Key messages
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There seems to be little to no difference in either benefits or harms when the use of atherectomy (a minimally invasive procedure that uses a device to cut or grind away the hardened fatty plaques) is compared to conventional treatments, including balloon angioplasty (a balloon is used to stretch the narrowed or blocked artery) with or without stenting (a tube used to hold open the segment of artery). However, this is based on poor-quality evidence and hence the findings from this review are very uncertain.
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Larger, better-designed studies are needed to better evaluate the use of atherectomy compared to other conventional treatments.
What is peripheral arterial disease?
Peripheral arterial disease is a common condition in which fatty plaques cause narrowing or blockage of the arteries of the legs. Individuals with this condition may experience pain while walking, pain at rest or leg ulceration due to inadequate blood supply. The number of people with peripheral arterial disease is increasing globally.
How is this condition treated?
Treatment options are walking therapy, open surgery using a blood vessel or graft to bypass the narrowed or blocked section of the artery, or minimally invasive surgery. The options for minimally invasive surgery include balloon angioplasty, when a deflated balloon is passed into the narrowing over a wire, then blown up to stretch the artery, and stenting (used in addition to balloon angioplasty), which holds open the balloon-stretched section for extra support.
A final option, less commonly used, is a technique called atherectomy. This treatment uses a device that cuts or grinds away the hardened deposition (atheroma) within the artery. Atherectomy is less well researched compared to the other treatment methods. Despite this, the use of atherectomy is increasing.
What did we want to find out?
The main question we wanted to evaluate was whether atherectomy was better than balloon angioplasty, stenting or open bypass surgery for treating people with peripheral arterial disease. We also wanted to find out if atherectomy was better than balloon angioplasty for peripheral arterial disease located in the leg, above the knee and whether the use of drug-releasing balloons or stents had any effects on outcomes.
What did we do?
We searched for studies that compared atherectomy to any of the other methods for treating peripheral arterial disease. We combined the results of these studies with the studies already identified in the two previous versions of this review. We rated our overall confidence in the studies based on their design and size.
What did we find?
We found four new studies that compared atherectomy to other minimally invasive treatment options (balloon angioplasty with or without stenting), to make a total of 11 studies, with a total of 814 participants, included in this review. Only one study compared atherectomy to stenting, with the remainder comparing atherectomy to balloon angioplasty. The majority of studies were either performed in Europe or the United States, with the remaining study from China. We did not find any studies comparing atherectomy to open bypass surgery.
From evaluating the data from the studies identified, there seems to be little to no difference between atherectomy and balloon angioplasty or primary stenting when looking at the following outcomes: maintaining vessel patency (openness) at 6 and 12 months, the risk of death, the risk of subsequent disease or injury to the heart or blood vessels, the likelihood of needing repeat treatment on the target artery or the overall risk of complications.
What are the limitations of the evidence?
We are not confident in the evidence because, in several of the studies, it is possible that the participants and assessors were aware of which treatment individuals were receiving. Furthermore, not all participants were followed up for the entire length of the studies, and not all of the studies provided data about everything we were interested in.
How up-to-date is this evidence?
This review is an update of previous Cochrane reviews published in 2014 and 2020. The evidence is up-to-date as of January 2025.
Read the full abstract
Symptomatic peripheral arterial disease (PAD) has several treatment options, including angioplasty, stenting, exercise therapy, and bypass surgery. Atherectomy is an alternative procedure, in which atheroma is cut or ground away within the artery. This is the first update of a Cochrane Review published in 2014.
Objectives
To evaluate the benefits and harms of atherectomy as a treatment for peripheral arterial disease compared to other treatments.
Search strategy
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Allied and Complementary Medicine (AMED) databases, and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers from 13 August 2019 to 28 January 2025.
Selection criteria
We included all randomised controlled trials that compared atherectomy with other established treatments. All participants had symptomatic PAD with either claudication or critical limb ischaemia and evidence of lower limb arterial disease.
Data collection and analysis
Two review authors screened studies for inclusion, extracted data, assessed risk of bias and used GRADE criteria to assess the certainty of the evidence. We resolved any disagreements through discussion. Outcomes of interest were: primary patency (at six and 12 months), all-cause mortality, fatal and non-fatal cardiovascular events, initial technical failure rates, target vessel revascularisation rates (TVR; at six and 12 months); and complications.
Main results
We included seven studies, with a total of 527 participants and 581 treated lesions. We found two comparisons: atherectomy versus balloon angioplasty (BA) and atherectomy versus BA with primary stenting. No studies compared atherectomy with bypass surgery. Overall, the evidence from this review was of very low certainty, due to a high risk of bias, imprecision and inconsistency.
Six studies (372 participants, 427 treated lesions) compared atherectomy versus BA. We found no clear difference between atherectomy and BA for the primary outcomes: six-month primary patency rates (risk ratio (RR) 1.06, 95% confidence interval (CI) 0.94 to 1.20; 3 studies, 186 participants; very low-certainty evidence); 12-month primary patency rates (RR 1.20, 95% CI 0.78 to 1.84; 2 studies, 149 participants; very low-certainty evidence) or mortality rates (RR 0.50, 95% CI 0.10 to 2.66, 3 studies, 210 participants, very low-certainty evidence). One study reported cardiac failure and acute coronary syndrome as causes of death at 24 months but it was unclear which arm the participants belonged to, and one study reported no cardiovascular events.
There was no clear difference when examining: initial technical failure rates (RR 0.48, 95% CI 0.22 to 1.08; 6 studies, 425 treated vessels; very low-certainty evidence), six-month TVR (RR 0.51, 95% CI 0.06 to 4.42; 2 studies, 136 treated vessels; very low-certainty evidence) or 12-month TVR (RR 0.59, 95% CI 0.25 to 1.42; 3 studies, 176 treated vessels; very low-certainty evidence). All six studies reported complication rates (RR 0.69, 95% CI 0.28 to 1.68; 6 studies, 387 participants; very low-certainty evidence) and embolisation events (RR 2.51, 95% CI 0.64 to 9.80; 6 studies, 387 participants; very low-certainty evidence). Atherectomy may be less likely to cause dissection (RR 0.28, 95% CI 0.14 to 0.54; 4 studies, 290 participants; very low-certainty evidence) and may be associated with a reduction in bailout stenting (RR 0.26, 95% CI 0.09 to 0.74; 4 studies, 315 treated vessels; very low-certainty evidence). Four studies reported amputation rates, with only one amputation event recorded in a BA participant. We used subgroup analysis to compare the effect of plain balloons/stents and drug-eluting balloons/stents, but did not detect any differences between the subgroups.
One study (155 participants, 155 treated lesions) compared atherectomy versus BA and primary stenting, so comparison was extremely limited and subject to imprecision. This study did not report primary patency. The study reported one death (RR 0.38, 95% CI 0.04 to 3.23; 155 participants; very low-certainty evidence) and three complication events (RR 7.04, 95% CI 0.80 to 62.23; 155 participants; very low-certainty evidence) in a very small data set, making conclusions unreliable. We found no clear difference between the treatment arms in cardiovascular events (RR 0.38, 95% CI 0.04 to 3.23; 155 participants; very low-certainty evidence). This study found no initial technical failure events, and TVR rates at six and 24 months showed little difference between treatment arms (RR 2.27, 95% CI 0.95 to 5.46; 155 participants; very low-certainty evidence and RR 2.05, 95% CI 0.96 to 4.37; 155 participants; very low-certainty evidence, respectively).
Authors' conclusions
This review update shows that the evidence is still very uncertain about the effect of atherectomy on primary patency, mortality and cardiovascular event rates compared to plain balloon angioplasty with or without stenting alone. We identified no evidence of differences in target vessel revascularisation rates and complication rates, although this is again uncertain. The included studies were small, heterogeneous and at high risk of bias. Larger studies that are powered to detect clinically meaningful, patient-centred outcomes are required.
Funding
This Cochrane review had no dedicated funding.
Registration
Protocol and previous versions available via 10.1002/14651858.CD006680, 10.1002/14651858.CD006680.pub3.
