Journal of vascular surgery. Venous and lymphatic disorders · 2017
Randomized double-blinded study comparing medical treatment versus iliac vein stenting in chronic venous disease.
Сравнительное исследованиеСтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Rossi Fabio H, Kambara Antonio M, Izukawa Nilo M, Rodrigues Thiago O, Rossi Cybelle B, Sousa Amanda G, Metzger Patrick B, Thorpe Patricia E
Аннотация
OBJECTIVE: Iliac vein stenting has emerged as the procedure of choice in the treatment of iliac vein obstruction (IVO). However, clinical outcomes have never been studied by a randomized clinical trial. Our purpose was to compare medical and endovascular treatment results in symptomatic chronic venous disease (CVD) patients with significant IVO documented by intravascular ultrasound (IVUS).
METHODS: Patients with Clinical, Etiology, Anatomy, and Pathophysiology clinical class C3 to C6 and a visual analog scale for pain (VAS pain) score >3 were considered eligible. We randomly assigned limbs with ≥50% IVO on IVUS to undergo medical treatment alone or medical treatment plus iliac vein stenting. The patient and clinical physician were blinded. Primary outcomes included change from baseline in VAS pain score, Venous Clinical Severity Score, and 36-Item Short Form Health Survey quality of life questionnaire. Secondary outcomes included stent integrity, migration, and patency rates at 6 months.
RESULTS: Of 207 CVD patients, 58 (28%) were eligible and eight (14%) were excluded; 51 of 85 class C3 to C6 limbs (60%) had ≥50% IVO by IVUS. Iliac vein stenting, in randomized patients, was 100% technically successful. At 6 months' follow-up, the mean VAS pain score declined from a median of 8 to 2.5 in patients receiving stents and from 8 to 7 in patients receiving only medical treatment (P < .001). The Venous Clinical Severity Score dropped from a median of 18.5 to 11 after stenting and from 15 to 14 with medical treatment (P < .001). The 36-Item Short Form Health Survey (0-100) improved from a total median score of 53.9 to 85.0 with stenting and 48.3 to 59.8 after medical treatment (P < .001). There was no stent fracture or migration, and the primary, assisted primary, and secondary patency rates were 92%, 96%, and 100%, respectively (median, 11.8; range, 6-18 months).
CONCLUSIONS: Endovascular treatment of IVO with stenting is safe and promotes effective relief of symptoms and improvement in quality of life compared with medical treatment alone in symptomatic CVD patients. Our results echo those achieved in numerous previously published nonrandomized clinical series.
METHODS: Patients with Clinical, Etiology, Anatomy, and Pathophysiology clinical class C3 to C6 and a visual analog scale for pain (VAS pain) score >3 were considered eligible. We randomly assigned limbs with ≥50% IVO on IVUS to undergo medical treatment alone or medical treatment plus iliac vein stenting. The patient and clinical physician were blinded. Primary outcomes included change from baseline in VAS pain score, Venous Clinical Severity Score, and 36-Item Short Form Health Survey quality of life questionnaire. Secondary outcomes included stent integrity, migration, and patency rates at 6 months.
RESULTS: Of 207 CVD patients, 58 (28%) were eligible and eight (14%) were excluded; 51 of 85 class C3 to C6 limbs (60%) had ≥50% IVO by IVUS. Iliac vein stenting, in randomized patients, was 100% technically successful. At 6 months' follow-up, the mean VAS pain score declined from a median of 8 to 2.5 in patients receiving stents and from 8 to 7 in patients receiving only medical treatment (P < .001). The Venous Clinical Severity Score dropped from a median of 18.5 to 11 after stenting and from 15 to 14 with medical treatment (P < .001). The 36-Item Short Form Health Survey (0-100) improved from a total median score of 53.9 to 85.0 with stenting and 48.3 to 59.8 after medical treatment (P < .001). There was no stent fracture or migration, and the primary, assisted primary, and secondary patency rates were 92%, 96%, and 100%, respectively (median, 11.8; range, 6-18 months).
CONCLUSIONS: Endovascular treatment of IVO with stenting is safe and promotes effective relief of symptoms and improvement in quality of life compared with medical treatment alone in symptomatic CVD patients. Our results echo those achieved in numerous previously published nonrandomized clinical series.
Предметные рубрики MeSH
AdultAgedAngioplasty, BalloonCardiovascular AgentsChronic DiseaseComputed Tomography AngiographyConstriction, PathologicDouble-Blind MethodFemaleHumansIliac VeinMaleMiddle AgedMultidetector Computed TomographyPain MeasurementPeripheral Vascular DiseasesPhlebographyProspective StudiesSeverity of Illness IndexStentsTime FactorsTreatment OutcomeUltrasonography, DopplerUltrasonography, InterventionalVascular PatencyVenous Insufficiency