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Evidence Summary

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Some new anticoagulant pills reduce cardiovascular events and serious bleeding

Sharma M, Cornelius VR, Patel JP, et al. Efficacy and Harms of Direct Oral Anticoagulants in the Elderly for Stroke Prevention in Atrial Fibrillation and Secondary Prevention of Venous Thromboembolism: Systematic Review and Meta-Analysis. Circulation. 2015;132:194-204.

Review question

In people 75 years of age or older who have atrial fibrillation (abnormal heart beat) or venous thromboembolism (blood clots in veins), are new anticoagulant pills (blood thinners) safe and effective compared with other blood thinners such as warfarin?

Background

People with conditions such as atrial fibrillation or venous thromboembolism are at increased risk of developing (more) blood clots, which can increase the risk of lung embolism, heart attacks, or stroke.  Doctors may prescribe anticoagulant pills to reduce the formation of blood clots. Warfarin, a vitamin K antagonist, is the anticoagulant pill prescribed most often. It requires careful monitoring by doctors and can cause serious bleeding. Newer anticoagulant pills are available and may be more effective, safer, and easier to take.

How the review was done

The researchers did a systematic review, searching for published studies up to June 2014. They found 12 randomized controlled trials with 31,418 people 75 years of age or older.

People in the trials had acute atrial fibrillation or venous thromboembolism.

New anticoagulant pills included dabigatran, rivaroxaban, apixaban, and edoxaban.

New anticoagulant pills were compared with warfarin or another vitamin K antagonist.

Outcomes were cardiovascular events (stroke or systemic embolism, venous thromboembolism), and serious bleeding.

What the researchers found

Compared with warfarin or another vitamin K antagonist:

  • dabigatran, 150 mg, and apixaban reduced rates of stroke or systemic embolism;
  • edoxaban, 60 mg, reduced rate of repeat venous thromboembolism; and
  • apixaban and edoxaban, 30 and 60 mg, reduced rates of serious bleeding.

Conclusion

In people 75 years of age and older with acute venous thromboembolism or atrial fibrillation, some new anticoagulant pills reduce stroke or systemic embolism, repeat venous thromboembolism, or serious bleeding compared with vitamin K antagonists.

New anticoagulant pills vs vitamin K antagonists in people 75 years and older who have venous thromboembolism or atrial fibrillation

Outcomes

Drug

Number of trials (number of people)

Rate of events with new anticoagulant pills

Rate of events with vitamin K antagonists

Effect of new anticoagulant pills at 3 to 34 months

Stroke or systemic embolism (SSE)

Dabigatran, 150 mg

1 trial (4889 people)

2.8%

4.2%

About 14 fewer people out of 1000 had SSE

 

Dabigatran, 110 mg

1 trial (4772 people)

3.7%

4.2%

No difference between groups*

 

Rivaroxaban

1 trial (6164 people)

4.1%

5.0%

No difference between groups*

 

Apixaban

2 trials (5746 people)

2.8%

3.9%

About 11 fewer people out of 1000 had SSE

 

Edoxaban, 60 mg

1 trial (5668 people)

4.9%

5.9%

No difference between groups*

 

Edoxaban, 30 mg

1 trial (5626 people)

6.6%

5.9%

No difference between groups*

Repeat venous thromboembolism

Dabigatran, 150 mg

2 trials (529 people)

1.2%

1.8%

No difference between groups*

 

Rivaroxaban

2 trials (1283 people)

2.3%

3.7%

No difference between groups*

 

Apixaban

1 trial (749 people)

1.8%

3.6%

No difference between groups*

 

Edoxaban, 60 mg

1 trial (1104 people)

2.5%

5.0%

About 25 fewer people out of 1000 had repeat venous thromboembolism

Serious bleeding

Dabigatran, 150 mg

3 trials (4726 people)

9.8%

8.4%

No difference between groups*

 

Dabigatran, 110 mg

1 trial (4114 people)

9.2%

9.0%

No difference between groups*

 

Rivaroxaban

4 trials (7082 people)

6.4%

6.1%

No difference between groups*

 

Apixaban

2 trials (6423 people)

4.9%

7.5%

About 26 fewer people out of 1000 had serious bleeding

 

Edoxaban, 60 mg

1 trial (5668 people)

7.5%

9.1%

About 16 fewer people out of 1000 had serious bleeding

 

Edoxaban, 30 mg

1 trial (5626 people)

4.3%

9.1%

About 48 fewer people out of 1000 had serious bleeding

*Although the rates for the 2 groups look different, the differences were not statistically significant. This means that the difference could simply be due to chance rather than due to the different treatments.




Glossary

Randomized controlled trials
Studies where people are assigned to one of the treatments purely by chance.
Systematic review
A comprehensive evaluation of the available research evidence on a particular topic.
Vascular
The body's network of blood vessels. It includes the arteries, veins, and capillaries that carry blood to and from the heart.

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