Table 2. Clinical outcomes by HBR.
| ARC-HBR | PRECISE-DAPT | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| HBR (n=453) | Non-HBR (n=2,527) | HR (95% CI) | p-value | HBR (n=504) | Non-HBR (n=2,476) | HR (95% CI) | p-value | |||
| Primary outcome | ||||||||||
| NACE | 24 (5.4) | 48 (1.9) | 2.87 (1.76–4.69) | <0.001 | 27 (5.5) | 45 (1.9) | 3.09 (1.92–4.98) | <0.001 | ||
| Secondary outcome | ||||||||||
| Major bleeding | 12 (2.7) | 14 (0.6) | 4.91 (2.27–10.61) | <0.001 | 14 (2.9) | 12 (0.5) | 5.96 (2.76–12.88) | <0.001 | ||
| MACCE | 14 (3.2) | 34 (1.4) | 2.34 (1.26–4.36) | 0.006 | 15 (3.1) | 33 (1.4) | 2.31 (1.25–4.25) | 0.006 | ||
| Death | 10 (2.3) | 5 (0.2) | 11.37 (3.89–33.25) | <0.001 | 9 (1.9) | 6 (0.2) | 7.59 (2.70–21.31) | <0.001 | ||
| Myocardial infarction | 2 (0.5) | 11 (0.4) | 1.03 (0.23–4.65) | 0.968 | 3 (0.6) | 10 (0.4) | 1.52 (0.42–5.51) | 0.524 | ||
| Stent thrombosis | 1 (0.2) | 2 (0.1) | 2.84 (0.26–31.29) | 0.373 | 0 (0) | 3 (0.1) | NA | NA | ||
| Stroke | 2 (0.5) | 6 (0.2) | 1.89 (0.38–0.38) | 0.426 | 3 (0.6) | 5 (0.2) | 3.04 (0.73–12.71) | 0.109 | ||
| Target-vessel revascularization | 1 (0.2) | 16 (0.6) | 0.36 (0.05–2.68) | 0.295 | 1 (0.2) | 16 (0.7) | 0.32 (0.04–2.39) | 0.239 | ||
Data are presented as number (% of the cumulative rates at 12 months according to Kaplan-Meier event rates). The p-values are from log-rank tests.
ARC-HBR = Academic Research Consortium for High Bleeding Risk; CI = confidence interval; HBR = high bleeding risk; HR = hazard ratio; MACCE = major adverse cardiac and cerebrovascular event; NA = not applicable; NACE = net adverse clinical event; PRECISE-DAPT = Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy.