| Literature DB >> 26680544 |
Kevser Gülcihan Balcı1, Mustafa Mücahit Balcı, Uğur Canpolat, Fatih Şen, Mehmet K Akboğa, Muhammed Süleymanoğlu, Serdar Kuyumcu, Orhan Maden, Hatice Selçuk, Mehmet Timur Selçuk.
Abstract
OBJECTIVE: The aim of this study was to compare health-related quality of life (HRQoL) measures between novel oral anticoagulants (NOACs) and warfarin-treated Turkish patients who had been started on oral anticoagulants (OACs) due to non-valvular atrial fibrillation (AF) and to determine the effects of OACs on patient's emotional status, anxiety and depression.Entities:
Year: 2015 PMID: 26680544 PMCID: PMC5331393 DOI: 10.5152/AnatolJCardiol.2015.6334
Source DB: PubMed Journal: Anatol J Cardiol ISSN: 2149-2263 Impact factor: 1.596
Figure 1Flowchart of the study
Baseline characteristics of the study groups (n=182)
| Variables | Warfarin group (n=91) | NOAC group (n=91) | |
|---|---|---|---|
| Age, years, mean±SD | 64.8±10.2 | 66.2±10.1 | 0.347[ |
| Female gender | 48 (52.7%) | 43 (47.3%) | 0.459[ |
| Education level | |||
| Uneducated | 17 (18.7%) | 24 (26.4%) | 0.273[ |
| Primary school | 66 (72.5%) | 63 (69.2%) | |
| Middle and high school | 8 (8.8%) | 4 (4.4%) | |
| Marital status | |||
| Married | 80 (87.9%) | 68 (74.7%) | 0.022[ |
| Unmarried (single, divorced or widowed) | 11 (12.1%) | 23 (25.3%) | |
| Duration of OAC therapy (m) | 20 (9–38) | 9 (7–12.5) | <0.001[ |
| Medication | - | ||
| Warfarin | 91 (100%) | - | |
| Dabigatran 150 mg bid | - | 37 (40.7%) | |
| Dabigatran 110 mg bid | - | 10 (11.0%) | |
| Rivaroxaban 20 mg od | - | 16 (17.6%) | |
| Apixaban 5 mg bid | - | 26 (28.6%) | |
| Apixaban 2.5 mg bid | - | 2 (2.2%) | |
| LVEF, % | 55 (15–65) | 60 (15–60) | 0.267[ |
| Hypertension, n (%) | 67 (73.6%) | 66 (72.5%) | 0.867[ |
| Coronary artery disease, n (%) | 54 (59.3%) | 38 (41.8%) | 0.018[ |
| Diabetes mellitus, n (%) | 17 (18.7%) | 18 (19.8%) | 0.851[ |
| Heart failure, n (%) | 27 (29.7%) | 25 (27.5%) | 0.743[ |
| CHA2DS2–VASc, median | 3 (1–8) | 3 (1–7) | 0.421[ |
| MC (MMAS-4 scores of <2, n (%) | 70 (76.9%) | 78 (85.7%) | 0.128[ |
| AN of hospital admissions, mean±S.D. | 12.8±3.5 | 5.0±1.3 | <0.001[ |
| EHRA score, median, min–max | |||
| 1 | 34 (37.4%) | 54 (59.3%) | 0.010[ |
| 2 | 44 (48.4%) | 26 (28.6%) | |
| 3 | 13 (14.3%) | 10 (11.0%) | |
| 4 | 0 (0.0%) | 1 (1.1%) | |
| HAS-BLED score | |||
| 0–2 | 72 (79.1%) | 68 (74.7%) | 0.824[ |
| ≥3 | 19 (20.9%) | 23 (25.3%) |
Student’s t-test,
Pearson chi-square test,
Mann–Whitney U test; AN: annual number, CHA2DS2-VASc: congestive heart failure, history of hypertension, age, diabetes mellitus, history of stroke/TIA/embolic event, vascular disease, female gender; EHRA - European Heart Rhythm Association; HAS-BLED - hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalised ratio, elderly, drug/alcohol use; LVEF - left ventricular ejection fraction; m: months; MC - medical compliance; MMAS - Morisky Medication Adherence Scale; NOAC - novel oral anticoagulant
Figure 2Comparison of health-related quality of life measures between the study groups
BP - bodily pain; GH - general health; MF - mental functioning; NOAC - novel oral anticoagulant; PF - physical functioning; RE - role emotional; RP - role-physical; SF - social functioning; VT - vitality
Figure 3Comparison of Hospital Anxiety and Depression Scale scores between the study groups
HADS - Hospital Anxiety and Depression Scale; HADS-A - anxiety subscale of HADS; HADS-D - depression subscale of HADS; NOAC - novel oral anticoagulant
Correlation analysis showing the association of quality of life, anxiety and depression levels with EHRA score and annual number of hospital admissions
| EHRA score | Annual number hospital admissions | |||
|---|---|---|---|---|
| R | R | |||
| Physical functioning | −0.624 | <0.001 | −0.375 | <0.001 |
| Role physical | −0.507 | <0.001 | −0.410 | <0.001 |
| Bodily pain | −0.532 | <0.001 | −0.328 | <0.001 |
| General health | −0.558 | <0.001 | −0.371 | <0.001 |
| Vitality | −0.451 | <0.001 | −0.402 | <0.001 |
| Social functioning | −0.481 | <0.001 | −0.600 | <0.001 |
| Role emotional | −0.376 | <0.001 | −0.493 | <0.001 |
| Mental functioning | −0.375 | <0,001 | −0.269 | <0.001 |
| HADS-A | −0.073 | 0.326 | 0.397 | <0.001 |
| HADS-D | 0.018 | 0.813 | 0.260 | <0.001 |
Spearman’s correlation analysis; EHRA - European Heart Rhythm Association; HADS - Hospital Anxiety and Depression Scale; HADS-A - Anxiety subscale of HADS; HADS-D - Depression subscale of HADS
Figure 4Comparison of the percentage of patients who experienced a bleeding episode between the study groups
NOAC - novel oral anticoagulant
Comparison of unfavourable effects of oral anticoagulant therapies (n=182)
| Variables | Warfarin group (n=91) | NOAC group (n=91) | |
|---|---|---|---|
| History of bleeding, n (%) | 40 (44.0%) | 5 (5.5%) | <0.001[ |
| Type of bleeding, n (%) | - | ||
| Gingival bleeding | 10 (11.0%) | 1 (1.1%) | |
| Bruising | 13 (14.3%) | 1 (1.1%) | |
| Melena | 2 (2.2%) | - | |
| Haematuria | 4 (4.4%) | - | |
| Epistaxis | 11 (12.1%) | 3 (3.3%) |
Pearson chi-square test, NOAC - Novel oral anticoagulant
Comparison of quality of life, anxiety and depression levels of patients according to the occurrence of any type bleeding event (n=182)
| Variables | Bleeding (-) (n=137) | Bleeding (+) (n=45) | |
|---|---|---|---|
| Physical functioning | 71.3±21.2 | 53.1±20.5 | <0.001 |
| Role physical | 70.8±28.0 | 38.3±31.3 | <0.001 |
| Bodily pain | 75.5±23.3 | 52.2±27.6 | <0.001 |
| General health | 55.9±20.6 | 34.2±22.8 | <0.001 |
| Vitality | 55.4±19.8 | 39.6±19.9 | <0.001 |
| Social functioning | 76.2±21.3 | 49.2±23.4 | <0.001 |
| Role emotional | 69.3±25.6 | 45.9±23.9 | <0.001 |
| Mental functioning | 68.6±14.5 | 59.6±14.1 | <0.001 |
| HADS-A | 5.3±1.4 | 5.5±1.5 | 0.352 |
| HADS-D | 4.2±1.3 | 4.8±1.3 | 0.002 |
Student’s t-test, HADS - Hospital Anxiety and Depression Scale; HADS-A - Anxiety subscale of HADS; HADS-D - Depression subscale of HADS
Comparison of quality of life, anxiety, depression levels and annual number of hospital admissions between warfarin and NOAC groups after adjusting for age, gender, duration of OAC therapy and drug compliance
| Variables | Warfarin group (n=91) | NOAC group (n=91) | |
|---|---|---|---|
| Physical functioning | 58.8 (52.5–65.0) | 68.4 (60.9–75.8) | 0.100 |
| Role physical | 45.6 (36.3–54.9) | 73.8 (62.8–84.8) | <0.001 |
| Bodily pain | 57.2 (49.4–65.0) | 77.1 (67.9–86.4) | 0.006 |
| General health | 40.0 (33.5–46.5) | 55.4 (47.7–63.1) | 0.011 |
| Vitality | 44.1 (38.1–50.2) | 57.4 (50.2–64.6) | 0.019 |
| Social functioning | 53.9 (48.0–59.9) | 82.2 (75.2–89.2) | <0.001 |
| Role emotional | 45.7 (38.1–53.3) | 78.0 (69.0–87.0) | <0.001 |
| Mental functioning | 60.3 (55.7–64.9) | 70.4 (65.0–75.9) | 0.019 |
| HADS-A | 6.2 (5.8–6.6) | 4.6 (4.2–5.1) | <0.001 |
| HADS-D | 4.9 (4.5–5.3) | 3.6 (3.1–4.1) | <0.001 |
| Annual number of hospital admissions | 12.8 (11.9–13.7) | 4.9 (3.8–6.0) | <0.001 |
Analysis of covariance (ANCOVA); data were given as mean (95% confidence interval) after adjusting for age, gender, duration of oral anticoagulant therapy and drug compliance; HADS - Hospital Anxiety and Depression Scale; HADS-A - Anxiety subscale of HADS; HADS-D - Depression subscale of HADS