Key messages
- Using balloons that coat the inside of blood vessels with medicines (drug-eluting) to treat peripheral arterial disease led to better results in terms of whether a person received more than one treatment for the same artery during the study (target lesion revascularization), whether a treated artery became narrowed again (binary restenosis), and the difference in millimeters between the treated segment and how narrow it was on follow-up (late lumen loss).
- There was no difference between drug-eluting balloons and uncoated, plain balloon angioplasty in amputation, amputation-free survival, death, change in a way of measuring disease severity (the ankle-brachial index), quality of life scores, or walking ability.
What is peripheral arterial disease of the lower legs, and what are drug-eluting balloons?
Peripheral arterial disease of the lower legs is a condition where blood supply to the lower legs is not as good as it should be because of blockages in the blood vessels (tubes that carry blood around the body). It affects many people. In its most serious form, it can lead to pain, infections, and amputation due to poor blood flow. People with peripheral arterial disease are usually first treated with medicines and habit changes, including strategies to stop smoking and a walking program to improve their general health, which in turn can improve their condition. However, medicines and habit changes do not work for all people, and some may need an operation. This operation can be traditional open surgery or a less invasive procedure known as angioplasty, which uses a balloon to open the blockages in the arteries. A new type of angioplasty, known as drug-eluting balloon angioplasty, is a promising alternative to traditional balloon angioplasty for treating peripheral arterial disease. Unlike traditional plain balloons, drug-eluting balloons also coat the inside of the blood vessels with medicines that are used to treat cancer (chemotherapy), such as paclitaxel, in hopes of stopping the worsening of peripheral arterial disease even after surgery and preventing or delaying its complications.
What did we want to find out?
The goal of this review was to find out how drug-eluting balloon angioplasty compares with plain balloon angioplasty for treating peripheral arterial disease of the lower legs.
What did we do?
We combined 31 studies (clinical trials) that randomly assigned 5292 participants having an angioplasty for peripheral arterial disease to either receive drug-eluting balloon angioplasty or plain balloon angioplasty. The studies included thigh and leg arteries above and below the knee. The studies were carried out in Europe, the USA, China, Singapore, Jordan, Japan, and New Zealand, and all used drug-eluting balloons with the drug paclitaxel. Participants were followed up for up to five years after surgery.
What did we find?
At up to five years, there were better results for drug-eluting balloons based on an indicator of whether a person received more than one treatment to the same artery during the period covered by the study (target lesion revascularization). At up to two years, there were also better results for binary restenosis, which happens when a treated artery becomes narrowed again after being previously treated. At up to six months, there were better results in terms of the difference in millimeters between the treated segment and how narrow it was on follow-up (late lumen loss). There was no evidence of a difference between drug-eluting balloon and uncoated angioplasty in amputation, amputation-free survival, death, change in the ankle-brachial index (a measure of disease severity), quality of life scores, or walking ability.
What are the limitations of the evidence?
There were differences in the way that participants were given anti-clotting medication to be taken by mouth after surgery. Other concerns included various studies reporting results for the same outcome that differed more than would be expected, and results that showed both an important difference as well as no difference between treatments. This meant that we had to lower our confidence in the evidence. Our confidence in the evidence was low for the outcome target lesion revascularization and moderate for amputation, binary restenosis, death, and change in the ankle-brachial index.
How up to date is this evidence?
This review updates our previous review from 2016. The evidence is up to date to March 2023.
Baca abstrak penuh
Atherosclerotic peripheral arterial disease (PAD) can lead to chronic limb-threatening ischemia (CLTI) and limb loss. Treatments include lifestyle modifications, medications, and both open and minimally invasive operative approaches, including balloon angioplasty. Drug-eluting balloon (DEB) angioplasty is a promising alternative to uncoated balloon angioplasty for treating PAD. Ballooning and coating the inside of atherosclerotic vessels with cytotoxic agents inhibits cellular mechanisms responsible for atherosclerosis and neointimal hyperplasia, thereby preventing or postponing its complications. Although economic analyses may have demonstrated the cost-effectiveness of DEB angioplasty, they remain considerably more expensive than uncoated balloons, and there is uncertainty around their effectiveness. This is an update of our previously published 2016 review.
Matlamat
To evaluate the benefits and harms of DEB angioplasty compared with uncoated, plain old balloon angioplasty (POBA) in people with symptomatic lower-limb PAD.
Kaedah Pencarian
We systematically searched the following databases for randomized controlled trials and controlled clinical trials: Cochrane Vascular Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase Ovid, and CINAHL EBSCO. We also searched the WHO International Clinical Trials Registry Platform and ClinicalTrials.gov. We used the bibliographies of relevant papers to identify other studies. The most recent searches were carried out on 13 March 2023.
Kriteria Pemilihan
We included randomized controlled trials comparing DEB angioplasty with POBA for intermittent claudication or critical limb ischemia (CLI).
Pengumpulan Data dan Analisis
We used standard Cochrane methods. Our primary outcome was amputation. Our secondary outcomes included amputation-free survival, secondary vessel patency, change in ankle-brachial index (ABI), change in quality of life (QoL), change in functional walking ability, and all-cause mortality. We used GRADE to assess the certainty of evidence for selected outcomes (amputation, secondary vessel patency including target lesion revascularization and binary restenosis, change in ABI, and all-cause mortality).
Keputusan Utama
A total of 31 trials randomizing 5292 participants met the inclusion criteria. Nineteen trials included femoropopliteal arterial lesions, nine included tibial arterial lesions, and three included both. The trials were carried out in Europe, the US, China, Singapore, Jordan, Japan, and New Zealand. All trials used paclitaxel. All but four trials were industry-sponsored. There was heterogeneity in the frequency of stent deployment and antiplatelet regimens between trials. Participants were followed up for up to five years.
There were better outcomes with DEB angioplasty for target lesion revascularization at one year, from 204 per 1000 lesions with POBA to 80 per 1000 lesions with DEB angioplasty (odds ratio (OR) 0.34, 95% confidence interval (CI) 0.28 to 0.41; 23 studies, 4172 participants; P < 0.00001; low-certainty evidence). DEB angioplasty was also superior for binary restenosis at one year, from 443 per 1000 vessels with POBA to 187 per 1000 vessels with DEB angioplasty (OR 0.29, 95% CI 0.23 to 0.38; 8 studies, 1288 participants; P < 0.00001; moderate-certainty evidence). There was no difference between DEB angioplasty and POBA in amputation at one year, from 16 per 1000 participants with POBA to 22 per 1000 participants with DEB angioplasty (OR 1.45, 95% CI 0.91 to 2.29; 27 studies, 4469 participants; P = 0.12; moderate-certainty evidence); all-cause mortality, from 45 per 1000 participants with POBA to 44 per 1000 participants with DEB angioplasty (OR 0.97, 95% CI 0.71 to 1.32; 25 studies, 4312 participants; P = 0.83; moderate-certainty evidence); or change in ABI, from 0.1 to 0.35 higher with POBA and 0.03 higher to 0.03 lower with DEB angioplasty (mean difference (MD) 0, 95% CI -0.03 to 0.03; 5 studies, 1156 participants; P = 0.96; moderate-certainty evidence), although none of the studies were powered to detect a significant difference in these clinical endpoints.
Kesimpulan Pengarang
Meta-analysis of 31 trials with 5292 participants demonstrated that there may be evidence of an advantage of DEB angioplasty compared with POBA in several anatomic endpoints including late lumen loss, target lesion revascularization (low-certainty evidence), and binary restenosis (moderate-certainty evidence). Conversely, there may be little to no evidence of advantage with DEB angioplasty for clinical endpoints such as amputation (moderate-quality evidence), amputation-free survival, death (moderate-quality evidence), change in ABI (moderate-quality evidence), QoL, or functional walking ability. Well-designed randomized trials with long-term follow-up are needed to further compare DEB angioplasty with POBA adequately for both anatomic and clinical study endpoints.
