What is the clinical evidence from this study?

Study design: Meta-Analysis. Population: Non-valvular atrial fibrillation (n=2287288). Intervention: Non-vitamin K antagonist oral anticoagulants (NOACs) vs. Warfarin. Primary outcome: Stroke (HR 0.77, 95% CI 0.69-0.87, p=<0.01).

August 11, 2021Open Access

Direct comparison of non-vitamin K antagonist oral anticoagulant versus warfarin for stroke prevention in non-valvular atrial fibrillation: a systematic review and meta-analysis of real-world evidences

Q: What are the key findings of this study?

Non-vitamin K antagonist oral anticoagulants significantly reduced the risk of stroke compared to warfarin in patients with non-valvular atrial fibrillation (HR 0.77).

Key Result

Non-vitamin K antagonist oral anticoagulants significantly reduced the risk of stroke compared to warfarin in patients with non-valvular atrial fibrillation (HR 0.77).

Study Design

Type

Meta-Analysis (n=2,287,288)

Structured PICO

Do NOACs reduce stroke risk in patients with non-valvular atrial fibrillation compared to warfarin in a real-world setting?

Population

34 real-world studies pooling 2,287,288 patients with non-valvular atrial fibrillation (NVAF), multinational (America, Asia, and Europe). Mean CHA2DS2-VASc score ranged from 2 to 4.7, and HAS-BLED score ranged from 1.27 to 3.9.

Intervention

Non-vitamin K antagonist oral anticoagulants (NOACs) as a class, including apixaban, dabigatran, edoxaban, and rivaroxaban.

Comparator

Warfarin

Outcome

Stroke riskhard clinical

In a real-world setting of over 2.2 million NVAF patients, NOACs were more effective than warfarin at reducing stroke, all-cause mortality, major bleeding, and intracranial bleeding, though gastrointestinal bleeding risk was comparable.

Main Result

Effect estimate: HR 0.77 (95% CI 0.69-0.87)

p-value: p=<0.01

Limitations

Almost all involved studies did not provide data about the treatment regimen's compliance or persistence.
The time in therapeutic range (TTR) of warfarin users was not reported in almost all studies.
Did not conduct subgroup analysis comparing warfarin with a low or high dose of NOACs because of limited available data.
Precise inclusion or exclusion criteria and outcomes definitions varied among the involved studies.
Residual confounding factors with unmeasured variables could not be excluded due to the characteristic of real-world data.

Abstract

BACKGROUND: To overcome the several drawbacks of warfarin, non-vitamin K antagonist oral anticoagulants (NOACs) were developed. Even though randomized controlled trials (RCTs) provided high-quality evidence, the real-world evidence is still needed. This systematic review and meta-analysis proposed to measure the safety and efficacy profile between warfarin and NOACs in non-valvular atrial fibrillation (NVAF) patients in preventing stroke. RESULTS: We collected articles about the real-world studies comparing warfarin and NOACs for NVAF patients recorded in electronic scientific databases such as Embase, ProQuest, PubMed, and Cochrane. The pooled hazard ratio (HR) and 95% confidence interval (CI) were estimated using the generic inverse variance method. A total of 34 real-world studies, including 2287288 NVAF patients, were involved in this study. NOACs effectively reduced the stroke risk than warfarin (HR 0.77; 95% CI 0.69 to 0.87; p < 0.01). Moreover, NOACs effectively lowered all-cause mortality risk (HR 0.71; 95% CI 0.63 to 0.81; p < 0.01). From the safety aspect, compared to warfarin, NOACs significantly reduced major bleeding risk (HR 0.68; 95% CI 0.54 to 0.86; p < 0.01) and intracranial bleeding risk (HR 0.54; 95% CI 0.42 to 0.70; p < 0.01). However, NOACs administration failed to decrease gastrointestinal bleeding risk (HR 0.78; 95% CI 0.58 to 1.06; p = 0.12). CONCLUSIONS: In NVAF patients, NOACs were found to be more effective than warfarin at reducing stroke risk. NOACSs also lowered the risk of all-cause mortality, cerebral hemorrhage, and severe bleeding in NVAF patients compared to warfarin.

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Cite This Study

Waranugraha et al. (Wed,) conducted a meta-analysis in Non-valvular atrial fibrillation (n=2,287,288). Non-vitamin K antagonist oral anticoagulants (NOACs) vs. Warfarin was evaluated on Stroke (HR 0.77, 95% CI 0.69-0.87, p=<0.01). Non-vitamin K antagonist oral anticoagulants significantly reduced the risk of stroke compared to warfarin in patients with non-valvular atrial fibrillation (HR 0.77).

synapsesocial.com/papers/6a10dc90acd1dbe0646486ac https://doi.org/https://doi.org/10.1186/s43044-021-00194-1

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