Table 2. Outcomes of SD-PA, HD-PA, and TA Among Patients With Hypoxemic COVID-19 Pneumonia, at Day 28.
| Outcome | No. (%) | HD-PA vs SD-PA | TA vs SD-PA | TA vs HD-PA | |||||
|---|---|---|---|---|---|---|---|---|---|
| SD-PA (n = 114) | HD-PA (n = 110) | TA (n = 110) | Absolute difference (95% CI) | P value | Absolute difference (95% CI) | P value | Absolute difference (95% CI) | P value | |
| Primary outcome | |||||||||
| Probability of a more favorable outcome, effect size (95% CI), %a | NAb | NAb | NAb | 47.3 (39.9 to 54.8) | .48 | 50.9 (43.4 to 58.3) | .82 | 53.5 (45.8 to 60.9) | .37 |
| Efficacy outcomes | |||||||||
| Composite thrombotic eventc | 23 (20)d | 6 (5) | 6 (5) | −14.8 (−6.2 to −23.2) | .001 | −14.7 (−6.2 to −23.2) | .001 | 0.0 (6.0 to −6.0) | > .99 |
| Venous thrombosis | 20 (18) | 5 (5) | 4 (4) | −13.0 (−5.0 to −21.0) | .002 | −13.9 (−6.1 to −21.7) | .001 | −0.9 (4.3 to −6.1) | > .99 |
| DVT (including CVC-related) | 7 (6) | 2 (2) | 1 (1) | −4.3 (0.7 to −9.4) | .17 | −5.2 (−0.5 to −10.0) | .07 | −0.9 (2.2 to −4.0) | > .99 |
| Pulmonary artery thrombosis | 15 (13) | 3 (3) | 3 (3) | −10.4 (−3.5 to −17.3) | .006 | −10.4 (−3.5 to −17.3) | .006 | 0.0 (4.3 to −4.3) | > .99 |
| Arterial thrombosis | 5 (4) | 1 (1) | 2 (2) | −3.5 (0.7 to −7.6) | .21 | −2.6 (1.9 to −7.1) | .45 | 0.9 (4.0 to −2.2) | > .99 |
| All-cause death | 16 (14) | 13 (12) | 14 (13) | −2.2 (6.6 to −11.0) | .69 | −1.3 (7.6 to −10.2) | .85 | 0.9 (9.6 to −7.8) | > .99 |
| Time to clinical improvement, de | 8 (5-13) | 9 (6-14) | 8 (5-14) | 0.0 (2.0 to −1.0) | .81 | −1.0 (1.0 to −2.0) | .52 | −1.0 (1.0 to −2.0) | .37 |
| Supplemental oxygen-free, d | 18 (0-23) | 16 (0-22) | 18 (0-23) | 0.0 (1.0 to −2.0) | .38 | 0.0 (1.0 to −1.0) | .71 | 0.0 (2.0 to −1.0) | .65 |
| Ventilator-free, d | 28 (15-28) | 28 (14-28) | 28 (11-28) | 0 | .82 | 0 | .76 | 0 | .94 |
| Vasopressor-free, d | 28 (26-28) | 28 (27-28) | 28 (26-28) | 0 | .98 | 0 | .89 | 0 | .87 |
| Sepsis-induced coagulopathy score at d 7f | |||||||||
| No. | 38 | 36 | 41 | NA | NA | NA | NA | NA | NA |
| Median (IQR) | 2 (2-2) | 2 (2-2) | 2 (2-3) | 0 | .64 | 0 | 1.1 | 0 | .26 |
| D-dimer at d 7, ng/mLg | |||||||||
| No. | 58 | 58 | 56 | NA | NA | NA | NA | NA | NA |
| Median (IQR) | 1898 (1140-5229) | 1981 (994-5220) | 1645 (825-3244) | −180.0 (510.0 to −935.0) | .68 | −583.0 (40.0 to −1327.0) | .06 | −410.0 (190.0 to −1150.0) | .18 |
| ICU stay, d | 15 (9-22) | 17 (11-30) | 14 (9-27) | 2.0 (5.0 to −1.0) | .19 | 0.0 (3.0 to −3.0) | .75 | −2.0 (1.0 to −5.0) | .24 |
| Hospital stay, d | 14 (9-22) | 16 (10-28) | 14 (8-24) | 2.0 (4.0 to −1.0) | .18 | 0.0 (2.0 to −3.0) | .87 | −2.0 (0.0 to −5.0) | .09 |
| EQ-5D-5L index value, d 90h | |||||||||
| No. | 60 | 71 | 70 | NA | NA | NA | NA | NA | NA |
| Median (IQR) | 1 (1-1) | 1 (1-1) | 1 (1-1) | 0 | .68 | 0 | .42 | 0 | .48 |
| EQ-5D-5L score at d 90i | |||||||||
| No. | 57 | 69 | 64 | NA | NA | NA | NA | NA | NA |
| Median (IQR) | 80 (70-90) | 80 (70-90) | 80 (60-90) | 0.0 (5.0 to −5.0) | .82 | −5.0 (0.0 to −10.0) | .19 | −5.0 (0.0 to −10.0) | .16 |
| All-cause death at d 90 | 22 (19) | 22 (20) | 18 (17) | 0.7 (11.1 to −9.7) | > .99 | −2.6 (7.5 to −12.7) | .73 | −3.3 (6.9 to −13.6) | .60 |
| Safety outcomes | |||||||||
| Major bleedingj | 3 (3) | 4 (4) | 4 (4) | 1.0 (5.6 to −3.6) | .72 | 1.0 (5.6 to −3.6) | .72 | 0.0 (4.9 to −4.9) | > .99 |
| Efficacy and safety outcomes | |||||||||
| Net clinical outcomek | 34 (30) | 18 (16) | 22 (20) | −13.5 (−2.6 to −24.3) | .02 | −9.8 (1.4 to −21.1) | .12 | 3.6 (13.8 to −6.5) | .60 |
Abbreviations: CVC, central venous catheter; DVT, deep vein thrombosis; EQ-5D-5L, Euroqol 5-dimension 5-level; HD-PA, high-dose prophylactic anticoagulation; ISTH, International Society on Thrombosis and Hemostasis; SD-PA, standard-dose prophylactic anticoagulation; SOFA, Sepsis-related Organ Failure Assessment; TA, therapeutic anticoagulation.
This was a ranked composite of death and time to clinical improvement in survivors, effect size % (95% CI). Probability of more favorable outcome (ie, probabilistic index) is the estimated probability that an individual randomly selected from 1 treatment group will have a higher score (more favorable outcome) than an individual randomly selected from the other group; it is mathematically equivalent to the area-under-the-receiver operating characteristic curve of Mann-Whitney.
No absolute value reported for the primary end point effect estimate, ie, probability of more favorable outcome because the probability for either group is itself the comparator effect estimate; their combined probability equals 100%.
Median (IQR) time to first thrombosis event was 6 (4-13) days in the SD-PA, 12 (8-22) days in the HD-PA group, and 11 (6-21) days in the TA group (P = .33).
Two patients had both a DVT and a pulmonary artery thrombosis, and 2 patients had both a pulmonary artery thrombosis and an arterial thrombosis.
Clinical improvement was defined as a decline of 2 points on the modified 7-category ordinal scale of clinical status.27
Assessment scores from 0-2 for platelet count, PT ratio, and total SOFA (sum of 4 items: respiratory SOFA, cardiovascular SOFA, hepatic SOFA, and kidney SOFA).30
Reference upper limit, 500 ng/mL (to convert to nmol/L, multiply by 4.476).
Preference-based health-related quality of life measured by 1 question for each of the 5 dimensions (mobility, self-care, usual activities, pain and discomfort, and anxiety and depression). Index values range from 1.0 (perfect health) to 0 (a state equivalent to death) to <0 (a health condition ranked worse than death).29
Visual analogue scale from 0-100 (0 being the worst health that the patient can imagine, and 100 being the best).29
Per the ISTH definition; median (IQR) time to major bleeding was 13 (10-26) d.
Composite outcome, including any composite thrombotic event, ISTH-defined major bleeding, and all-cause death.