Study Shows Need for Improved Data on Treatments for Chronic Lower Extremity Venous Disease
October 25, 2017—Findings from a systematic review and meta-analysis of endovascular and surgical revascularization for patients with chronic lower extremity venous insufficiency and varicose veins were recently published online by Sreekanth Vemulapalli, MD, et al in American Heart Journal (AHJ).
The background of the investigation is that despite increasing use of invasive therapies to treat chronic lower extremity venous disease, their comparative effectiveness is unknown, so this systematic review and meta-analysis was conducted to assess treatments for patients (symptomatic and asymptomatic) with lower extremity varicosities and/or lower extremity chronic venous insufficiency, incompetence, and/or reflux.
As summarized in AHJ, the investigators searched PubMed, Embase, and the Cochrane Database of Systematic Reviews for relevant English-language studies published from January 2000 to July 2016. They included comparative randomized controlled trials (RCTs) with > 20 patients and observational studies with > 500 patients. Short-, intermediate-, and long-term outcomes of placebo, mechanical compression therapy, and invasive therapies (surgical and endovascular) were included. The performed quality ratings and evidence grading and used random-effects models to compute summary estimates of effects.
The investigators identified 57 studies representing 105,878 enrolled patients, including 53 RCTs composed of 10,034 patients. They found that among the RCTs, 16 were good quality, 28 were fair quality, and nine were poor quality. Allocation concealment, double blinding, and reporting bias were inadequately addressed in 25/53 (47%), 46/53 (87%), and 15/53 (28.3%), respectively.
The investigators noted that heterogeneity in therapies, populations, and/or outcomes prohibited meta-analysis of comparisons between different endovascular therapies and between endovascular intervention and placebo/compression.
Meta-analysis evaluating venous stripping plus ligation (HL/S) compared with radiofrequency ablation revealed no difference in short-term bleeding (odds ratio [OR], 0.3; 95% confidence interval [CI], -0.16 to 5.38; P = .43) or reflux recurrence at 1 to 2 years (OR, 0.76; 95% CI, 0.37 to 1.55;P = .44).
Meta-analysis evaluating HL/S versus endovascular laser ablation revealed no difference in long-term symptom score (OR, 0.02; 95% CI, -0.19 to 0.23; P = .84) or quality of life at 2 years (OR, 0.06; 95% CI, -0.12 to 0.25; P = .5).
The paucity of high-quality comparative effectiveness and safety data in chronic lower extremity venous disease is concerning given the overall rise in endovascular procedures; more high-quality studies are needed to determine comparative effectiveness and guide policy and practice, concluded the investigators in AHJ.