Abstract Number: PB2111
Meeting: ISTH 2020 Congress
Theme: Venous Thromboembolism and Cardioembolism » Cancer Associated Thrombosis
Background: ADAM-VTE, a randomized clinical trial (RCT) for the treatment of cancer-associated acute venous thromboembolism (VTE) found superior efficacy with no major bleeding events in the apixaban arm compared to a dalteparin arm.
Aims: The ADAM-VTE Registry was established to assess the effect of anticoagulant choice on the safety and efficacy outcomes of the patients screened but who did not participate in the ADAM-VTE RCT at Mayo Clinic. The goal was to provide an internal validation of the clinical trial results.
Methods: Data of patients screened for trial participation from the Mayo Clinic Rochester MN campus who were not randomized in the ADAM VTE trial were reviewed to assess VTE recurrence, major bleeding, clinically- relevant non-major bleeding (CRNMB) and survival by treatment strategy.
Results: During trial recruitment (11/20/2015-10/2/2017), 288 patients at Mayo Clinic Rochester were screened for enrollment. Of these, 146 (50.7%) refused participation or did not meet inclusion criteria. One hundred thirty one patients (mean age 62.9±12.9 years, 45.9% females) (Table 1 demographics) were treated with either apixaban (n=53), enoxaparin (n=52), warfarin (n=12), rivaroxaban (n=6) or heparin (n=5). Three patients received more than one anticoagulant. The most common types of cancer were: gastrointestinal 23 (18.6%), genitourinary/ovarian 19 (15.3%), hematologic 19 (15.3%), pancreatic/hepatobiliary 16 (12.9%), lung 11 (8.9%), and breast 9 (7.3%). Major bleeding, CRNMB, and VTE recurrence were low and similar for apixaban and LMWH treatment groups (Table 2). Survival was significantly better for those patients treated with apixaban (p=0.03) potentially due to selection bias.
Conclusions: Although limited by small numbers, the ADAM VTE Registry found similar low rates of bleeding outcomes shown in the ADAM-VTE randomized clinical trial.
Demographic variables, n (%) | ADAM-VTE Registry (n=131) |
Any PE, n (%) | 75 (57.3) |
Any DVT, n (%) | 84 (64.1) |
Both PE and DVT, n (%) | 28 (21.4) |
Previous VTE, n (%) | 14 (10.9) |
Active chemotherapy, n (%) | 71 (57.3) |
Body weight kg, mean ± SD (range) | 86.0 ± 25.6 (43.0-213.0) |
Platelet count, mm3±SD (range) | 243.3 ± 124.0 (18.0-642.0) |
Creatinine Clearance, ml/min ± SD (range) | 1.0 ± 0.4 (0.4-3.4) |
[Table 1. Demographics.]
Outcome at 6-months | All patients (n=131) | Apixaban (n=53) | Enoxaparin (n=52) | p-value |
VTE recurrence | 1 (0.8%) | 0 (0%) | 0 (0%) | NS |
Major bleeding | 9 (7.0%) | 1 (1.9%) | 3 (5.7%) | 0.64 |
CRNMB | 4 (3.1%) | 1 (1.9%) | 1 (1.9%) | 1.0 |
Mortality | 22 (17.2%) | 3 (5.7%) | 14 (26.9%) | 0.03 |
[Table 2. Outcomes.]
To cite this abstract in AMA style:
Wysokinska E, Houghton D, Hodge D, Ashrani A, Wysokinski W, Loprinzi C, McBane R. Non-Randomized Patient Outcomes. ADAM-VTE Registry Analysis [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/non-randomized-patient-outcomes-adam-vte-registry-analysis/. Accessed April 26, 2024.« Back to ISTH 2020 Congress
ISTH Congress Abstracts - https://abstracts.isth.org/abstract/non-randomized-patient-outcomes-adam-vte-registry-analysis/