Table 4.
Ischemic and Bleeding Outcomes in All (Bare Metal and Drug-eluting Stent-Treated) Randomized Patients Comparing Continued Thienopyridine vs Placebo.
| Outcome | Continued Thienopyridine N=58621 |
Placebo N=57861 |
Hazard Ratio (95% CI) |
Log-rank P-Value |
|---|---|---|---|---|
|
| ||||
| No. of patients (%) | ||||
| Stent thrombosis* | 23 (0.41) | 74 (1.32) | 0.31 (0.19, 0.50) | <.001 |
| Definite | 19 (0.34) | 67 (1.20) | 0.28 (0.17, 0.47) | <.001 |
| Probable | 5 (0.09) | 7 (0.12) | 0.71 (0.23, 2.24) | 0.56 |
| MACCE (Death, MI, Stroke) | 244 (4.29) | 323 (5.74) | 0.73 (0.62, 0.87) | <.001 |
| Death, all cause | 106 (1.87) | 84 (1.50) | 1.31 (0.97, 1.75) | 0.07 |
| MI | 121 (2.15) | 223 (3.98) | 0.52 (0.42, 0.65) | <.001 |
| Stent thrombosis-related | 21 (0.38) | 72 (1.28) | 0.29 (0.18, 0.48) | <.001 |
| Non stent thrombosis-related | 104 (1.84) | 154 (2.75) | 0.65 (0.50, 0.84) | <.001 |
| Stroke (total) | 43 (0.76) | 48 (0.86) | 0.84 (0.55, 1.28) | 0.42 |
| Ischemic | 28 (0.50) | 39 (0.70) | 0.70 (0.43, 1.15) | 0.16 |
| Hemorrhagic | 14 (0.25) | 9 (0.16) | 1.31 (0.55, 3.12) | 0.53 |
| Type uncertain | 1 (0.02) | 1 (0.02) | 1.01 (0.06, 16.09) | 1.00 |
| Bleeding Complications** | Continued Thienopyridine N=5500 |
Placebo N=5425 |
Difference | Two-sided P Value for Difference |
|---|---|---|---|---|
|
| ||||
| No. of patients (%) | Percentage points (95% CI) | |||
| GUSTO Severe/Moderate | 135 (2.45) | 80 (1.47) | 0.98 (0.46, 1.50) | <.001 |
| GUSTO Severe | 44 (0.80) | 29 (0.53) | 0.27 (-0.04, 0.57) | 0.09 |
| GUSTO Moderate | 91 (1.65) | 52 (0.96) | 0.70 (0.27, 1.12) | 0.001 |
| BARC Types 2, 3, or 5 | 299 (5.44) | 151 (2.78) | 2.65 (1.91, 3.40) | <.001 |
| BARC Type 2 | 167 (3.04) | 79 (1.46) | 1.58 (1.03, 2.13) | <.001 |
| BARC Type 3 | 138 (2.51) | 74 (1.36) | 1.15 (0.63, 1.66) | <.001 |
| BARC Type 5 | 7 (0.13) | 5 (0.09) | 0.04 (-0.09, 0.16) | 0.58 |
Abbreviations: BARC, Bleeding Academic Research Consortium; GUSTO, Global Utilization of Streptokinase and TPA for Occluded Arteries, MACCE, major adverse cardiovascular and cerebrovascular events; MI, myocardial infarction.
Definite and probable stent thrombosis were determined according to the criteria of the Academic Research Consortium.
Percentages are Kaplan-Meier estimates.
Results for MACCE and stent thrombosis are for all randomized patients; patients not experiencing the endpoint are censored at 30 months or at last known follow-up, whichever is earlier.
Only patients who could be evaluated were included in this analysis (i.e., patients whose last contact date was ≥510 days after randomization or who had any adjudicated bleeding event at or before 540 days). Patients could have had more than one bleeding episode.