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Risk of venous thromboembolism in cancer patients treated with epoetins or blood transfusions.

ABSTRACT: AIMS:Anaemia is common in cancer patients, with treatments including epoetins and blood transfusions. Although an increased risk of venous thromboembolism (VTE) has been associated with both therapeutics, studies comparing the risk of VTE between epoetins and transfusions in cancer patients are lacking. METHODS:A nested case-control study investigated this risk using the German Pharmacoepidemiological Research Database. Cohort members were incident cancer patients receiving first time treatment with epoetin or transfusion. A subcohort including only patients receiving chemotherapy was created, since the formally approved indication of epoetins is chemotherapy-induced anaemia. Cases were defined as patients developing VTE. For each case up to 10 gender- and age-matched controls were selected from the cohort. Multiple confounder adjusted odds ratios (aORs) with 95% confidence intervals (CIs) for VTE and recent treatment with epoetins or transfusions (last 28 days before index date) compared with past anti-anaemic treatment were calculated by conditional logistic regression. RESULTS:Among 69?888 patients receiving first time treatment with epoetin or transfusion, 3316 VTE cases were identified. The aOR for VTE was 1.31 (95% CI 1.03, 1.65) for epoetins, 2.33 (95% CI 2.03, 2.66) for transfusions, and 2.24 (95% CI 1.34, 3.77) for epoetins and transfusions. Sensitivity analyses with a stricter VTE definition or an expanded time window yielded similar results. In the chemotherapy only subcohort the risk difference between epoetins and transfusions could not be verified (aOR 1.48, 95% CI 1.10, 1.98 vs. aOR 1.80, 95% CI 1.49, 2.19). Our study confirmed known VTE risk factors including previous VTE (aOR 14.76, 95% CI 12.79, 17.03) or surgery (aOR 1.83, 95% CI 1.67, 2.01). Epoetin-associated risk decreased after a safety warning by the European Medicines Agency setting maximum haemoglobin target values to 12 g dl(-1) . CONCLUSIONS:Transfusions could be associated with a higher VTE risk than epoetins in cancer patients. Moreover, current prescribing patterns may have decreased the VTE risk for epoetins.

SUBMITTER: Douros A

PROVIDER: S-EPMC5338129 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature

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Risk of venous thromboembolism in cancer patients treated with epoetins or blood transfusions.

Douros Antonios A Jobski Kathrin K Kollhorst Bianca B Schink Tania T Garbe Edeltraut E

British journal of clinical pharmacology 20160622 3

<h4>Aims</h4>Anaemia is common in cancer patients, with treatments including epoetins and blood transfusions. Although an increased risk of venous thromboembolism (VTE) has been associated with both therapeutics, studies comparing the risk of VTE between epoetins and transfusions in cancer patients are lacking.<h4>Methods</h4>A nested case-control study investigated this risk using the German Pharmacoepidemiological Research Database. Cohort members were incident cancer patients receiving first ...[more]

PMID: 27206325

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Project description:ImportanceIncreasing evidence supports the role of red blood cells (RBCs) in physiological hemostasis and pathologic thrombosis. Red blood cells are commonly transfused in the perioperative period; however, their association with postoperative thrombotic events remains unclear.ObjectiveTo examine the association between perioperative RBC transfusions and postoperative venous thromboembolism (VTE) within 30 days of surgery.Design, setting, and participantsThis analysis used prospectively collected registry data from the American College of Surgery National Surgical Quality Improvement Program (ACS-NSQIP) database, a validated registry of 525 teaching and nonteaching hospitals in North America. Participants included patients in the ACS-NSQIP registry who underwent a surgical procedure from January 1 through December 31, 2014. Data were analyzed from July 1, 2016, through March 15, 2018.Main outcomes and measuresRisk-adjusted odds ratios (aORs) were estimated using multivariable logistic regression. The primary outcome was the development of postoperative VTE (deep venous thrombosis [DVT] and pulmonary embolism [PE]) within 30 days of surgery that warranted therapeutic intervention; DVT and PE were also examined separately as secondary outcomes. Subgroup analyses were performed by surgical subtypes. Propensity score matching was performed for sensitivity analyses.ResultsOf 750 937 patients (56.8% women; median age, 58 years; interquartile range, 44-69 years), 47 410 (6.3%) received at least 1 perioperative RBC transfusion. Postoperative VTE occurred in 6309 patients (0.8%) (DVT in 4336 [0.6%]; PE in 2514 [0.3%]; both DVT and PE in 541 [0.1%]). Perioperative RBC transfusion was associated with higher odds of VTE (aOR, 2.1; 95% CI, 2.0-2.3), DVT (aOR, 2.2; 95% CI, 2.1-2.4), and PE (aOR, 1.9; 95% CI, 1.7-2.1), independent of various putative risk factors. A significant dose-response effect was observed with increased odds of VTE as the number of intraoperative and/or postoperative RBC transfusion events increased (aOR, 2.1 [95% CI, 2.0-2.3] for 1 event; 3.1 [95% CI, 1.7-5.7] for 2 events; and 4.5 [95% CI, 1.0-19.4] for ≥3 events vs no intraoperative or postoperative RBC transfusion; P < .001 for trend). In subgroup analyses, the association between any perioperative RBC transfusion and postoperative VTE remained statistically significant across all surgical subspecialties analyzed. The association between any perioperative RBC transfusion and the development of postoperative VTE also remained robust after 1:1 propensity score matching (47 142 matched pairs; matched OR, 1.9; 95% CI, 1.8-2.1).Conclusions and relevanceThe results of this study suggest that perioperative RBC transfusions may be significantly associated with the development of new or progressive postoperative VTE, independent of several putative confounders. These findings, if validated, should reinforce the importance of rigorous perioperative management of blood transfusion practices.

Project description:Importance:Although malignancy is an established risk factor for venous thromboembolism (VTE), the risk of VTE specifically in patients with keratinocyte carcinoma (KC) has not been previously studied. Objective:To determine the risk of VTE in patients with KC compared with patients not diagnosed with cancer and with patients diagnosed with common malignant neoplasms associated with VTE. Design, Setting, and Participants:Population-based retrospective analysis of patient insurance claims made between January 1, 2007, and December 31, 2014, from the Truven MarketScan Commercial and Medicare Supplemental Databases. Patients treated across the United States were divided into 3 cohorts: patients with KC, patients with pancreatic cancer or acute myelogenous leukemia who are thus at high risk for VTE, and patients without a history of common malignant neoplasms. Patients were excluded from the KC cohort if they had a history of another type of cancer. Data were analyzed between April 1, 2017, and January 15, 2018. Main Outcomes and Measures:Diagnosis of VTE within 1 year following the index date (for the KC and high-risk cohorts, the date of the initial diagnosis of cancer; for the control cohort, the date following 365 days of continuous insurance enrollment). Logistic regression was used to assess the risk of VTE in the KC cohort compared with the high-risk and control cohorts before and after matching across patient characteristics and known risk factors for VTE. Results:Of 5 753 613 potentially eligible patients, the final sample consisted of 740 246 patients (12.8%) across 3 cohorts. Of the 740 246 study participants, 417 839 were in the KC cohort (223 986 [53.6%] men, mean [SD] age, 64.2 [13.6] years); 314 736 were in the control cohort (135 203 [43.0%] men, 42.9 [15.2] years); and 7671 were in the high-risk cohort (3502 [45.7%] men, 59.4 [14.4] years) The risk of VTE in the KC cohort was lower compared with the high-risk cohort in univariable analysis (odds ratio [OR], 0.22; 95% CI, 0.20-0.23; P < .001), multivariable analysis (OR, 0.29; 95% CI, 0.26-0.32; P < .001), and after matching across patient characteristics and known risk factors (OR, 0.52; 95% CI, 0.35-0.78; P = .001). The risk of VTE in the KC cohort was higher in the univariable analysis (OR, 2.31; 95% CI, 2.23-2.41; P < .001), lower in the multivariable analysis (OR, 0.85; 95% CI, 0.80-0.90; P < .001), and not different after matching of patient characteristics and risk factors (OR, 0.95; 95% CI, 0.89-1.01; P = .08) than that of the control cohort. Conclusions and Relevance:The results of this study provided no evidence supporting the increased risk of VTE in the KC cohort compared with the control cohort. Given the inherent risks of chemoprophylaxis, the need for prophylactic anticoagulation in patients with KC who are scheduled for surgery should be carefully considered. Level of Evidence:NA.

Project description:ImportanceThe size of the risk of recurrent venous thromboembolism (VTE) after surgery in patients with a history of VTE is not well known.ObjectivesTo estimate the risk of and to identify the factors associated with recurrent VTE in patients undergoing surgery who have a history of VTE.Design, setting, and participantsThis population-based, follow-up cohort study includes patients with VTE who participated in the Multiple Environment and Genetic Assessment (MEGA) study. Original data were collected from March 1999 to April 2010. Data analysis began in June 1999 and ended in April 2010.ExposuresSurgery following a first VTE.Main outcomes and measurementsKaplan-Meier analyses were used to estimate cumulative incidences of recurrent VTE. Cox regression with a time-dependent covariate (surgery) was used to calculate the hazard ratio (HR) for developing recurrent VTE after surgery compared with no surgery.ResultsOverall, 3741 patients (mean [SD] age, 48.4 [12.8] years; 2020 [54.0%] women) with a history of VTE were included in the analysis, amounting to 18 899 person-years, with a median (interquartile range) follow-up of 5.7 (3.0-7.2) years. Of the 3741 patients, 580 (15.5%) underwent surgery and 601 (16.1%) developed a recurrent thrombotic event. The 1-month cumulative incidence of recurrent VTE for all surgery types was 2.1% (95% CI, 1.2%-3.6%), which increased to 3.3% (95% CI, 2.1%-5.1%) at 3 months and 4.6% (95% CI, 3.1%-6.6%) at 6 months. At 6 months, risk of recurrent VTE ranged from 2.3% to 9.3%, depending on surgery type. In addition to surgery type, factor V Leiden mutation (HR, 3.4; 95% CI, 1.6-7.4) and male sex (HR, 2.7; 95% CI, 1.3-5.8) were associated with increased risk of recurrent VTE.Conclusions and relevanceSurgery was associated with an increased risk of recurrent VTE in patients with a history of VTE; risk remained high for up to 6 months after the procedure. This study suggests that high-risk individuals may be identified based on surgery type, sex, and the presence of factor V Leiden mutation. These findings stress the need for revision of the current thromboprophylactic approach to prevent recurrence in these patients.

Dataset Information

Risk of venous thromboembolism in cancer patients treated with epoetins or blood transfusions.

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Risk of venous thromboembolism in cancer patients treated with epoetins or blood transfusions.

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