Importance: Low-molecular-weight heparin is recommended over warfarin for the treatment of acute venous thromboembolism (VTE) in patients with active cancer largely based on results of a single, large trial.
Objective: To study the efficacy and safety of tinzaparin vs warfarin for treatment of acute, symptomatic VTE in patients with active cancer.
Design, Settings, And Participants: A randomized, open-label study with blinded central adjudication of study outcomes enrolled patients in 164 centers in Asia, Africa, Europe, and North, Central, and South America between August 2010 and November 2013. Adult patients with active cancer (defined as histologic diagnosis of cancer and receiving anticancer therapy or diagnosed with, or received such therapy, within the previous 6 months) and objectively documented proximal deep vein thrombosis (DVT) or pulmonary embolism, with a life expectancy greater than 6 months and without contraindications for anticoagulation, were followed up for 180 days and for 30 days after the last study medication dose for collection of safety data.
Interventions: Tinzaparin (175 IU/kg) once daily for 6 months vs conventional therapy with tinzaparin (175 IU/kg) once daily for 5 to 10 days followed by warfarin at a dose adjusted to maintain the international normalized ratio within the therapeutic range (2.0-3.0) for 6 months.
Main Outcomes And Measures: Primary efficacy outcome was a composite of centrally adjudicated recurrent DVT, fatal or nonfatal pulmonary embolism, and incidental VTE. Safety outcomes included major bleeding, clinically relevant nonmajor bleeding, and overall mortality.
Results: Nine hundred patients were randomized and included in intention-to-treat efficacy and safety analyses. Recurrent VTE occurred in 31 of 449 patients treated with tinzaparin and 45 of 451 patients treated with warfarin (6-month cumulative incidence, 7.2% for tinzaparin vs 10.5% for warfarin; hazard ratio [HR], 0.65 [95% CI, 0.41-1.03]; P = .07). There were no differences in major bleeding (12 patients for tinzaparin vs 11 patients for warfarin; HR, 0.89 [95% CI, 0.40-1.99]; P = .77) or overall mortality (150 patients for tinzaparin vs 138 patients for warfarin; HR, 1.08 [95% CI, 0.85-1.36]; P = .54). A significant reduction in clinically relevant nonmajor bleeding was observed with tinzaparin (49 of 449 patients for tinzaparin vs 69 of 451 patients for warfarin; HR, 0.58 [95% CI, 0.40-0.84]; P = .004).
Conclusions And Relevance: Among patients with active cancer and acute symptomatic VTE, the use of full-dose tinzaparin (175 IU/kg) daily compared with warfarin for 6 months did not significantly reduce the composite measure of recurrent VTE and was not associated with reductions in overall mortality or major bleeding, but was associated with a lower rate of clinically relevant nonmajor bleeding. Further studies are needed to assess whether the efficacy outcomes would be different in patients at higher risk of recurrent VTE.
Trial Registration: clinicaltrials.gov Identifier: NCT01130025.
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http://dx.doi.org/10.1001/jama.2015.9243 | DOI Listing |
Sci Rep
December 2024
Department of Urology, The Jikei University School of Medicine, Kashiwa Hospital, Kashiwashita 163-1, Kashiwa, Chiba, 277-8567, Japan.
To evaluate the safety and efficacy of the Saroa Surgical Robot System in robot-assisted laparoscopic radical prostatectomy (RARP). We enrolled 60 patients who underwent RARP using either the Saroa (n = 9) or da Vinci Xi (n = 51) systems at Jikei University Kashiwa Hospital from January 2022 to March 2024. We compared preoperative characteristics, perioperative outcomes, complications, and postoperative urinary continence at three months between the two groups.
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December 2024
National Centre for Diseases Prevention and Health Promotion, Istituto Superiore di Sanità, Rome, Italy.
This study aimed to calculate Italy's first national maternal mortality ratio (MMR) through an innovative record-linkage approach within the enhanced Italian Obstetric Surveillance System (ItOSS). A record-linkage retrospective cohort study was conducted nationwide, encompassing all women aged 11-59 years with one or more hospitalizations related to pregnancy or pregnancy outcomes from 2011 to 2019. Maternal deaths were identified by integrating data from the Death Registry and national and regional Hospital Discharge Databases supported by the integration of findings from confidential enquiries conducted through active surveillance.
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December 2024
Department of Gastroenterology, The Second Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang city, Jiangxi province, China.
P2X7 receptor (P2X7R) plays a role in regulating tumor progression, but it is unclear whether P2X7R affects the pathological characteristics of patients with gastric cancer and the activity of gastric cancer cells. Therefore, this study preliminarily investigated the relationship between P2X7R and clinicopathological features of patients with gastric cancer, and further explored the effect of P2X7R on the proliferation, migration and invasion of gastric cancer cells through functional experiments. The results showed that P2X7R was highly expressed in gastric cancer tissues and gastric cancer cells.
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December 2024
Faculty of Dental Medicine and Oral Health Sciences, McGill University, Montreal, Canada.
Accurate diagnosis of oral lesions, early indicators of oral cancer, is a complex clinical challenge. Recent advances in deep learning have demonstrated potential in supporting clinical decisions. This paper introduces a deep learning model for classifying oral lesions, focusing on accuracy, interpretability, and reducing dataset bias.
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December 2024
Molecular Biology and Genetics Laboratory (LGBM), UFMS - Federal University of Mato Grosso do Sul, Três Lagoas, Brazil.
Sickle cell anemia (SCA) is a monogenic blood disease with complex and multifactorial pathophysiology. The endocannabinoid system (ECS) could be a candidate for modulating SCA complications, such as priapism, as it has demonstrated an essential role in hematopoiesis, platelet aggregation, and immune responses. We evaluated the association of ECS-related single nucleotide polymorphisms (SNP) (FAAH rs324420, MAGL rs604300, CNR1 rs7766029, and CNR2 rs35761398) with priapism in a Brazilian SCA cohort.
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