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. 2018 Feb 13;319(6):567–578. doi: 10.1001/jama.2017.21906

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.

a

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.

b

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.

c

Composed of aspirin, adenosine diphosphate receptor antagonist (clopidogrel, prasugrel, or ticagrelor), anticoagulant, and β-blocker among patients eligible to receive all medications.

d

Composed of aspirin, adenosine diphosphate receptor antagonist (clopidogrel, prasugrel, or ticagrelor), statin, and β-blocker among discharged patients eligible to receive all medications.

e

Among discharged patients who reported smoking at baseline.