OC 54.1 - Rivaroxaban or placebo for extended antithrombotic prophylaxis after laparoscopic surgery for colorectal cancer

Tuesday, July 12, 2022

10:45 AM – 11:00 AM

Location: ExCel Center, ICC Capital Suite Room 14-16

Presentation Format: In-Person

Presenting Author(s)

CB

Cecilia Becattini, PhD

Professor
University of Perugia
Perugia, Umbria, Italy

Co-Author(s)

UP

Ugo Pace

MD
National Cancer Institute, "G. Pascale" Foundation, Napoli
Napoli, Campania, Italy
FP

Felice Pirozzi

MD
Department of General Surgery, Santa Maria delle Grazie Hospital, Pozzuoli
Pozzuoli, Campania, Italy
AD

Annibale Donini

Professor
Oncology Surgery, University of Perugia, Perugia
Perugia, Umbria, Italy
GA

Giampiero Avruscio

Professor
University Hospital of Padua, Padua
Padova, Veneto, Italy
FR

Fabio Rondelli

Professor
S. Giovanni Battista Hospital, Foligno
Foligno, Umbria, Italy
MB

Michela Boncompagni

MD
General Surgery, S. Maria della Misericordia Hospital, Perugia
Perugia, Umbria, Italy
DC

Damiano Chiari

MD
, Istituto Clinico Humanitas Mater Domini, Castellanza, Varese
Castellanza, Lombardia, Italy
MD

Marco De Prizio

MD
General Surgery, S. Donato Hospital, Arezzo
Arezzo, Toscana, Italy
AV

Adriana Visonà

MD
Vascular Medicine, S.Giacomo Apostolo Hospital, Catelfranco Veneto, Treviso
Treviso, Veneto, Italy
RD

Raffaele De Luca

MD
Surgical Oncology IRCCS Istituto Tumori " Giovanni Paolo II, Bari
Bari, Puglia, Italy
FG

Francesco Guerra

MD
General Surgery, Ospedali Riuniti Marche Nord – Pesaro
Pesaro, Marche, Italy
AM

Andrea Muratore

MD
General Surgery, E. Agnelli Hospital – Pinerolo
Pinerolo, Piemonte, Italy
GP

Giuseppe Portale

MD
General Surgery, Cittadella Hospital, AULSS 6 Euganea
Cittadella, Veneto, Italy
Marc Righini, MD

MD
Division of Angiology and Hemostasis, Geneva University Hospital and Faculty of Medicine, Geneva, Switzerland
Geneve, Geneve, Switzerland
SF

Stefania Frasson

Project manager
Research Department, FADOI Foundation, Milan
Milano, Lombardia, Italy
FD

Francesco Dentali

Professor
ASST “Sette Laghi”, Insubria University, Varese
Varese, Lombardia, Italy
PD

Paolo Del Rio

MD
National Cancer Institute, "G. Pascale" Foundation, Napoli
Napoli, Campania, Italy
GG

Gualberto Gussoni

Project manager
Research Department, FADOI Foundation, Milan
Milano, Lombardia, Italy
Giancarlo Agnelli, MD

Professor
University of Perugia
Perugia, Umbria, Italy

Background: The clinical benefit of extended prophylaxis for venous thromboembolism after laparoscopic surgery for cancer is unclear. The efficacy and safety of direct oral anticoagulants for this indication are unexplored.

Aims: To assess the efficacy and safety of extended prophylaxis with rivaroxaban in comparison to placebo after laparoscopic surgery for colorectal cancer.

Methods: PROLAPS-II was a randomized, double-blind, placebo-controlled, investigator-initiated, superiority study. Consecutive patients who had laparoscopic surgery for colorectal cancer. All patients received antithrombotic prophylaxis with low-molecular-weight heparin from surgery to randomization. Patients were randomized to receive rivaroxaban (10mg once daily) or placebo to be started at 7±2 days after surgery and given for the subsequent 3 weeks. The primary study outcome was the composite of symptomatic objectively confirmed venous thromboembolism, asymptomatic ultrasonography-detected deep vein thrombosis or venous thromboembolism-related death at 28±2 days after surgery. The primary safety outcome was major bleeding.

Results: Patient recruitment was prematurely closed due to study drug expiry after the inclusion of 582 of the 646 planned patients. A primary study outcome event occurred in 11 of 282 patients in the placebo group compared with three of 287 in the rivaroxaban group (3.9 vs 1.0%; risk difference -0.029, 95% CI -0.054 to -0.003; P=0.028). Major bleeding occurred in none of the patients in the placebo group and in two patients in the rivaroxaban group (0.7%, 95% CI 0 to 1.0).
In addition, four patients withdrawn study treatment because of adverse effects (2 rivaroxaban and 2 placebo patients). The number needed to treat to achieve the prevention of one primary study outcome event was 34. The number needed to harm to have a major bleeding complication was 143.

Conclusion(s): Oral rivaroxaban was more effective than placebo for extended prevention of venous thromboembolism after laparoscopic surgery for colorectal cancer without an increase in major bleeding. (ClinicalTrials.gov. number NCT03055026)