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F. Couturaud et al.
Table 2. Primary and secondary outcomes according to study group assignment. Warfarin
(N=50) 171.5 person-years
P Valuea
<0.001
<0.001
0.22
0.33
0.36
0.36
0.31
0.59
Placebo (N=54) 186.1 person-years
Hazard Ratio (95% CI)a
0.03 (0.01 to 0.51)
0.03 (0.01 to 0.51)
-
-
0.72 (0.35 to 1.46)
0.72 (0.35 to 1.46)
-
0.52 (0.05 to 5.73)
During the study treatment period of 18 months
Primary composite outcome,b n. (%)
Recurrent venous thromboembolism, n. (%) Fatal pulmonary embolismc
Symptomatic non-fatal pulmonary embolism Symptomatic proximal deep-vein thrombosis Symptomatic distal deep-vein thrombosis
Major bleeding, no. (%) Fatal
Non-fatal
Death from causes other than VTE
or major bleeding, n. (%)
During the entire study period of 42 months
Composite outcome, n. (%)
Recurrent VTE, n. (%)
Fatal pulmonary embolismc
Symptomatic non-fatal pulmonary embolism Symptomatic proximal deep-vein thrombosis Symptomatic distal deep-vein thrombosis
Major bleeding, n. (%) Fatal
Non-fatal
Death from causes other than VTE
or major bleeding, n. (%)
N. with event(s) (%)a
0 (0.0)
0 (0.0) 0
0
0
0
0 0 0
0 (0.0)
14 (36.8)
14 (36.8)d 0
1
12
1d
1 (2.0)e 0
1
1 (2.0)
16 (29.6)
16 (29.6) 1
2
12
1d
0 0 0
1 (1.9)
17 (31.5)
17 (31.5) 1
2
13
1d
0 (0.0) 0
0
2 (3.8)
aPercentages are Kaplan-Meier estimates; all confidence intervals and P values were estimated using a Cox proportional hazards regression model. bThe primary outcome was the composite of symptomatic recurrent venous thromboembolism (including objectively confirmed non-fatal symptomatic pulmonary embolism or proximal deep-vein throm- bosis or fatal venous thromboembolism) and non-fatal or fatal major bleeding up to 18 months. cSudden death classified as fatal pulmonary embolism by the Critical Events Committee. dFor two patients, symptomatic recurrent venous thrombosis occurred as contralateral distal deep-vein thrombosis; these two events were validated by the independ- ent Critical Events Committee.eOne patient experienced recurrent venous thromboembolism 24 months after warfarin was discontinued owing to major bleeding.The same patient experienced rectorrhagia 10 months later (at 968 days), associated with a fall in hemoglobin level ≥2 g/dL, and requiring transfusion of two units of packed red cells. HR: hazard ratio; 95% CI: 95% confidence interval;VTE: venous thromboembolism.
Figure 2. Kaplan-Meier estimates of the probability of the composite outcome of recurrent venous thromboembolism and major bleeding during the entire study period, according to study group. The unadjusted hazard ratios (95% confidence interval) warfarin/placebo were 0.03 (0.01 to 0.51) during the treatment period and 0.72 (0.35 to 1.46) during the entire study period.
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haematologica | 2019; 104(7)