Review of venous thromboembolism and race: the generalizability of treatment guidelines for high-risk populations

Abstract

The American College of Chest Physicians (ACCP) has established guidelines for the treatment of VTE, but the generalizability to all populations is unclear. In this review we analyzed the rate of reporting and enrollment of blacks and women in clinical trials cited in the ACCP guidelines for treatment of unprovoked VTE. We extracted data from clinical trials cited by the ACCP that compared durations of anticoagulation therapy for the treatment of unprovoked VTE. We excluded trials that treated surgical or cancer patients. For trials that did not report race/ethnicity we contacted the primary investigators via email for enrollment data. The final analysis included 17 randomized clinical trials with a total patient population of N = 13,693. All trials reported data on sex; conversely, 2 trials (11.8 %) reported race/ethnicity within the primary manuscript. We ultimately acquired data on race/ethnicity from the primary investigator in 5 additional trials for a total race/ethnicity data from 7 trials. There were 7573 males (55.3 %) and 6120 females (44.7 %) enrolled in these studies. Among trials that reported race and ethnicity the total patient population was N = 5368; 5171 (96.3 %) white, 115 (2.1 %) black, 65 (1.4 %) Asian and 7 (0.25 %) Hispanic. Racial/ethnic minorities are underreported and under represented in clinical trials forming the cornerstone of ACCP guidelines for the optimal duration for VTE treatment. Conversely, the reporting and inclusion of women was substantive. The guidelines for unprovoked VTE treatment may not be generalizable to racially and ethnically diverse patient populations.

Racial disparities in cancer-associated thrombosis

“… 44 There are additional risk assessment models, including the Prophylaxis of Thromboembolism during Chemotherapy (PROTECHT), Charité Onkologie (CONKO), and Vienna scores, but none of the risk models include race/ethnicity as a predictive variable. 45-47 Racial/ethnic minorities have historically been underrepresented in prior clinical trials looking at treatment of unprovoked VTE, 48 which may be why this parameter has not been included in predictive models.…”

Venous Thromboembolism Prophylaxis and Treatment in Patients With Cancer: ASCO Clinical Practice Guideline Update

“…Indeed, a recent review of guidelines for unprovoked VTE treatment suggests that findings may not be generalizable to racially and ethnically diverse patient populations. 141 Specifically related to VTE in cancer, some studies suggest greater risk of VTE in black patients with cancer and lower risk in Asian patients with cancer. [142][143][144] In an analysis of the SAVE-ONCO thromboprophylaxis trial control arm, after adjustment for baseline characteristics, the risk of VTE in black patients was more than three times All doses are given as subcutaneous injections except as indicated; renal and liver function as well as weight and potential drug-drug interactions must be taken into account when selecting agents and doses.…”

Characteristics of the Wells Score and Associated Factors of Pulmonary Embolisms in Inpatients with Deep Venous Thrombosis

“…Our data showed 8.9% acute DVT, which was quite low compared with 21.0-24.0% of suspected DVT inpatients in other studies. 9,15 This might be influenced by differences in race 18,19 , diseases, environment, medical/mechanical prophylaxis 20,21 or selection bias. Proximal and isolated distal DVT were 92.0% and 18.0%, respectively, compared to other studies with 55.0-57.0% and 43.0-45.0%, respectively.…”