 0.39 [0.22, 0.69] | 0.46 [0.25, 0.84] | 0.35 [0.20, 0.64] | 0.39 [0.22, 0.69] | 0.36 [0.18, 0.72] | 0.38 [0.16, 0.87] |
| Definite ST | 0.51 [0.26, 0.99] | 0.49 [0.25, 0.97] | 0.46 [0.23, 0.92] | 0.51 [0.26, 0.99] | 0.62 [0.29, 1.36] | 0.52 [0.18, 1.44] |
| TD | 0.78 [0.48, 1.27] | 0.77 [0.46, 1.32] | 0.78 [0.47, 1.27] | 0.78 [0.48, 1.27] | 0.49 [0.26, 0.95] b | 1.22 [0.65, 2.28] |
| ACS-only RCTs—1-year follow-up | ||||||
| MACE | 0.93 [0.72, 1.20] | 0.97 [0.73, 1.30] | NA. | NA. | 0.86 [0.63, 1.19] | 0.95 [0.68, 1.33] |
| CD or MI | 0.52 [0.36, 0.75] | 0.53 [0.35, 0.80] | NA. | NA. | 0.48 [0.30, 0.75] | 0.56 [0.35, 0.90] |
| Non-fatal MI | 0.48 [0.31, 0.73] | 0.45 [0.27, 0.74] | NA. | NA. | 0.55 [0.33, 0.92] | 0.44 [0.25, 0.77] |
| CD | 0.66 [0.33, 1.31] | 0.77 [0.37, 1.61] | NA. | NA. | 0.30 [0.11, 0.81] | 1.11 [0.43, 2.85] |
| Clinically driven TLR | 1.55 [1.10, 2.19] | 1.46 [0.99, 2.15] | NA. | NA. | 1.69 [1.09, 2.63] | 1.53 [0.97, 2.40] |
| Probable or definite ST | 0.35 [0.20, 0.64] | 0.42 [0.22, 0.78] | NA. | NA. | 0.32 [0.15, 0.65] | 0.31 [0.12, 0.77] |
| Definite ST | 0.46 [0.23, 0.92] | 0.43 [0.21, 0.89] | NA. | NA. | 0.54 [0.24, 1.24] | 0.39 [0.12, 1.25] |
| TD | 0.78 [0.47, 1.27] | 0.77 [0.45, 1.32] | NA. | NA. | 0.47 [0.24, 0.93] b | 1.23 [0.64, 2.35] |
| Total (all RCTs)—5-year follow-up—Interim Results | ||||||
| MACE | 0.82 [0.66, 1.02] | 0.91 [0.70, 1.19] | 0.74 [0.58, 0.95] b | NA. | 0.83 [0.62, 1.10] | Expected |
| CD or MI | 0.57 [0.42, 0.77] | 0.67 [0.46, 0.97] | 0.53 [0.38, 0.73] | NA. | 0.53 [0.35, 0.80] | Expected |
| Non-fatal MI | 0.56 [0.39, 0.80] | 0.59 [0.37, 0.92] | 0.54 [0.37, 0.80] | NA. | 0.57 [0.35, 0.93] | Expected |
| CD | 0.68 [0.39, 1.19] | 0.93 [0.47, 1.82] | 0.59 [0.31, 1.11] | NA. | 0.55 [0.25, 1.24] | Expected |
| Clinically driven TLR | 1.01 [0.75, 1.35] | 1.00 [0.71, 1.42] | 0.94 [0.66, 1.32] | NA. | 1.13 [0.77, 1.66] | Expected |
| Probable or definite ST | 0.30 [0.14, 0.61] | 0.45 [0.19, 1.05] | 0.25 [0.12, 0.55] | NA. | 0.22 [0.07, 0.70] | Expected |
| Definite ST | 0.25 [0.11, 0.55] | 0.37 [0.14, 0.99] | 0.20 [0.09, 0.49] | NA. | 0.22 [0.07, 0.70] | Expected |
| TD | 1.03 [0.74, 1.45] | 1.14 [0.75, 1.73] | 0.95 [0.65, 1.37] | NA. | 1.05 [0.65, 1.69] | Expected |
| ACS-only RCTs—5-year follow-up—Interim Results | ||||||
| MACE a | 0.74 [0.58, 0.95] | 0.81 [0.59, 1.12] c | NA. | NA. | 0.65 [0.44, 0.95] c | Expected |
| CD or MI | 0.53 [0.38, 0.73] | 0.61 [0.40, 0.95] | NA. | NA. | 0.42 [0.25, 0.71] | Expected |
| Non-fatal MI | 0.54 [0.37, 0.80] | 0.56 [0.33, 0.94] c | NA. | NA. | 0.53 [0.30, 0.94] c | Expected |
| CD | 0.59 [0.31, 1.11] | 0.83 [0.38, 1.84] c | NA. | NA. | 0.33 [0.11, 1.00] c | Expected |
| Clinically driven TLR | 0.94 [0.66, 1.32] | 0.88 [0.56, 1.37] c | NA. | NA. | 1.03 [0.60, 1.76] c | Expected |
| Probable or definite ST a | 0.25 [0.12, 0.55] | 0.37 [0.15, 0.93] c | NA. | NA. | 0.13 [0.03, 0.57] c | Expected |
| Definite ST a | 0.20 [0.09, 0.49] | 0.28 [0.09, 0.85] c | NA. | NA. | 0.13 [0.03, 0.57] c | Expected |
| TD | 0.95 [0.65, 1.37] | 1.02 [0.63, 1.65] c | NA. | NA. | 0.85 [0.48, 1.53] c | Expected |
a sensitivity analysis in ACS at 5-year follow-up results in the RR and confidence intervals of individual RCTs; b borderline shift with 3 or fewer RCTs contributing to the pooled estimate; c results based on a single-trial; NA—Not applicable.