Table 2. Clinical Outcomes According to Presence of Comorbid Diabetes.
| Diabetes group | No diabetes group | P value for interaction | |||||||
|---|---|---|---|---|---|---|---|---|---|
| No. (%) | HR (95% CI)a | P value | No. (%) | HR (95% CI)a | P value | ||||
| Clopidogrel (n = 925) | Aspirin (n = 935) | Clopidogrel (n = 1785) | Aspirin (n = 1793) | ||||||
| Composite end point | 58 (6.3) | 84 (9.2) | 0.69 (0.49-0.96) | .03 | 94 (5.3) | 123 (7.0) | 0.76 (0.58-1.00) | .046 | .65 |
| Primaryb | |||||||||
| Thromboticc | 36 (4.0) | 53 (5.8) | 0.68 (0.45-1.04) | .07 | 63 (3.6) | 93 (5.3) | 0.68 (0.49-0.93) | .02 | .99 |
| Bleeding | |||||||||
| Any (BARC type 2, 3, or 5) | 24 (2.7) | 37 (4.1) | 0.65 (0.39-1.09) | .11 | 37 (2.1) | 50 (2.8) | 0.74 (0.48-1.13) | .17 | .71 |
| Major (BARC type 3 or 5) | 14 (1.6) | 25 (2.7) | 0.57 (0.29-1.09) | .09 | 19 (1.1) | 28 (1.6) | 0.68 (0.38-1.22) | .20 | .68 |
| MACEd | 28 (3.1) | 50 (5.4) | 0.56 (0.35-0.89) | .01 | 55 (3.1) | 53 (3.0) | 1.04 (0.72-1.52) | .83 | .04 |
| All-cause death | 22 (2.4) | 18 (2.0) | 1.24 (0.66-2.30) | .51 | 29 (1.7) | 18 (1.0) | 1.62 (0.90-2.92) | .11 | .53 |
| Cardiac death | 11 (1.2) | 6 (0.7) | 1.85 (0.68-5.00) | .23 | 8 (0.5) | 8 (0.5) | 1.01 (0.38-2.68) | .99 | .39 |
| MI | 3 (0.3) | 12 (1.3) | 0.25 (0.07-0.89) | .03 | 15 (0.9) | 17 (1.0) | 0.89 (0.44-1.78) | .74 | .09 |
| Target-vessel MI | 0 | 8 (0.9) | 0.06 (0.00-0.47) | .003 | 9 (0.5) | 9 (0.5) | 1.01 (0.40-2.53) | .99 | .01 |
| Stroke | 3 (0.3) | 23 (2.5) | 0.13 (0.04-0.44) | .001 | 15 (0.9) | 20 (1.1) | 0.75 (0.39-1.47) | .41 | .01 |
| Ischemic | 3 (0.3) | 13 (1.4) | 0.23 (0.07-0.81) | .02 | 11 (0.6) | 13 (0.7) | 0.85 (0.38-1.90) | .69 | .09 |
| Hemorrhagic | 0 | 10 (1.1) | 0.05 (0.00-0.37) | <.001 | 4 (0.2) | 7 (0.4) | 0.58 (0.17-1.97) | .38 | .04 |
| Readmission due to ACS | 22 (2.4) | 35 (3.9) | 0.63 (0.37-1.08) | .09 | 44 (2.5) | 74 (4.2) | 0.59 (0.41-0.86) | .06 | .85 |
| Unstable angina | 18 (2.0) | 23 (2.5) | 0.79 (0.43-1.46) | .46 | 29 (1.7) | 56 (3.2) | 0.52 (0.33-0.81) | .004 | .28 |
| Urgent revascularization | 13 (1.4) | 19 (2.1) | 0.69 (0.34-1.40) | .30 | 31 (1.8) | 39 (2.2) | 0.80 (0.50-1.28) | .35 | .74 |
| Any revascularization | 15 (1.7) | 23 (2.5) | 0.66 (0.34-1.26) | .21 | 41 (2.3) | 46 (2.6) | 0.90 (0.59-1.37) | .61 | .43 |
| Target vessel revascularization | 7 (0.8) | 17 (1.9) | 0.41 (0.17-1.00) | .049 | 30 (1.7) | 31 (1.8) | 0.97 (0.59-1.61) | .92 | .10 |
| Target lesion revascularization | 4 (0.4) | 13 (1.4) | 0.31 (0.10-0.95) | .04 | 20 (1.2) | 23 (1.3) | 0.87 (0.48-1.59) | .66 | .11 |
| Definite or probable stent thrombosis | 1 (0.1) | 8 (0.9) | 0.13 (0.02-1.01) | .05 | 9 (0.5) | 8 (0.5) | 1.13 (0.44-2.94) | .80 | .06 |
| Any minor gastrointestinal complications | 95 (10.5) | 107 (11.7) | 0.89 (0.68-1.17) | .41 | 177 (10.1) | 213 (12.1) | 0.83 (0.68-1.01) | .07 | .68 |
Abbreviations: ACS, acute coronary syndrome; BARC, Bleeding Academic Research Consortium; HR, hazard ratio; MACE, major adverse cardiovascular event; MI, myocardial infarction.
The 95% CIs for secondary end points have not been adjusted for multiple testing and therefore no clinical inferences can be made from these analyses.
Primary composite end point was defined as a composite of all-cause death, nonfatal MI, stroke, readmission due to ACS, and major bleeding events (BARC type 3 or 5).
Thrombotic composite end point was defined as a composite of cardiac death, nonfatal MI, ischemic stroke, readmission due to ACS, and definite or probable stent thrombosis.
Major adverse cardiovascular event was defined as a composite of all-cause death, myocardial infarction, or stroke.