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The Cochrane Database of Systematic... Sep 2020Symptomatic peripheral arterial disease (PAD) has several treatment options, including angioplasty, stenting, exercise therapy, and bypass surgery. Atherectomy is an... (Meta-Analysis)
Meta-Analysis
BACKGROUND
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 effectiveness of atherectomy for peripheral arterial disease compared to other established treatments.
SEARCH METHODS
The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, 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 to 12 August 2019.
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 very uncertain about the effect of atherectomy on patency, mortality and cardiovascular event rates compared to plain balloon angioplasty, with or without stenting. We detected no clear differences in initial technical failure rates or TVR, but there may be reduced dissection and bailout stenting after atherectomy although this is uncertain. Included studies were small, heterogenous and at high risk of bias. Larger studies powered to detect clinically meaningful, patient-centred outcomes are required.
Topics: Acute Coronary Syndrome; Angioplasty, Balloon; Atherectomy; Cause of Death; Heart Failure; Humans; Peripheral Arterial Disease; Randomized Controlled Trials as Topic; Stents
PubMed: 32990327
DOI: 10.1002/14651858.CD006680.pub3 -
EuroIntervention : Journal of EuroPCR... Jul 2020
Review
Topics: Atherectomy; Atherectomy, Coronary; Coronary Artery Disease; Humans; Treatment Outcome; United States; Vascular Calcification
PubMed: 31422928
DOI: 10.4244/EIJ-D-19-00295 -
JACC. Cardiovascular Interventions Apr 2014Rotational atherectomy facilitates percutaneous coronary intervention for complex de novo lesions with severe calcification. A strategy of routine rotational atherectomy... (Review)
Review
Rotational atherectomy facilitates percutaneous coronary intervention for complex de novo lesions with severe calcification. A strategy of routine rotational atherectomy has not, however, conferred reduction in restenosis or major adverse cardiac events. As it is technically demanding, rotational atherectomy is also uncommon. At this 25-year anniversary since the introduction of rotational atherectomy, we sought to review the current state-of-the-art in rotational atherectomy technique, safety, and efficacy data in the modern era of drug-eluting stents, strategies to prevent and manage complications, including slow-flow/no-reflow and burr entrapment, and appropriate use in the context of the broader evolution in the management of stable ischemic heart disease. Fundamental elements of optimal technique include use of a single burr with burr-to-artery ratio of 0.5 to 0.6-rotational speed of 140,000 to 150,000 rpm, gradual burr advancement using a pecking motion, short ablation runs of 15 to 20 s, and avoidance of decelerations >5,000 rpm. Combined with meticulous technique, optimal antiplatelet therapy, vasodilators, flush solution, and provisional use of atropine, temporary pacing, vasopressors, and mechanical support may prevent slow-flow/no-reflow, which in contemporary series is reported in 0.0% to 2.6% of cases. On the basis of the results of recent large clinical trials, a subset of patients with complex coronary artery disease previously assigned to rotational atherectomy may be directed instead to medical therapy alone or bypass surgery. For patients with de novo severely calcified lesions for which rotational atherectomy remains appropriate, referral centers of excellence are required.
Topics: Atherectomy, Coronary; Coronary Artery Disease; Diagnostic Imaging; Humans; Patient Selection; Predictive Value of Tests; Risk Factors; Treatment Outcome; Vascular Calcification
PubMed: 24630879
DOI: 10.1016/j.jcin.2013.12.196 -
Seminars in Vascular Surgery Dec 2008Surgical bypass has long been considered the "gold standard" for treatment of peripheral arterial disease. Endovascular therapy with percutaneous transluminal... (Review)
Review
Surgical bypass has long been considered the "gold standard" for treatment of peripheral arterial disease. Endovascular therapy with percutaneous transluminal angioplasty and adjunctive stenting has recently become a primary treatment of lower extremity peripheral arterial disease. However, there has been concern regarding the long-term patency of percutaneous interventions and the increased need for reintervention. An alternative to standard percutaneous transluminal angioplasty and stent is the excision of the obstructing arterial plaque using atherectomy devices. There are several different types of atherectomy devices including directional atherectomy devices, such as the SilverHawk Atherectomy (EV3, Minneapolis, MN) device, orbital atherectomy devices, such as the CSI DiamondBack 360 (CSI, Minneapolis, MN) rotational atherectomy device, such as the Pathway Jetstream (Pathway Medical Technologies, Inc., Kirkland, WA), the Rotablator device (Boston Scientific, Natick, MA), and laser atherectomy devices, including the Spectranetics Excimer Laser (Spectranetics, Colorado Springs, CO). All of these devices will be reviewed. Multiple series, including our experience with atherectomy devices, will be discussed. Overall, atherectomy devices have an important emerging role for complex lesions, especially those extending into tibial vessels. Atherectomy devices have the distinct advantage of removing the obstructing atherosclerotic or intimal hyperplastic lesions without the disadvantage of a foreign body such as a stent in the artery. If reintervention is required after atherectomy, this can be generally accomplished at the same site with low risk of complications or discomfort to the patient. Finally, atherectomy also does not preclude use of bypass for the treatment of peripheral arterial disease nor, in most cases, change the anastomotic sites if surgical bypass is required, in contrast to stenting.
Topics: Adult; Aged; Aged, 80 and over; Amputation, Surgical; Atherectomy; Equipment Design; Female; Humans; Laser Therapy; Male; Middle Aged; Patient Selection; Peripheral Vascular Diseases; Reoperation; Time Factors; Treatment Outcome; Vascular Patency
PubMed: 19073311
DOI: 10.1053/j.semvascsurg.2008.11.007 -
Cardiovascular Revascularization... May 2022
Topics: Atherectomy; Atherectomy, Coronary; Coronary Angiography; Coronary Artery Disease; Humans; Treatment Outcome; Vascular Calcification
PubMed: 34887204
DOI: 10.1016/j.carrev.2021.11.025 -
Journal of Interventional Cardiology Feb 2018
Topics: Atherectomy; Atherectomy, Coronary; Humans; Treatment Outcome; Vascular Calcification
PubMed: 29430783
DOI: 10.1111/joic.12487 -
Zentralblatt Fur Chirurgie Oct 2023Catheter-based atherectomy has been discussed for some years, although the conclusions have been controversial. Recent study data did show the feasibility of...
Catheter-based atherectomy has been discussed for some years, although the conclusions have been controversial. Recent study data did show the feasibility of multifunctional atherectomy devices for complex lesion morphologies, with moderate material use. This is then thus an alternative to bypass surgery, although a direct comparison is lacking.The results of the ByCross approval study were compared to technical and clinical data from various atherectomy systems in terms of range of indication, limitations as defined by the manufacturer, the success and complication rate and the instructions for use. As in many recent studies, a residual stenosis ≤ 50% after atherectomy and ≤ 30% in the completion imaging was defined as the primary endpoint and proof of technical success.Lesions recruited for the ByCross study were more complex than in other studies, with respect to the lesion length (124.7 mm vs. 34 mm in the EASE study and 67.2 mm in the VISION study) and the degree of stenosis (99.4% vs. 88.5% in the EASE and 78,7% in the VISION study). Calcification was also more severe - as defined by the PACSS (Peripheral Artery Calcification Severity Score). ByCross allowed recanalisation of lesions without wire passage prior to atherectomy (26.82%), which is a must for all other systems. The variable tip diameter of the ByCross can achieve a lumen gain of 4.7 mm without tip or wire exchange or run time limits. The 0% rate of embolic events, which is unique for atherectomy device approval studies, can be explained by the working principle and the high aspiration rate. No vessel injuries occurred, and the 6-month follow-up results showed 0% revascularisation rate.New generation atherectomy systems offer safe and effective enlargement of the endovascular portfolio. The ByCross device is an atherectomy, thrombectomy and crossing device free from investment and has a wider range of indications for the iliac and the femorodistal segments, which supports ByCross atherectomy as an alternative for bypass surgery.
Topics: Humans; Treatment Outcome; Constriction, Pathologic; Atherectomy
PubMed: 37699429
DOI: 10.1055/a-2156-5891 -
The American Journal of Nursing Dec 1996
Comparative Study Review
Topics: Angioplasty; Atherectomy, Coronary; Coronary Disease; Hospitalization; Humans; Male; Middle Aged; Patient Education as Topic; Postoperative Complications
PubMed: 8961861
DOI: No ID Found -
Catheterization and Cardiovascular... Mar 2016Percutaneous coronary intervention of heavily calcified lesions can be challenging. Although the ROTAXUS trial did not demonstrate long-term clinical benefit with...
Percutaneous coronary intervention of heavily calcified lesions can be challenging. Although the ROTAXUS trial did not demonstrate long-term clinical benefit with routine rotational atherectomy, atherectomy remains an indispensable tool to achieve acute procedural success. Until new data becomes available determining when and how to optimally use coronary atherectomy depends heavily on personal experience and clinical judgment.
Topics: Atherectomy; Atherectomy, Coronary; Coronary Angiography; Coronary Artery Disease; Humans; Retrospective Studies; Treatment Outcome
PubMed: 26994979
DOI: 10.1002/ccd.26486 -
EuroIntervention : Journal of EuroPCR... Jul 2020
Topics: Atherectomy, Coronary; Coronary Angiography; Coronary Artery Disease; Humans
PubMed: 32686649
DOI: 10.4244/EIJV16I4A45