Table 2.
Thirty-day outcomes of randomized clinical trials comparing an invasive treatment strategy to a delayed invasive or ischemia-guided approach among STEMI patients treated with fibrinolysis.
| Study | Outcome | Risk in Invasive Group (n/N) |
Risk in Selective Group (n/N) |
Relative Risk (95% CI) |
p-value |
|---|---|---|---|---|---|
| PRAGUE[16] | Death/Reinfarction/Stroke* | 15/100 | 23/99 | 0.65 (0.36, 1.16) | 0.14‡ |
| Death | 12/100 | 14/99 | 0.85 (0.41, 1.74) | 0.66‡ | |
| Reinfarction | 7/100 | 10/99 | 0.69 (0.27, 1.75) | 0.43‡ | |
| Stroke | 3/100 | 1/99 | 2.97 (0.31, 28.1) | 0.62‡ | |
| SIAM-3[18]† | CABG | 0/82 | 0/81 | - | 1.00 |
| TLR | 2/82 | 2/81 | 0.99 (0.14, 6.84)‡ | 0.685 | |
| Ischemic Events | 3/82 | 20/81 | 0.15 (0.05, 0.48)‡ | 0.01 | |
| Reinfarction | 2/82 | 2/81 | 0.99 (0.14, 6.84)‡ | 0.685 | |
| Death | 4/82 | 8/81 | 0.49 (0.15, 1.58)‡ | 0.179 | |
| Death/Reinfarction | 6/82 | 10/81 | 0.59 (0.23, 1.55)‡ | 0.208 | |
| Death/Reinfarction/TLR | 6/82 | 11/81 | 0.54 (0.21, 1.39)‡ | 0.146 | |
| Death/Reinfarction/TLR/Ischemic Events | 7/82 | 25/81 | 0.28 (0.13, 0.60)‡ | 0.001 | |
| GRACIA-1[19] | Death | 6/248 | 6/251 | 1.01 (0.33, 3.10) | 0.84 |
| Non-Fatal Reinfarction | 3/248 | 4/251 | 0.76 (0.17, 3.36) | 0.98 | |
| Death/Non-Fatal Reinfarction | 9/248 | 9/251 | 1.01 (0.41, 2.51) | 0.97 | |
| Death/Non-Fatal Reinfarction/Revascularization | 12/248 | 16/251 | 0.76 (0.37, 1.57) | 0.46 | |
| CAPITAL-AMI[20] | Death/Recurrent MI/Recurrent Unstable Ischemia, Stroke | 8/86 | 18/84 | 0.43 (0.20, 0.93) | 0.03 |
| Death | 2/86 | 3/84 | 0.64 (0.11, 3.75) | 0.68 | |
| Reinfarction | 4/86 | 11/84 | 0.35 (0.12, 1.06) | 0.06 | |
| Recurrent Unstable Ischemia | 6/86 | 15/84 | 0.39 (0.16, 0.95) | 0.04 | |
| Stroke | 1/86 | 1/84 | 0.97 (0.61, 15.18) | 1.00 | |
| Death/Reinfarction/Stroke | 6/86 | 14/84 | 0.41 (0.17, 1.03) | 0.06 | |
| Leipzig[23] | Death | 2/82 | 4/82 | 0.50 (0.09, 2.65)‡ | 0.68‡ |
| Non-Fatal Reinfarction | 3/82 | 7/82 | 0.43 (0.11, 1.60)‡ | 0.33‡ | |
| Stroke | 0/82 | 1/82 | - | 1.00‡ | |
| Major bleeding | 4/82 | 5/82 | 0.80 (0.22, 2.87)‡ | 1.00‡ | |
| Death/Reinfarction/Stroke/Major Bleeding | 9/82 | 17/82 | 0.52 (0.23, 1.18) | 0.13¥ | |
| WEST[25] | Death/Reinfarction/Refractory Ischemia/CHF/Cardiogenic Shock/Major Ventricular Arrhythmia* | 25/104 | 25/100 | 0.96 (0.59, 1.56) ‡ | 0.87‡ |
| Death | 1/104 | 4/100 | 0.24 (0.03, 2.11) ‡ | 0.21‡ | |
| Reinfarction | 6/104 | 9/100 | 0.64 (0.24, 1.74) ‡ | 0.38‡ | |
| CHF | 15/104 | 15/100 | 0.96 (0.50, 1.86)‡ | 0.91‡ | |
| Cardiogenic Shock | 4/104 | 6/100 | 0.64 (0.19, 2.20)‡ | 0.53‡ | |
| Refractory Ischemia | 3/104 | 0/100 | - | 0.25‡ | |
| Major Ventricular Arrhythmias | 1/104 | 1/100 | 0.96 (0.06, 15.2)‡ | 1.00‡ | |
| CARESS-AMI[26] | Death/Reinfarction/Refractory Ischemia* | 13/297 | 32/300 | 0.41 (0.22, 0.77)‡ | 0.005 |
| Death | 9/297 | 14/300 | 0.65 (0.29, 1.48)‡ | 0.40 | |
| Reinfarction | 4/297 | 6/300 | 0.67 (0.19, 2.36)‡ | 0.75 | |
| Refractory Ischemia | 1/297 | 12/300 | 0.08 (0.01, 0.64)‡ | 0.003 | |
| TRANSFER AMI[27] | Death/Reinfarction/Recurrent Ischemia/New or Worsening CHF/Cardiogenic Shock* | 59/536 | 90/522 | 0.64 (0.47, 0.87) | 0.004 |
| Death | 24/536 | 18/522 | 1.30 (0.71, 2.36) | 0.39 | |
| Reinfarction | 18/536 | 30/522 | 0.57 (0.33, 1.04) | 0.06 | |
| Death/Reinfarction | 38/536 | 47/522 | 0.79 (0.52, 1.19) | 0.25 | |
| Recurrent Ischemia | 1/536 | 11/522 | 0.09 (0.01, 0.68) | 0.003 | |
| Death/Reinfarction/Recurrent Ischemia | 39/536 | 58/522 | 0.65 (0.44, 0.96) | 0.03 | |
| New or Worsening CHF | 16/536 | 29/522 | 0.54 (0.30, 0.98) | 0.04 | |
| Cardiogenic Shock | 24/536 | 16/522 | 1.46 (0.79, 2.72) | 0.23 | |
| NORDISTEMI[28] | Death/Reinfarction/Stroke/New Ischemia | 14/134 | 28/132 | 0.49 (0.27, 0.89)‡ | 0.02‡ |
| Death/Reinfarction/Stroke | 6/134 | 13/132 | 0.45 (0.18, 1.16)‡ | 0.09‡ | |
| Death | 3/134 | 3/132 | 0.99 (0.20, 4.79)‡ | 1.00‡ | |
| Reinfarction | 2/134 | 7/132 | 0.28 (0.06, 1.33)‡ | 0.10‡ | |
| Stroke | 3/134 | 5/132 | 0.59 (0.14, 2.42)‡ | 0.50‡ | |
| Recurrent Ischemia | 8/134 | 16/132 | 0.49 (0.22, 1.11)‡ | 0.08‡ | |
Abbreviations: CHF: congestive heart failure; CI: confidence interval; MI: myocardial infarction; TLR: target lesion revascularization.
*Denotes primary endpoint of the trial. † Data are based on the 163 patients who met the secondary inclusion criteria rather than the 197 who were randomized. †† Data are based on the 197 patients who were randomized. ‡ Calculated using data presented in the original manuscript. ¥ Denotes p-value from log-rank test.