Table 3. Unadjusted and Adjusted Primary and Secondary Trial Outcomes Using Mixed-Effects Logistic Regression Models That Account for Within-Hospital Clustering and Clustering and Temporal Trends.
Outcomes | No. (%) | Cluster-Adjusted Difference, % (95% CI)a | Cluster-Adjusted Odds Ratio (95% CI)a | Primary Analysis Difference, % (95% CI)a | Primary Analysis Odds Ratio (95% CI)a | ICC | |
---|---|---|---|---|---|---|---|
Control (n = 10 066) | Intervention (n = 11 308) | ||||||
Primary outcome | |||||||
30-d MACE | 645 (6.4) | 602 (5.3) | −0.51 (−1.28 to 0.26) | 0.92 (0.81-1.04) | −0.09 (−1.32 to 1.14) | 0.98 (0.80-1.21) | 0.15 |
Secondary outcomes | |||||||
30-d mortality | 509 (5.1) | 445 (3.9) | −0.65 (−1.34 to 0.03) | 0.87 (0.75-1.00) | −0.28 (−1.35 to 0.80) | 0.94 (0.74-1.19) | 0.18 |
30-d cardiovascular mortality | 494 (4.9) | 434 (3.8) | −0.58 (−1.24 to 0.09) | 0.88 (0.76-1.02) | −0.26 (−1.31 to 0.80) | 0.94 (0.74-1.20) | 0.19 |
In-hospital mortality | 331 (3.3) | 321 (2.8) | −0.05 (−0.58 to 0.47) | 0.98 (0.82-1.17) | −0.23 (−1.07 to 0.60) | 0.93 (0.70-1.22) | 0.18 |
30-d reinfarction | 121 (1.2) | 135 (1.2) | 0.12 (−0.31 to 0.55) | 1.08 (0.82-1.42) | 0.50 (−0.24 to 1.24) | 1.39 (0.87-2.22) | 0.33 |
30-d stroke | 60 (0.6) | 90 (0.8) | 0.20 (−0.05 to 0.45) | 1.34 (0.94-1.93) | 0.14 (−0.23 to 0.52) | 1.24 (0.71-2.15) | 0.14 |
30-d major GUSTO bleedingb | 19 (0.2) | 30 (0.3) | 0.13 (−0.05 to 0.30) | 1.56 (0.84-2.88) | 0.23 (−0.05 to 0.52) | 2.34 (0.93-5.89) | 0.20 |
Optimal in-hospital medicationc | 3122 (31.7) | 3878 (35.8) | 8.61 (6.98 to 10.23) | 1.70 (1.57-1.85) | 6.00 (3.90 to 8.11) | 1.45 (1.28-1.64) | 0.40 |
Optimal discharge medicationd | 5454 (61.8) | 6483 (64.0) | 9.97 (8.32 to 11.61) | 1.73 (1.59-1.87) | 8.66 (6.30 to 11.03) | 1.61 (1.42-1.82) | 0.28 |
Tobacco cessation advicee | 3526 (96.0) | 2618 (94.7) | 0.30 (−1.20 to 1.80) | 1.06 (0.80-1.39) | 0.30 (−2.15 to 2.76) | 1.06 (0.67-1.67) | 0.37 |
Abbreviations: ICC, intracluster correlation; MACE; major adverse cardiovascular events, defined as death, reinfarction, stroke, and major GUSTO bleeding.
Odds ratios represent effect of intervention compared with control and are calculated as the difference in marginal effects (intervention group minus control group) in a mixed-effects logistic regression model including a random-effects term to account for within-hospital clustering. Primary analysis additionally accounted for temporal trends.
Major bleeding is defined by the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) criteria, which is defined by intracerebral hemorrhage or bleeding resulting in substantial hemodynamic compromise requiring treatment.
Composed of aspirin, adenosine diphosphate receptor antagonist (clopidogrel, prasugrel, or ticagrelor), anticoagulant, and β-blocker among patients eligible to receive all medications.
Composed of aspirin, adenosine diphosphate receptor antagonist (clopidogrel, prasugrel, or ticagrelor), statin, and β-blocker among discharged patients eligible to receive all medications.
Among discharged patients who reported smoking at baseline.