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Primary prevention of venous thromboembolism in medical and surgical oncology patients.

ABSTRACT: Recent data suggest that patients with a malignancy have a seven-fold increased risk for venous thromboembolism (VTE) compared with those without cancer, suggesting that these patients may benefit from thromboprophylaxis. Mechanisms for the prevention of thromboembolism can be divided into two broad categories: mechanical and pharmacological. Although generally used in combination with pharmacotherapy, little evidence exists for the efficacy of mechanical modalities either in the broader population of patients at risk for VTE or for patients with cancer specifically. A recent study using graduated compression stockings (GCS) for thromboprophylaxis showed no support for the use of stockings in acute stroke patients. Established pharmacological modalities, including warfarin, unfractionated heparin (UFH), low-molecular-weight heparin (LMWH), and the factor Xa inhibitor fondaparinux, have been shown to reduce risk for VTE in general medical and surgical populations. In medical cancer patients, only limited data are available for the efficacy of thromboprophylaxis. In contrast, considerable evidence indicates that thromboprophylaxis is warranted in patients undergoing cancer surgery. The most recent evidence suggests that catheter-related thrombosis is not prevented by current pharmacological modalities. On 22 May 2009, a group of clinicians based in the United Kingdom (UK) met in London, UK, to evaluate recent data on cancer thrombosis. This article (the second of four) briefly reviews key data on the prevention of VTE in medical and surgical oncology patients, providing context for a brief transcript of the surrounding discussion and a consensus statement, developed by meeting attendees, on the implications of this information for UK clinical practice.

SUBMITTER: Stanley A

PROVIDER: S-EPMC3315366 | biostudies-other | 2010 Apr

REPOSITORIES: biostudies-other

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Project description:Failure to recognize the presence of competing risk or to account for it may result in misleading conclusions. We aimed to perform a competing risk analysis to assess the efficacy of the low molecular weight heparin dalteparin versus unfractionated heparin (UFH) in venous thromboembolism (VTE) in medical-surgical critically ill patients, taking death as a competing risk.This was a secondary analysis of a prospective randomized study of the Prophylaxis for Thromboembolism in Critical Care Trial (PROTECT) database. A total of 3746 medical-surgical critically ill patients from 67 intensive care units (ICUs) in 6 countries receiving either subcutaneous UFH 5000 IU twice daily (n?=?1873) or dalteparin 5000 IU once daily plus once-daily placebo (n?=?1873) were included for analysis.A total of 205 incident proximal leg deep vein thromboses (PLDVT) were reported during follow-up, among which 96 were in the dalteparin group and 109 were in the UFH group. No significant treatment effect of dalteparin on PLDVT compared with UFH was observed in either the competing risk analysis or standard survival analysis (also known as cause-specific analysis) using multivariable models adjusted for APACHE II score, history of VTE, need for vasopressors, and end-stage renal disease: sub-hazard ratio (SHR)?=?0.92, 95% confidence interval (CI): 0.70-1.21, P-value?=?0.56 for the competing risk analysis; hazard ratio (HR)?=?0.92, 95% CI: 0.68-1.23, P-value?=?0.57 for cause-specific analysis. Dalteparin was associated with a significant reduction in risk of pulmonary embolism (PE): SHR?=?0.54, 95% CI: 0.31-0.94, P-value?=?0.02 for the competing risk analysis; HR?=?0.51, 95% CI: 0.30-0.88, P-value?=?0.01 for the cause-specific analysis. Two additional sensitivity analyses using the treatment variable as a time-dependent covariate and using as-treated and per-protocol approaches demonstrated similar findings.This competing risk analysis yields no significant treatment effect on PLDVT but a superior effect of dalteparin on PE compared with UFH in medical-surgical critically ill patients. The findings from the competing risk method are in accordance with results from the cause-specific analysis.clinicaltrials.gov Identifier: NCT00182143.

Project description:ImportanceWhile hospital-associated venous thromboembolism (HA-VTE) is a known complication of hospitalization, contemporary incidence and outcomes data are scarce and methodologically contested.ObjectiveTo define and validate an automated electronic health record (EHR)-based algorithm for retrospective detection of HA-VTE and examine contemporary HA-VTE incidence, previously reported risk factors, and outcomes.Design, setting, and participantsThis cohort study was conducted using hospital admissions between January 1, 2013, and June 30, 2021, with follow-up until December 31, 2021. All medical (non-intensive care unit) admissions at an integrated health care delivery system with 21 hospitals in Northern California during the study period were included. Data were analyzed from January to June 2022.ExposuresPreviously reported risk factors associated with HA-VTE and administration of pharmacological prophylaxis were evaluated as factors associated with HA-VTE.Main outcomes and measuresYearly incidence rates and timing of HA-VTE events overall and by subtype (deep vein thrombosis, pulmonary embolism, both, or unknown), as well as readmissions and mortality rates.ResultsAmong 1 112 014 hospitalizations involving 529 492 patients (268 797 [50.8%] women; 75 238 Asian [14.2%], 52 697 Black [10.0%], 79 398 Hispanic [15.0%], and 307 439 non-Hispanic White [58.1%]; median [IQR] age, 67.0 [54.0-79.0] years), there were 13 843 HA-VTE events (1.2% of admissions) occurring in 10 410 patients (2.0%). HA-VTE events increased from 307 of 29 095 hospitalizations (1.1%) in the first quarter of 2013 to 551 of 33 729 hospitalizations (1.6%) in the first quarter of 2021. Among all HA-VTE events, 10 746 events (77.6%) were first noted after discharge. In multivariable analyses, several factors were associated with increased odds of HA-VTE, including active cancer (adjusted odds ratio [aOR], 1.96; 95% CI, 1.85-2.08), prior VTE (aOR, 1.71; 95% CI, 1.63-1.79), and reduced mobility (aOR, 1.63; 95% CI, 1.50-1.77). Factors associated with decreased likelihood of HA-VTE included Asian race (vs non-Hispanic White: aOR, 0.65; 95% CI, 0.61-0.69), current admission for suspected stroke (aOR, 0.73; 95% CI, 0.65-0.81), and Hispanic ethnicity (vs non-Hispanic White: aOR, 0.81; 95% CI, 0.77-0.86). HA-VTE events were associated with increased risk of readmission (hazard ratio [HR], 3.33; 95% CI, 3.25-3.41) and mortality (HR, 1.63; 95% CI, 1.57-1.70).Conclusions and relevanceThis study found that HA-VTE events occurred in 1.2% of medical admissions, increased over time, and were associated with increased adverse outcomes. These findings suggest that approaches designed to mitigate occurrence and outcomes associated with HA-VTE may remain needed.

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Primary prevention of venous thromboembolism in medical and surgical oncology patients.

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