Table 2

Incidences and hazard ratios for recurrent venous thrombosis

Vitamin, N/py (ir %)Placebo, N/py (ir %)HR vitamin versus placebo*
Intention-to-treat analysis    
    Hyperhomocysteinemic group 26/387 (6.7) 24/403 (6.0) 1.14 (0.65-1.98) 
    Normohomocysteinemic group 17/412 (4.1) 26/373 (7.0) 0.58 (0.32-1.08) 
    Overall 43/799 (5.4) 50/776 (6.4) 0.84 (0.56-1.26) 
On-treatment analysis    
    Hyperhomocysteinemic group 24/338 (7.1) 22/344 (6.4) 1.13 (0.63-2.02) 
    Normohomocysteinemic group 16/363 (4.4) 22/337 (6.5) 0.65 (0.34-1.24) 
    Overall 40/702 (5.7) 44/682 (6.4) 0.88 (0.57-1.36) 
Intention-to-treat analysis with exclusion of early recurrences    
    Hyperhomocysteinemic group 17/387 (4.4) 21/403 (5.2) 0.84 (0.44-1.60) 
    Normohomocysteinemic group 15/412 (3.6) 20/373 (5.4) 0.66 (0.34-1.30) 
    Overall 32/799 (4.0) 41/776 (5.3) 0.76 (0.48-1.21) 
Intention-to-treat analysis beginning after cessation of anticoagulation    
    Hyperhomocysteinemic group 23/338 (6.8) 24/347 (6.9) 0.98 (0.55-1.74) 
    Normohomocysteinemic group 17/379 (4.5) 24/338 (7.1) 0.62 (0.33-1.15) 
    Overall 40/717 (5.6) 48/685 (7.0) 0.80 (0.52-1.21) 
Vitamin, N/py (ir %)Placebo, N/py (ir %)HR vitamin versus placebo*
Intention-to-treat analysis    
    Hyperhomocysteinemic group 26/387 (6.7) 24/403 (6.0) 1.14 (0.65-1.98) 
    Normohomocysteinemic group 17/412 (4.1) 26/373 (7.0) 0.58 (0.32-1.08) 
    Overall 43/799 (5.4) 50/776 (6.4) 0.84 (0.56-1.26) 
On-treatment analysis    
    Hyperhomocysteinemic group 24/338 (7.1) 22/344 (6.4) 1.13 (0.63-2.02) 
    Normohomocysteinemic group 16/363 (4.4) 22/337 (6.5) 0.65 (0.34-1.24) 
    Overall 40/702 (5.7) 44/682 (6.4) 0.88 (0.57-1.36) 
Intention-to-treat analysis with exclusion of early recurrences    
    Hyperhomocysteinemic group 17/387 (4.4) 21/403 (5.2) 0.84 (0.44-1.60) 
    Normohomocysteinemic group 15/412 (3.6) 20/373 (5.4) 0.66 (0.34-1.30) 
    Overall 32/799 (4.0) 41/776 (5.3) 0.76 (0.48-1.21) 
Intention-to-treat analysis beginning after cessation of anticoagulation    
    Hyperhomocysteinemic group 23/338 (6.8) 24/347 (6.9) 0.98 (0.55-1.74) 
    Normohomocysteinemic group 17/379 (4.5) 24/338 (7.1) 0.62 (0.33-1.15) 
    Overall 40/717 (5.6) 48/685 (7.0) 0.80 (0.52-1.21) 

N indicates the number of recurrences; py, person years; ir, annual incidence in percent.

*

HR is hazard ratio (95% CI), adjusted for study center, sex, and hyperhomocysteinemia or normohomocysteinemia.

Early recurrences are recurrences before 2 months after cessation of anticoagulation.

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