Widening damaged blood vessels using balloons coated in a drug called paclitaxel improves blood flow and reduces the risk of a further operation within a year compared to cheaper, uncoated balloons. Rates of amputation and death were no different between groups, though there were few of these events.
This review of 11 studies included over 1,800 adults with peripheral arterial disease (PAD) restricting the blood flow in their legs. Though performing the minimally invasive surgical procedure using coated balloons improved some outcomes up to a year, they did not have an effect on risk of amputation or death. Other important outcomes such as quality of life were inconclusive.
Costs were not considered in this review, but the reduced rate of reoperation may offset the increased cost of the coated balloons. It should be noted that most studies were industry-funded and no information was provided on any safety issues concerning the drug coated balloons.
Why was this study needed?
PAD causes narrowing of the blood vessels in the legs. This can result in pain when walking, called intermittent claudication. An estimated 20% of people aged over 60 in the UK have PAD and 6% have intermittent claudication. In 20% this progresses to pain at rest or gangrene needing amputation.
Initial management includes exercise, medication to dilate the blood vessels or to reduce blood clotting and modification of cardiovascular risk factors including smoking, overweight, high blood pressure, lipids and diabetes.
If treatment fails to improve symptoms, angioplasty (inserting a balloon into the blood vessel to widen it) is the least invasive surgical approach. Paclitaxel is a drug which reduces scar tissue, which can progress to narrowing of the blood vessel after angioplasty. The researchers wanted to see if coating the balloon with paclitaxel prevents the complications of arterial disease or the problem recurring compared with cheaper uncoated balloons.
What did this study do?
This Cochrane systematic review and meta-analysis pooled the findings from 11 randomised controlled trials comparing angioplasty using balloons coated with paclitaxel with uncoated balloons. It included 1,838 adults, who were followed up for 12 to 24 months.
There was a lot of variation between studies in terms of which artery was being treated and whether stents were implanted at the same time as the balloon. Whether the clot reducing drugs aspirin, clopidogrel or both were prescribed, and for how long, also differed, as did the dose of the paclitaxel coating.
Most of the included studies (9/11) were sponsored by manufacturers of the coated balloons and their authors all declared competing financial interests. However, the included studies were of moderate to high quality therefore we can feel confident in their findings.
What did it find?
- There was no difference between the balloon types in the risk of amputation within 12 months of the operation. There were an estimated 22 amputations per 1,000 people with drug coated balloons compared to 14 per 1,000 with uncoated balloons (odds ratio [OR] 1.56, 95% confidence interval [CI] 0.73 to 3.33, 1649 participants in nine studies).
- The estimated number of deaths up to 12 months was also similar at 43 per 1,000 for drug coated balloons and 46 per 1,000 for uncoated balloons (OR 1.09, 95% CI 0.64 to 1.85).
- Vessel patency, good blood flow on imaging, was achieved in 64% of people with drug coated balloons compared to 48% with uncoated ones at 12 months (OR 1.92, 95% CI 1.45 to 2.56; 882 participants in three studies). This improvement remained at 24 months (OR 3.51, 95% CI 2.26 to 5.46; 406 participants in two studies). Of note, this analysis excluded one eligible study because of its high risk of bias.
- Further surgery was required in 13% of those with balloons within 12 months compared to 26% of those with uncoated balloons (OR 0.40, 95% CI 0.31 to 0.51, 1900 participants in 11 studies).
- Neither intervention had any meaningful impact on quality of life, but this was based on three dissimilar studies. However, ability to walk was substantially improved by both types of balloons. According to the Walking Impairment Questionnaire (WIQ) which scores 0 as inability to walk and 100 no difficulty, the scores improved by around 36 points by six months.
What does current guidance say on this issue?
2012 NICE guidelines recommend angioplasty for people with intermittent claudication or critical limb ischaemia if exercise, lifestyle modifications and vessel-dilating medication have not controlled symptoms. They do not specify whether drug coated or uncoated balloons should be used.
Depending on the location and extent of the narrowing, patient preference and suitability for surgery, further options include inserting a stent or bypass surgery. There is however wide variation in practice in type of angioplasty, use of stents and bypass procedures.
What are the implications?
Overall, drug coated balloons were as good as or slightly better than uncoated balloons. Risk of amputation or death was similar across groups, but these events were rare. Similar results were seen in another recent systematic review on this topic, which included many of the same studies, but did not include procedures below the knee.
There was anatomical evidence that both types of balloons improved blood flow through the vessels and ability to walk but impacts on quality of life were not adequately assessed. In addition, any potential side effects from the paclitaxel coating were not reported.
A formal economic evaluation was not performed, but drug coated balloons reduced the rate of reoperation and this should be taken into account when considering the increased cost of drug coated balloons.
Citation and Funding
Kayssi A, Al-Atassi T, Oreopoulos G, et al. Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs. Cochrane Database Syst Rev. 2016;(8):CD011319.
The Cochrane Vascular editorial base is supported by the Chief Scientist Office, Scottish Government Health Directorates, The Scottish Government, UK.
NICE. Lutonix drug-coated balloon for peripheral arterial disease. MIB72. London: National Institute for Health and Care Excellence; 2016. This guidance was withdrawn in October 2019.
NICE. Peripheral arterial disease: diagnosis and management. CG147. London: National Institute for Health and Care Excellence; 2012.
Jongsma H, Bekken JA, de Vries JP, et al. Drug-eluting balloon angioplasty versus uncoated balloon angioplasty in patients with femoropopliteal arterial occlusive disease. J Vasc Surg. 2016;64(5):1503-14.
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