Risks of thromboembolism and bleeding with thromboprophylaxis in patients with atrial fibrillation: A net clinical benefit analysis using a 'real world' nationwide cohort study

Jonas Bjerring Olesen; Gregory Y H Lip; Jesper Lindhardsen; Deirdre A Lane; Ole Ahlehoff; Morten Lock Hansen; Jakob Raunsø; Janne Schurmann Tolstrup; Peter Riis Hansen; Gunnar Hilmar Gislason; Christian Torp-Pedersen

doi:10.1160/th11-05-0364

Risks of thromboembolism and bleeding with thromboprophylaxis in patients with atrial fibrillation: A net clinical benefit analysis using a 'real world' nationwide cohort study

Jonas Bjerring Olesen, Gregory Y H Lip, Jesper Lindhardsen, Deirdre A Lane, Ole Ahlehoff, Morten Lock Hansen, Jakob Raunsø, Janne Schurmann Tolstrup, Peter Riis Hansen, Gunnar Hilmar Gislason, Christian Torp-Pedersen

371 Citations (Scopus)

Abstract

It was the aim of this study to determine the efficacy and safety of vitamin K antagonists (VKAs) and acetylsalicylic acid (ASA) in patients with non-valvular atrial fibrillation (AF), with separate analyses according to predicted thromboembolic and bleeding risk. By individual levellinkage of nationwide registries, we identified all patients discharged with non-valvular AF in Denmark (n=132,372). For every patient, the risk of stroke and bleeding was calculated by CHADS ₂, HA ₂DS ₂-VASc, and HAS-BLED. During follow-up, treatment with VKA and ASA was determined time-dependently. VKA consistently lowered the risk of thromboembolism compared to ASA and no treatment; the combination of VKA+ASA did not yield any additional benefit. In patients at high thromboembolic risk, hazard ratios (95% confidence interval) for thromboembolism were: 1.81 (1.73-1.90), 1.14 (1.06-1.23), and 1.86 (1.78-1.95) for ASA, VKA+ASA, and no treatment, respectively, compared to VKA. The risk of bleeding was increased with VKA, ASA, and VKA+ASA compared to no treatment, the hazard ratios were: 1.0 (VKA; reference), 0.93 (ASA; 0.89-0.97), 1.64 (VKA+ASA; 1.55-1.74), and 0.84 (no treatment; 0.81-0.88), respectively. There was a neutral or positive net clinical benefit (ischaemic stroke vs. intracranial haemorrhage) with VKA alone in patients with a CHADS ₂ score of ≥0, and CHA ₂DS ₂-VASc score of ≥1. This large cohort study confirms the efficacy of VKA and no effect of ASA treatment on the risk of stroke/thromboembolism. Also, the risk of bleeding was increased with both VKA and ASA treatment, but the net clinical benefit was clearly positive, in favour of VKA in patients with increased risk of stroke/thromboembolism.

Original language	English
Journal	Thrombosis and Haemostasis
Volume	106
Issue number	4
Pages (from-to)	739-49
Number of pages	11
ISSN	0340-6245
DOIs	https://doi.org/10.1160/th11-05-0364
Publication status	Published - 1 Oct 2011

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Olesen, J. B., Lip, G. Y. H., Lindhardsen, J., Lane, D. A., Ahlehoff, O., Hansen, M. L., Raunsø, J., Tolstrup, J. S., Hansen, P. R., Gislason, G. H., & Torp-Pedersen, C. (2011). Risks of thromboembolism and bleeding with thromboprophylaxis in patients with atrial fibrillation: A net clinical benefit analysis using a 'real world' nationwide cohort study. Thrombosis and Haemostasis, 106(4), 739-49. https://doi.org/10.1160/th11-05-0364

Risks of thromboembolism and bleeding with thromboprophylaxis in patients with atrial fibrillation: A net clinical benefit analysis using a 'real world' nationwide cohort study. / Olesen, Jonas Bjerring; Lip, Gregory Y H; Lindhardsen, Jesper et al.

In: Thrombosis and Haemostasis, Vol. 106, No. 4, 01.10.2011, p. 739-49.

Research output: Contribution to journal › Journal article › Research › peer-review

Olesen, JB, Lip, GYH, Lindhardsen, J, Lane, DA, Ahlehoff, O, Hansen, ML, Raunsø, J, Tolstrup, JS, Hansen, PR , Gislason, GH & Torp-Pedersen, C 2011, 'Risks of thromboembolism and bleeding with thromboprophylaxis in patients with atrial fibrillation: A net clinical benefit analysis using a 'real world' nationwide cohort study', Thrombosis and Haemostasis, vol. 106, no. 4, pp. 739-49. https://doi.org/10.1160/th11-05-0364

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title = "Risks of thromboembolism and bleeding with thromboprophylaxis in patients with atrial fibrillation: A net clinical benefit analysis using a 'real world' nationwide cohort study",

abstract = "It was the aim of this study to determine the efficacy and safety of vitamin K antagonists (VKAs) and acetylsalicylic acid (ASA) in patients with non-valvular atrial fibrillation (AF), with separate analyses according to predicted thromboembolic and bleeding risk. By individual levellinkage of nationwide registries, we identified all patients discharged with non-valvular AF in Denmark (n=132,372). For every patient, the risk of stroke and bleeding was calculated by CHADS 2, HA 2DS 2-VASc, and HAS-BLED. During follow-up, treatment with VKA and ASA was determined time-dependently. VKA consistently lowered the risk of thromboembolism compared to ASA and no treatment; the combination of VKA+ASA did not yield any additional benefit. In patients at high thromboembolic risk, hazard ratios (95% confidence interval) for thromboembolism were: 1.81 (1.73-1.90), 1.14 (1.06-1.23), and 1.86 (1.78-1.95) for ASA, VKA+ASA, and no treatment, respectively, compared to VKA. The risk of bleeding was increased with VKA, ASA, and VKA+ASA compared to no treatment, the hazard ratios were: 1.0 (VKA; reference), 0.93 (ASA; 0.89-0.97), 1.64 (VKA+ASA; 1.55-1.74), and 0.84 (no treatment; 0.81-0.88), respectively. There was a neutral or positive net clinical benefit (ischaemic stroke vs. intracranial haemorrhage) with VKA alone in patients with a CHADS 2 score of ≥0, and CHA 2DS 2-VASc score of ≥1. This large cohort study confirms the efficacy of VKA and no effect of ASA treatment on the risk of stroke/thromboembolism. Also, the risk of bleeding was increased with both VKA and ASA treatment, but the net clinical benefit was clearly positive, in favour of VKA in patients with increased risk of stroke/thromboembolism.",

author = "Olesen, {Jonas Bjerring} and Lip, {Gregory Y H} and Jesper Lindhardsen and Lane, {Deirdre A} and Ole Ahlehoff and Hansen, {Morten Lock} and Jakob Rauns{\o} and Tolstrup, {Janne Schurmann} and Hansen, {Peter Riis} and Gislason, {Gunnar Hilmar} and Christian Torp-Pedersen",

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T1 - Risks of thromboembolism and bleeding with thromboprophylaxis in patients with atrial fibrillation: A net clinical benefit analysis using a 'real world' nationwide cohort study

AU - Olesen, Jonas Bjerring

AU - Lip, Gregory Y H

AU - Lindhardsen, Jesper

AU - Lane, Deirdre A

AU - Ahlehoff, Ole

AU - Hansen, Morten Lock

AU - Raunsø, Jakob

AU - Tolstrup, Janne Schurmann

AU - Hansen, Peter Riis

AU - Gislason, Gunnar Hilmar

AU - Torp-Pedersen, Christian

PY - 2011/10/1

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N2 - It was the aim of this study to determine the efficacy and safety of vitamin K antagonists (VKAs) and acetylsalicylic acid (ASA) in patients with non-valvular atrial fibrillation (AF), with separate analyses according to predicted thromboembolic and bleeding risk. By individual levellinkage of nationwide registries, we identified all patients discharged with non-valvular AF in Denmark (n=132,372). For every patient, the risk of stroke and bleeding was calculated by CHADS 2, HA 2DS 2-VASc, and HAS-BLED. During follow-up, treatment with VKA and ASA was determined time-dependently. VKA consistently lowered the risk of thromboembolism compared to ASA and no treatment; the combination of VKA+ASA did not yield any additional benefit. In patients at high thromboembolic risk, hazard ratios (95% confidence interval) for thromboembolism were: 1.81 (1.73-1.90), 1.14 (1.06-1.23), and 1.86 (1.78-1.95) for ASA, VKA+ASA, and no treatment, respectively, compared to VKA. The risk of bleeding was increased with VKA, ASA, and VKA+ASA compared to no treatment, the hazard ratios were: 1.0 (VKA; reference), 0.93 (ASA; 0.89-0.97), 1.64 (VKA+ASA; 1.55-1.74), and 0.84 (no treatment; 0.81-0.88), respectively. There was a neutral or positive net clinical benefit (ischaemic stroke vs. intracranial haemorrhage) with VKA alone in patients with a CHADS 2 score of ≥0, and CHA 2DS 2-VASc score of ≥1. This large cohort study confirms the efficacy of VKA and no effect of ASA treatment on the risk of stroke/thromboembolism. Also, the risk of bleeding was increased with both VKA and ASA treatment, but the net clinical benefit was clearly positive, in favour of VKA in patients with increased risk of stroke/thromboembolism.

AB - It was the aim of this study to determine the efficacy and safety of vitamin K antagonists (VKAs) and acetylsalicylic acid (ASA) in patients with non-valvular atrial fibrillation (AF), with separate analyses according to predicted thromboembolic and bleeding risk. By individual levellinkage of nationwide registries, we identified all patients discharged with non-valvular AF in Denmark (n=132,372). For every patient, the risk of stroke and bleeding was calculated by CHADS 2, HA 2DS 2-VASc, and HAS-BLED. During follow-up, treatment with VKA and ASA was determined time-dependently. VKA consistently lowered the risk of thromboembolism compared to ASA and no treatment; the combination of VKA+ASA did not yield any additional benefit. In patients at high thromboembolic risk, hazard ratios (95% confidence interval) for thromboembolism were: 1.81 (1.73-1.90), 1.14 (1.06-1.23), and 1.86 (1.78-1.95) for ASA, VKA+ASA, and no treatment, respectively, compared to VKA. The risk of bleeding was increased with VKA, ASA, and VKA+ASA compared to no treatment, the hazard ratios were: 1.0 (VKA; reference), 0.93 (ASA; 0.89-0.97), 1.64 (VKA+ASA; 1.55-1.74), and 0.84 (no treatment; 0.81-0.88), respectively. There was a neutral or positive net clinical benefit (ischaemic stroke vs. intracranial haemorrhage) with VKA alone in patients with a CHADS 2 score of ≥0, and CHA 2DS 2-VASc score of ≥1. This large cohort study confirms the efficacy of VKA and no effect of ASA treatment on the risk of stroke/thromboembolism. Also, the risk of bleeding was increased with both VKA and ASA treatment, but the net clinical benefit was clearly positive, in favour of VKA in patients with increased risk of stroke/thromboembolism.

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DO - 10.1160/th11-05-0364

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VL - 106

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JO - Thrombosis et diathesis haemorrhagica

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ER -

Risks of thromboembolism and bleeding with thromboprophylaxis in patients with atrial fibrillation: A net clinical benefit analysis using a 'real world' nationwide cohort study

Abstract

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