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Effectiveness evidence poor for venous disease treatments
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Evidence was not strong enough to adequately compare endovascular interventions and endovascular vs. other interventions in patients with lower-extremity venous conditions, according to a report in the American Heart Journal.
As Cardiology Today’s Intervention previously reported, a Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) panel had low confidence that there is sufficient evidence for interventions for many classes of patients with venous disease.
Sreekanth Vemulapalli, MD, from the division of cardiology of the department of medicine at Duke University School of Medicine and Duke Clinical Research Institute, and colleagues performed a systematic review and meta-analysis of patients with lower-extremity varicosities and/or lower-extremity chronic venous insufficiency, incompetence or reflux.
They analysis included 57 studies of 105,878 patients, including 53 randomized controlled trials of 10,034 patients.
Among the randomized controlled trials, 28 were of fair quality and nine were of poor quality. Allocation concealment was inadequately addressed in 47%, double blinding was inadequately addressed in 87% and reporting bias was inadequately addressed in 28.3%, according to the researchers.
Heterogeneity in therapies, populations or outcomes prevented a meta-analysis of comparisons between different endovascular therapies and between endovascular therapies and placebo or compression, Vemulapalli and colleagues wrote.
An analysis of venous stripping plus ligation vs. radiofrequency ablation found no different in short-term bleeding (OR = 0.3; 95% CI, –0.16 to 5.38) or reflux recurrence (OR = 0.76; 95% CI, 0.37-1.55), according to the researchers.
A meta-analysis of venous stripping plus ligation vs. endovascular laser ablation found no difference in long-term symptom score (OR = 0.02; 95% CI, –0.19 to 0.23) or quality of life at 2 years (OR = 0.06; 95% CI, –0.12 to 0.25), they wrote.
“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,” Vemulapalli and colleagues wrote. “More high-quality studies are needed to determine comparative effectiveness and guide policy and practice.” – by Erik Swain
Disclosures: Vemulapalli reports he has received research grants from Abbott Vascular. Another researcher reports he has received research grants from AstraZeneca.
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