A prospective cohort study of catheter-related thrombosis in cancer patients treated with 1 month of anticoagulation after catheter removal.

The duration of anticoagulation in patients with catheter- related thrombosis (CRT) is not standardized. This is a multiinstitutional prospective pilot study in patients with cancer and upper extremity CRT. Patients received therapeutic enoxaparin for 1 month after catheter removal. Incidence of recurrent thrombosis, hemorrhage, and postthrombotic syndrome (PTS) using the modified Villalta scale, and functional limitation using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire were assessed at months 1, 3, and 6 after catheter removal. Clopper-Pearson exact 95% confidence intervals (CI), Pearson correlations, and Skillings-Mack, and Wilcoxon signed ranks tests were done. Twenty-seven patients from three institutions were enrolled. Feasibility outcomes were not met. Seventy percent (n = 19) of the cohort had hematologic malignancies. Excluding two patients who were still on enoxaparin at study withdrawal, the median total duration of therapeutic enoxaparin was 32 [interquartile range (IQR) 30-52] days in the remaining 25 patients. During the 6 months after catheter removal, the incidence of recurrent thrombosis was 0% (n = 0/20, 95% CI 0-17%) and major hemorrhage was 5% (n = 1/20, 95% CI 0.13-25%). One patient (5%, 95% CI 0.13-25%) had PTS in the affected arm at any visit, and none had severe PTS. Higher PTS scores were associated with higher DASH scores. DASH scores at month 6 were significantly lower compared with month 1 (P = 0.0066). No deaths occurred. A multicenter pilot study of treatment with anticoagulation for 1 month after catheter removal did not meet feasibility outcomes but we found no recurrent thrombosis and a low incidence of PTS.

Anticoagulation in cancer-associated thromboembolism with thrombocytopenia: a prospective, multicenter cohort study.

Venous thromboembolism (VTE) with concurrent thrombocytopenia is frequently encountered in patients with cancer. Therapeutic anticoagulation in the setting of thrombocytopenia is associated with a high risk of hemorrhage. Retrospective analyses suggest the utility of modified-dose anticoagulation in this population. To assess the incidence of hemorrhage or thrombosis according to anticoagulation strategy, we performed a prospective, multicenter, observational study. Patients with active malignancy, acute VTE, and concurrent thrombocytopenia (platelet count <100 000/µL) were enrolled. The cumulative incidences of hemorrhage or recurrent VTE were determined considering death as a competing risk. Primary outcomes were centrally adjudicated and comparisons made according to initial treatment with full-dose or modified-dose anticoagulation. A total of 121 patients were enrolled at 6 hospitals. Seventy-five patients were initially treated with full-dose anticoagulation (62%) and 33 (27%) with modified-dose anticoagulation; 13 (11%) patients received no anticoagulation. Most patients who received modified-dose anticoagulation had a hematologic malignancy (31 of 33 [94%]) and an acute deep vein thrombosis (28 of 33 [85%]). In patients who initially received full-dose anticoagulation, the cumulative incidence of major hemorrhage at 60 days was 12.8% (95% confidence interval [CI], 4.9-20.8) and 6.6% (95% CI, 2.4-15.7) in those who received modified-dose anticoagulation (Fine-Gray hazard ratio, 2.18; 95% CI, 1.21-3.93). The cumulative incidence of recurrent VTE at 60 days in patients who initially received full-dose anticoagulation was 5.6% (95% CI, 0.2-11) and 0% in patients who received modified-dose anticoagulation. In conclusion, modified-dose anticoagulation appears to be a safe alternative to therapeutic anticoagulation in patients with cancer who develop deep vein thrombosis in the setting of thrombocytopenia.

A pilot randomized trial of atorvastatin as adjunct therapy in patients with acute venous thromboembolism.

Venous thromboembolism (VTE) is the third most common cardiovascular disease and optimizing treatment is essential. In this single-center pilot study, we sought to investigate the effects of statins in addition to anticoagulation in patients with acute VTE. We enrolled patients over 18 with an acute proximal lower extremity deep vein thrombosis with or without pulmonary embolism. Patients were randomized to anticoagulation alone (with either warfarin or rivaroxaban) or anticoagulation and atorvastatin 40 mg daily and followed for 9 months. The primary objective was to determine if adjunct atorvastatin reduced thrombin generation, measured by endogenous thrombin potential and/or peak thrombin concentration. Secondary endpoints included recurrent VTE, arterial thrombosis, bleeding events, lipidomic profiles, and symptoms of post thrombotic syndrome. A total of 21 patients were enrolled (11 anticoagulation only and 10 anticoagulation and atorvastatin) over 3.5 years. Endogenous thrombin potential or peak thrombin was not significantly recued with the addition of atorvastatin. Atorvastatin did significantly reduce the mean LDLs at 3 months, without reduction of either d-dimer or high-sensitivity-C reactive protein. Given the low recruitment rate, continuation of the study was deemed futile and the study was terminated early. Barriers to enrollment and completion of study included the many ineligible patients by exclusion criteria (e.g., preexisting statin use, active malignancy, etc.) and high rate of lost follow-up. The pilot study was terminated early but could inform obstacles for future studies investigating the effects of statins in the management of patients with VTE.