Rivaroxaban vs placebo for extended antithrombotic prophylaxis after laparoscopic surgery for colorectal cancer

Abstract

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. PROLAPS-II was a randomized, double-blind, placebo-controlled, investigator-initiated, superiority study aimed at assessing the efficacy and safety of extended prophylaxis with rivaroxaban after laparoscopic surgery for colorectal cancer. Consecutive patients who had laparoscopic surgery for colorectal cancer 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. All patients received antithrombotic prophylaxis with low-molecular-weight heparin from surgery to randomization. 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. Patient recruitment was prematurely closed due to study drug expiry after 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%; odds ratio, 0.26; 95% confidence interval, 0.07 to 0.94; log-rank P=0.032). Major bleeding occurred in none of the patients in the placebo group and in two patients in the rivaroxaban group (0.7%, 95% confidence interval 0 to 1.0). 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. Trial registration: ClinicalTrials.gov. number NCT03055026

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

“…The two larger studies of extended postoperative thromboprophylaxis are discussed in detail in the Recommendations section. 11,12 Five eligible RCTs addressed VTE treatment. Two of the five 19,20 assessed rivaroxaban and did not alter recommendations from the 2019 guideline, which listed rivaroxaban as an option for VTE treatment.…”

Antiaggreganti piastrinici e anticoagulanti: le competenze dell’internista

“…64 È una condizione in continuo incremento dal punto di vista epidemiologico, 65 determina un aumento di circa il 50% della probabilità di sviluppare FA, 66 senza tuttavia rappresentare un fattore di rischio per ictus o sanguinamento. 67 L'obesità comporta una serie di conseguenze dal punto di vista fisiopatologico, tra cui un aumento dell'attività del citocromo P450 2E1 (CYP2E1) e dell'attività di coniugazione di fase II, 68 Impiego degli anticoagulanti nella fibrillazione atriale non si verificavano differenze significative tra apixaban e warfarin nell'incidenza di ictus/embolia sistemica (HR 0,76, 95% CI 0,55-1,05) o di eventi emorragici (HR 0,84, 95% 0,67-1,07). 69 Nell'EN-GAGE AF-TIMI 48 un aumento del BMI era associato ad un minor rischio di eventi trombotici, ad una migliore sopravvivenza, ma ad un maggior rischio di sanguinamento.…”

“…Lo studio PRO-LAPS II, 67 sponsorizzato da FADOI, ha arruolato 582 pazienti per comparare l'efficacia e la sicurezza di una profilassi estesa a 4 settimane dopo intervento laparoscopico per neoplasia colorettale. Dopo una settimana di EBPM profilattica i pazienti sono stati randomizzati a rivaroxaban 10 mg al dì o placebo.…”

Rivaroxaban bei tumorassoziierter venöser Thromboembolie

“…Informationen zum Design der Studie PRO-LAPSII zur verlängerten Primärprävention der CAT bei stationären tumorchirurgischen Patienten finden sich in der Supplement-Tabelle 1 [23]. In der Rivaroxaban-Gruppe trat der kombinierte thromboembolische Endpunkt signifikant seltener auf als in der Placebo-Gruppe (1,0 % vs. 3,9 %; HR 0,27; 95 % KI 0,07-0,96).…”