Table 2.
Outcomes | No. of Participants (Studies), Follow-up | Quality of the Evidence (GRADE) | Relative Effect (95% CI) | Anticipated Absolute
Effects |
|
Risk With Warfarin 5 mg Loading Dose Nomogram | Risk Difference With Warfarin 10 mg Loading Dose Nomogram (95% CI) | ||||
Bleeding events |
420 (3 studiesa-c), 5-90 dd |
Very lowe-g due to
indirectness, imprecision |
OR 1.90 (0.17-21.1) |
5 per 1,000 |
0 more per 1,000 (from 10 fewer to 20 more)h |
Recurrent VTE | 420 (3 studiesa-c) | Very lowe-g due to indirectness, imprecision | Not estimable | 0 per 1,000 | 10 more per 1,000 (from 30 more to 0 more)i |
GRADE = Grades of Recommendations, Assessment, Development, and Evaluation. See Table 1 legend for expansion of other abbreviation.
All pooled studies included only patients with acute VTE. Studies from which data could be pooled are Kovacs et al,9 Quiroz et al,10 and Schulman et al.11
Minimal loss to follow-up; adherence to intention-to-treat principle in two of three studies; follow-up period short but adequate for this outcome; any lack of blinding should not impact objective outcome (laboratory value, INR); adequate allocation concealment; sample size calculations reported for two of three studies.
Results based on only three studies; one study shows no difference; one shows statistically significant reduction in time to therapeutic INR; and one had two parts to it, where one showed statistically significant reduction and the other did not.
Mean follow-up period of 5 d for patients in the loading dose warfarin group from Schulman et al11 (this was the shortest period, only mean is available).
Data collectors unblinded.
Indirect given application aimed at outpatients with VTE; follow-up period is very short in two of three studies (5 d-2 wk).
No studies were powered to detect differences in bleeding events between groups. Number of events is too sparse to draw any conclusions.
Very small number of events; risk difference calculated.
OR not estimable; absolute risk difference calculated.