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September 9, 2014European Heart Journal

Telemedicine-guided, very low-dose international normalized ratio self-control in patients with mechanical heart valve implants

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Key result

Telemedicine-guided very low-dose INR self-control once weekly reduced the risk of grade III complications compared to low-dose INR (HR 0.307; 95% CI 0.102-0.926; P=0.036).

Why the study?

Does telemedicine-guided very low-dose INR self-control reduce major bleeding and thrombotic events in patients with mechanical heart valve implants compared to low-dose INR self-control?

Population

1,571 patients with mechanical heart valve implants

Comparison

Telemedicine-guided very low-dose INR… vs Low-dose INR self-control

Design

RCT, randomly assigned

Follow-up

2 years

Authors

HKHeinrich KoertkeHeart and Diabetes Center North Rhine-WestphaliaAZArmin ZittermannHeart and Diabetes Center North Rhine-WestphaliaOWOtto WagnerKepler Universitätsklinikum

Discussion

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Implication

Supports telemedicine-guided very low-dose INR self-control in mechanical valve patients; extends RCT evidence for fewer major complications.

Study Design

Type

RCT (n=1,571)

Structured PICO

Does telemedicine-guided very low-dose INR self-control reduce major bleeding and thrombotic events in patients with mechanical heart valve implants compared to low-dose INR self-control?

P
Population
1,571 patients with mechanical heart valve implants (AVR, MVR, or DVR) performing INR self-control, followed for 2 years.
I
Intervention
Telemedicine-guided very low-dose INR self-control (INR target range, AVR: 1.6-2.1; MVR/DVR: 2.0-2.5) performed once a week (VLO group) or twice a week (VLT group)
C
Comparator
Low-dose INR self-control (LOW group) (INR target range, AVR: 1.8-2.8; MVR/DVR: 2.5-3.5)
O
Outcome
Grade III complications (major bleeding and thrombotic events)composite

Main Result

Hazard Ratio: 0.307 (95% CI 0.102–0.926)

p-value: p=0.036

Telemedicine-guided very low-dose INR self-control reduces bleeding risk without increasing thrombotic risk in patients with mechanical aortic valve replacement, though twice-weekly testing was associated with increased mortality.

Limitations

  • Given the small number of MVR and DVR patients, results are only valid for AVR patients.
  • Small number of MVR and DVR patients, making results only valid for AVR patients

Cite This Study

Koertke et al. (2014) conducted an RCT in Mechanical heart valve implants (n=1,571). Very low-dose INR self-control vs. Low-dose INR self-control was evaluated on Composite of grade III complications (major bleeding and thrombotic events) (HR 0.307, 95% CI 0.102-0.926, p=0.036). Telemedicine-guided very low-dose INR self-control once weekly reduced the risk of grade III complications compared to low-dose INR (HR 0.307; 95% CI 0.102-0.926; P=0.036).

synapsesocial.com/papers/6a93e7ec00963b0dd7fc09behttps://doi.org/10.1093/eurheartj/ehu330

Topics

Valvular heart diseaseAnticoagulation in AF
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Also Consider

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