Table 2.
Clinical outcomes comparing between Wave-1 and Wave-2
| Endpoints | Wave-1 | Wave-2 | Crude HR | P value | Adjusted HR | P value | ||||
| (n=4278) | (n=4723) | |||||||||
| Patients with event (n) | (95% CI) | (95% CI) | ||||||||
| (Cumulative 3-year incidence) | ||||||||||
| All-cause death | 654 | (15.5%) | 722 | (15.7%) | 1.02 | (0.91 to 1.13) | 0.77 | 0.92 | (0.83 to 1.03) | 0.14 |
| Cardiovascular death | 475 | (11.3%) | 524 | (11.4%) | 1.01 | (0.89 to 1.15) | 0.86 | 0.93 | (0.82 to 1.06) | 0.26 |
| Cardiac death | 448 | (10.7%) | 489 | (10.7%) | 1.00 | (0.88 to 1.14) | 1.00 | 0.93 | (0.81 to 1.05) | – |
| Sudden cardiac death | 47 | (1.2%) | 45 | (1.1%) | 0.88 | (0.59 to 1.33) | 0.54 | 0.76 | (0.50 to 1.15) | – |
| Non-cardiovascular death | 179 | (4.7%) | 198 | (4.8%) | 1.03 | (0.84 to 1.26) | 0.80 | 0.90 | (0.73 to 1.10) | 0.29 |
| Non-cardiac death | 206 | (5.4%) | 233 | (5.7%) | 1.05 | (0.87 to 1.27) | 0.61 | 0.91 | (0.75 to 1.10) | – |
| Myocardial infarction | 169 | (4.3%) | 202 | (4.8%) | 1.10 | (0.90 to 1.35) | 0.36 | 1.04 | (0.85 to 1.28) | 0.72 |
| Definite stent thrombosis* | 81 | (2.3%) | 60 | (1.5%) | 0.65 | (0.47 to 0.91) | 0.01 | 0.59 | (0.43 to 0.81) | 0.001 |
| Stroke | 191 | (4.9%) | 243 | (5.7%) | 1.17 | (0.97 to 1.42) | 0.10 | 1.09 | (0.90 to 1.31) | 0.40 |
| Hospitalisation for heart failure | 267 | (7.0%) | 305 | (7.4%) | 1.06 | (0.90 to 1.25) | 0.50 | 0.97 | (0.82 to 1.14) | 0.68 |
| Major bleeding | 492 | (12.0%) | 741 | (16.5%) | 1.39 | (1.25 to 1.56) | <0.001 | 1.34 | (1.20 to 1.51) | 0.005 |
| Target vessel revascularisation | 1017 | (26.3%) | 816 | (19.5%) | 0.70 | (0.64 to 0.77) | <0.001 | 0.69 | (0.63 to 0.76) | – |
| Ischaemia-driven target vessel revascularisation | 353 | (9.1%) | 364 | (8.7%) | 0.94 | (0.81 to 1.09) | 0.43 | 0.92 | (0.79 to 1.06) | – |
| Any coronary revascularisation | 1277 | (33.0%) | 1112 | (26.6%) | 0.76 | (0.70 to 0.83) | <0.001 | 0.75 | (0.69 to 0.81) | – |
| Ischaemia-driven any coronary revascularisation | 472 | (12.3%) | 522 | (12.6%) | 1.02 | (0.90 to 1.15) | 0.80 | 0.99 | (0.87 to 1.12) | – |
The risk of Wave-2 relative to Wave-1 was expressed as HR with 95% CI. The covariates for the multivariate Cox proportional hazard models are indicated in table 1.
Myocardial infarction was based on the ARTS definition.
Major bleeding was defined as GUSTO moderate/severe bleeding.
*Definite stent thrombosis was based on the ARC definition and was analysed only for patients who underwent PCI with stent implantation (3739 patients in Wave-1 and 4241 patients in Wave-2).
ARC, Academic Research Consortium; ARTS, Arterial Revascularisation Therapy Study; GUSTO, Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries; PCI, percutaneous coronary intervention.