The author noticed some errors in Douros et al. 1
Specifically, sex was incorrectly assigned in the analysis dataset of the InGef database male patients were labelled as female patients and female patients were labelled as male patients. To fix the error the following changes are required in the article.
In the Results section, page 7, the text is corrected from “Concomitant use of DOACs and antiplatelet agents was associated with a decreased risk of major bleeding among male patients (weighted HR, 0.54; 95% CI, 0.30–0.96; I2, 0.00) but not among female patients (weighted HR, 1.05; 95% CI, 0.62–1.77; I2, 0.00). Moreover, while there was no association between concomitant use of DOACs and antiplatelet agents and the risk of all‐cause mortality among male patients (weighted HR, 0.95; 95% CI, 0.56–1.60; I2, 0.00), there was a nonsignificant trend toward an increased risk among female patients (weighted HR, 1.64; 95% CI, 0.98–2.72; I2, 0.00). However, secondary analyses were based on few events and should be interpreted with caution (results presented in Tables S5 and S6 in Appendix S1).” to “Secondary analyses for the primary outcomes major bleeding and all‐cause mortality (not feasible for recurrent VTE) did not suggest an effect modification by age or sex. However, they were based on few events and should be interpreted with caution (results presented in eTables 5 and 6 in Appendix S1).”
Also, in the Discussion section (page 8, paragraph 1), the text is corrected from “Finally, our secondary analyses suggested more favorable effects for male patients.” to “Finally, our secondary analyses suggested no effect modification by sex, which is congruent with the results in the RCTs.”
Importantly, the programming error did not affect any of the results of the primary analyses. Therefore, the main conclusions of the study remain unchanged.
The corrected Tables are given below.2, S6, S5
TABLE 2.
Baseline characteristics of patients with VTE initiating concomitant use of oral anticoagulants and antiplatelet agents before and after propensity score weighting (InGef database)
| Characteristic a | Before weighting | After weighting | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| DOACs + APs (n = 1234) | VKAs + APs (n = 493) | SMD | DOACs + APs (n = 1235) | VKAs + APs (n = 489) | SMD | |||||
| Age, in years (mean, SD) | 74.8 | 11.8 | 72.7 | 11.1 | 0.181 | 74.2 | 11.6 | 74.0 | 11.5 | 0.016 |
| Female sex | 549 | 44.5 | 201 | 40.8 | 0.075 | 535 | 43.3 | 209 | 42.6 | 0.014 |
| Comorbidities | ||||||||||
| Obesity | <5 | – | 0 | 0.0 | NA | – | – | – | – | NA |
| Varicose veins/PTS | 36 | 2.9 | 12 | 2.4 | 0.029 | 35 | 2.9 | 15 | 3.1 | −0.016 |
| Arterial hypertension | 1,140 | 92.4 | 449 | 91.1 | 0.048 | 1,135 | 91.9 | 448 | 91.6 | 0.011 |
| Congestive heart failure | 479 | 38.8 | 189 | 38.3 | 0.010 | 477 | 38.6 | 182 | 37.3 | 0.028 |
| Myocardial infarction | 174 | 14.1 | 63 | 12.8 | 0.038 | 170 | 13.8 | 65 | 13.3 | 0.013 |
| Stroke | 293 | 23.7 | 91 | 18.5 | 0.127 | 275 | 22.3 | 112 | 22.8 | −0.013 |
| Diabetes mellitus | 513 | 41.6 | 210 | 42.6 | −0.021 | 519 | 42.1 | 210 | 43.0 | −0.018 |
| Chronic kidney disease | 320 | 25.9 | 179 | 36.3 | −0.230 | 357 | 28.9 | 141 | 28.9 | 0.000 |
| Moderate to severe liver disease | 11 | 0.9 | 5 | 1.0 | NA | – | – | – | – | NA |
| Inflammatory bowel disease | 20 | 1.6 | 16 | 3.3 | −0.114 | 26 | 2.1 | 10 | 2.1 | 0.002 |
| Cancer | 298 | 24.2 | 109 | 22.1 | 0.048 | 291 | 23.6 | 113 | 23.1 | 0.011 |
| Bleeding | 234 | 19.0 | 91 | 18.5 | 0.013 | 233 | 18.9 | 90 | 18.4 | 0.012 |
| Fracture | 81 | 6.6 | 18 | 3.7 | 0.126 | 71 | 5.7 | 27 | 5.4 | 0.013 |
| Major surgery | 472 | 38.3 | 209 | 42.4 | −0.085 | 486 | 39.4 | 189 | 38.6 | 0.017 |
| Comedications | ||||||||||
| APs, duration in days (mean, SD) | 195.8 | 125.7 | 179.6 | 127.0 | 0.128 | 190.6 | 126.3 | 188.6 | 126.5 | 0.015 |
| Oral contraceptives | 9 | 0.7 | 6 | 1.2 | NA | – | – | – | – | NA |
| Hormone replacement therapy | 0 | 0.0 | 0 | 0.0 | NA | – | – | – | – | NA |
| Tamoxifen | 7 | 0.6 | 7 | 1.4 | NA | – | – | – | – | NA |
| Systemic corticosteroids | 248 | 20.1 | 96 | 19.5 | 0.016 | 244 | 19.8 | 95 | 19.4 | 0.010 |
| SSRIs | 133 | 10.8 | 45 | 9.1 | 0.054 | 127 | 10.3 | 49 | 10.1 | 0.007 |
| Proton pump inhibitors | 756 | 61.3 | 277 | 56.2 | 0.104 | 739 | 59.8 | 293 | 59.9 | −0.002 |
| NSAIDs | 470 | 38.1 | 191 | 38.7 | −0.013 | 474 | 38.4 | 193 | 39.5 | −0.021 |
| Proxies of overall health | ||||||||||
| Number of hospitalizations | ||||||||||
| 0 | 417.00 | 33.79 | 158.00 | 32.05 | 0.037 | 411.31 | 33.32 | 164.10 | 33.53 | −0.005 |
| 1 | 356.00 | 28.85 | 146.00 | 29.61 | −0.017 | 359.76 | 29.14 | 142.18 | 29.05 | 0.002 |
| 2 | 195.00 | 15.80 | 96.00 | 19.47 | −0.098 | 208.73 | 16.91 | 82.40 | 16.84 | 0.002 |
| >2 | 266.00 | 21.56 | 93.00 | 18.86 | 0.066 | 254.71 | 20.63 | 100.69 | 20.58 | 0.001 |
| Number of non‐antithrombotic drugs | ||||||||||
| 0–10 | 561.00 | 45.46 | 235.00 | 47.67 | −0.044 | 568.90 | 46.08 | 225.64 | 46.11 | −0.001 |
| 11–15 | 386.00 | 31.28 | 129.00 | 26.17 | 0.112 | 366.87 | 29.72 | 142.12 | 29.04 | 0.015 |
| ≥16 | 287.00 | 23.26 | 129.00 | 26.17 | −0.068 | 298.73 | 24.20 | 121.60 | 24.85 | −0.015 |
S Suppressed due to small numbers (<5) as per confidentiality agreement with the data custodians contributing data to the InGef database.
Abbreviations: APs, antiplatelet agents; DOACs, direct oral anticoagulants; InGef, Institute for Applied Health Research Berlin;NA, not applicable; NSAIDs, non‐steroidal anti‐inflammatory drugs; PTS, post‐thrombotic syndrome; SD, standard deviation; SMD; SSRIs, selective serotonin reuptake inhibitors; standardized mean difference; VKAs, vitamin K antagonists.
Values are numbers (percentages) unless stated otherwise.
TABLE S6.
Association between concomitant use of DOACs and antiplatelet agents and the risk of all‐cause mortality compared with concomitant use of VKAs and antiplatelet agents among patients with VTE (secondary analyses)
| Stratification factor | Analysis | Weighted a HR (95% CI) | I 2 |
|---|---|---|---|
| Sex | Male | ||
| RAMQ | 0.94 (0.48 to 1.82) | ||
| InGef | 1.59 (0.68 to 3.73) | ||
| Overall | 1.15 (0.68 to 1.94) | 0.00 | |
| Female | |||
| RAMQ | 1.66 (0.88 to 3.13) | ||
| InGef | 0.96 (0.41 to 2.25) | ||
| Overall | 1.36 (0.81 to 2.28) | 0.03 | |
| Age | ≤80 years | ||
| RAMQ | 0.51 (0.20 to 1.27) | ||
| InGef | 1.17 (0.52 to 2.61) | ||
| Overall | 0.80 (0.35 to 1.79) | 0.43 | |
| >80 years | |||
| RAMQ | 1.94 (1.11 to 3.38) | ||
| InGef | 1.39 (0.56 to 3.42) | ||
| Overall | 1.77 (1.10 to 2.84) | 0.00 |
Abbreviations: DOACs, direct oral anticoagulants; VKAs, vitamin K antagonists; VTE, venous thromboembolism; HR, hazard ratio; CI, confidence interval; RAMQ, Régie de l'assurance maladie du Québec; InGef, Institute for Applied Health Research Berlin.
After propensity score based inverse probability of treatment weighting.
TABLE S5.
Association between concomitant use of DOACs and antiplatelet agents and the risk of major bleeding compared with concomitant use of VKAs and antiplatelet agents among patients with VTE (secondary analyses)
| Stratification factor | Analysis | Weighted a HR (95% CI) | I 2 |
|---|---|---|---|
| Sex | Male | ||
| RAMQ | 0.50 (0.26 to 0.97) | ||
| InGef | 1.35 (0.62 to 2.94) | ||
| Overall | 0.80 (0.30 to 2.14) | 0.73 | |
| Female | |||
| RAMQ | 0.84 (0.41 to 1.72) | ||
| InGef | 0.70 (0.20 to 2.48) | ||
| Overall | 0.80 (0.43 to 1.50) | 0.00 | |
| Age | ≤80 years | ||
| RAMQ | 0.56 (0.30 to 1.06) | ||
| InGef | 1.63 (0.69 to 3.84) | ||
| Overall | 0.92 (0.32 to 2.60) | 0.74 | |
| >80 years | |||
| RAMQ | 0.75 (0.35 to 1.60) | ||
| InGef | 0.59 (0.20 to 1.73) | ||
| Overall | 0.69 (0.37 to 1.29) | 0.00 | |
| Type of bleeding b | Gastrointestinal bleeding b | ||
| RAMQ | 0.85 (0.45 to 1.63) | ||
| InGef | 1.19 (0.47 to 3.05) | ||
| Overall | 0.95 (0.56 to 1.61) | 0.00 | |
| Other major bleeding | |||
| RAMQ | 0.40 (0.18 to 0.88) | ||
| InGef | 1.22 (0.46 to 3.26) | ||
| Overall | 0.67 (0.23 to 2.00) | 0.67 |
The authors apologise for the error.
Supporting information
Supplementary Material
Footnotes
Abbreviations: DOACs, direct oral anticoagulants; VKAs, vitamin K antagonists; VTE, venous thromboembolism; HR, hazard ratio; CI, confidence interval; InGef, Institute for Applied Health Research Berlin; RAMQ, Régie de l'assurance maladie du Québec.
After propensity score based inverse probability of treatment weighting.
The low number of exposed events precluded an analysis on the risk of intracranial haemorrhage.
REFERENCE
- 1. Douros A, Basedow F, Cui Y, Walker J, Enders D, Tagalakis V. Effectiveness and safety of direct oral anticoagulants with antiplatelet agents in patients with venous hromboembolism: a multi‐database cohort study. Res Pract Thromb Haemost. 2022;6:e12643. doi: 10.1002/rth2.12643 [DOI] [PMC free article] [PubMed] [Google Scholar]
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Supplementary Materials
Supplementary Material