Table 2. Ischemic and Bleeding Outcomes In Randomized Bare Metal Stent-Treated Patients.
Patients were randomized to continued thienopyridine or placebo plus aspirin 12 months after receiving a bare metal stent. The effectiveness endpoints, stent thrombosis and MACCE, are shown over the primary analysis period, e.g. 12-30 months after enrollment. For the safety endpoint of GUSTO severe or moderate bleeding, patients whose last contact date was ≥ 510 days post randomization or who experienced any adjudicated bleeding outcome at or before 540 days were included.
| Continued Thienopyridine N=8421 |
Placebo N=8451 |
Hazard Ratio (95% CI) |
Log-rank P-Value | |
|---|---|---|---|---|
|
| ||||
| Ischemic Outcomes | No. of patients (%) | |||
| Stent thrombosis* | 4 (0.50) | 9 (1.11) | 0.49 (0.15, 1.64) | 0.24 |
| Definite | 4 (0.50) | 9 (1.11) | 0.49 (0.15, 1.64) | 0.24 |
| Probable | 0 (0.00) | 0 (0.00) | N/A | . |
| MACCE (death, MI, stroke) | 33 (4.04) | 38 (4.69) | 0.92 (0.57, 1.47) | 0.72 |
| Death, all cause | 8 (0.99) | 10 (1.24) | 0.90 (0.35, 2.33) | 0.83 |
| MI | 22 (2.70) | 25 (3.10) | 0.91 (0.51, 1.62) | 0.74 |
| Stent thrombosis-related | 4 (0.50) | 9 (1.11) | 0.49 (0.15, 1.64) | 0.24 |
| Non stent thrombosis-related | 18 (2.21) | 16 (1.99) | 1.12 (0.57, 2.20) | 0.74 |
| Stroke (total) | 6 (0.73) | 5 (0.62) | 1.22 (0.37, 4.01) | 0.74 |
| Ischemic | 4 (0.49) | 5 (0.62) | 0.82 (0.22, 3.05) | 0.77 |
| Hemorrhagic | 1 (0.12) | 0 (0.00) | N/A | 0.32 |
| Type Uncertain | 1 (0.12) | 0 (0.00) | N/A | 0.32 |
| Bleeding Complications** | Continued Thienopyridine N=790 |
Placebo N=776 |
Risk Difference | 2-Sided P Value for Difference |
|---|---|---|---|---|
|
| ||||
| No. of patients (%) | Percentage points (95% CI) | |||
| GUSTO Severe/Moderate | 16 (2.03) | 7 (0.90) | 1.12% (-0.06%,2.31%) | 0.07 |
| GUSTO Severe | 6 (0.76) | 3 (0.39) | 0.37% (-0.37%,1.12%) | 0.33 |
| GUSTO Moderate | 10 (1.27) | 4 (0.52) | 0.75%(-0.18%,1.68%) | 0.12 |
| BARC Types 2, 3, or 5 | 36 (4.56) | 14 (1.80) | 2.75% (1.02%,4.48%) | 0.002 |
| BARC Type 2 | 22 (2.78) | 7 (0.90) | 1.88% (0.56%,3.21%) | 0.01 |
| BARC Type 3 | 16 (2.03) | 6 (0.77) | 1.25% (0.09%,2.41%) | 0.04 |
| BARC Type 5 | 0 (0.00) | 1 (0.13) | -0.13% (-0.38%,0.12%) | 0.31 |
Abbreviations: ARC, Academic Research Consortium; 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.
Please see Supplementary Appendix: Table 3 for GUSTO and BARC definitions.
Definite and probable stent thrombosis were determined according to the criteria of the Academic Research Consortium.
The primary safety end point was moderate or severe bleeding as assessed according to GUSTO criteria. 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. The secondary analysis of bleeding is assessed according to the criteria of the BARC criteria.
Percentages are Kaplan-Meier estimates.