Comparing Safety and Efficacy of Rivaroxaban with Warfarin for Patients after Successful Stent Placement for Chronic Iliofemoral Occlusion: A Retrospective Single Institution Study.

OBJECTIVE: The aim was to compare the safety and effectiveness of rivaroxaban and warfarin as anticoagulants for treating patients with post-thrombotic syndrome (PTS) with chronic iliofemoral venous occlusion undergoing iliofemoral venous stenting. METHODS: This single institution retrospective study analysed patients with PTS with chronic iliofemoral venous occlusion who were prescribed rivaroxaban or warfarin for one year after successfully undergoing iliofemoral venous stenting. The primary safety and efficacy endpoints were bleeding complication rate and primary patency rate at one year. Secondary outcomes included Villalta score, symptom recurrence rate, ulcer healing rate, and clinically driven target lesion revascularisation (CD-TLR) rate during follow up. RESULTS: From January 2016 to December 2017, 154 legs from 154 patients were included in this study (69 in rivaroxaban group and 85 in warfarin group). The groups were well matched for patient demographics, clinical characteristics, and procedural details. There was no significant difference between the rivaroxaban group and warfarin group in bleeding complication rate (10% vs. 16%, p = .23, hazard ratio [HR] 0.58, 95% confidence interval [CI] 0.25 - 1.37) at one year, as well as major bleeding complication rate (0% vs. 2%, p = .20, HR 0.16, 95% CI 0.01 - 2.61) and minor bleeding complication rate (10% vs. 14%, p = .40, HR 0.67, 95% CI 0.27 - 1.66). The primary patency rate was higher in the rivaroxaban group at one year (84% vs. 71%, p = .049, HR 0.50, 95% CI 0.26 - 0.96) and at two years (79% vs. 63%, p = .037, HR 0.52, 95% CI 0.29 - 0.93). At a mean follow up of 24 months (range 1 - 42 months), the rivaroxaban group had a significantly lower post-operative Villalta score (4.87 ± 3.51 vs. 6.88 ± 5.85, p = .010, t = 2.64, 95% CI 0.50 - 3.52), lower rate of symptom recurrence (4% vs. 32%, p < .001), lower CD-TLR rates (3% vs. 13%, p = .039), and higher ulcer healing rate (90% vs. 59%, p = .004) than the warfarin group. CONCLUSION: For PTS patients with chronic iliofemoral venous occlusion undergoing iliofemoral venous stenting, rivaroxaban probably exhibited similar safety but superior efficacy to warfarin. However, further prospective control studies with large sample size are necessary to confirm the results.

Electrical calf muscle stimulation in patients with post-thrombotic syndrome and residual venous obstruction after anticoagulation therapy.

BACKGROUND: The aim of this study was to assess the impact of electrical calf muscle stimulation (EMS) on clinical and ultrasound outcomes in patients with post-thrombotic syndrome (PTS) and residual venous obstruction (RVO). METHODS: This was a prospective, comparative, non-randomized clinical trial involving patients who had completed a standard 6-month course of anticoagulation therapy for a first episode of unprovoked femoro-popliteal DVT and had signs of RVO in the affected veins and PTS as shown by a Villalta Score of >5. A blinded outcome assessor performed the ultrasound evaluations. A total of 60 patients in the age range from 40 to 86 years (mean 58.5±11.4) consisting of 38 men and 22 women were enrolled. They were divided into two groups of 30 participants each. Both groups (experimental and control) were treated by active walking, below-knee graduated compression stockings, and micronized purified flavonoid fraction. In the experimental group, EMS with «Veinoplus VI¼ device (three applications for 30 min every day) was also used. The patients were followed for 12 months with monthly DUS to reveal recurrent DVT and changes in RVO. The clinical criteria for treatment efficacy included changes in Villalta, VCSS and CIVIQ-20 scores. RESULTS: Recurrent DVT was found in seven of 30 patients in the control group and in zero of 30 patients in the experimental group (23.3% versus 0%, P=0.01). Through the follow-up period the degree of RVO decreased in all affected veins in both groups (P<0.01). The most significant changes were found in the popliteal vein; 60.8% decreased to 28.8% in the experimental group and 50.9% to 27.3% in the control group (P<0.01) with significant differences between the groups (P<0.01). VCSS, Villalta and CIVIQ-20 scores also significantly decreased in both groups (P<0.01). In the group with EMS, changes in the current parameters were more intensive (P<0.01). CONCLUSIONS: There is an ongoing process of deep vein recanalization during the 12 months after anticoagulant therapy cessation. Use of EMS in PTS treatment allows for reduction of recurrent DVT rates, increase the speed of deep vein recanalization and leads to additional improvement in the clinical PTS outcomes.

Evolución clínica y ultrasonográfica del síndrome postrombótico en su primer año de evolución / Clinical and ultrasonographic progression of posthrombotic syndrome in its first year

Introduccións: La insuficiencia venosa crónica es característica principal del síndrome postrombótico donde el estasis venoso es típico. Objetivos: Describir la evolución clínica y ultrasonográfica del síndrome postrombótico durante su primer año. Métodos: Estudio descriptivo prospectivo en 20 hombres (55,6 por ciento) y 16 mujeres (44,4 por ciento) con una edad promedio de 55,8 ± 14,2 años (IC95 por ciento : 41,6 ­ 70 años), ingresados en el Servicio de Flebolinfología del Instituto Nacional de Angiología y Cirugía Vascular con el diagnóstico de trombosis venosa profunda de los miembros inferiores. Las variables estudiadas fueron: tipos de síntomas clínicos, tipo de evolución ultrasonográfica por ecodoppler, estadios clínicos del síndrome postrombótico, tiempo y porcentaje de recanalización. Resultadoss: A los seis meses de evolución predominó la sintomatología severa (47,2 por ciento); en el sector fémoro­poplíteo la clasificación de buena. Al año, fue más frecuente la clasificación de moderada (52,8 por ciento) y de muy buena en el sector poplíteo; el edema pretibial fue el signo que predominó. En los sectores ocluidos fémoro-poplíteo el porcentaje de recanalización promedio aumentó al año y fue superior (p < 0,05) al obtenido a los seis meses. Se encontró asociación significativa entre el porcentaje de recanalización y el período de evolución (X2= 41,41; p= 0,0000); y entre el estadio clínico y el porcentaje de recanalización (X2= 32,95; p= 0,0000). Conclusións: durante el primer año de presentarse el síndrome postrombótico pueden ocurrir cambios clínicos y evolución favorable en la recanalización del sistema venoso profundo(AU)

Introduction: Chronic venous insufficiency is the main characteristic of the posthrombotic syndrome where the vein stasis is typical. Objective: to describe the clinical and ultrasonographic progression of the post-thrombotic syndrome in its first year. Methods: A descriptive prospective study was conducted in 20 men (55.6 percent) and 16 women (44.4 percent), with average age of 55.8 ± 14.2 years (IC95 percent : 41.6 ­ 70 years) diagnosed as deep venous thrombosis of the lower limb patients and hospitalized in the phlebolymphology service of the National Institute of Angiology and Vascular Surgery. The studied variables were types of clinical symptoms, type of ultrasonographic progression using Echodoppler device, clinical stagings of the posthrombotic syndrome, and time and percentage of re-canalization. Results: After six months of progression, severe symptoms predominated (47.2 percent); and in the femoral-popliteal area the classification was good. After a year, the moderate classification was more frequent (52.8 percent) and extremely good in the popliteal sector; the pretibial edema was the predominant sign (50 percent). In the occluded popliteal-femoral sector, the percentage of average re-canalization increased after a year, being higher (p< 0.05) than that of six months. A significant association was found between the percentage of re-channeling and the period of progression (X2= 41.41; p= 0.0000); and between the clinical staging and the percentage of re-canalization (X2= 32.95, p= 0.0000). Conclusions: During the first year of existence of the posthrombotic syndrome, clinical changes and favorable progression may occur in the re-canalization of the deep venous system(AU)