The benefit of rivaroxaban in thromboprophylaxis after oncologic lung surgery remains unknown. To evaluate the efficacy and safety of rivaroxaban, patients who underwent thoracic surgery for lung cancer were enrolled, and randomly assigned to rivaroxaban or nadroparin groups in a 1:1 ratio; anticoagulants were initiated 12–24 h after surgery and continued until discharge. Four hundred participants were required according to a noninferiority margin of 2%, assuming venous thromboembolism (VTE) occurrence rates of 6.0% and 12.6% for patients in the rivaroxaban and nadroparin groups, respectively. The primary efficacy outcome was any VTE during the treatment and 30‐day follow‐up periods. The safety outcome was any on‐treatment bleeding event. Finally, 403 patients were randomized (intention‐to‐treat [ITT] population), with 381 included in per‐protocol (PP) population. The primary efficacy outcomes occurred in 12.5% (25/200) of the rivaroxaban group and 17.7% (36/203) of the nadroparin group (absolute risk reduction, −5.2%; 95% confidence interval [CI], [−12.2–1.7]), indicating the noninferiority of rivaroxaban in ITT population. Sensitivity analysis was performed in the PP population and yielded similar results, confirming the noninferiority of rivaroxaban. In the safety analysis population, the incidence of any on‐treatment bleeding events did not differ significantly between the groups (12.2% for rivaroxaban vs. 7.0% for nadroparin; relative risk [RR], 1.9; 95% CI, [0.9–3.7]; p = .08), including major bleeding (9.7% vs. 6.5%; RR, 1.6 [95% CI, 0.9–3.7]; p = .24), and nonmajor bleeding (2.6% vs. 0.5%; RR, 5.2 [95% CI, 0.6–45.2]; p = .13). Rivaroxaban for thromboprophylaxis after oncologic lung surgery was shown to be noninferior to nadroparin.
Background: Non-small-cell lung cancer (NSCLC) with additional nodule(s) located in the same lobe or ipsilateral different lobe were designated as T3 and T4, respectively, which was merely defined by anatomical location of additional nodule(s), regardless of other prognostic factors. Methods: A total of 4711 patients with T1-4, N0-2, M0 NSCLC undergoing complete resection were identified between 2009 and 2014, including 145 patients with additional nodule(s) in the same lobe (T3-Add) and 174 patients with additional tumor nodule(s) in ipsilateral different lobe (T4-Add). Overall survival (OS) was compared using multivariable Cox regression models and propensity score matching analysis (PSM). Results: T3-Add patients [T3-Add versus T3, hazard ratio (HR), 0.695; 95% confidence interval (CI), 0.528–0.915; p = 0.009] and comparable OS with T2b patients through multivariable Cox analysis, and further validated by PSM. T4-Add patients carried a wide spectrum of prognosis, and the largest diameter of single tumor was screened out as the most effective indicator for distinguishing prognosis. T4-Add (⩽3 cm) patients had better OS than T4 patients [T4-Add (⩽3 cm) versus T4, HR, 0.629; 95% CI, 0.455–0.869; p = 0.005] and comparable OS with T3 patients. And T4-Add (>3 cm) patients had comparable OS with T4 patients. Conclusion: NSCLC patients with additional nodule(s) in the same lobe and ipsilateral different lobe (maximum tumor diameter ⩽ 3 cm) should be further validated and considered restaging as T2b and T3 in the forthcoming 9th tumor, node, and metastasis staging system.
Background Survival time varies greatly in patients with idiopathic pulmonary fibrosis (IPF). An assessment method that can accurately assess the severity and prognosis of idiopathic pulmonary fibrosis is currently lacking. This study aimed to develop a new method, which can be easily used to assess pulmonary fibrosis severity. Method 1. Development of a HRCT combined pulmonary function & physiological parameter (CTPF) assessment method: The method included two parts. 1) CT-based fibrosis staging: Four representative lung CT sections were selected and evenly divided into 100 small areas. The percentage of honeycomb lesion area in the four sections was determined fibrosis stage,2) PF-based severity grade: FVC%pred,DLco%pred,SpO2% age and gender were used to assess PF severity grade. 2. Validation of the new method: The method was used to assess 192 patients with IPF. Two radiologists used the CT-based fibrosis staging method to determine the fibrosis stage. Pulmonologist determined the PF severity grade. 3. Statistical analyses: Intra-group correlation coefficient to estimate the consistency between the CT scores from the two radiologists. Spearman correlation coefficient to evaluate the correlation between CT scores and lung function parameters. The competitive risk Fine–Gray model was used to analyze the relationship between CT-based stage/PF-based grade and prognosis. CT-based stage, PF-based grade, and GAP stage were used as predictors to predicted the death risk. Results 1. The intra-group correlation coefficient of the CT scores of the two radiologists was 0.95, P<0.05. 2. The CT scores negatively correlated with pulmonary function. 3. The CTPF comprehensive model, showed higher predictive accuracy. Conclusion Combined CT-based staging and PF-based grading methods CTPF can be adopted easily in clinical practice, and can assess IPF severity and predict death risk more accurately.
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