November 20, 2015PLoS ONEOpen Access

Extended Anticoagulant and Aspirin Treatment for the Secondary Prevention of Thromboembolic Disease: A Systematic Review and Meta-Analysis

Q: What is the clinical evidence from this study?

Study design: Meta-Analysis. Population: Unprovoked venous thromboembolism (DVT or PE) (n=6778). Intervention: Extended anticoagulation (Vitamin K antagonists, DOACs, or aspirin) vs. Placebo. Primary outcome: Recurrent venous thromboembolism (VTE) during the treatment period (OR 0.21, 95% CI 0.11-0.42, p=<0.0001).

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Key result

Extended treatment with vitamin K antagonists, DOACs, or aspirin significantly reduced the risk of recurrent venous thromboembolism (OR 0.21) compared to placebo in patients with unprovoked VTE.

Why the study?

Does extended anticoagulation with VKA, DOACs, or aspirin reduce recurrent VTE in patients with unprovoked DVT or PE after initial 3-month treatment?

Population

6,778 patients with an unprovoked DVT or PE who had been treated for at least 3 months with a VKA or DOAC…

Comparison

Extended anticoagulation with vitamin K… vs Placebo or observation.

Design

Meta-analysis, All the studies included were randomized, double-blinded…

Follow-up

average 19.4 ± 11.7 months (range 6 to 37 months)

Authors

PMPaul E. MarikUniversity of Vermont RCRodrigo CavallazziUniversity of Louisville

Discussion

Member takes

Implication

Supports extended antithrombotic therapy after unprovoked VTE; confirms benefit of VKA, DOAC, or aspirin over placebo.

Study Design

Type

Meta-Analysis (n=6,778)

Blinding

Double-blind

Randomization

Randomized

Multicenter

Yes

Structured PICO

Does extended anticoagulation with VKA, DOACs, or aspirin reduce recurrent VTE in patients with unprovoked DVT or PE after initial 3-month treatment?

Population

6,778 patients with an unprovoked DVT or PE (or clinical equipoise regarding continuation) who had been treated for at least 3 months with a VKA or DOAC, pooled from 7 RCTs.

Intervention

Extended anticoagulation with vitamin K antagonists (VKA), direct oral anticoagulants (DOACs), or aspirin for at least 6 additional months.

Comparator

Placebo or observation.

Outcome

Recurrent VTE (DVT or PE), major bleeding episodes, and mortality during the treatment period.hard clinical

Main Result

Effect estimate: OR 0.21 (95% CI 0.11-0.42)

Absolute Event Rate: 2.8% vs 9.7%

p-value: p=<0.0001

Extended treatment with VKAs, DOACs, or aspirin significantly reduces the risk of recurrent VTE in patients with unprovoked DVT or PE, with VKAs and DOACs being more effective than aspirin.

Limitations

Patient population and the duration of the active treatment and extended treatment phases were not the same across studies.
The three DOAC studies included patients with provoked VTE and did not stratify outcomes according to whether the provoking event was provoked or unprovoked.
The duration of extended anticoagulation averaged only 18.5 months, precluding strong recommendations regarding lifelong therapy.
The search strategy was limited to the MEDLINE and CENTRAL databases.
Patient population and duration of treatment phases were not the same across studies
DOAC studies included patients with provoked VTE and did not stratify outcomes
Average duration of extended anticoagulation was only 18.5 months, precluding strong recommendations for lifelong therapy
Search strategy limited to MEDLINE and CENTRAL

Cite This Study

Marik et al. (2015) conducted a meta-analysis in Unprovoked venous thromboembolism (DVT or PE) (n=6,778). Extended anticoagulation (Vitamin K antagonists, DOACs, or aspirin) vs. Placebo was evaluated on Recurrent venous thromboembolism (VTE) during the treatment period (OR 0.21, 95% CI 0.11-0.42, p=<0.0001). Extended treatment with vitamin K antagonists, DOACs, or aspirin significantly reduced the risk of recurrent venous thromboembolism (OR 0.21) compared to placebo in patients with unprovoked VTE.

synapsesocial.com/papers/6a15849072316eef384e2727 https://doi.org/10.1371/journal.pone.0143252

Topics

Anticoagulation in AF

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November 20, 2015PLoS ONEOpen Access

Extended Anticoagulant and Aspirin Treatment for the Secondary Prevention of Thromboembolic Disease: A Systematic Review and Meta-Analysis

View Full Paper

Ask AI

Bookmark

Key result

Extended treatment with vitamin K antagonists, DOACs, or aspirin significantly reduced the risk of recurrent venous thromboembolism (OR 0.21) compared to placebo in patients with unprovoked VTE.

Why the study?

Does extended anticoagulation with VKA, DOACs, or aspirin reduce recurrent VTE in patients with unprovoked DVT or PE after initial 3-month treatment?

Population

6,778 patients with an unprovoked DVT or PE who had been treated for at least 3 months with a VKA or DOAC…

Comparison

Extended anticoagulation with vitamin K… vs Placebo or observation.

Design

Meta-analysis, All the studies included were randomized, double-blinded…

Follow-up

average 19.4 ± 11.7 months (range 6 to 37 months)

Authors

PMPaul E. MarikUniversity of Vermont RCRodrigo CavallazziUniversity of Louisville

Discussion

Member takes

Implication

Supports extended antithrombotic therapy after unprovoked VTE; confirms benefit of VKA, DOAC, or aspirin over placebo.

Study Design

Type

Meta-Analysis (n=6,778)

Blinding

Double-blind

Randomization

Randomized

Multicenter

Yes

Structured PICO

Does extended anticoagulation with VKA, DOACs, or aspirin reduce recurrent VTE in patients with unprovoked DVT or PE after initial 3-month treatment?

Population

6,778 patients with an unprovoked DVT or PE (or clinical equipoise regarding continuation) who had been treated for at least 3 months with a VKA or DOAC, pooled from 7 RCTs.

Intervention

Extended anticoagulation with vitamin K antagonists (VKA), direct oral anticoagulants (DOACs), or aspirin for at least 6 additional months.

Comparator

Placebo or observation.

Outcome

Recurrent VTE (DVT or PE), major bleeding episodes, and mortality during the treatment period.hard clinical

Main Result

Effect estimate: OR 0.21 (95% CI 0.11-0.42)

Absolute Event Rate: 2.8% vs 9.7%

p-value: p=<0.0001

Extended treatment with VKAs, DOACs, or aspirin significantly reduces the risk of recurrent VTE in patients with unprovoked DVT or PE, with VKAs and DOACs being more effective than aspirin.

Limitations

Patient population and the duration of the active treatment and extended treatment phases were not the same across studies.
The three DOAC studies included patients with provoked VTE and did not stratify outcomes according to whether the provoking event was provoked or unprovoked.
The duration of extended anticoagulation averaged only 18.5 months, precluding strong recommendations regarding lifelong therapy.
The search strategy was limited to the MEDLINE and CENTRAL databases.
Patient population and duration of treatment phases were not the same across studies
DOAC studies included patients with provoked VTE and did not stratify outcomes
Average duration of extended anticoagulation was only 18.5 months, precluding strong recommendations for lifelong therapy
Search strategy limited to MEDLINE and CENTRAL

Cite This Study

synapsesocial.com/papers/6a15849072316eef384e2727 https://doi.org/10.1371/journal.pone.0143252

Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

Topics

Anticoagulation in AF

View Full Paper

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