fondaparinux and Colorectal-Neoplasms

We aimed to assess the safety and efficacy of fondaparinux (FPNX) for patients undergoing laparoscopic colorectal surgery (LAC).. Patients scheduled for LAC received once-daily subcutaneous injections of FPNX 1.5-2.5 mg for 4-8 days. The primary endpoint was the incidence of bleeding events. The secondary endpoint was the incidence of deep vein thrombosis (DVT) and pulmonary embolism (PE).. Among 128 patients evaluable for efficacy, 119 patients were administered FPNX. Nine patients were excluded owing to intraoperative events, including conversion to open surgery among others. Thirteen patients discontinued treatment owing to anastomotic bleeding (n = 5), anastomotic leakage (n = 3), bleeding at drain insertion site (n = 2), subcutaneous bleeding (n = 1), drug-induced rash (n = 1), and sepsis (n = 1). Among the FPNX discontinuations, there were eight cases of bleeding (6.7%), and two cases of major bleeding (1.7%). In multivariate analysis, operative time >300 min was identified as a risk factor for bleeding events (p = 0.001) secondary to FPNX. The incidence rate of DVT was 2.5% (3/119 cases); these patients were asymptomatic.. 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.

Topics: Adult; Aged; Aged, 80 and over; Colorectal Neoplasms; Factor Xa Inhibitors; Female; Fondaparinux; Hemorrhage; Humans; Laparoscopy; Male; Middle Aged; Polysaccharides; Postoperative Complications; Prospective Studies; Thromboembolism; Venous Thrombosis

Pharmacological thromboprophylaxis after colorectal cancer (CRC) surgery is internationally recommended for venous thromboembolism (VTE) prevention. The aim of this retrospective study was to evaluate the risk factors of postoperative bleeding after elective surgery for patients with primary CRC receiving pharmacological thromboprophylaxis of fondaparinux or enoxaparin.. We experienced consecutive 266 patients who underwent elective surgery for CRC during the study period. Finally, the medical records of 218 patients with CRC administrated fondaparinux or enoxaparin following surgery were retrospectively reviewed to evaluate symptomatic VTE until 28 days and postoperative bleeding comparing perioperative D-dimer levels.. The significant differences in TNM classification staging and type of thromboprophylaxis were observed between postoperative bleeding-negative and bleeding-positive group. There was no statistical significance among other backgrounds of patients between the two groups. One case (0.46%) of symptomatic VTE and total 11 cases (5%) of postoperative bleeding were observed. In the univariate analysis, fondaparinux thromboprophylaxis and early disease-stage CRC (stages 0 and I) were associated with risk for postoperative bleeding. Multivariate analysis revealed that fondaparinux thromboprophylaxis was identified as an independent risk factor of postoperative bleeding. Moreover, preoperative levels of D-dimer in patients with stage IV CRC were significantly higher than those with the other stages. The significant elevation in preoperative D-dimer was also observed in patients with stage II CRC compared to those with stage I CRC. Perioperative levels of D-dimer in patients with advanced disease-stage CRC (stages II, III, and IV) were significantly higher than those in patients with early disease-stage CRC.. Fondaparinux administration and early disease-stage CRC appeared to be risk factors for postoperative bleeding in patients with pharmacological thromboprophylaxis undergoing surgical treatment for CRC. Patients' hypercoagulative condition depending on disease progression of CRC might be related to the occurrence of postoperative bleeding following CRC surgery.

Topics: Aged; Anticoagulants; Colorectal Neoplasms; Disease Progression; Elective Surgical Procedures; Enoxaparin; Female; Fondaparinux; Humans; Incidence; Male; Middle Aged; Neoplasm Staging; Postoperative Hemorrhage; Prognosis; Retrospective Studies; Treatment Outcome; Venous Thromboembolism

Venous thromboembolism is the most common preventable cause of hospital death. The objective of this study was to clarify risk factors for postoperative bleeding related to thromboprophylaxis after laparoscopic colorectal cancer surgery.. The study was conducted at 23 Japanese institutions and included patients with colorectal cancer who underwent laparoscopic or open surgery followed by fondaparinux treatment. We performed a retrospective analysis from a prospectively maintained database. We used multivariate analyses to evaluate clinical risk factors for prophylaxis-related bleeding events.. Different prophylactic treatments for postoperative venous thromboembolism may be necessary in laparoscopic vs open surgery for colorectal cancer.

Topics: Adult; Aged; Aged, 80 and over; Anticoagulants; Colorectal Neoplasms; Female; Fondaparinux; Humans; Japan; Laparoscopy; Male; Middle Aged; Polysaccharides; Postoperative Hemorrhage; Retrospective Studies; Risk Factors; Venous Thromboembolism

The aim of this study was to examine the safety and efficacy of fondaparinux (FPX) for venous thromboembolism (VTE) prophylaxis after colorectal cancer surgery.. Records of 953 patients with colorectal cancer who underwent resection between 2006 and 2013 were reviewed. Patients were divided into two groups: the FPX group (n = 362), treated with subcutaneous FPX plus intermittent pneumatic compression (IPC) and the IPC group (n = 591), treated with IPC alone. The incidence of symptomatic VTE, major bleeding, minor bleeding, and other postoperative complications were compared using propensity score matching.. Symptomatic VTE occurred only in one patient (0.2%) in the IPC group. In the FPX group, the incidence of major and minor bleeding was 0.55% (2 of 362) and 9.4% (34 of 362), respectively. After propensity score matching, there were no differences between the two groups in the incidence of symptomatic VTE, major bleeding, and other common postoperative complications. Only the incidence of minor bleeding was significantly higher in the FPX group compared to the IPC group.. FPX is potentially an effective form of VTE prophylaxis; it is safe in terms of both postoperative bleeding and other common complications after colorectal cancer surgery.

Topics: Adult; Aged; Anticoagulants; Colorectal Neoplasms; Combined Modality Therapy; Drug Administration Schedule; Female; Fondaparinux; Humans; Incidence; Intermittent Pneumatic Compression Devices; Male; Matched-Pair Analysis; Middle Aged; Polysaccharides; Postoperative Complications; Postoperative Hemorrhage; Propensity Score; Retrospective Studies; Treatment Outcome; Venous Thromboembolism

Venous thromboembolism (VTE) is a serious threat for all cancer patients. This study was aimed to assess the VTE treatment of cancer patients in the ambulatory care setting.. This is a prospective non-interventional study, which includes ambulatory cancer patients from office-based oncologists. A standardized case report form was used to obtain data on patient characteristics, treatment regimens, duration of treatment, and side effects.. Specialists from 34 centers included data from 76 patients. The median patient age was 62 years (range 33-81 years). The 4 most common cancer types were breast cancer (32%), colorectal cancer (18%), lymphoma and lung cancer (each 8%). 18% of the acute VTE cases were treated as inpatients, 80% as outpatients, and 99% with low-molecular-weight heparin (LMWH), unfractionated heparin (UFH), or fondaparinux. After the acute phase, secondary prophylaxis with LMWH/UFH/fondaparinux was planned in 61% of the patients, with oral anticoagulation in 39%. During acute-phase treatment and secondary prophylaxis, no patient had recurrent VTE. 4 patients (5%) experienced minor bleedings.. This study shows that many ambulatory cancer patients with VTE have early tumors, no metastases, and an excellent performance score. Most patients receive LMWHs for secondary prophylaxis, as recommended by the national and international guidelines. Still, a relevant percentage is switched to oral anticoagulants. © 2015 S. Karger GmbH, Freiburg.

Topics: Adult; Aged; Aged, 80 and over; Ambulatory Care; Breast Neoplasms; Colorectal Neoplasms; Female; Fondaparinux; Germany; Guideline Adherence; Heparin; Heparin, Low-Molecular-Weight; Humans; Lung Neoplasms; Lymphoma; Male; Middle Aged; Neoplasms; Polysaccharides; Prospective Studies; Recurrence; Surveys and Questionnaires; Venous Thromboembolism

To investigate the safety and efficacy of fondaparinux (FPX) for venous thromboembolism (VTE) prophylaxis in Japanese patients undergoing colorectal cancer surgery.. The subjects of this multicenter, open-label, prospective observational study were patients undergoing resection of the colon/rectum for colorectal cancer. All patients were given FPX 2.5 or 1.5 mg by subcutaneous injection, once daily for 4-8 days, starting 24 h after surgery. The primary endpoint was any major bleeding event and the secondary endpoint was any symptomatic VTE event.. Between February 2009 and December 2010, 619 patients from 23 institutions were enrolled in this study. The median duration of FPX prophylaxis was 4 days. The incidence of major bleeding was 0.81 % [5/619, 95 % confidence interval (CI) 0.3-1.9] and the incidence of minor bleeding was 9.5 % (59/619, 95 % CI 7.3-12.1). There was no fatal bleeding or symptomatic VTE. Multivariable analysis revealed the following to be risk factors for bleeding events: preoperative platelet count <15 × 10(4)/µl [odds ratio (OR) 4.521], male sex (OR 2.078), and blood loss during surgery <50 ml (OR 2.019).. The administration of 2.5/1.5 mg FPX 24 h after colorectal cancer surgery is safe and effective.

Topics: Aged; Anticoagulants; Asian People; Colorectal Neoplasms; Female; Fondaparinux; Humans; Injections, Subcutaneous; Male; Middle Aged; Polysaccharides; Postoperative Complications; Premedication; Prospective Studies; Safety; Time Factors; Treatment Outcome; Venous Thromboembolism