Low Body Weight Increases the Risk of Ischemic Stroke and Major Bleeding in Atrial Fibrillation: The COOL-AF Registry
Abstract
:1. Introduction
2. Methods
2.1. Study Population
2.2. Study Protocol and Data Collection
2.3. Outcome Measurement
2.4. Statistical Analysis
3. Results
3.1. LBW and Outcomes
3.2. Subgroup Analyses
3.3. Multivariate Analysis
3.4. Body Weight as a Continuous Variable
3.5. Sensitivity Analysis
3.6. Effects of OAC on Clinical Outcomes
3.7. Net Clinical Benefit
4. Discussion
Limitations
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Acknowledgments
Conflicts of Interest
References
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Characteristics | All (n = 3367) | BW < 50 (n = 380) | BW ≥ 50 (n = 2987) | p |
---|---|---|---|---|
Age (years) | 67.2 ± 11.2 | 74.1 ± 10.2 | 66.4 ± 11.1 | <0.001 |
Female | 1397 (41.5%) | 284 (74.7%) | 1113 (37.3%) | <0.001 |
Time after NVAF diagnosis (years) | 3.4 ± 4.3 | 3.2 ± 3.9 | 3.4 ± 4.4 | 0.362 |
Type of NVAF | 0.070 | |||
- Paroxysmal | 1131 (33.6%) | 115 (30.3%) | 1016 (34.0%) | |
- Persistent | 642 (19.1%) | 64 (16.8%) | 578 (19.4%) | |
- Permanent | 1594 (47.3%) | 201 (52.9%) | 1393 (46.6%) | |
Symptomatic NVAF | 2600 (77.2%) | 292 (76.8%) | 2308 (77.3%) | 0.852 |
History of heart failure | 897 (26.6%) | 93 (24.5%) | 804 (26.9%) | 0.310 |
History of coronary artery disease | 543 (16.1%) | 44 (11.6%) | 499 (16.7%) | 0.010 |
CIED | 329 (9.8%) | 45 (11.8%) | 284 (9.5%) | 0.149 |
History of ischemic stroke/TIA | 573 (17.0%) | 72 (18.9%) | 501 (16.8%) | <0.001 |
Hypertension | 2299 (68.3%) | 229 (60.3%) | 2070 (69.3%) | <0.001 |
Diabetes mellitus | 834 (24.8%) | 44 (11.6%) | 790 (26.4%) | <0.001 |
Current smoker | 676 (20.1%) | 34 (8.9%) | 642 (21.5%) | <0.001 |
Dyslipidemia | 1901 (56.5%) | 163 (42.9%) | 1738 (58.2%) | <0.001 |
Renal replacement therapy | 38 (1.1%) | 3 (0.8%) | 35 (1.2%) | 0.795 |
Dementia | 28 (0.8%) | 4 (1.1%) | 24 (0.8%) | 0.549 |
History of bleeding | 322 (9.6%) | 45 (11.8%) | 277 (9.3%) | 0.109 |
CHA2DS2-VASc score | <0.001 | |||
- 0 | 198 (5.9%) | 4 (1.1%) | 194 (6.5%) | |
- 1 | 422 (12.5%) | 21 (5.5%) | 401 (13.4%) | |
- ≥2 | 2747 (81.6%) | 355 (93.4%) | 2392 (80.1%) | |
HAS-BLED score | <0.001 | |||
- 0 | 489 (14.5%) | 25 (6.6%) | 464 (15.5%) | |
- 1–2 | 2354 (69.9%) | 281 (73.9%) | 2073 (69.4%) | |
- ≥3 | 524 (15.6%) | 74 (19.5%) | 450 (15.1%) | |
Antiplatelet | 882 (26.2%) | 81 (21.3%) | 801 (26.8%) | 0.022 |
Anticoagulant | 2535 (75.3%) | 293 (77.1%) | 2242 (75.1%) | 0.384 |
- Warfarin | 2310 (68.6%) | 276 (72.6%) | 2034 (68.1%) | 0.073 |
- NOACs | 225 (6.7%) | 17 (4.5%) | 208 (7.0%) | 0.067 |
For warfarin group | ||||
- Time in therapeutic range (%) | 53.5 ± 26.4 | 53.0 ± 26.2 | 53.6 ± 26.4 | 0.722 |
- Time under therapeutic range (%) | 32.1 ± 27.6 | 29.9 ± 26.2 | 32.4 ± 27.8 | 0.158 |
- Time above therapeutic range (%) | 14.1 ± 17.5 | 17.0 ± 19.9 | 13.7 ± 17.1 | 0.010 |
- Baseline INR | 2.2 ± 0.8 | 2.4 ± 0.9 | 2.2 ± 0.8 | <0.001 |
All (n = 3367) | BW < 50 (n = 380) | BW ≥ 50 (n = 2987) | p-Value | |
---|---|---|---|---|
Ischemic stroke/TIA | 99 (2.9%) | 23 (6.1%) | 76 (2.5%) | <0.001 |
Major bleeding | 148 (4.4%) | 27 (7.1%) | 121 (4.1%) | 0.006 |
ICH | 48 (1.4%) | 11 (2.9%) | 37 (1.2%) | 0.010 |
Death | 260 (7.7%) | 63 (16.6%) | 197 (6.6%) | <0.001 |
Ischemic stroke/TIA or major bleeding or death | 414 (12.3%) | 90 (23.7%) | 324 (10.8%) | <0.001 |
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Krittayaphong, R.; Chichareon, P.; Komoltri, C.; Kornbongkotmas, S.; Yindeengam, A.; Lip, G.Y.H., on behalf of the COOL-AF Investigators. Low Body Weight Increases the Risk of Ischemic Stroke and Major Bleeding in Atrial Fibrillation: The COOL-AF Registry. J. Clin. Med. 2020, 9, 2713. https://doi.org/10.3390/jcm9092713
Krittayaphong R, Chichareon P, Komoltri C, Kornbongkotmas S, Yindeengam A, Lip GYH on behalf of the COOL-AF Investigators. Low Body Weight Increases the Risk of Ischemic Stroke and Major Bleeding in Atrial Fibrillation: The COOL-AF Registry. Journal of Clinical Medicine. 2020; 9(9):2713. https://doi.org/10.3390/jcm9092713
Chicago/Turabian StyleKrittayaphong, Rungroj, Ply Chichareon, Chulalak Komoltri, Sakaorat Kornbongkotmas, Ahthit Yindeengam, and Gregory Y. H. Lip on behalf of the COOL-AF Investigators. 2020. "Low Body Weight Increases the Risk of Ischemic Stroke and Major Bleeding in Atrial Fibrillation: The COOL-AF Registry" Journal of Clinical Medicine 9, no. 9: 2713. https://doi.org/10.3390/jcm9092713