Table 3.
Study Endpoints During Follow‐up
| Variables | Second Generation, n = 722 | First Generation, n = 520 | HR (95% CI) | P Value |
|---|---|---|---|---|
| Any death, MI, ST, stroke or TIA, urgent revascularization (primary endpoint) | 19 (2.6) | 32 (6.2) | 2.31 (1.31‐4.07) | 0.0039 |
| ST (revascularized or not) or any urgent revascularization (main secondary) | 6 (0.8) | 12 (2.3) | 2.68 (1.01‐7.15) | 0.0486 |
| Any death, recurrent ACS, stroke or TIA | 16 (2.2) | 29 (5.6) | 2.48 (1.35‐4.57) | 0.0035 |
| Death or resuscitated cardiac arrest | 7 (1.0) | 9 (1.7) | 1.77 (0.66‐4.74) | 0.26 |
| Death or MI | 12 (1.7) | 19 (3.7) | 2.16 (1.05‐4.44) | 0.0371 |
| Any death, MI, ST, stroke or TIA, urgent revascularization, STEEPLE major bleed (net clinical benefit) | 22 (3.0) | 35 (6.7) | 2.18 (1.28‐3.72) | 0.0042 |
| Any death | 7 (1.0) | 9 (1.7) | 1.77 (0.66‐4.74) | 0.26 |
| MI | 7 (1.0) | 11 (2.1) | 2.12 (0.82‐5.47) | 0.12 |
| ST | 0 (0.0) | 3 (0.6) | ||
| ACS | 8 (1.1) | 16 (3.1) | 2.71 (1.16‐6.33) | 0.0213 |
| Stroke or TIA | 4 (0.6) | 6 (1.2) | 2.02 (0.57‐7.14) | 0.28 |
| Urgent revascularization | 6 (0.8) | 11 (2.1) | 2.45 (0.91‐6.62) | 0.08 |
| STEEPLE major bleed | 3 (0.4) | 4 (0.8) | 1.79 (0.40‐8.02) | 0.44 |
| STEEPLE minor bleed | 4 (0.6) | 3 (0.6) | 1.02 (0.23‐4.55) | 0.98 |
| STEEPLE major or minor bleed | 7 (1.0) | 7 (1.3) | 1.35 (0.47‐3.85) | 0.57 |
Abbreviations: ACS, acute coronary syndrome; CI, confidence interval; HR, hazard ratio; MI, myocardial infarction; ST, stent thrombosis; STEEPLE, Safety and Efficacy of Enoxaparin in Percutaneous Coronary Intervention Patients, an International Randomized Evaluation; TIA, transient ischemic attack.
Data are presented as n (%).