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. 2026 Feb 3;273(2):113. doi: 10.1007/s00415-026-13635-1

NOACs effects in the secondary prevention of atrial fibrillation-related ischemic stroke/TIA: a systematic review and meta-analysis

Jiali Zhao 1,✉, Chunfu Chen 1, Lin Lu 2, Lina Wang 3, Fudi Chen 4,✉
PMCID: PMC12868035  PMID: 41632318

Abstract

Aims

Rivaroxaban has been approved for the primary prevention of stroke with non-valvular atrial fibrillation caused by one or more risk factors. However, the optimal antithrombotic therapy for secondary prevention of stroke in atrial fibrillation (AF) with ischemic stroke/transient ischemic attack (TIA) had been uncertain. We compared the safety and efficacy of novel oral anticoagulants. (NOACs) and Warfarin in treating AF with ischemic stroke.

Methods

Seven databases were searched from inception up to December 2024 for studies comparing NOACs and Warfarin in AF with ischemic stroke. 7 randomized controlled trials (RCTs) and 9 cohort studies with 128,808 patients were included. A random-effects model or fix effects model was used.

Results

Pooled results showed that the NOACs are superior to Warfarin in the prevention of stroke or systemic embolism (RR 0.90, 95%CI [0.82,1.0], P = 0.04) and all-cause mortality (RR 0.83, 95%CI [0.76,0.92], P = 0.0003). As well as NOACs has lower risk in total bleeding (RR 0.79, 95%CI [0.76,0.83], P < 0.00001), fatal bleeding (RR0.64, 95% CI [0.54,0.76], P < 0.00001), hemorrhagic stroke (RR0.50, 95%CI [0.43,0.58], P < 0.00001), and intracranial bleeding (RR 0.49, 95%CI [0.36,0.65], P < 0.00001) than Warfarin.

Conclusion

In the secondary prevention with AF related to ischemic stroke, NOACs showed potential advantages over Warfarin in the incidence of stroke or systemic embolism, all-cause mortality, total bleeding, fatal bleeding, hemorrhagic stroke, and intracranial bleeding.

Keywords: NOACs, Warfarin, Secondary prevention, AF, Ischemic stroke

Introduction

Ischemic stroke (IS) is a disease with high morbidity, high disability, and high mortality. The mortality analysis in China from 1990 to 2017 pointed out that stroke, ischemic heart disease, lung cancer, chronic obstructive pulmonary disease, and liver cancer were the top five leading causes of death in China in 2017 [1]. About 25% of ischemic stroke are cardioembolic which the most common cause is atrial fibrillation (AF). In addition, cardiogenic cerebral embolism is in general severe and prone to early and long-term recurrence [2]. Non-valvular AF carries a fivefold increased risk of stroke. [3].

Currently, rivaroxaban 15 mg and 20 mg doses have been approved by the National Institute for Clinical Quality Management (NICE) in the UK for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF) caused by one or more risk factors. However, the optimal antithrombotic therapy for secondary prevention of stroke in AF with ischemic stroke/TIA patient had been uncertain. Until recently, many meta-analyses focus on the general safety and efficacy of NOACs vs Warfarin for patients with AF [4–6], but less attention was paid to NOACs in secondary prevention in patients with atrial fibrillation related to ischemic stroke.

Therefore, the present study conducted a comprehensive systemic review and meta-analysis of safety and efficacy of NOACs for secondary prevention in AF patients with ischemic stroke/TIA.

Methods

Data source and searching

This study followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta Analyses) statement to conduct a meta-analysis. To comprehensively obtain the original research on the prognostic effects of novel oral anticoagulants (NOACs) for the treatment of atrial fibrillation combined with ischemic stroke, the following databases were searched by computer: PubMed, Web of Science, Cochrane Library, Embase, CNKI, VIP, and WanFang with search time from inception up to December 2024. The search terms/keywords are as follows: “non–vitamin K antagonist oral anticoagulants”, “novel oral anticoagulants”, “NOACs”, “direct oral anticoagulants”, “DOACs”, “factor-Xa-inhibitors”, “apixaban”, “edoxaban”, “dabigatran”, “rivaroxaban”, “anticoagulant therapy”, “atrial fibrillation”, “ischemic stroke”, “cerebral infarction”, “transient ischemic attack”, and “secondary prevention”. Search terms were combined using Boolean operators (AND and OR) to create a comprehensive search strategy. There was no restriction on language.

Study selection

The inclusion criteria were: (1) research subjects: patients with atrial fibrillation combined with ischemic stroke, which can be atrial fibrillation combined with acute stroke or atrial fibrillation combined with previous ischemic stroke. (2) Intervention measures: NOACs. Control: vitamin K antagonists, such as Warfarin. (3) Outcome measures: effectiveness indicators include stroke, systemic embolism, and mortality rate et al., while safety indicators mainly refer to various bleeding conditions, including total bleeding, major bleeding, intracranial bleeding, hemorrhage stroke etc. (4) Randomized controlled trials (RCTs) or cohort studies.

Exclusion criteria: (1) animal experiments, reviews, case reports, and critical literature, (2) literature whose full text cannot be obtained or whose outcome measures cannot be obtained, (3) repeated publication, (4) literature with inconsistent research designs, such as treatment drug mismatch, primary stroke prevention, etc.; (5) other low-quality literature.

Data extraction and quality assessment

Two investigators independently completed the literature screening work according to the inclusion and exclusion criteria mentioned above. The information to be extracted includes: author and publication year, study design, specific treatment measures for non-VKA group and control group, sample size, age, gender, CHADS2 score, follow-up time, outcome variable results, etc. Any disagreements were resolved by discussion. If the included literature is RCT, the risk of bias in the included literatures was analyzed using the Cochrane Risk of Bias Tool. If the included literature type is a cohort study, the quality of each study will be evaluated based on The Newcastle Ottawa Scale (NOS).

Statistical analysis

The extracted data were analyzed using RevMan5.3 software. The categorical variable uses RR (risk ratio), and the continuous variable uses MD (mean difference). Each effect size was represented using 95% CI. When P ≥ 0.1 and I2 ≤ 50%, it indicates homogeneity. A fixed-effects model was used for meta-analysis. On the contrary, a random-effects model is selected for analysis. Use funnel plot to evaluate publication bias in included literature. P < 0.05 represents statistical significance.

Results

Search results and characteristics of included studies

According to the search strategy, 1001 potentially relevant records were returned. One hundred seventy-five articles were duplicates; seven hundred seventy-nine irrelevant researches were excluded after reading titles and abstracts; forty-seven articles were further assessed for eligibility. Sixteen articles (include seven RCTs and nine cohort studies) were included in the current study [7–22] (Fig. 1, and Table 1).

Fig. 1.

Fig. 1

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Document retrieval and screening process

Table 1.

Basic characteristics of inclusion study

Study Study design Treatment Sample size (n) Age (years) Gender (M/F) CHADS2 score Median follow-up time (years)
Non-VKA Control Non-VKA Control Non-VKA Control Non-VKA Control Non-VKA Control
Diener et al. [7] RCT Dabigatran, 150/110 mg twice daily Warfarin placebo or to dose-adjusted warfarin 2428 1195 70.8 ± 10.1 70.4 ± 9.5 1533/895 746/449 NR NR 2.0
Easton et al. [8] RCT Apixaban, 5 mg twice daily Warfarin placebo or to dose-adjusted Warfarin 1694 1742 70.1 ± 9.5 70.1 ± 9.5 2152 (62.6%) 3.7 ± 0.9 3.7 ± 0.9 1.8
Hankey et al. [9] RCT Rivaroxaban, 20 mg daily Warfarin (dose adjusted) 3754 3714 71 (64–76) 71 (64–77) 2272/1482 2266/1448 4 (3–5) 4 (3–5) 1.85
Tanahashi et al. [10] RCT Rivaroxaban, 15 mg daily Warfarin (dose adjusted) 408 405 70.3 ± 8.24 70.4 ± 7.50 345/63 327/78 3.49 ± 0.92 3.47 ± 0.92 1.85
Larsen et al. [11] RCS Dabigatran, 150/110 mg twice daily Warfarin 646 1825 69 (64–74) 76 (69–82) 414/232 1022/803 2.64 ± 0.74 3.15 ± 0.90 1.05
Rost et al. [12] RCT Edoxaban, 60/30 mg once daily Warfarin (dose adjusted) 3982 1991 70.4 ± 9.2 70.4 ± 9.2 3694 (61.8%) NR NR 2.8
Coleman et al. [13] RCS NOACs (dabigatran, rivaroxaban, or apixaban) Warfarin 4842 4842 NR NR 2570/2272 2780/2062 5 (4–6) 5 (4–6) 0.5
Hong et al. [14] RCT Rivaroxaban, 10–15 mg daily Warfarin (dose adjusted) 95 88 70.2 ± 10.1 70.6 ± 10.9 55/40 42/36 2.7 ± 1.7 2.3 ± 1.4 0.1
Jia Gui et al. [15] RCS Dabigatran, 75 mg twice daily Warfarin (dose adjusted) 95 95 73.0 ± 6.1 73.0 ± 6.1 NR NR 4.9 ± 1.2 4.9 ± 1.2 1
Jin [16] RCS Rivaroxaban, 20 mg daily Warfarin (dose adjusted) 34 35 74.34 ± 4.31 72.29 ± 4.87 21/13 19/16 4.26 ± 0.90 4.00 ± 1.06 1
Xian et al. [17] RCS NOACs (dabigatran, rivaroxaban, or apixaban) Warfarin 4041 7621 80 (74–86) 80 (74–86) 1764/2277 3329/4292 4 (3–5) 4 (3–5) 4
Xu et al. [18] RCS Dabigatran, 110 mg twice daily Warfarin (dose adjusted) 44 48 77.27 ± 8.50 75.69 ± 6.09 23/21 22/26 5.00 ± 1.28 5.10 ± 1.19 0.25
Lin et al. [19] RCS NOACs (dabigatran, rivaroxaban, edoxaban, or apixaban) Warfarin 37,129 38,840 74.83 ± 9.63 69.75 ± 12.83 NR NR 6.22 ± 1.51 5.80 ± 1.67 2.22
Xia et al. [20] RCS Dabigatran, 220 mg daily Warfarin, 3 mg daily 86 77 78.0 ± 7.7 76.5 ± 8.4 41/45 46/31 NR NR 0.5
Labovitz et al. [21] RCT Apixaban (early use) Warfarin (dose adjusted) 41 47 72.6 ± 14.9 74.3 ± 10.5 15/26 24/23 3.8 ± 1.6 4.3 ± 1.5 0.5
Diener et al. [22] RCS Dabigatran VKAs 5874 1050 80.0 (63.0–91.0) 79.0 (62.0–90.0) 2885/2989 648/402 NR NR 0.25
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Risk of bias and quality evaluation of included studies

Two evaluators conducted quality evaluations on the selected seven RCTs literature based on Cochrane Systematic Reviewer’s Handbook 5.0. Six studies were randomized clearly describing allocation concealment and double-blind evaluation as low-risk. Furthermore, one study lacked a random sequence generation method which was defined with unclear risk. Five trials applied a double-blind design, and six trials applied a blinded design in outcome assessment. By checking protocols in ClinicalTrials.gov and data in trials, neither attrition bias nor reporting bias was found. (Figs. 2, 3).

Fig. 2.

Fig. 2

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Bias risk map of RCT studies

Fig. 3.

Fig. 3

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Risk of bias summary of included RCT studies

Efficacy outcomes

Stroke, systemic embolism, myocardial infarction, and mortality are the efficacy outcomes in the secondary prevention of AF-related ischemic stroke/TIA. Eleven trials have reported data on stroke and systemic embolism, thirteen trials have reported data on ischemic or unknown stroke, five trials have reported data on disabling or fetal stroke, eight trials have reported data on mortality. There was lower significant heterogeneity (I2 = 8%) for the outcome of stroke or systemic embolism. The fixed-effects model (RR 0.90, 95% CI [0.82, 1.00], P = 0.04) suggests a significant reduction in stroke and systemic embolism in the NOACs (Fig. 4). The ischemic stroke or unknown stroke (RR 0.82, 95%CI [0.66, 1.02], P = 0.08) and the disabling or fatal stroke (RR 0.91, 95%CI [0.78, 1.05], P = 0.19) in the NOAC group compared with the Warfarin group was not significantly different (Figs. 5, 6). There was lower heterogeneity for the outcome of myocardial infarction, the fixed-effects model (RR1.24 95% CI [0.95,1.62], P = 0.12) indicate no significantly different (Fig. 7). Compared with Warfarin, mortality rate with NOACs was associated with a significantly fewer risk (RR 0.83 95% CI [0.76, 0.92], P = 0.0003, Fig. 8).

Fig. 4.

Fig. 4

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Stroke or systemic embolism

Fig. 5.

Fig. 5

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Ischemic or unknown stroke

Fig. 6.

Fig. 6

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Disabling or fatal stroke

Fig. 7.

Fig. 7

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Myocardial infarction

Fig. 8.

Fig. 8

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Death from any cause

Safety outcomes

The safety endpoints were various bleeding conditions, including total bleeding, fatal bleeding, hemorrhagic stroke, intracranial bleeding, extracranial bleeding and gastrointestinal bleeding of using NOACs or Warfarin after AF-related ischemic stroke/TIA. We used a fixed-effect model to evaluate the data on total bleeding, fatal bleeding, gastrointestinal bleeding, and hemorrhagic stroke. (P ≥ 0.1 and I2 ≤ 50%) based on lower heterogeneity. The pooled evidence indicated that compared with the Warfarin, NOACs had reduced the incidence of total bleeding events (RR0.79, 95%CI [0.76,0.83], P < 0.00001. Figure 9), fatal bleeding (RR0.64, 95% CI [0.54,0.76], P < 0.00001. Figure 10), and hemorrhagic stroke (RR0.50, 95%CI [0.43,0.58], P < 0.00001. Figure 11). And then, there is no significant difference in gastrointestinal bleeding (RR1.00, 95% CI [0.89, 1.11], P = 0.98. Figure 12). Because of the data’s high heterogeneity, we analyzed intracranial bleeding and extracranial bleeding using a random-effect model. Compared with the Warfarin groups, NOACs had reduced the incidence of intracranial bleeding events (RR0.49, 95% CI [0.36, 0.65], P < 0.00001. Figure 13). However, there was no significant difference in extracranial bleeding between NOACs and Warfarin (RR 0.92, 95% CI [0.59, 1.41], P = 0.69. Figure 14).

Fig. 9.

Fig. 9

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Total bleeding events

Fig. 10.

Fig. 10

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Fatal bleeding

Fig. 11.

Fig. 11

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Hemorrhagic stroke

Fig. 12.

Fig. 12

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Gastrointestinal bleeding

Fig. 13.

Fig. 13

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Intracranial bleeding events

Fig. 14.

Fig. 14

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Extracranial bleeding

Discussion

7 RCT studies and 9 cohort studies were identified suitable for synthesis of data and meta-analysis, which included 7 trials of factor Xa inhibitors, 6 trials of direct thrombin inhibitors (factor II a), as well as 3 trials NOCAS (FXa inhibitors and FIIa inhibitors) with 128,808 patients. Based on our results, the NOACs are superior to Warfarin in the prevention of stroke or systemic embolism and all-cause mortality. As well as NOCAs has lower risk in total bleeding, hemorrhagic stroke, intracranial bleeding, and fatal bleeding than Warfarin.

The important complication of atrial fibrillation is cardiogenic cerebral embolism. Ischemic stroke caused by atrial fibrillation accounts for 16%–21% of stroke [23]. In the study about 402 patients with ischemic cardioembolic stroke, AF was documented in 79% of patients, the most frequent cardiac source of emboli in cardioembolic stroke was hypertrophic hypertensive cardiac disease complicated with atrial fibrillation. Second, it was isolated atrial fibrillation [24]. AF stroke had a greater acute neurological impairment and worse early outcomes than non-AF stroke [25]. In addition, the harm of AF combined with ischemic stroke (IS) to patient is that mortality and disability are twice that of general type IS, and it can also significantly increase the risk of dementia [26, 27]. Previous studies or meta-analyses on NOACs, such as ROCKET and RF-LY studies, have mainly focused on the effectiveness and safety of primary stroke prevention in NVAF patients, as well as the incidence of bleeding and systemic embolism in atrial fibrillation patients after the use of anticoagulants. However, because cardiogenic cerebral embolism is, in general, severe and prone to early and long-term recurrence, more attention should be paid to the safety and effectiveness of secondary prevention of atrial fibrillation with stroke. Subgroup analysis of ROCKET research [9] has been conducted on AF combined with ischemic stroke/TIA, suggesting the treatment effects of rivaroxaban and Warfarin in patients with previous stroke or TIA were consistent with those in patients without previous stroke or TIA and with the overall trial. These results support the use of rivaroxaban as an alternative to Warfarin for prevention of recurrent as well as initial stroke in patients with AF. In the J-ROCKET AF trial [10], these findings suggest rivaroxaban was associated with a lower incidence of intracranial bleeding than Warfarin with previous stroke/TIA/non-CNS systemic embolism and the incidence of stroke was comparable to Warfarin, showing consistency with the results of a subgroup analysis of ROCKET AF and the global ROCKET AF trial.

According to the findings, there were statistical differences in efficacy and lower incidence of in intracranial bleeding NOACs versus Warfarin, which is associated with compliance of patient and different molecular mechanisms. Warfarin is easily influenced by various foods and drugs, and regular monitoring of INR and timely adjustment of drug dosage are required during medication, which greatly affects the patient’s long-term medication compliance and safety. NOACs, such as rivaroxaban, apixaban, edoxaban, and dabigatran, are expected to improve this situation. Dabigatran is a direct thrombin inhibitor with a wider safe treatment window. Rivaroxaban, apixaban, and edoxaban are a Xa factor inhibitor that can specifically and directly inhibit Xa factor, blocking thrombin production, inhibiting thrombus formation, while not affecting the activity of generated thrombin without affecting the physiological hemostatic function, and almost completely absorbed when taken with meals, and therefore which is not needed to monitor coagulation function during medication [28]. NOACs have a large molecular weight and high polarity, and have a weak ability to penetrate the blood–brain barrier, which may reduce their direct impact on brain tissue micro-vessels.

However, there were some limitations in our meta-analysis. First, we included all NOACs together without categorizing them because of limited number studies. Nevertheless, similar meta-analyses have previously included all NOACs [4–6]. These may not cause significant bias, as they all act on key coagulation factors. An essential line of future research would pay attention to sex differences, the causes of rare cardioembolic strokes, and so on, to achieve the best treatment strategies. A study in Barcelona reported that women are more likely to experience neurological deficits from cardioembolic stroke and have worse early prognosis [29]. However, 16 articles we had included mainly focused on NOACs on AF-related ischemic stroke and did not mention the relationship between prognosis and gender, so we did not conduct a subgroup analysis of female patients which is the second limitation. Lastly, early diagnosis and prediction of AF are important for the primary and secondary prevention of cardioembolic stroke. Bayés syndrome is a predictor of AF and cardioembolic ischemic stroke, which should be considered and investigated as a possible cardioembolic cause of cryptogenic stroke in the future [30].

Conclusion

In our meta-analysis about the secondary prevention with AF related to ischemic stroke, the incidence of stroke or systemic embolism and all-cause mortality is lower in NOACs compared to Warfarin. The incidence of total bleeding, fatal bleeding, hemorrhagic stroke, and intracranial bleeding is lower than Warfarin. NOACs were found to be comparable to Warfarin with respect to the incidence of disabling or fatal stroke, myocardial infarction, gastrointestinal bleeding and extracranial bleeding.

Acknowledgements

Not applicable.

Abbreviations

NOACs

Novel oral anticoagulants

VKA

Vitamin K antagonists

AF

Atrial fibrillation

IS

Ischemic stroke

TIA

Transient ischemic attack

RCT

Randomized controlled trials

Authors’ contributions

JZ: conceptualization, review and evaluated the literature, drafted and review the manuscript, and project administration. CC, LL, and LW: investigation, supervision, review the manuscript. FC: conceptualization, reviewed and evaluated the literature, reviewed the manuscript. All authors read and approved the final manuscript.

Funding

This study is supported by the Medical and Health Science and Technology Development Plan Project of Shandong Province (No.202203070766).

Availability of data and materials

All data generated or analyzed during this study are included in this published article.

Declarations

Competing interests

The authors declare that they have no competing interests.

Ethics approval and consent to participate

Not applicable.

Consent for publication

Not applicable.

Contributor Information

Jiali Zhao, Email: zhaojiali1105@163.com.

Fudi Chen, Email: cfd13579@163.com.

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Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Data Availability Statement

All data generated or analyzed during this study are included in this published article.

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