Oral anticoagulation, aspirin, or no therapy in patients with nonvalvular AF with 0 or 1 stroke risk factor based on the CHA2DS2-VASc score
Open accessAbstract
Background Even a single additional stroke risk factor in patients with atrial fibrillation may confer a risk of stroke. However, there is no consensus on how best to treat these patients.Objectives Our objective was to investigate the risk of stroke and bleeding and the impact of antithrombotic therapy among low-risk patients, i.e., with 0 or 1 CHA2DS2-VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke/transient ischemic attack, vascular disease, age 65 to 74 years, sex category) score risk factor.Methods The nationwide cohort for this study was established by linking data from the Danish Civil Registration System, the Danish National Patient Register, and the Danish National Prescription Registry. We studied 39,400 patients discharged with incident nonvalvular atrial fibrillation with 0 or 1 CHA2DS2-VASc risk factor; 23,572 were not treated, 5,353 were initiated on aspirin, and 10,475 were initiated on warfarin.Results Stroke event rates for untreated low-risk patients (CHA2DS2-VASc = 0 [male], 1 [female]) were 0.49 per 100 person-years at 1 year and 0.47 per 100 person-years at full follow-up (intention-to-treat). Bleeding event rates among untreated low-risk patients were 1.08 per 100 person-years at 1 year and 0.97 at full follow-up. The presence of 1 additional stroke risk factor (CHA2DS2-VASc = 1 [male], = 2 [female]) among untreated patients increased the stroke rate at 1 year to 1.55 per 100 person-years, representing a significant 3.01-fold increase. At the 1-year follow-up, bleeding increased 2.35-fold, and death increased 3.12-fold.Conclusions Low-risk patients (CHA2DS2-VASc = 0 [male], 1 [female]) have a truly low risk for stroke and bleeding. With 1 additional stroke risk factor (CHA2DS2-VASc = 1 [male], = 2 [female]), there was a significant increase in event rates (particularly mortality) if nonanticoagulated.
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In many patients with one clinical risk factor (CHA2DS2-VASc score of 1 for men, and 2 for women), anticoagulation seems to provide a clinical benefit.
“In many of these patients, anticoagulation seems to provide a clinical benefit.[371][372][373][374][375]”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [373]
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“‘Low risk’ patients were defined as those males with a CHA2DS2-VASc score=0 or females with a CHA2DS2-VASc = 1; ‘moderate risk’ was defined as male patients with a CHA2DS2-VASc score = 1; ‘high risk’ was defined as patients with a CHA2DS2-VASc score ≥2[21].”
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“Based on the CHA2DS2-VASc score, “low risk” was defined as a CHA2DS2-VASc 0 in males or 1 in females; “moderate risk” as male patients with CHA2DS2-VASc = 1; and “high risk” with CHA2DS2-VASc ≥ 2 (Camm et al., 2012; Lip et al., 2015).”
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“and the censoring approach, and the results were materially unaffected by the 2 different approaches.(27) In contrast, Friberg et al(28) attempted to establish a treatment-free population by”
ResultAnalysis of Outcomes in Ischemic vs Nonischemic Cardiomyopathy in Patients With Atrial Fibrillation
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“This right-censoring approach has also previously been used to estimate stroke rates in an untreated AF population.(25,26) As depicted in Table 2, other factors than study design choices contribute to the challenge of using administrative hospital discharge databases to reliably estimating stroke risk according to spe…”
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“Low-risk patients were defined as those men with a CHA 2 DS 2 -VASc score =0 or women with a CHA 2 DS 2 -VASc =1; moderate risk was defined as male patients with a CHA 2 DS 2 -VASc score =1; high risk was defined as patients with a CHA 2 DS 2 -VASc score ≥2.(14)”
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“However, more contemporary studies have found that stroke rate in such lowrisk patients is <1% per year, as defined by age <65 years and the absence of any established stroke risk factors (27).”
BackgroundMatching the NOAC to the Patient
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“12 gender as a risk factor for those with CHA2DS2-VASc=1, the American guidelines (in contrast to European guidelines) could potentially be recommending anticoagulation for women who may be at truly low risk for stroke (thus, potential drug overuse), whereas anticoagulants may be underused in men at moderate risk of s…”
BackgroundMinno, A. D., Spadarella, G., Spadarella, E., Tremoli, E., & Minno, G. D. (2015) · Thrombosis Research · doi:10.1016/j.thromres.2015.10.016 · Cited by 32 · see citing works
“The HAS-BLED score has been validated for predicting bleeding risk in patients onwarfarin; on no antithrombotic therapy, in those taking DOACs and/or aspirin, [84] in those undergoing bridging therapy (both AF and non-AF patients), [85] and in those on triple therapy following an ACS (in a cohort that included both AF…”
BackgroundXiong, Q., Chen, S., Senoo, K., Proietti, M., Hong, K., & Lip, G. Y. H. (2015) · International Journal of Cardiology · doi:10.1016/j.ijcard.2015.05.115 · Cited by 30 · see citing works
“49 per 100 person-years at 1-year [28].”
BackgroundAtrial fibrillation and stroke: a practical guide
Best, J. G., Bell, R., Haque, M. M., Chandratheva, A., & Werring, D. J. (2019) · Practical Neurology · doi:10.1136/practneurol-2018-002089 · Cited by 30 · see citing works
Lip, G. Y. H. (2015) · European Heart Journal · doi:10.1093/eurheartj/ehv431 · Cited by 29 · see citing works
Lip, G. Y. H., Skjøth, F., Rasmussen, L. H., Nielsen, P. B., & Larsen, T. B. (2015) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2015.05.044 · Cited by 27 · see citing works
“However, the previously published ICSS (International Carotid Stenting Study) data provided little information on the kind of stent that was used (2).”
BackgroundResultPre-Diabetes Increases Stroke Risk in Patients With Nonvalvular Atrial Fibrillation
Kezerle, L., Tsadok, M. A., Akriv, A., Senderey, A. B., Bachrach, A., Leventer‐Roberts, M., & Haim, M. (2021) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2020.12.030 · Cited by 27 · see citing works
Tiwari, S., Løchen, M., Jacobsen, B. K., Hopstock, L. A., Nyrnes, A., Njølstad, I., Mathiesen, E. B., & Schirmer, H. (2016) · Open Heart · doi:10.1136/openhrt-2016-000439 · Cited by 25 · see citing works
Proietti, M., & Lip, G. Y. H. (2016) · The American Journal of Medicine · doi:10.1016/j.amjmed.2016.03.024 · Cited by 24 · see citing works
Choi, S. Y., Kim, M. H., Lee, K. M., Cho, Y., Park, J. S., Yun, S., & Lip, G. Y. H. (2020) · Thrombosis and Haemostasis · doi:10.1055/a-1336-0476 · Cited by 24 · see citing works
Maeda, T., Nishi, T., Funakoshi, S., Tada, K., Tsuji, M., Satoh, A., Kawazoe, M., Yoshimura, C., & Arima, H. (2020) · Journal of the American Heart Association · doi:10.1161/jaha.119.014574 · Cited by 23 · see citing works
Głowicki, B., Matusik, P. T., Plens, K., & Undas, A. (2019) · Canadian Journal of Cardiology · doi:10.1016/j.cjca.2019.01.014 · Cited by 22 · see citing works
Fanning, L., Ilomäki, J., Bell, J. S., & Darzins, P. J. (2017) · European Journal of Clinical Pharmacology · doi:10.1007/s00228-017-2297-0 · Cited by 21 · see citing works
Stroke prevention in atrial fibrillation: State of the art
Li, Y., & Lip, G. Y. H. (2018) · International Journal of Cardiology · doi:10.1016/j.ijcard.2018.09.057 · Cited by 21 · see citing works
“Overall, the use of OAC should still be considered given the positive net clinical benefit (NCB) in such ‘medium-risk’ patients[20, 24-31].”
Background2023 Guideline for the management of hypertension in the elderly population in China
Hua, Q., Fan, L., Wang, Z., & Li, J. (2024) · 老年心脏病学杂志：英文版 · doi:10.26599/1671-5411.2024.06.001 · Cited by 20 · see citing works
Lip, G. Y. H., Potpara, T., Boriani, G., & Blomström‐Lundqvist, C. (2016) · Journal of Internal Medicine · doi:10.1111/joim.12468 · Cited by 19 · see citing works
Abdel-Qadir, H. M., Singh, S. M., Pang, A., Austin, P. C., Jackevicius, C. A., Tu, K., Dorian, P., & Ko, D. T. (2021) · JAMA Cardiology · doi:10.1001/jamacardio.2021.1232 · Cited by 18 · see citing works
Senoo, K., An, Y., Ogawa, H., Lane, D. A., Wolff, A., Shantsila, E., Akao, M., & Lip, G. Y. H. (2016) · Heart · doi:10.1136/heartjnl-2016-309741 · Cited by 18 · see citing works
Atrial fibrillation in athletes: From epidemiology to treatment in the novel oral anticoagulants era
Sanna, G. D., Gabrielli, E., Vito, E. D., Nusdeo, G., Prisco, D., & Parodi, G. (2018) · Journal of Cardiology · doi:10.1016/j.jjcc.2018.04.011 · Cited by 17 · see citing works
Potpara, T., Dagres, N., Mujović, N. M., Vasić, D., Ašanin, M., Nedeljkovic, M. A., Marín, F. R., Fauchier, L., Blomström‐Lundqvist, C., & Lip, G. Y. H. (2016) · Advances in Therapy · doi:10.1007/s12325-016-0458-7 · Cited by 16 · see citing works
“[57] 2015 Danish nationwide administrative databases 129/8573 1.”
BackgroundJackson, L. R., Kim, S., Fonarow, G. C., Freeman, J. V., Gersh, B. J., Go, A. S., Hylek, E. M., Kowey, P. R., Mahaffey, K. W., Singer, D. E., et al. (2018) · Journal of the American Heart Association · doi:10.1161/jaha.118.008764 · Cited by 16 · see citing works
“Lip and colleagues in a large Danish cohort of patients with AF demonstrated that in untreated patients with 1 additional stroke risk factor (CHA2DS2VASc=1 [male],=2 [female]), strokes rates increased 3-fold compared with untreated low-risk patients (CHA2DS2VASc=0 [male], =1 [female]).(20) Similarly, Chao and colleagu…”
BackgroundManagement of Atrial Fibrillation in Elderly Adults
Desai, Y. B., El‐Chami, M. F., León, A. R., & Merchant, F. M. (2016) · Journal of the American Geriatrics Society · doi:10.1111/jgs.14483 · Cited by 15 · see citing works
“The most-recent American College of Cardiology/AHA guidelines on AF management recommend anticoagulation for stroke risk reduction in individuals with a CHA2DS2-VASc score of 2 or greater (Class I recommendation),(11) but more recent data has suggested that even individuals with a CHA2DS2-VASc of 1—assuming that femal…”
BackgroundTailored Practical Management of Patients With Atrial Fibrillation: A Risk Factor-Based Approach
Pastori, D., Menichelli, D., Gingis, R., Pignatelli, P., & Violi, F. (2019) · Frontiers in Cardiovascular Medicine · doi:10.3389/fcvm.2019.00017 · Cited by 15 · see citing works
“Recent evidence showed that patients with one additional risk factor beyond sex are at increased risk of thromboembolic events, suggesting that OAC should probably be considered also in this subgroup of patients (20).”
BackgroundChinese Guidelines for the Diagnosis and Management of Atrial Fibrillation
Ma, C., Wu, S., Liu, S., & Han, Y. (2024) · 老年心脏病学杂志：英文版 · doi:10.26599/1671-5411.2024.03.009 · Cited by 16 · see citing works
Savino, J. A., & Halperin, J. L. (2016) · Circulation · doi:10.1161/circulationaha.115.016715 · Cited by 14 · see citing works
“of 2 were included) compared with a Danish cohort, which included women without additional stroke risk factors.(22) The”
ResultIlomäki, J., Fanning, L., Keen, C., Sluggett, J. K., Page, A. T., Korhonen, M. J., Meretoja, A., Namara, K. M., & Bell, J. S. (2019) · Journal of Alzheimer s Disease · doi:10.3233/jad-190094 · Cited by 14 · see citing works
Thromboembolic risk stratification in atrial fibrillation—beyond clinical risk scores
Wan, D., Andrade, J. G., & Laksman, Z. (2021) · Reviews in Cardiovascular Medicine · doi:10.31083/j.rcm2202042 · Cited by 15 · see citing works
“Study results are conflicting but are based on observed rates of stroke in registries or unanticoagulated cohorts, rather than large clinical trials [36, 39, 40].”
BackgroundRivard, L., Khairy, P., Talajic, M. R., Tardif, J., Healey, J. S., Black, S. E., Andrade, J. G., Field, T. S., Nault, I., Bherer, L., et al. (2026) · Nature Medicine · doi:10.1038/s41591-025-04101-y · Cited by 14 · see citing works
“At the time of trial design, observational studies and selected clinical trials suggested that 15 mg daily could offer substantial stroke prevention while reducing bleeding risk in certain populations 36,38 .”
InfluentialAPPLICATION OF PREDICTION SCORES IN CLINICAL MEDICINE
Belyalov, F. I. (2016) · Russian Journal of Cardiology · doi:10.15829/1560-4071-2016-12-23-27 · Cited by 13 · see citing works
Risk Stratification Models in Atrial Fibrillation
Shahid, F., & Lip, G. Y. H. (2017) · Seminars in Thrombosis and Hemostasis · doi:10.1055/s-0036-1597285 · Cited by 13 · see citing works
Ueberham, L., Dagres, N., Potpara, T., Bollmann, A., & Hindricks, G. (2017) · Advances in Therapy · doi:10.1007/s12325-017-0616-6 · Cited by 11 · see citing works
“patients with a single additional stroke risk factor was associated with reduced risk of stroke and mortality [22, 23].”
BackgroundLee, J., Joung, B., Cha, M., Lee, J. H., Lim, W., Kim, T., Shin, S. Y., Uhm, J., Lim, H. E., Kim, J., et al. (2018) · Korean Journal of Medicine · doi:10.3904/kjm.2018.93.2.87.e1 · Cited by 11 · see citing works
Menichelli, D., Ettorre, E., Pani, A., Violi, F., Pignatelli, P., & Pastori, D. (2019) · Current Problems in Cardiology · doi:10.1016/j.cpcardiol.2019.02.002 · Cited by 11 · see citing works
Lip, G. Y. H. (2015) · Expert Review of Cardiovascular Therapy · doi:10.1586/14779072.2015.1071665 · Cited by 11 · see citing works
Kamili, K., Zheng, T., Luo, C., Wang, X., & Tian, G. (2024) · Lipids in Health and Disease · doi:10.1186/s12944-023-01990-1 · Cited by 10 · see citing works
Dobesh, P. P., & Fanikos, J. R. (2016) · Europe PMC (PubMed Central) · doi:10.4022/jafib.1481 · Cited by 10 · see citing works
Anticoagulation in pulmonary arterial hypertension: a decision analysis
Jose, A., Eckman, M. H., & Elwing, J. (2019) · Pulmonary Circulation · doi:10.1177/2045894019895451 · Cited by 10 · see citing works
Martínez‐Sellés, M., Lambert, J. L., Barrios, V., Díez‐Villanueva, P., Pinilla, J. M. G., Cosín, J., Ariza‐Solé, A., Mirabet, S., Escobar, C., Dı́az-Castro, Ó., et al. (2016) · Revista Española de Cardiología · doi:10.1016/j.recesp.2015.10.015 · Cited by 9 · see citing works
Anticoagulation in atrial fibrillation and chronic heart failure
Boos, C. J., & Brown, L. (2015) · Current Opinion in Cardiology · doi:10.1097/hco.0000000000000245 · Cited by 9 · see citing works
History of Percutaneous Left Atrial Appendage Occlusion with AMPLATZER Devices
Meier, B., Stegink, W., & Tzikas, A. (2018) · Interventional Cardiology Clinics · doi:10.1016/j.iccl.2017.12.007 · Cited by 9 · see citing works
Patients With Atrial Fibrillation and a CHA2DS2-VASc Score of 1
Huisman, M. V. (2015) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2015.02.010 · Cited by 9 · see citing works
“(8) is also much higher than in a large Swedish cohort recently published in the Journal (7).”
BackgroundMartínez‐Rubio, A., Alcazar, M. D., Cadena, A. S., & Martínez-Torrecilla, R. (2016) · European Cardiology Review · doi:10.15420/ecr.2016:30:1 · Cited by 8 · see citing works
“There is thus no argument for using aspirin instead of anticoagulation because of bleeding risk.(49) Aspirin plus antiplatelet therapy or, less effectively, aspirin alone may, however, be considered in patients who refuse oral anticoagulant treatment.”
BackgroundLee, J., Joung, B., Cha, M., Lee, J. H., Lim, W., Kim, T., Shin, S. Y., Uhm, J., Lim, H. E., Kim, J., et al. (2018) · Korean Journal of Medicine · doi:10.3904/kjm.2018.93.2.87 · Cited by 8 · see citing works
“NOAC은 기계 판막이 있는 환자(근거수준 B) 또는 중등도 이상의 승모판 협착이 있는 환자(근거수준 C)에게는 권장 되지 않는다(class III, level of evidence B or C) [12,14, 15,42,40-44,54].”
Andersson, T., Magnuson, A., Bryngelsson, I., Fröbert, O., Henriksson, K. M., Edvardsson, N. G., & Poçi, D. (2017) · PLoS ONE · doi:10.1371/journal.pone.0176846 · Cited by 8 · see citing works
Wang, J., Zhang, D.-P., Liu, H.-B., Zhong, J., & Yang, X. (2018) · Europe PMC (PubMed Central) · doi:10.11909/j.issn.1671-5411.2018.03.005 · Cited by 8 · see citing works
Al‐Jabi, S. W., Dalu, A. A., Koni, A. A., Khdour, M. R., Taha, A. A., Amer, R. A., & Zyoud, S. H. (2022) · Thrombosis Journal · doi:10.1186/s12959-022-00374-2 · Cited by 8 · see citing works
“However, if non-anticoagulated, there is a significant increase in the mortality rate in patients with stroke risk factors [5], morbidity, and negative effects on quality of life [6].”
BackgroundHow to Manage Occult Atrial Fibrillation Detected on Long-Term Monitoring
Lip, G. Y. H. (2016) · Circulation · doi:10.1161/circulationaha.115.016797 · Cited by 7 · see citing works
“untreated, which was lowered by the use of OAC but not lowered with aspirin.(17) Mortality was increased (≈11%) in”
BackgroundLee, K. H., Joung, B., Lee, S., Hwang, Y. M., Park, J., Baek, Y., Park, Y. M., Park, J., Park, H. C., Park, H. W., et al. (2018) · Korean Journal of Medicine · doi:10.3904/kjm.2018.93.2.110 · Cited by 7 · see citing works
Anticoagulación oral en la enfermedad renal crónica con fibrilación auricular
Gómez-Fernández, P., Santana, A. M., & Barrionuevo, J. D. D. A. (2020) · Nefrología · doi:10.1016/j.nefro.2020.08.007 · Cited by 7 · see citing works
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Individualising Anticoagulant Therapy in Atrial Fibrillation Patients
Alings, M. (2016) · Arrhythmia & Electrophysiology Review · doi:10.15420/aer.2016.20.3 · Cited by 7 · see citing works
“55 % in patients with one additional risk factor.(22)”
BackgroundGolive, A., May, H. T., Bair, T. L., Jacobs, V., Crandall, B. G., Cutler, M. J., Day, J. D., Mallender, C. D., Osborn, J. S., Stevens, S. M., et al. (2017) · The American Journal of Cardiology · doi:10.1016/j.amjcard.2017.03.256 · Cited by 7 · see citing works
“55 per 100 person-years.(2) Recently, the Taiwan National Health Insurance Research Database reported that male patients aged 20 to 49 years with a CHA2DS2-VASc score of 1 experienced an ischemic stroke rate of 1.”
BackgroundTao, J. Z., & Oprea, A. D. (2019) · Seminars in Cardiothoracic and Vascular Anesthesia · doi:10.1177/1089253219870627 · Cited by 7 · see citing works
Nicol, E. D., Karim, N., Semple, T. R., Baleswaran, S., Owen, R., Riad, O. H. M. A., Markides, V., Padley, S. P. G., & Wong, T. (2024) · Journal of the American Heart Association · doi:10.1161/jaha.123.030147 · Cited by 6 · see citing works
“The CHA 2 DS 2 - VASc score is effective in identifying patients with low thromboembolic risk 32 ; however, in those who have 1 additional risk factor and thus do not need to be anticoagulated, the annual stroke risk ranges from <1% 32 to 3.5% 31 depending on which stroke-risk variable is present.”
BackgroundInfluentialChinese Guidelines for the Diagnosis and Management of Atrial Fibrillation
Chinese Society of Cardiology, C. M. A., & Heart Rhythm Committee of Chinese Society of Biomedical Engineering (2024) · Cardiology Discovery · doi:10.1097/cd9.0000000000000123 · Cited by 7 · see citing works
- Authors
- Lip, G. Y. H., Skjøth, F., Rasmussen, L. H., & Larsen, T. B.
- Affiliations
- Birmingham City Hospital (GB)
- Aalborg University Hospital (DK)
- Aalborg University (DK)
- Corresponding author
- Lip, Gregory Y.H.
- Venue
- Journal of the American College of Cardiology
- Publisher
- Elsevier BV
- Published
- 2015-04
- Volume
- 65
- Issue
- 14
- Pages
- 1385-1394
- ISSN
- 0735-1097 (ISSN-L)
- OpenAlex
- W2161837371
- Cited by
- 171
- References
- 26
- Citations by year
- 2026: 6 · 2025: 5 · 2024: 9 · 2023: 9 · 2022: 5 · 2021: 9 · 2020: 7 · 2019: 17 · 2018: 16 · 2017: 21 · 2016: 43 · 2015: 24
- FWCI
- 25.21
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Journal of the American College of Cardiology (publishedVersion)
- PubMed (publishedVersion)
- VBN Forskningsportal (Aalborg Universitet) (submittedVersion)
- Funders
- AstraZeneca
- Sanofi
- Astellas Pharma
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
- Health Sciences › Medicine › Epidemiology › Acute Ischemic Stroke Management
- Health Sciences › Medicine › Internal Medicine › Venous Thromboembolism Diagnosis and Management
- Keywords
- non-valvular atrial fibrillation, CHA2DS2-VASc score, stroke risk, bleeding risk, oral anticoagulation, warfarin, aspirin, antithrombotic therapy, low-risk patients, stroke prevention, mortality, sex differences, stroke risk factors, civil registration, patient registry, incident atrial fibrillation
- MeSH terms
- Administration, Oral, Aged, Anticoagulants, Aspirin, Atrial Fibrillation, Blood Coagulation, Denmark, Female, Humans, Male, Registries, Risk Factors, Cohort Studies, Stroke
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