Literature DB >> 35592813

Corrigendum.

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Abstract

[This corrects the article DOI: 10.1002/rth2.12643.].
© 2022 The Authors. Research and Practice in Thrombosis and Haemostasis published by Wiley Periodicals LLC on behalf of International Society on Thrombosisand Haemostasis (ISTH).

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Year:  2022        PMID: 35592813      PMCID: PMC9101590          DOI: 10.1002/rth2.12717

Source DB:  PubMed          Journal:  Res Pract Thromb Haemost        ISSN: 2475-0379


The author noticed some errors in Douros et al. 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 weightingAfter weighting
DOACs + APs (n = 1234)VKAs + APs (n = 493)SMDDOACs + APs (n = 1235)VKAs + APs (n = 489)SMD
Age, in years (mean, SD)74.811.872.711.10.18174.211.674.011.50.016
Female sex54944.520140.80.07553543.320942.60.014
Comorbidities
Obesity<500.0NANA
Varicose veins/PTS362.9122.40.029352.9153.1−0.016
Arterial hypertension1,14092.444991.10.0481,13591.944891.60.011
Congestive heart failure47938.818938.30.01047738.618237.30.028
Myocardial infarction17414.16312.80.03817013.86513.30.013
Stroke29323.79118.50.12727522.311222.8−0.013
Diabetes mellitus51341.621042.6−0.02151942.121043.0−0.018
Chronic kidney disease32025.917936.3−0.23035728.914128.90.000
Moderate to severe liver disease110.951.0NANA
Inflammatory bowel disease201.6163.3−0.114262.1102.10.002
Cancer29824.210922.10.04829123.611323.10.011
Bleeding23419.09118.50.01323318.99018.40.012
Fracture816.6183.70.126715.7275.40.013
Major surgery47238.320942.4−0.08548639.418938.60.017
Comedications
APs, duration in days (mean, SD)195.8125.7179.6127.00.128190.6126.3188.6126.50.015
Oral contraceptives90.761.2NANA
Hormone replacement therapy00.000.0NANA
Tamoxifen70.671.4NANA
Systemic corticosteroids24820.19619.50.01624419.89519.40.010
SSRIs13310.8459.10.05412710.34910.10.007
Proton pump inhibitors75661.327756.20.10473959.829359.9−0.002
NSAIDs47038.119138.7−0.01347438.419339.5−0.021
Proxies of overall health
Number of hospitalizations
0417.0033.79158.0032.050.037411.3133.32164.1033.53−0.005
1356.0028.85146.0029.61−0.017359.7629.14142.1829.050.002
2195.0015.8096.0019.47−0.098208.7316.9182.4016.840.002
>2266.0021.5693.0018.860.066254.7120.63100.6920.580.001
Number of non‐antithrombotic drugs
0–10561.0045.46235.0047.67−0.044568.9046.08225.6446.11−0.001
11–15386.0031.28129.0026.170.112366.8729.72142.1229.040.015
≥16287.0023.26129.0026.17−0.068298.7324.20121.6024.85−0.015

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 factorAnalysisWeighted a HR (95% CI) I 2
SexMale
RAMQ0.94 (0.48 to 1.82)
InGef 1.59 (0.68 to 3.73)
Overall 1.15 (0.68 to 1.94) 0.00
Female
RAMQ1.66 (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
RAMQ0.51 (0.20 to 1.27)
InGef1.17 (0.52 to 2.61)
Overall0.80 (0.35 to 1.79)0.43
>80 years
RAMQ1.94 (1.11 to 3.38)
InGef1.39 (0.56 to 3.42)
Overall1.77 (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 factorAnalysisWeighted a HR (95% CI) I 2
SexMale
RAMQ0.50 (0.26 to 0.97)
InGef 1.35 (0.62 to 2.94)
Overall 0.80 (0.30 to 2.14) 0.73
Female
RAMQ0.84 (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
RAMQ0.56 (0.30 to 1.06)
InGef1.63 (0.69 to 3.84)
Overall0.92 (0.32 to 2.60)0.74
>80 years
RAMQ0.75 (0.35 to 1.60)
InGef0.59 (0.20 to 1.73)
Overall0.69 (0.37 to 1.29)0.00
Type of bleeding b Gastrointestinal bleeding b
RAMQ0.85 (0.45 to 1.63)
InGef1.19 (0.47 to 3.05)
Overall0.95 (0.56 to 1.61)0.00
Other major bleeding
RAMQ0.40 (0.18 to 0.88)
InGef1.22 (0.46 to 3.26)
Overall0.67 (0.23 to 2.00)0.67
Baseline characteristics of patients with VTE initiating concomitant use of oral anticoagulants and antiplatelet agents before and after propensity score weighting (InGef database) 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. The authors apologise for the error. 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) 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. 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) Supplementary Material Click here for additional data file.
  1 in total

1.  Effectiveness and safety of direct oral anticoagulants with antiplatelet agents in patients with venous thromboembolism: A multi-database cohort study.

Authors:  Antonios Douros; Frederike Basedow; Ying Cui; Jochen Walker; Dirk Enders; Vicky Tagalakis
Journal:  Res Pract Thromb Haemost       Date:  2022-01-10
  1 in total

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