Highlights
- •Benefit of extended VTE prophylaxis after laparoscopic cancer surgery undefined.
- •A randomized, double-blind study in laparoscopic surgery for colorectal cancer.
- •To assess the clinical benefit of extended prophylaxis with rivaroxaban.
- •PROLAPS II is the first study with an oral anti-Xa agent in cancer surgery.
Abstract
Background
The clinical benefit of extending prophylaxis for venous thromboembolism (VTE) beyond
hospital discharge after laparoscopic surgery for cancer is undefined. Extended prophylaxis
with rivaroxaban is effective in reducing post-operative VTE after major orthopedic
surgery without safety concern.
Methods
PROLAPS II is an investigator-initiated, randomized, double-blind study aimed at assessing
the efficacy and safety of extended antithrombotic prophylaxis with rivaroxaban compared
with placebo after laparoscopic surgery for colorectal cancer in patients who had
received antithrombotic prophylaxis with low molecular-weight heparin for 7 ± 2 days
(NCT03055026). Patients are randomized to receive rivaroxaban (10 mg once daily) or
placebo for 3 weeks (up to day 28 ± 2 from surgery).
The primary study outcome is a composite of symptomatic objectively confirmed VTE,
asymptomatic ultrasonography-detected DVT or VTE-related death at 28 ± 2 days from
laparoscopic surgery. The primary safety outcome is major bleeding defined according
to the International Society of Thrombosis and Haemostasis. Symptomatic objectively
confirmed VTE, asymptomatic ultrasonography-detected DVT, major bleeding or death
by day 28 ± 2 and by day 90 from surgery are secondary outcomes.
Assuming an 8% event rate with placebo and 60% reduction in the primary study outcome
with rivaroxaban, 323 patients per group are necessary to show a statistically significant
difference between the study groups.
Discussion
The PROLAPS II is the first study with an oral anti-Xa agent in cancer surgery. The
study has the potential to improve clinical practice by answering the question on
the clinical benefit of extending prophylaxis after laparoscopic surgery for colorectal
cancer.
Keywords
Abbreviations:
VTE (venous thromboembolism), LMWH (low-molecular-weight heparin), DVT (ultrasonography-detected), OR (Odds Ratio), Cl (Confidence Interval), RRR (Relative Risk Reduction), LOCF (Last Observation Carried Forward), FAS (Full Analysis Set), PP (Per Protocol), DSMB (Data Safety Monitoring Board)To read this article in full you will need to make a payment
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Article info
Publication history
Published online: December 06, 2019
Accepted:
November 19,
2019
Received in revised form:
November 15,
2019
Received:
August 26,
2019
Footnotes
Funding: the study is supported by a grant in aid from Bayer HealthCare
Identification
Copyright
© 2019 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.
