PB0933 - A randomized clinical trial to evaluate the effect of rosuvastatin with enoxaparin on circulating tissue factor extracellular vesicles following ovarian cancer surgery

Monday, July 11, 2022

6:30 PM – 7:30 PM

Location: Exhibition

Presentation Format: In-Person

Co-Author(s)

AO

Alm Osataphan

Physician
BIDMC
Boston, Massachusetts, United States

Presenting Author(s)

RP

Rushad Patell, MD

Assistant Professor of Medicine
Division of Hematology and Hematologic Malignancies, Beth Israel Deaconess Medical Center, Boston, MA
Boston, Massachusetts, United States

Co-Author(s)

RR

Rachel P. Rosovsky

Associate Professor
Massachusetts General Hospital
Boston, Massachusetts, United States
PE

Pavania Elavalakanar

Research Coordinator
Division of Hematology and Hematologic Malignancies, Beth Israel Deaconess Medical Center, Boston, MA
Boston, Massachusetts, United States
AB

Amy Bregar

Physician
MGH
Boston, Massachusetts, United States
AR

Amanda Ramos

Researcher
MGH
Boston, Massachusetts, United States
LG

Leslie Garrett

Physician
BIDMC
Boston, Massachusetts, United States
SR

Siyang Ren

Statistician
Dana Farber
Boston, Massachusetts, United States
DN

Donna Neuberg

Senior Lecturer
Dana Farber
Boston, Massachusetts, United States
MS

Meghan Shea

Physician
BIDMC
Boston, Massachusetts, United States
JZ

Jeffrey Zwicker, MD

Chief, Benign Hematology
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States

Background: Ovarian cancer is among the most prothrombotic tumor diagnoses, and the majority of venous thromboembolism (VTE) occur within 60 days of surgery. Tissue factor bearing extracellular vesicles (TF-EV) are prothrombotic and have been linked to thrombosis in cancer and hypercoagulability of surgery. Rosuvastatin has been shown to reduce the generation of EV and decrease VTE risk in non-cancer populations. Whether rosuvastatin reduces TF-EV and prevents VTE following ovarian cancer surgery is unknown.

Aims: To evaluate effect of combining rosuvastatin with enoxaparin on circulating TF-EV following ovarian cancer surgery.

Methods: In a pilot trial for women undergoing ovarian cancer, women were randomized to enoxaparin 40 mg daily for 30 days or enoxaparin 40 mg for 30 days with rosuvastatin 40 mg daily from days 15 to 60. Women who did not want randomization received enoxaparin 40 mg for 30 days per standard of care. Total EV and TF-EV were assessed by flow cytometry. Bilateral lower extremity ultrasound was performed on day 30 and 60.

Results: Sixteen women received enoxaparin alone and seven women were randomized to enoxaparin with rosuvastatin. Circulating TF-EV were markedly elevated after surgery and decreased with time (Figure 1). There was no difference in number of circulating TF-EV with enoxaparin versus enoxaparin with rosuvastatin on day 30 (7.7±10.9 x103 TF-EV /uL versus 5.7±5.1 x103 TF-EV /uL, p=0.65) or day 60 (5.6±6.2 TF-EV/uL vs. 3.8±3.6x103 TF-EV/uL, p=0.53 respectively). Similarly, there were no differences in CRP or D-dimer between groups. No one experienced lower extremity deep vein thrombosis although portal vein thrombosis was diagnosed in enoxaparin arm. No major hemorrhages were observed.

Conclusion(s): The addition of rosuvastatin to enoxaparin following ovarian cancer surgery does not appear to impact number of circulating EV-TF nor alter markers of coagulation. Asymptomatic DVT was not observed in this cohort following ovarian cancer surgery.