Table 2.
Comparison of outcomes and endpoints between the study groups
Parameter | 5 mg group [n = 25] | 3 mg group [n = 25] | p value |
---|---|---|---|
TRT, days [mean ± SD] | 5.3 ± 2.0 | 6.6 ± 2.0 | 0.033a,c |
Patients reached target INR in the first 3–5 days [n (%)] | 14 (56) | 7 (28) | 0.080b |
Proportion of time spent in therapeutic INR, % [median (IQR)] | 38 (25–44) | 29 (24–33) | 0.091a |
Number of INR readings > 4 [median (IQR)] | 0.0 (0.0–2.0) | 0.0 (0.0–0.5) | 0.009a,c |
Number of in-range readings [median (IQR)] | 3 (2–4) | 2 (2–3) | 0.023a,c |
Patients experienced major bleeding event [n (%)] | 4 (16) | 5 (20) | 0.589b |
Patients experienced minor bleeding event [n (%)] | 11 (44) | 5 (20) | 0.022b,c |
Patients experienced any bleeding event [n (%)] | 13 (52) | 8 (32) | 0.094b |
Total number of bleeding events [median (IQR)] | 1 (0–2) | 0 (0–1) | 0.052a |
Number of bridging days [median (IQR)] | 3.0 (2.0–4.0) | 6.0 (3.5–6.5) | < 0.001a,c |
Enoxaparin overall cost, USD [median (IQR)] | 24.8 (16.5–35.6) | 49.6 (30.8–57.5) | 0.002a,c |
Follow-up period, days [mean ± SD] | 9.0 ± 2.8 | 8.6 ± 2.5 | 0.557a |
TRT time required to reach the lower limit of therapeutic INR, INR international normalized ratio, IQR interquartile range, SD standard deviation
aAnalysis of covariance
bLogistic regression
cp value < 0.05: significant