Jantoven (Page 7 of 9)

14.3 Myocardial Infarction

WARIS (The Warfarin Re-Infarction Study) was a double-blind, randomized study of 1214 patients 2 to 4 weeks post-infarction treated with warfarin to a target INR of 2.8 to 4.8. The primary endpoint was a composite of total mortality and recurrent infarction. A secondary endpoint of cerebrovascular events was assessed. Mean follow-up of the patients was 37 months. The results for each endpoint separately, including an analysis of vascular death, are provided in Table 7:

Table 7: WARIS — Endpoint Analysis of Separate Events
Event Warfarin (N=607) Placebo (N=607) RR (95% CI) % Risk Reduction (p -value)
RR=Relative risk; Risk reduction=(1 — RR); CI=Confidence interval; MI=Myocardial infarction; py=patient years

Total Patient Years of Follow-up

2018

1944

Total Mortality

94 (4.7/100 py)

123 (6.3/100 py)

0.76 (0.60, 0.97)

24 (p=0.030)

Vascular Death

82 (4.1/100 py)

105 (5.4/100 py)

0.78 (0.60, 1.02)

22 (p=0.068)

Recurrent MI

82 (4.1/100 py)

124 (6.4/100 py)

0.66 (0.51, 0.85)

34 (p=0.001)

Cerebrovascular Event

20 (1.0/100 py)

44 (2.3/100 py)

0.46 (0.28, 0.75)

54 (p=0.002)

WARIS II (The Warfarin, Aspirin, Re-Infarction Study) was an open-label, randomized study of 3630 patients hospitalized for acute myocardial infarction treated with warfarin to a target INR 2.8 to 4.2, aspirin 160 mg per day, or warfarin to a target INR 2.0 to 2.5 plus aspirin 75 mg per day prior to hospital discharge. The primary endpoint was a composite of death, nonfatal reinfarction, or thromboembolic stroke. The mean duration of observation was approximately 4 years. The results for WARIS II are provided in the Table 8.

Table 8: WARIS II — Distribution of Events According to Treatment Group
Event Aspirin (N=1206) Warfarin (N=1216) Aspirin plus Warfarin (N=1208) Rate Ratio (95% CI) p -value
CI=confidence interval
ND=not determined
*
Major bleeding episodes were defined as nonfatal cerebral hemorrhage or bleeding necessitating surgical intervention or blood transfusion.
The rate ratio is for aspirin plus warfarin as compared with aspirin.
The rate ratio is for warfarin as compared with aspirin.
§
Minor bleeding episodes were defined as non-cerebral hemorrhage not necessitating surgical intervention or blood transfusion.
Includes death, nonfatal reinfarction, and thromboembolic cerebral stroke.

No. of Events

Major Bleeding *

8

33

28

3.35 (ND)4.00 (ND)

NDND

Minor Bleeding §

39

103

133

3.21 (ND)2.55 (ND)

NDND

Composite Endpoints

241

203

181

0.81 (0.69-0.95)0.71 (0.60-0.83)

0.030.001

Reinfarction

117

90

69

0.56 (0.41-0.78)0.74 (0.55-0.98)

<0.0010.03

Thromboembolic Stroke

32

17

17

0.52 (0.28-0.98)0.52 (0.28-0.97)

0.030.03

Death

92

96

95

0.82

There were approximately four times as many major bleeding episodes in the two groups receiving warfarin than in the group receiving aspirin alone. Major bleeding episodes were not more frequent among patients receiving aspirin plus warfarin than among those receiving warfarin alone, but the incidence of minor bleeding episodes was higher in the combined therapy group.

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