Table 2.
Clinical outcomes in intention to treat and per protocol populations. Values are number of events/number of patients at risk (% cumulative incidence) unless stated otherwise
| Outcome | Intention to treat population | Per protocol population | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| P2Y12 inhibitor (n=11 634) | Aspirin + P2Y12 inhibitor (n=11 674) | Hazard ratio (95% CI) | τ2 | P value | P2Y12 inhibitor (n=10 766) | Aspirin + P2Y12 inhibitor (n=11 195) | Hazard ratio (95% CI) | τ2 | P value | ||
| Death, MI, or stroke* | 303 (2.94) | 338 (3.36) | 0.90 (0.77 to 1.05) | 0.00 | 0.18 | 283 (2.95) | 315 (3.27) | 0.93 (0.79 to 1.09) | 0.00 | 0.38 | |
| Death or MI | 259 (2.49) | 299 (3.0) | 0.87 (0.74 to 1.03) | 0.00 | 0.10 | 245 (2.53) | 287 (2.99) | 0.88 (0.74 to 1.05) | 0.00 | 0.15 | |
| Death: | |||||||||||
| All cause | 107 (0.98) | 137 (1.40) | 0.80 (0.62 to 1.03) | 0.00 | 0.08 | 107 (1.05) | 128 (1.36) | 0.88 (0.68 to 1.15) | 0.01 | 0.35 | |
| Cardiovascular | 61 (0.57) | 90 (0.90) | 0.69 (0.50 to 0.95) | 0.00 | 0.03 | 61 (0.61) | 83 (0.86) | 0.77 (0.56 to 1.08) | 0.00 | 0.13 | |
| Non-cardiovascular | 42 (0.38) | 42 (0.46) | 1.03 (0.67 to 1.58) | 0.15 | 0.89 | 42 (0.40) | 41 (0.46) | 1.10 (0.71 to 1.70) | 0.19 | 0.66 | |
| MI | 167 (1.64) | 181 (1.79) | 0.93 (0.75 to 1.14) | 0.01 | 0.47 | 153 (1.61) | 177 (1.81) | 0.89 (0.72 to 1.10) | 0.01 | 0.28 | |
| Stroke: | |||||||||||
| Any | 51 (0.51) | 45 (0.41) | 1.10 (0.73 to 1.64) | 0.09 | 0.65 | 45 (0.48) | 34 (0.32) | 1.32 (0.84 to 2.08) | 0.00 | 0.22 | |
| Ischaemic | 38 (0.39) | 36 (0.33) | 1.01 (0.63 to 1.60) | 0.07 | 0.98 | 35 (0.39) | 27 (0.26) | 1.27 (0.76 to 2.11) | 0.00 | 0.35 | |
| Haemorrhagic | 6 (0.05) | 2 (0.02) | 2.53 (0.49 to 13.0) | 0.00 | 0.26 | 5 (0.05) | 2 (0.02) | 2.21 (0.40 to 12.09) | 0.00 | 0.36 | |
| Stent thrombosis: | |||||||||||
| Definite | 23 (0.24) | 26 (0.28) | 0.85 (0.48 to 1.50) | 0.00 | 0.56 | 17 (0.20) | 25 (0.28) | 0.72 (0.38 to 1.33) | 0.00 | 0.29 | |
| Probable | 6 (0.05) | 7 (0.06) | 0.72 (0.23 to 2.26) | 0.00 | 0.57 | 4 (0.04) | 7 (0.06) | 0.51 (0.13 to 2.06) | 0.00 | 0.34 | |
| Possible | 27 (0.26) | 48 (0.52) | 0.56 (0.35 to 0.90) | 0.00 | 0.02 | 27 (0.28) | 47 (0.53) | 0.59 (0.37 to 0.94) | 0.00 | 0.03 | |
| Definite or probable | 27 (0.27) | 32 (0.34) | 0.81 (0.49 to 1.37) | 0.00 | 0.43 | 21 (0.23) | 31 (0.34) | 0.68 (0.38 to 1.19) | 0.00 | 0.17 | |
| Any | 52 (0.52) | 79 (0.85) | 0.65 (0.46 to 0.92) | 0.00 | 0.02 | 47 (0.51) | 77 (0.86) | 0.61 (0.42 to 0.88) | 0.00 | 0.008 | |
| BARC bleeding: | |||||||||||
| 2, 3, or 5 | 295 (2.91) | 493 (4.76) | 0.59 (0.51 to 0.69) | 0.00 | <0.001 | 277 (2.93) | 475 (4.76) | 0.60 (0.52 to 0.70) | 0.00 | <0.001 | |
| 3 or 5 | 97 (0.89) | 197 (1.83) | 0.49 (0.39 to 0.63) | 0.03 | <0.001 | 91 (0.90) | 176 (1.71) | 0.53 (0.41 to 0.69) | 0.03 | <0.001 | |
| 5 | 3 (0.03) | 5 (0.06) | 0.67 (0.11 to 4.02) | 0.00 | 0.66 | 3 (0.04) | 5 (0.06) | 0.69 (0.11 to 4.12) | 0.00 | 0.68 | |
| TIMI bleeding: | |||||||||||
| Major | 44 (0.45) | 93 (0.94) | 0.47 (0.33 to 0.68) | 0.29 | <0.001 | 44 (0.48) | 82 (0.87) | 0.55 (0.38 to 0.79) | 0.20 | 0.001 | |
| Minor | 136 (1.43) | 242 (2.4) | 0.56 (0.45 to 0.69) | 0.00 | <0.001 | 132 (1.48) | 230 (2.37) | 0.57 (0.46 to 0.71) | 0.00 | <0.001 | |
| Major or minor | 179 (1.88) | 331 (3.33) | 0.53 (0.45 to 0.64) | 0.04 | <0.001 | 175 (1.96) | 309 (3.25) | 0.56 (0.47 to 0.68) | 0.04 | <0.001 | |
| NACE | 384 (3.69) | 504 (4.94) | 0.76 (0.67 to 0.87) | 0.02 | <0.001 | 359 (3.71) | 460 (4.71) | 0.81 (0.70 to 0.93) | 0.01 | 0.002 | |
BARC=Bleeding Academy Research Consortium; MI=myocardial infarction; NACE=net adverse clinical events, defined as composite of all cause death, myocardial infarction, stroke, and BARC type 3 or type 5 bleeding; TIMI=Thrombolysis in Myocardial Infarction.
*
P value for non-inferiority=0.005 in per protocol population; non-inferiority testing was performed on one sided α of 5% corresponding to 90% CIs; other P values are two sided for superiority; 95% CIs are shown.