Rivaroxaban or vitamin-K antagonists following early endovascular thrombus removal and stent placement for acute iliofemoral deep vein thrombosis.

BACKGROUND: The optimal anticoagulant following catheter-based therapy of acute iliofemoral deep vein thrombosis (IFDVT) is unknown. METHODS: From the Swiss Venous Stent registry, an ongoing prospective cohort study, we performed a subgroup analysis of patients with acute IFDVT who underwent catheter-based early thrombus removal followed by nitinol stent placement. Duplex ultrasound and Villalta scores were used to determine patency rates and incidence of the post-thrombotic syndrome (PTS) in patients treated with either rivaroxaban (n = 73) or a vitamin K-antagonist (VKA; n = 38) for a minimum duration of 3 months. RESULTS: Mean follow-up duration was 24 ±â€¯19 months (range 3 to 77 months). Anticoagulation therapy was time-limited (3 to 12 months) in 56% of patients (47% in the rivaroxaban group and 58% in the VKA group, p = 0.26), with shorter mean duration of anticoagulation in the rivaroxaban group (180 ±â€¯98 days versus 284 ±â€¯199 days, p = 0.01). Overall, primary and secondary patency rates at 24 months were 82% (95%CI, 71-89%) and 95% (95%CI, 87-98%), respectively, with no difference between the rivaroxaban (87% [95%CI, 76-94%] and 95% [95%CI, 85-98%]) and the VKA group (72% [95%CI, 52-86%] and 94% [95%CI, 78-99%]; p > 0.10 for both). Overall, 86 (86%) patients were free from PTS at latest follow-up, with no difference between the rivaroxaban and the VKA groups (57 [85%] versus 29 [88%]; p = 0.76). Two major bleeding complications (1 in each group) occurred in the peri-interventional period, without any major bleeding thereafter. CONCLUSIONS: In patients with acute IFDVT treated with catheter-based early thrombus removal and venous stent placement, the effectiveness and safety of rivaroxaban and VKA appear to be similar. CLINICAL TRIAL REGISTRATION: The study is registered on the National Institutes of Health website (ClinicalTrials.gov; identifier NCT02433054).

[Recanalization of lower-limb deep veins as an index of efficacy of treatment for acute venous thrombosis]. / Rekanalizatsiia glubokikh ven nizhnikh konechnostei kak pokazatel' éffektivnosti lecheniia ostrogo venoznogo tromboza.

The authors analysed the results of examination and treatment of a total of 102 patients presenting with iliofemoral venous thrombosis. During treatment, ultrasonographic duplex scanning was used to determine the localization of the proximal margin of thrombotic masses, the time of appearing of the first signs of recanalization, its degree at various levels of the deep venous system, as well as alteration in velocity of the venous blood flow in the deep veins of the lower limbs. The dynamics of clinical symptoms was assessed by the visual analogue scale. Clinical and instrumental examination was performed on day 10, and then 1, 3, 6 and 12 months after the beginning of treatment. The patients were subdivided into three groups. Group One comprised 38 patients receiving therapy with low-molecular-weight heparin (enoxaprin) followed by switching to indirect anticoagulants (warfarin) combined with venotonics (original highly-purified diosmin 600 mg once daily). Group Two was composed of 33 patients receiving rivaroxaban at a dose of 15 mg twice daily for 3 weeks, followed by 20 mg once daily. Group Tree patients (n=31) were also given rivaroxaban according to the above-described standard regimen but in combination with venotonics (original highly-purified diosmin 600 mg once daily). The obtained findings showed that prescribing rivaroxaban to patients from the first day of the disease made it possible to considerably improve and accelerate the processes of restoration of patency of deep veins of lower extremities as compared with the patients taking vitamin K antagonists (warfarin). In patients receiving rivaroxaban, there were no cases of residual thrombotic occlusions of the major veins, and recanalization in three fourths of patients was assessed as good and in the remaining third as moderate. In the warfarin group, occlusion in the iliac veins was noted to persist persisted in 13% of patients, with good recanalization observed only in half of the patients. Addition of venotonics (original highly-purified diosmin) to anticoagulants from the first day demonstrated safety of this therapeutic regimen (with no cases of clinically significant haemorrhagic complications revealed) and its high efficacy as compared with monotherapy with rivaroxaban. A combination of diosmin with rivaroxaban turned out more efficient than a combination of diosmin with warfarin.

Combination of factor Xa inhibition and antiplatelet therapy after stenting in patients with iliofemoral post-thrombotic venous obstruction.

OBJECTIVES: Studies addressing optimal postprocedural pharmacological management after endovascular stenting of iliofemoral post-thrombotic venous obstruction are lacking. We report our early clinical experience with a combination of rivaroxaban and clopidogrel in patients after iliofemoral post-thrombotic venous obstruction stenting. METHODS: Demographic, procedural, and follow-up data of nine patients (seven women; mean age of 32 ± 11 years) undergoing 10 procedures for iliofemoral post-thrombotic venous obstruction performed between August 2012 and January 2014 were retrospectively reviewed. After endovascular intervention, all patients were administered 20 mg rivaroxaban once daily (s.i.d.) and 75 mg clopidogrel s.i.d. or every second day depending on the individual drug responsiveness for at least six months. The adenosine diphosphate-induced platelet aggregation (platelet aggregation, in aggregation units × min) was assessed on a Multiplate analyzer. Patency was verified venographically at procedure end and was evaluated with duplex ultrasound in regular follow-ups. RESULTS: Iliofemoral venous flow was successfully re-established by percutaneous endovascular angioplasty and stent implantation in nine left-sided and one bilateral iliofemoral post-thrombotic venous obstruction. Under dual treatment strategy of rivaroxaban and clopidogrel with platelet aggregation control (median (range): 285 aggregation units × min (192; 402)), none of the patients experienced restenosis or stent thrombosis, respectively. After a median follow-up of 14 months (range: 6-26 months), the primary patency rate was 100% and no in-stent restenosis, stent occlusion or relevant minor or major bleeding occurred. CONCLUSION: Combined factor Xa inhibition and tailored antiplatelet therapy after stenting of iliofemoral post-thrombotic venous obstruction were safe and performed favorably in terms of vessel patency.

Angiosarcoma of common iliac vein.

Angiosarcoma is a rare malignant tumour of endothelial cells. Primary angiosarcoma of venous origin is extremely rare, and has a very poor prognosis. A 63-year-old woman with retroperitoneal mass underwent en bloc resection on a part of iliac vein followed by adjuvant radiotherapy. No recurrence was detected during 3 years of follow-up.

[Resection of the Right External Iliac Artery and Vein after Local Recurrence of Cecal Cancer].

A 62-year-old woman was admitted with abdominal pain and distention in July 2013. Computed tomography (CT) revealed a small bowel obstruction caused by an ileocecal tumor, and colonoscopy revealed a type 3 cecal tumor. Because an ileus tube was not effective to relieve her symptoms, she was transferred to the Department of Surgery for an emergency operation. Open resection of the ileocecal tumor along with the right ureter and psoas was performed. Histological examination showed that cancer cells were present in the radial margin. The patient was treated with a post-operative course of chemotherapy (capecitabine and oxaliplatin), but the level of carcinoembryonic antigen was increasing; positron emission tomography (PET) revealed a local cancer recurrence. Although the right external iliac artery and reconstructed right ureter were encased by the tumor, there were no signs of lymph node metastasis or distant metastasis. Because the tumor was localized, we decided to perform a re-excision. Intraoperatively, the right external iliac vein was difficult to separate from the tumor. Therefore, we resected the right ureter, kidney, and right external iliac artery and vein en bloc. The right external iliac artery and vein were replaced with grafts. Histopathologically, the reconstructed right ureter was completely invaded by the tumor, and cancer cells had invaded the nearby adventitia of the artery, but the surgical margin was negative. Four months after the second operation, peritoneal dissemination was detected on PET. The patient was followed-up in an outpatient clinic without chemotherapy.

New and effective treatment of experimentally induced venous thrombosis with anti-inflammatory rPSGL-Ig.

BACKGROUND: P-selectin antagonism decreases thrombosis and inflammation in animal models of venous thrombosis (VT) prophylaxis. This study defines results using a P-selectin receptor antagonist for VT treatment. METHODS: Eight juvenile baboons underwent 6 h of iliofemoral venous stasis to produce an occlusive VT. Two days later, animals were treated for 14 days with rPSGL-Ig, 4 mg/kg (n3), LMWH (n2) or saline (n3) and treatment continued weekly (rPSGL-Ig) or daily (LMWH, saline). The animals were examined and sacrificed 14 days after treatment initiation (n4) or on day 90 (n4). RESULTS: Percent spontaneous vein reopening revealed a significant increase (p <0.05) in the proximal iliac vein in rPSGL-Ig and LMWH animals compared to controls (62%, 70% vs 8%), without differences in inflammation. No anticoagulation, thrombocytopenia, or wound complications were found in rPSGL-Ig animals. At 90 days, recanalization with iliac vein valve competence was found in treated animals. CONCLUSIONS: rPSGL-Ig successfully treated established VT without anticoagulation.

Anti-P-selectin antibody decreases inflammation and thrombus formation in venous thrombosis.

PURPOSE: Venous thrombosis and inflammation are interrelated. P-selectin contributes to activation of leukocyte-mediated inflammation. Therefore, we hypothesized that the neutralization of P-selectin would decrease vein wall inflammation and thrombosis. METHODS: Twelve baboons underwent infrarenal inferior vena caval balloon occlusion to induce thrombosis. Two groups of four baboons received neutralizing intravenous anti-P-selectin antibody (PSab) GA6 or CY1748 before occlusion and at days 2 and 4. Four baboons received saline control injections. One baboon per group was killed at days 2, 6, and 13, and at 2 months. Analysis included phlebography, ultrasound, gadolinium (Gd)-enhanced magnetic resonance venography (reflecting vein wall inflammation), and histologic, morphometric, and protein evaluation of the vein wall. Thrombus presence or absence was assessed. RESULTS: By day 2 in PSab baboons, vein wall Gd enhancement was decreased in the mid-inferior vena cava and the right iliac vein (p < 0.05; GA6 vs control baboons), normalizing by 2 months. The mid-inferior vena cava revealed fewer neutrophils and total leukocytes in PSab baboons; however, for GA6 in the right iliac vein these decreases were not present despite the absence of Gd enhancement; they were decreased with CY1748. PSab baboons demonstrated significantly less thrombus than control baboons (p < 0.01, GA6 and CY1748 vs control baboons). CONCLUSIONS: Anti-P-selectin antibody decreases vein wall inflammation and thrombus formation. Inhibition of P-selectin may be useful in venous thrombosis prophylaxis.