Table 3. Clinical outcomes by HBR and antiplatelet therapy strategy.
| ARC-HBR | PRECISE-DAPT | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| HBR | Non-HBR | Therapy × HBR Interaction p-value |
HBR | Non-HBR | Therapy × HBR Interaction p-value |
|||||||||||
| Ticagrelor-based 12-month DAPT (n=241) | Ticagrelor monotherapy after 3-month DAPT (n=212) | HR (95% CI) | Ticagrelor-based 12-month DAPT (n=1,250) | Ticagrelor monotherapy after 3-month DAPT (n=1,277) | HR (95% CI) | Ticagrelor-based 12-month DAPT (n=263) | Ticagrelor monotherapy after 3-month DAPT (n=241) | HR (95% CI) | Ticagrelor-based 12-month DAPT (n=1,228) | Ticagrelor monotherapy after 3-month DAPT (n=1,248) | HR (95% CI) | |||||
| Primary outcome | ||||||||||||||||
| NACE | 19 (8.0) | 5 (2.4) | 0.30 (0.11–0.80) | 32 (2.6) | 16 (1.3) | 0.49 (0.27–0.89) | 0.400 | 22 (8.5) | 5 (2.2) | 0.25 (0.09–0.66) | 29 (2.4) | 16 (1.3) | 0.54 (0.29–0.99) | 0.178 | ||
| Secondary outcome | ||||||||||||||||
| Major bleeding | 11 (4.7) | 1 (0.5) | 0.10 (0.01–0.81) | 12 (1.0) | 2 (0.2) | 0.16 (0.04–0.73) | 0.728 | 13 (5.1) | 1 (0.4) | 0.09 (0.01–0.65) | 10 (0.8) | 2 (0.2) | 0.20 (0.04–0.89) | 0.518 | ||
| MACCE | 10 (4.2) | 4 (2.0) | 0.46 (0.15–1.47) | 20 (1.6) | 14 (1.1) | 0.69 (0.35–1.36) | 0.560 | 11 (4.3) | 4 (1.7) | 0.41 (0.13–1.27) | 19 (1.6) | 14 (1.1) | 0.73 (0.36–1.45) | 0.389 | ||
| Death | 6 (2.5) | 4 (2.0) | 0.77 (0.22–2.74) | 2 (0.2) | 3 (0.2) | 1.48 (0.25–8.84) | 0.563 | 5 (1.9) | 4 (1.7) | 0.90 (0.24–3.36) | 3 (0.2) | 3 (0.2) | 0.99 (0.20–4.89) | 0.932 | ||
| Myocardial infarction | 2 (0.8) | 0 (0) | NA | 8 (0.7) | 3 (0.2) | 0.37 (0.10–1.39) | NA | 3 (1.2) | 0 (0) | NA | 7 (0.6) | 3 (0.2) | 0.42 (0.11–1.63) | NA | ||
| Stent thrombosis | 1 (0.4) | 0 (0) | NA | 0 (0) | 2 (0.2) | NA | NA | 0 (0) | 0 (0) | NA | 1 (0.1) | 2 (0.2) | 1.97 (0.18–21.75) | NA | ||
| Stroke | 2 (0.8) | 0 (0) | NA | 3 (0.2) | 3 (0.2) | 0.98 (0.20–4.87) | NA | 3 (1.2) | 0 (0) | NA | 2 (0.2) | 3 (0.2) | 1.48 (0.25–8.86) | NA | ||
| Target-vessel revascularization | 1 (0.4) | 0 (0) | NA | 8 (0.7) | 8 (0.6) | 0.98 (0.37–2.62) | NA | 1 (0.4) | 0 (0) | NA | 8 (0.7) | 8 (0.7) | 0.99 (0.37–2.63) | NA | ||
Data are presented as number (% of the cumulative rates at 12 months according to Kaplan-Meier event rates). The p-values are from Cox regression test of therapy × HBR interaction.
ARC-HBR = Academic Research Consortium for High Bleeding Risk; CI = confidence interval; DAPT = dual-antiplatelet therapy; 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.