Table 2. Primary and Secondary End Points in CYP2C19 Loss-of-Function Allele Carriers.
| No. (%) | Difference in 12-mo event rates, % (95% CI)a | HR for genotype-guided therapy (95% CI)b | P valueb | ||
|---|---|---|---|---|---|
| Genotype-guided therapy (N = 903) | Conventional therapy (N = 946) | ||||
| Primary end point | |||||
| CV death, MI, stroke, severe recurrent ischemia, stent thrombosis | 35 (4.0) | 54 (5.9) | −1.8 (−3.9 to 0.1) | 0.66 (0.43 to 1.02) | .06 |
| Secondary end points | |||||
| Severe recurrent ischemia | 19 (2.2) | 29 (3.2) | −1.0 (−2.6 to 0.5) | 0.68 (0.38 to 1.22) | .19 |
| BARC bleeding | |||||
| 2,3,5c,d | 26 (3.0) | 16 (1.8) | 1.3 (−0.1 to 2.7) | 1.72 (0.92 to 3.20) | .08 |
| 3,5c,d | 17 (2.0) | 14 (1.5) | 0.5 (−0.8 to 1.8) | 1.27 (0.63 to 2.59) | .50 |
| TIMI major or minor bleeding (primary adverse events end point) | 16 (1.9) | 14 (1.6) | 0.3 (−0.9 to 1.6) | 1.22 (0.60 to 2.51) | .58 |
| Myocardial infarction | 11 (1.3) | 14 (1.5) | −0.3 (−1.3 to 0.8) | 0.82 (0.37 to 1.81) | .62 |
| Major bleeding | 11 (1.3) | 11 (1.2) | 0.1 (−1.0 to 1.1) | 1.05 (0.45 to 2.44) | .90 |
| Death from any cause | 6 (0.7) | 10 (1.1) | −0.4 (−1.2 to 0.5) | 0.56 (0.20 to 1.54) | .25 |
| CV death | 4 (0.5) | 8 (0.9) | −0.4 (−1.2 to 0.4) | 0.49 (0.15 to 1.64) | .24 |
| Stent thrombosis | 2 (0.2) | 8 (0.9) | −0.6 (−1.4 to 0.0) | 0.25 (0.05 to 1.18) | .05 |
| Minor bleeding | 5 (0.6) | 3 (0.3) | 0.2 (−0.3 to 0.9) | 2.27 (0.57 to 9.08) | .23 |
| Stroke | 2 (0.2) | 4 (0.4) | −0.2 (−0.8 to 0.3) | 0.51 (0.09 to 2.79) | .42 |
Abbreviations: BARC, Bleeding Academic Research Consortium; CV, cardiovascular; HR, hazard ratio; MI, myocardial infarction; TIMI, Thrombolysis in Myocardial Infarction.
Confidence intervals for differences in Kaplan-Meier rates were estimated by bootstrapping.
Hazard ratios, confidence intervals, and P values are from Cox proportional hazards regression models adjusting for age, sex, coronary artery disease presentation, and site (factors used for stratified randomization).
BARC 5 results not shown, as there are were no fatal bleeds.
BARC is a classification system for bleeding events categorizing bleeds into levels of severity, with higher numbers indicating greater severity. Class 2 are generally overt bleeds requiring medical intervention or evaluation but with minimal blood loss (<3-g/dL decrease in hemoglobin level); class 3 is generally more serious (either in amount of bleeding or location of bleed); class 4 is bleeding related to coronary artery bypass graft surgery; class 5 is fatal bleeding. More precise descriptions can be found in Mehran et al.7