Efficacy and safety of thromboembolism prophylaxis with fondaparinux in Japanese colorectal cancer patients undergoing laparoscopic surgery: A phase II study

Tokuhara, Katsuji; Matsushima, Hideyuki; Ueyama, Yosuke; Nakatani, Kazuyoshi; Yoshioka, Kazuhiko; Kon, Masanori

doi:10.1016/j.ijsu.2017.04.014

Cited by 10 publications

(11 citation statements)

References 19 publications

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“…A search of PubMed, PubMed Central, and Google Scholar for the terms “colon or colorectal surgery” and “VTE” and of reference lists of retrieved articles identified 20 relevant papers . Many of these studies were retrospective analyses that relied on database searches.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of anticoagulant prophylaxis for prevention of postoperative venous thromboembolism in Japanese patients undergoing laparoscopic colorectal cancer surgery

Hata

Yasui

Ikeda

et al. 2019

Annals of Gastroent Surgery

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Aim To investigate the efficacy and safety of anticoagulant prophylaxis to prevent postoperative venous thromboembolism (VTE) during laparoscopic colorectal cancer (CRC) surgery, which is unknown in Japanese patients. Methods We conducted this randomized controlled trial at nine institutions in Japan from 2011 to 2015. It included 302 eligible patients aged 20 years or older who underwent elective laparoscopic surgery for CRC. Patients were randomly assigned to an intermittent pneumatic compression (IPC) therapy group or to an IPC + anticoagulation therapy group. Anticoagulation therapy comprised fondaparinux or enoxaparin for postoperative VTE prophylaxis. Postoperative VTE was diagnosed based on enhanced multi‐detector helical computed tomography. The primary endpoint was VTE incidence, including asymptomatic cases, the secondary endpoint was incidence of major bleeding, and we conducted an intention‐to‐treat analysis. This study is registered in UMINCTR (UMIN000008435). Results Postoperative VTE incidence was 5.10% with IPC therapy (n = 157) and 2.76% with IPC + anticoagulant therapy (n = 145; P = .293). We identified no symptomatic VTE cases. The major bleeding rates were 1.27% with IPC alone and 1.38% with the combination (P = .936). The overall bleeding rates were 7.69% for enoxaparin and 13.6% for fondaparinux (P = .500), and there were no bleeding‐related deaths. Conclusion Anticoagulant prophylaxis did not reduce the incidence of VTE and the incidence of major bleeding was comparable between the two groups. Usefulness of perioperative anticoagulation was not demonstrated in this study. Pharmacological prophylaxis must be restricted in Japanese patients with higher risk of VTE.

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Section: Introductionmentioning

confidence: 99%

Efficacy and safety of anticoagulant prophylaxis for prevention of postoperative venous thromboembolism in Japanese patients undergoing laparoscopic colorectal cancer surgery

Hata

Yasui

Ikeda

et al. 2019

Annals of Gastroent Surgery

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“…As a type of anticoagulant, fondaparinux has been widely used to prevent VTE and is considered to have certain clinical advantages in cancer patients ( 18 ). For example, one research shows that the incidence of VTE is 2.5% in colorectal cancer patients who received fondaparinux, which proves that it is effective in VTE prevention ( 19 ). Another study finds that fondaparinux reduces VTE and major bleeding events compared with warfarin in cancer patients ( 14 ).…”

Section: Discussionmentioning

confidence: 99%

“…Furthermore, the bleeding events caused by VTE are also noteworthy. A previous study found that the incidence of major bleeding in patients with colorectal cancer after surgery who received fondaparinux was 1.7% ( 19 ). In our study, similar findings revealed that the rates of the bleeding event in cancer patients who received fondaparinux were 2.68% in the hospital and 0.90% at M1.…”

Section: Discussionmentioning

confidence: 99%

“…At present, there were only a few studies reporting the incidence of adverse events in cancer patients who received fondaparinux. A previous study revealed that the incidence rate of adverse events was 10.9% during fondaparinux treatment in colorectal cancer patients undergoing laparoscopic surgery ( 19 ). This was similar to our results, which observed that the rate of adverse events in cancer patients who received fondaparinux was 14.73%.…”

Section: Discussionmentioning

confidence: 99%

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Efficacy and safety of fondaparinux in preventing venous thromboembolism in Chinese cancer patients: a single-arm, multicenter, retrospective study

Wang

Su²,

Xie

et al. 2023

Front. Oncol.

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ObjectiveFondaparinux is a synthetic anticoagulant for the prevention of venous thromboembolism (VTE), and its administration in Chinese cancer patients is rarely reported. This study aimed to assess the efficacy and safety of fondaparinux in preventing VTE in Chinese cancer patients.MethodsA total of 224 cancer patients who received fondaparinux treatment were reviewed in this single-arm, multicenter, retrospective study. Meanwhile, VTE, bleeding, death, and adverse events of those patients in the hospital and at 1 month after treatment (M1) were retrieved, respectively.ResultsThe in-hospital VTE rate was 0.45% and there was no (0.00%) VTE occurrence at M1. The in-hospital bleeding rate was 2.68%, among which the major bleeding rate was 2.23% and the minor bleeding rate was 0.45%. Moreover, the bleeding rate at M1 was 0.90%, among which both the major and minor bleeding rates were 0.45%. The in-hospital death rate was 0.45% and the death rate at M1 was 0.90%. Furthermore, the total rate of adverse events was 14.73%, including nausea and vomiting (3.13%), gastrointestinal reactions (2.23%), and reduced white blood cells (1.34%).ConclusionFondaparinux could effectively prevent VTE with low bleeding risk and acceptable tolerance in cancer patients.

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“…Scores range from 0 to 28, with higher scores indicating a better methodological quality of study. The following cut-points have been suggested to categorize studies by quality: excellent (26)(27)(28), good (20)(21)(22)(23)(24)(25), fair (15)(16)(17)(18)(19), and poor ( < 14).…”

Section: Quality Assessmentmentioning

confidence: 99%

Venous thromboembolism among Asian populations with localized colorectal cancer undergoing curative resection: is pharmacological thromboprophylaxis required? A systematic review and meta-analysis

Tan,

et al. 2024

Ann Coloproctol

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We compared the incidence of venous thromboembolism (VTE) among Asian populations with localized colorectal cancer undergoing curative resection with and without the use of pharmacological thromboprophylaxis (PTP). Methods: A comprehensive literature search was undertaken to identify relevant studies published from January 1, 1980 to February 28, 2022. The inclusion criteria were patients who underwent primary tumor resection for localized nonmetastatic colorectal cancer; an Asian population or studies conducted in an Asian country; randomized controlled trials, case-control studies, or cohort studies; and the incidence of symptomatic VTE, deep vein thrombosis, and/or pulmonary embolism as the primary study outcomes. Data were pooled using a random-effects model. This study was registered in PROSPERO on October 11, 2020 (No. CRD42020206793). Results: Seven studies (2 randomized controlled trials and 5 observational cohort studies) were included, encompassing 5,302 patients. The overall incidence of VTE was 1.4%. The use of PTP did not significantly reduce overall VTE incidence: 1.1% (95% confidence interval [CI], 0%-3.1%) versus 1.9% (95% CI, 0.3%-4.4%; P = 0.55). Similarly, PTP was not associated with significantly lower rates of symptomatic VTE, proximal deep vein thrombosis, or pulmonary embolism. Conclusion:The benefit of PTP in reducing VTE incidence among Asian patients undergoing curative resection for localized colorectal cancer has not been clearly established. The decision to administer PTP should be evaluated on a case-by-case basis and with consideration of associated bleeding risks.

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Efficacy and safety of thromboembolism prophylaxis with fondaparinux in Japanese colorectal cancer patients undergoing laparoscopic surgery: A phase II study

Abstract: There were no cases of PE. It is necessary to establish strict criteria for VTE prophylaxis with FPNX after LAC for Japanese patients considering the incidence of bleeding events.

Cited by 10 publications

References 19 publications

Efficacy and safety of anticoagulant prophylaxis for prevention of postoperative venous thromboembolism in Japanese patients undergoing laparoscopic colorectal cancer surgery

Efficacy and safety of anticoagulant prophylaxis for prevention of postoperative venous thromboembolism in Japanese patients undergoing laparoscopic colorectal cancer surgery

Efficacy and safety of fondaparinux in preventing venous thromboembolism in Chinese cancer patients: a single-arm, multicenter, retrospective study

Venous thromboembolism among Asian populations with localized colorectal cancer undergoing curative resection: is pharmacological thromboprophylaxis required? A systematic review and meta-analysis

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