A Systematic Review of the Efficacy and Safety of Direct Oral Anticoagulants in Atrial Fibrillation Patients with Diabetes Using a Risk Index
Diabetes mellitus (DM) represents an independent risk factor for chronic AF and is associated with unfavorable outcomes. We aimed to evaluate the efficacy and safety of direct oral anticoagulants (DOACs) in patients with atrial fibrillation (AF), with and without diabetes mellitus (DM), using a new...
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| Format: | Article |
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MDPI AG
2021-06-01
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| Series: | Journal of Clinical Medicine |
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| Online Access: | https://www.mdpi.com/2077-0383/10/13/2924 |
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| author | Domenico Acanfora Marco Matteo Ciccone Valentina Carlomagno Pietro Scicchitano Chiara Acanfora Alessandro Santo Bortone Massimo Uguccioni Gerardo Casucci |
| author_facet | Domenico Acanfora Marco Matteo Ciccone Valentina Carlomagno Pietro Scicchitano Chiara Acanfora Alessandro Santo Bortone Massimo Uguccioni Gerardo Casucci |
| author_sort | Domenico Acanfora |
| collection | DOAJ |
| description | Diabetes mellitus (DM) represents an independent risk factor for chronic AF and is associated with unfavorable outcomes. We aimed to evaluate the efficacy and safety of direct oral anticoagulants (DOACs) in patients with atrial fibrillation (AF), with and without diabetes mellitus (DM), using a new risk index (RI) defined as: RI <inline-formula><math xmlns="http://www.w3.org/1998/Math/MathML" display="inline"><semantics><mrow><mo>=</mo><mfrac><mrow><mrow><mi>Rate</mi><mtext> </mtext><mi>of</mi><mtext> </mtext><mi>Events</mi></mrow></mrow><mrow><mrow><mi>Rate</mi><mtext> </mtext><mi>of</mi><mtext> </mtext><mi>Patients</mi><mtext> </mtext><mi>at</mi><mtext> </mtext><mi>Risk</mi></mrow></mrow></mfrac></mrow></semantics></math></inline-formula>. In particular, an RI lower than 1 suggests a favorable treatment effect. We searched MEDLINE, MEDLINE In-Process, EMBASE, PubMed, and the Cochrane Central Register of Controlled Trials. The risk index (RI) was calculated in terms of efficacy (rate of stroke/systemic embolism (stroke SEE)/rate of patients with and without DM; rate of cardiovascular death/rate of patients with and without DM) and safety (rate of major bleeding/rate of patients with and without DM) outcomes. AF patients with DM (n = 22,057) and 49,596 without DM were considered from pivotal trials. DM doubles the risk index for stroke/SEE, major bleeding (MB), and cardiovascular (CV) death. The RI for stroke/SEE, MB, and CV death was comparable in patients treated with warfarin or DOACs. The lowest RI was in DM patients treated with Rivaroxaban (stroke/SEE, RI = 0.08; CV death, RI = 0.13). The RIs for bleeding were higher in DM patients treated with Dabigatran (RI110 = 0.32; RI150 = 0.40). Our study is the first to use RI to homogenize the efficacy and safety data reported in the DOACs pivotal studies against warfarin in patients with and without DM. Anticoagulation therapy is effective and safe in DM patients. DOACs appear to have a better efficacy and safety profile than warfarin. The use of DOACs is a reasonable alternative to vitamin-K antagonists in AF patients with DM. The RI can be a reasonable tool to help clinicians choose between DOACs or warfarin in the peculiar set of AF patients with DM. |
| first_indexed | 2024-03-10T09:56:55Z |
| format | Article |
| id | doaj.art-99c88a0e83f848f89e957d6de0e46fa3 |
| institution | Directory Open Access Journal |
| issn | 2077-0383 |
| language | English |
| last_indexed | 2024-03-10T09:56:55Z |
| publishDate | 2021-06-01 |
| publisher | MDPI AG |
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| series | Journal of Clinical Medicine |
| spelling | doaj.art-99c88a0e83f848f89e957d6de0e46fa32023-11-22T02:16:51ZengMDPI AGJournal of Clinical Medicine2077-03832021-06-011013292410.3390/jcm10132924A Systematic Review of the Efficacy and Safety of Direct Oral Anticoagulants in Atrial Fibrillation Patients with Diabetes Using a Risk IndexDomenico Acanfora0Marco Matteo Ciccone1Valentina Carlomagno2Pietro Scicchitano3Chiara Acanfora4Alessandro Santo Bortone5Massimo Uguccioni6Gerardo Casucci7Unit of Internal Medicine, San Francesco Hospital, Viale Europa 21, 82037 Telese Terme, ItalySection of Cardiovascular Diseases, Department of Emergency and Organ Transplantation, School of Medicine, University of Bari, Piazza Umberto I, 1, 70121 Bari, ItalyUnit of Internal Medicine, San Francesco Hospital, Viale Europa 21, 82037 Telese Terme, ItalySection of Cardiovascular Diseases, Department of Emergency and Organ Transplantation, School of Medicine, University of Bari, Piazza Umberto I, 1, 70121 Bari, ItalyUnit of Internal Medicine, San Francesco Hospital, Viale Europa 21, 82037 Telese Terme, ItalyDivision of Cardiac Surgery, Department of Emergency and Organ Transplantation, University of Bari, 70121 Bari, ItalyCardiology Unit, San Camillo Hospital, 00152 Rome, ItalyUnit of Internal Medicine, San Francesco Hospital, Viale Europa 21, 82037 Telese Terme, ItalyDiabetes mellitus (DM) represents an independent risk factor for chronic AF and is associated with unfavorable outcomes. We aimed to evaluate the efficacy and safety of direct oral anticoagulants (DOACs) in patients with atrial fibrillation (AF), with and without diabetes mellitus (DM), using a new risk index (RI) defined as: RI <inline-formula><math xmlns="http://www.w3.org/1998/Math/MathML" display="inline"><semantics><mrow><mo>=</mo><mfrac><mrow><mrow><mi>Rate</mi><mtext> </mtext><mi>of</mi><mtext> </mtext><mi>Events</mi></mrow></mrow><mrow><mrow><mi>Rate</mi><mtext> </mtext><mi>of</mi><mtext> </mtext><mi>Patients</mi><mtext> </mtext><mi>at</mi><mtext> </mtext><mi>Risk</mi></mrow></mrow></mfrac></mrow></semantics></math></inline-formula>. In particular, an RI lower than 1 suggests a favorable treatment effect. We searched MEDLINE, MEDLINE In-Process, EMBASE, PubMed, and the Cochrane Central Register of Controlled Trials. The risk index (RI) was calculated in terms of efficacy (rate of stroke/systemic embolism (stroke SEE)/rate of patients with and without DM; rate of cardiovascular death/rate of patients with and without DM) and safety (rate of major bleeding/rate of patients with and without DM) outcomes. AF patients with DM (n = 22,057) and 49,596 without DM were considered from pivotal trials. DM doubles the risk index for stroke/SEE, major bleeding (MB), and cardiovascular (CV) death. The RI for stroke/SEE, MB, and CV death was comparable in patients treated with warfarin or DOACs. The lowest RI was in DM patients treated with Rivaroxaban (stroke/SEE, RI = 0.08; CV death, RI = 0.13). The RIs for bleeding were higher in DM patients treated with Dabigatran (RI110 = 0.32; RI150 = 0.40). Our study is the first to use RI to homogenize the efficacy and safety data reported in the DOACs pivotal studies against warfarin in patients with and without DM. Anticoagulation therapy is effective and safe in DM patients. DOACs appear to have a better efficacy and safety profile than warfarin. The use of DOACs is a reasonable alternative to vitamin-K antagonists in AF patients with DM. The RI can be a reasonable tool to help clinicians choose between DOACs or warfarin in the peculiar set of AF patients with DM.https://www.mdpi.com/2077-0383/10/13/2924atrial fibrillationDOACsdiabetes mellitusrisk index |
| spellingShingle | Domenico Acanfora Marco Matteo Ciccone Valentina Carlomagno Pietro Scicchitano Chiara Acanfora Alessandro Santo Bortone Massimo Uguccioni Gerardo Casucci A Systematic Review of the Efficacy and Safety of Direct Oral Anticoagulants in Atrial Fibrillation Patients with Diabetes Using a Risk Index Journal of Clinical Medicine atrial fibrillation DOACs diabetes mellitus risk index |
| title | A Systematic Review of the Efficacy and Safety of Direct Oral Anticoagulants in Atrial Fibrillation Patients with Diabetes Using a Risk Index |
| title_full | A Systematic Review of the Efficacy and Safety of Direct Oral Anticoagulants in Atrial Fibrillation Patients with Diabetes Using a Risk Index |
| title_fullStr | A Systematic Review of the Efficacy and Safety of Direct Oral Anticoagulants in Atrial Fibrillation Patients with Diabetes Using a Risk Index |
| title_full_unstemmed | A Systematic Review of the Efficacy and Safety of Direct Oral Anticoagulants in Atrial Fibrillation Patients with Diabetes Using a Risk Index |
| title_short | A Systematic Review of the Efficacy and Safety of Direct Oral Anticoagulants in Atrial Fibrillation Patients with Diabetes Using a Risk Index |
| title_sort | systematic review of the efficacy and safety of direct oral anticoagulants in atrial fibrillation patients with diabetes using a risk index |
| topic | atrial fibrillation DOACs diabetes mellitus risk index |
| url | https://www.mdpi.com/2077-0383/10/13/2924 |
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