Edoxaban for 12 Versus 3 Months in Cancer-associated Isolated Distal Deep Vein Thrombosis According to Different Doses: Insights from the ONCO DVT study.

BACKGROUND: The ONCO DVT study revealed the superiority of 12-month relative to 3-month edoxaban treatment for cancer-associated isolated distal deep vein thrombosis (DVT) regarding the thrombotic risk. METHODS: In this pre-specified subgroup analysis of the ONCO DVT study, we stratified the patients into those with a standard edoxaban dose (60 mg/day; N=151) and those with a reduced edoxaban dose (30 mg/day; N=450) and evaluated the clinical outcomes for the 12-month and 3-month treatments. RESULTS: The cumulative 12-month incidence of symptomatic recurrent venous thromboembolism was lower in the 12-month than 3-month group for both the 60 mg (1.3% vs. 11.6%, P=0.02; odds ratio [OR], 0.12; 95% CI, 0.01-0.97) and 30 mg (1.1% vs. 7.6%, P=0.002; OR, 0.14; 95% CI, 0.03-0.60) edoxaban subgroups, which was consistent across the edoxaban doses without a significant interaction (P =0.90). The 12-month cumulative incidence of major bleeding was higher in the 12-month group than 3-month group for the 60 mg edoxaban subgroup (14.3% vs. 4.4%, P=0.046; OR, 3.61; 95% CI, 0.97-13.52), whereas it did not significantly differ between the two groups for the 30 mg edoxaban subgroup (8.7% vs. 8.6%, P=0.89; OR, 0.97; 95% CI, 0.49-1.91), signaling there was a potential interaction (P=0.07). CONCLUSIONS: A 12-month edoxaban regimen for cancer-associated isolated distal DVT was consistently superior to a 3-month regimen, across the edoxaban doses for the thrombotic risk. However, caution was suggested for the standard dose of edoxaban due to the potential for an increased risk of bleeding with prolonged anticoagulation therapy.

The impact of renal function on clinical outcomes of patients with cancer-associated isolated distal deep vein thrombosis: Insights from the ONCO DVT study.

BACKGROUND: The multicenter, open-label, randomized clinical trial ONCO DVT compared 3-month and 12-month edoxaban treatment regimens for isolated distal deep vein thrombosis (DVT) and suggested potential benefits of prolonged edoxaban treatment in terms of thrombotic risk. However, the risk-benefit balance of prolonged edoxaban treatment in patients with renal function remains unclear. OBJECTIVES: To compare the safety and efficacy of 3-month and 12-month edoxaban treatment regimens in patients with cancer-associated isolated distal DVT and different renal functions. METHODS: This pre-specified subgroup analysis of the ONCO DVT study included 601 patients divided into subgroups according to renal function using a 50 mL/min creatinine clearance (Ccr) cutoff. The primary endpoint was symptomatic recurrent venous thromboembolism (VTE) and VTE-related death at 12 months and the major secondary endpoint was major bleeding at 12 months. RESULTS: Among the 601 patients, 131 (21.8 %) comprised the renal dysfunction subgroup. The primary endpoint occurred in 6 (9.7 %) and 1 (1.4 %) patients in the 3-month and 12-month edoxaban groups in the renal dysfunction subgroup, respectively, and in 16 (6.6 %) and 2 (0.9 %) patients in the no renal dysfunction subgroup, respectively. The major secondary endpoint occurred in 9 (14.5 %) and 7 (10.1 %) patients in the 12-month and 3-month edoxaban groups in the renal dysfunction subgroup, and in 13 (5.3 %) and 21 (9.3 %) patients in the no renal dysfunction subgroup, respectively. CONCLUSIONS: A 12-month edoxaban regiment was superior to a 3-month treatment in terms of thrombotic risk irrespective of renal function. A higher bleeding risk was not identified in patients with renal dysfunction who received prolonged edoxaban treatment.

Edoxaban for 12 Months Versus 3 Months in Patients With Cancer With Isolated Distal Deep Vein Thrombosis (ONCO DVT Study): An Open-Label, Multicenter, Randomized Clinical Trial.

BACKGROUND: The optimal duration of anticoagulation therapy for isolated distal deep vein thrombosis in patients with cancer is clinically relevant, but the evidence is lacking. The prolonged anticoagulation therapy could have a potential benefit for prevention of thrombotic events; however, it could also increase the risk of bleeding. METHODS: In a multicenter, open-label, adjudicator-blinded, randomized clinical trial at 60 institutions in Japan, we randomly assigned patients with cancer with isolated distal deep vein thrombosis, in a 1-to-1 ratio, to receive either a 12-month or 3-month edoxaban treatment. The primary end point was a composite of a symptomatic recurrent venous thromboembolism (VTE) or VTE-related death at 12 months. The major secondary end point was major bleeding at 12 months, according to the criteria of the International Society on Thrombosis and Haemostasis. The primary hypothesis was that a 12-month edoxaban treatment was superior to a 3-month edoxaban treatment with respect to the primary end point. RESULTS: From April 2019 through June 2022, 604 patients were randomized, and after excluding 3 patients who withdrew consent, 601 patients were included in the intention-to-treat population: 296 patients in the 12-month edoxaban group and 305 patients in the 3-month edoxaban group. The mean age was 70.8 years, 28% of the patients were men, and 20% of the patients had symptoms of deep vein thrombosis at baseline. The primary end point of a symptomatic recurrent VTE event or VTE-related death occurred in 3 of the 296 patients (1.0%) in the 12-month edoxaban group and in 22 of the 305 patients (7.2%) in the 3-month edoxaban group (odds ratio, 0.13; 95% CI, 0.03-0.44). The major secondary end point of major bleeding occurred in 28 of the 296 patients (9.5%) in the 12-month edoxaban group and in 22 of the 305 patients (7.2%) in the 3-month edoxaban group (odds ratio, 1.34; 95% CI, 0.75-2.41). The prespecified subgroups did not affect the estimates on the primary end point. CONCLUSIONS: In patients with cancer with isolated distal deep vein thrombosis, 12 months was superior to 3 months for an edoxaban treatment with respect to the composite outcome of a symptomatic recurrent VTE or VTE-related death. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03895502.

Endovascular coil embolization for an anomalous splenic artery aneurysm with a splenomesenteric trunk.

We present a case of a splenic artery (SA) aneurysm (SAA) that had arisen abnormally from the superior mesenteric artery in a 63-year-old man who underwent successful endovascular treatment. Although SAAs characterized by this anatomic abnormality are rare, in all 46 reported cases, the SAAs were located at the root of the SA and had originated abnormally from the superior mesenteric artery. This location is different from that of orthotopic SAAs, which are mostly located in the distal third of the SA. The differences in hemodynamics due to the anatomic abnormalities might play an important role in the formation of the anomalous SAAs.

Drug-Coated Balloon versus Plain Balloon Angioplasty in the Treatment of Infrainguinal Vein Bypass Stenosis: A Systematic Review and Meta-Analysis.

The optimal endovascular therapy for vein graft stenosis (VGS) following infrainguinal arterial bypass is yet to be established. Drug-coated balloons (DCB) have rapidly improved the inferior patency outcomes of angioplasty using a conventional plain balloon (PB). This study compares the efficacy of DCBs and PBs for the treatment of infrainguinal VGS. This systematic review and meta-analysis was performed according to the PRISMA statement. Multiple electronic searches were conducted in consultation with a health science librarian in September 2022. Studies describing the comparative outcomes of angioplasty using DCBs and PBs in the treatment of infrainguinal VGS were eligible. Datasets from one randomized controlled trial and two cohort studies with a total of 179 patients were identified. The results indicated no significant difference in target lesion revascularization between DCBs and PBs (OR, 0.64; 95% CI, 0.32-1.28; p = 0.21), with no significant heterogeneity between studies. Additionally, differences in primary patency, assisted primary patency, secondary patency, and graft occlusion were not significant. Subgroup analysis showed similar effects for different DCB devices. In conclusion, DCBs showed no significant benefit in the treatment of VGS compared to PBs. Given the small population size of this meta-analysis, future trials with a larger population are desired.

In Situ Reconstruction with Extended Debridement in Patients with Mycotic Abdominal Aortic Aneurysms.

The surgical outcomes in patients with mycotic aortic aneurysm are still poor. In situ reconstruction and extra-anatomical bypass are the 2 main surgical options used in these patients, both of which have postoperative complications: recurrence of infection and aortic stump blowout, respectively. We performed in situ reconstruction in 25 consecutive patients with mycotic abdominal aortic aneurysms together with extended debridement using an irrigation device, omental flap coverage, rifampicin-soaked prosthetic graft, and sufficient antibiotics administration. There were 3 in-hospital mortalities; however, no infection- or procedure-related adverse events were observed in other cases during the mid-term follow-up period.

Xenopericardial roll graft replacement for infectious pseudoaneurysms and graft infections of the aorta.

BACKGROUND: Which graft material is the optimal graft material for the treatment of infected aortic aneurysms and aortic graft infections is still a matter of controversy. Orthotopic aortic reconstruction with intraoperatively prepared xenopericardial roll grafts without omentopexy was performed as the "initial" operation to treat aortic infection or as a "rescue" operation to treat graft infection. Mid-term outcomes were evaluated. METHODS: Between 2009 and 2013, orthotopic xenopericardial roll graft replacement was performed to treat eight patients (male/female: 6/2; mean age: 69.5 [55-80] yr). Graft material: equine/bovine pericardium: 2/6; type of operation: initial 4/rescue 4; omentopexy 0. Additional operation: esophagectomy 2. Mean follow-up period: 2.6 ± 1.6 (1.1-5.1) years. RESULTS: Replacement: ascending 3, arch 1 (reconstruction of neck vessels with small xenopericardial roll grafts), descending 3, and thoracoabdominal 1. Pathogens: MRSA 2, MSSA 1, Candida 1, E. coli 1, oral bacillus 1, and culture negative 2. Postoperative local recurrence of infection: 0. Graft-related complications: stenosis 0, calcification 0, non-infectious pseudoaneurysm of anastomosis 2 (surgical repair: 1/TEVAR 1). In-hospital mortality: 2 (MOF: initial 1/rescue 1); Survival rate exclusive of in-hospital deaths (~3 y): 100 %, but one patient died of lung cancer (3.6 yr). CONCLUSIONS: Because xenopericardial roll grafts are not composed of synthetic material, the replacement procedure is simpler and less invasive than the standard procedure. Based on the favorable results obtained, this procedure may have the possibility to serve as an option for the treatment of aortic infections and aortic graft infections not only as a "rescue" treatment but as an "initial" treatment as well.

Ambulatory venous pressure measurements: new parameters derived from a mathematic hemodynamic model.

PURPOSE: The mechanism of venous pressure decrease during exercise still remains unclear. To explore the components involved with the regulation of ambulatory venous pressure, we reinvestigated the pattern of pressure decrease during tiptoe exercise with a newly developed mathematic model. METHODS: Seventeen healthy limbs of 16 volunteers (normal group) and 35 limbs of 33 patients with signs and symptoms of chronic venous insufficiency were studied. Seventeen limbs had superficial venous incompetence (SVI), and 18 showed deep venous incompetence with or without concomitant superficial venous reflux. All subjects were examined with ambulatory venous pressure measurements. As parameters obtained from serial phasic changes in pressure during tiptoe movements, the pressure reduction fraction per step (decreasing component) and the pressure increase per step (increasing component) were calculated with application of the mathematic hemodynamic model and assessed comparatively in the three groups with different types of reflux (normal, SVI, and deep venous incompetence group). RESULTS: The pressure increase per step was significantly different in each of the three groups (P <.0001, with analysis of variance), whereas no apparent difference was seen in the mean pressure reduction fraction per step among the groups. With addition of the inflation of ankle cuff, the value of pressure increase in limbs with SVI was significantly reduced (P =.0004, with Wilcoxon signed rank test), although no changes were seen in the pressure reduction fraction in each group. CONCLUSION: Our results indicate that the pressure reduction fraction, representing calf muscle pump function, is independent of the existence or site of valve incompetence. On the other hand, the pressure increase, corresponding to the degree of reflux during exercise, correlates strongly with the severity of venous insufficiency. The theoretic model can separate the two components responsible for ambulatory venous pressure changes, calf muscle pump function and venous reflux, and provide better understanding of venous hemodynamics.