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Cardiovascular Revascularization... Jun 2018Outcomes for debulking by atherectomy (ATH) for adjunctive treatment of below the knee (BTK) symptomatic arterial disease compared to percutaneous transluminal... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Outcomes for debulking by atherectomy (ATH) for adjunctive treatment of below the knee (BTK) symptomatic arterial disease compared to percutaneous transluminal angioplasty alone (PTA) are unclear.
METHODS
MEDLINE, EMBASE, PubMed and the Cochrane Central Register of Controlled Trials were queried from between 2000 and 2017 including studies comparing PTA alone to PTA-ATH. Random effect meta-analysis model was used to pool the data across the studies. Study endpoints included: vessel dissection, residual stenosis (<30%), mortality at 12months and amputation rates at 1 and 12months.
RESULTS
A total of 2587 patients (72.9years; 63% male) were included from 4 studies (2 prospective, one of which was randomized, and 2 retrospective) comparing PTA alone to ATH-PTA in patients with symptomatic infra-popliteal disease. There was no significant difference between the two approaches in terms of vessel dissection [OR 3.73 with 95% CI 0.83 to 16.64, p=0.08] or residual stenosis [OR 0.41 with 95% CI 0.11 to 1.60, p=0.18]. Clinical outcomes did not differ in terms of 12month mortality [OR 3.47 with 95% CI 0.15 to 81.37, p=0.44], or limb amputation at 1month [OR 1.23 with 95% CI 0.91 to 1.67, p=0.18] or 12months [OR: 1.02 with 95% CI 0.83 to 1.26, p=0.83].
CONCLUSION
In patients undergoing (BTK) intervention, PTA alone and ATH-PTA was associated with similar outcomes in terms of vessel dissection and residual stenosis, mortality at 12months, and limb amputation at 1 or 12months.
Topics: Aged; Angioplasty; Atherectomy; Female; Humans; Male; Peripheral Arterial Disease; Popliteal Artery; Risk Factors; Treatment Outcome
PubMed: 29269152
DOI: 10.1016/j.carrev.2017.09.014 -
International Angiology : a Journal of... Dec 2017The aim of this review is to explore the safety and effectiveness of intravascular ultrasound (IVUS) during lower limb endovascular interventions in patients with... (Review)
Review
INTRODUCTION
The aim of this review is to explore the safety and effectiveness of intravascular ultrasound (IVUS) during lower limb endovascular interventions in patients with peripheral arterial disease (PAD).
EVIDENCE ACQUISITION
A systematic review of the PubMed and Scopus databases was performed according to PRISMA guidelines. Clinical studies evaluating IVUS as an adjunct to angiography during revascularization procedures in patients with PAD were included.
EVIDENCE SYNTHESIS
Thirteen studies were identified, with a total number of 2258 patients having had IVUS for PAD intervention. Seven investigated the role of IVUS for angioplasty and stenting, with the majority being retrospective cohorts. Technical success and patency rates ranged from 90-100% and 45-100%, respectively, with a follow-up that ranged from 4.3-63 months. Three of these studies compared IVUS and non-IVUS guided angioplasty and demonstrated a significant difference in the events of amputations or re-interventions in favor of the IVUS group. Furthermore, five studies evaluated IVUS use in true-lumen re-entry, with the technical success ranging between 97-100%. In one study, where IVUS was used for atherectomy, the technical success was 100% and the long-term patency was 90% during a 12-month follow-up. Overall, no significant peri/postoperative IVUS related complications were reported, whereas, 2 studies suggested an IVUS-associated increase in procedure costs that ranged from $1080-$1333.
CONCLUSIONS
There is limited and heterogeneous evidence regarding the use of IVUS for the management of PAD. Further research is required to elucidate the optimal role of IVUS in PAD as well as the cost effectiveness of this approach for routine use in the management of PAD.
Topics: Amputation, Surgical; Angioplasty; Disease Management; Humans; Lower Extremity; Peripheral Arterial Disease; Stents; Ultrasonography, Interventional
PubMed: 28895369
DOI: 10.23736/S0392-9590.17.03866-4 -
Cardiovascular Intervention and... Oct 2018Compared to rotational atherectomy (RA), orbital atherectomy (OA) has been shown to decrease procedure failure and reintervention rates in the treatment of severely... (Comparative Study)
Comparative Study
Compared to rotational atherectomy (RA), orbital atherectomy (OA) has been shown to decrease procedure failure and reintervention rates in the treatment of severely calcified coronary artery lesions. Our objective was to explore the cost-effectiveness of OA compared to RA in the Japanese healthcare system. A decision-analytic model calculated reintervention rates and consequent total 1-year costs. Effectiveness inputs were therapy-specific target lesion revascularization (TLR) rates and all-cause mortality, pooled from clinical studies. Index and reintervention costs were determined based on claims data analysis of n = 33,628 subjects treated in 2014-2016. We computed incremental cost-effectiveness in Japanese Yen (JPY) per life year (LY) gained based on differences in 1-year cost and projected long-term survival, assuming OA device cost between JPY 350,000 and JPY 550,000. OA was found to be associated with improved clinical outcomes (12-month TLR rate 5.0 vs. 15.7%) and projected survival gain (8.34 vs. 8.16 LYs (+0.17), based on 1-year mortality of 5.5 vs. 6.8%). Total 1-year costs were lower for device cost of JPY 430,000 or less, and reached a maximum ICER of JPY 753,445 per LY at the highest assumed device cost, making OA dominant or cost-effective across the tested range, at ICERs substantially below the willingness-to-pay threshold. In conclusion, orbital atherectomy for the treatment of severely calcified coronary artery lesions, compared to rotational atherectomy, is a cost-effective treatment approach in the Japanese healthcare system due to improved clinical performance.
Topics: Aged; Atherectomy, Coronary; Coronary Artery Disease; Cost-Benefit Analysis; Female; Health Care Costs; Humans; Japan; Male; Middle Aged; Survival Rate; Treatment Outcome; Vascular Calcification
PubMed: 28875395
DOI: 10.1007/s12928-017-0488-3 -
BMJ (Clinical Research Ed.) Nov 2015What is the most safe and effective interventional treatment for coronary in-stent restenosis? (Meta-Analysis)
Meta-Analysis Review
STUDY QUESTION
What is the most safe and effective interventional treatment for coronary in-stent restenosis?
METHODS
In a hierarchical Bayesian network meta-analysis, PubMed, Embase, Scopus, Cochrane Library, Web of Science, ScienceDirect, and major scientific websites were screened up to 10 August 2015. Randomised controlled trials of patients with any type of coronary in-stent restenosis (either of bare metal stents or drug eluting stents; and either first or recurrent instances) were included. Trials including multiple treatments at the same time in the same group or comparing variants of the same intervention were excluded. Primary endpoints were target lesion revascularisation and late lumen loss, both at six to 12 months. The main analysis was complemented by network subanalyses, standard pairwise comparisons, and subgroup and sensitivity analyses.
STUDY ANSWER AND LIMITATIONS
Twenty four trials (4880 patients), including seven interventional treatments, were identified. Compared with plain balloons, bare metal stents, brachytherapy, rotational atherectomy, and cutting balloons, drug coated balloons and drug eluting stents were associated with a reduced risk of target lesion revascularisation and major adverse cardiac events, and with reduced late lumen loss. Treatment ranking indicated that drug eluting stents had the highest probability (61.4%) of being the most effective for target lesion vascularisation; drug coated balloons were similarly indicated as the most effective treatment for late lumen loss (probability 70.3%). The comparative efficacy of drug coated balloons and drug eluting stents was similar for target lesion revascularisation (summary odds ratio 1.10, 95% credible interval 0.59 to 2.01) and late lumen loss reduction (mean difference in minimum lumen diameter 0.04 mm, 95% credible interval -0.20 to 0.10). Risks of death, myocardial infarction, and stent thrombosis were comparable across all treatments, but these analyses were limited by a low number of events. Trials had heterogeneity regarding investigation periods, baseline characteristics, and endpoint reporting, with a lack of information at long term follow-up. Direct and indirect evidence was also inconsistent for the comparison between drug eluting stents and drug coated balloons.
WHAT THIS STUDY ADDS
Compared with other currently available interventional treatments for coronary in-stent restenosis, drug coated balloons and drug eluting stents are associated with superior clinical and angiographic outcomes, with a similar comparative efficacy.
FUNDING, COMPETING INTERESTS, DATA SHARING
This study received no external funding. The authors declare no competing interests. No additional data available.
Topics: Bayes Theorem; Coronary Restenosis; Drug-Eluting Stents; Humans; Immunosuppressive Agents; Myocardial Revascularization; Percutaneous Coronary Intervention; Randomized Controlled Trials as Topic; Stents
PubMed: 26537292
DOI: 10.1136/bmj.h5392 -
The Journal of Cardiovascular Surgery Feb 2015In the femoropopliteal segment, endovascular revascularization techniques have gained the role as a first line treatment strategy. Nitinol stent placement has improved... (Review)
Review
In the femoropopliteal segment, endovascular revascularization techniques have gained the role as a first line treatment strategy. Nitinol stent placement has improved the short- and mid-term primary patency rates in most lesion types and is therefore widely applied. Stenting has several shortcomings as in-stent restenosis, stent fractures and foreign material being left behind in the vessel. The concept of atherectomy is plaque debulking. This results in a potential reduction of inflation pressure requirements in angioplasty. Stent placement and consecutive in-stent restenosis may be avoided. In this non systematic literature review, the performance of different atherectomy techniques, such as direct atherectomy, orbital atherectomy, laser debulking and rotational atherectomy in the treatment of complex femoropopliteal lesions, including long lesions, moderately to heavily calcified lesions as well as occlusions and in-stent restenosis, has been analyzed.
Topics: Alloys; Atherectomy; Constriction, Pathologic; Equipment Failure; Femoral Artery; Graft Occlusion, Vascular; Humans; Inguinal Canal; Lasers, Excimer; Peripheral Vascular Diseases; Popliteal Artery; Severity of Illness Index; Stents; Treatment Outcome; Vascular Calcification; Vascular Patency
PubMed: 25399550
DOI: No ID Found -
Journal of Vascular and Interventional... Oct 2014The need for specialty devices to improve the technical outcome of endovascular interventions is dependent on the rate of early failure in such procedures. This... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
The need for specialty devices to improve the technical outcome of endovascular interventions is dependent on the rate of early failure in such procedures. This meta-analysis assessed procedural outcomes of such interventions to elucidate the rate of early procedural failures and the need for such specialty devices.
MATERIALS AND METHODS
MEDLINE and EMBASE were searched for contemporary studies (2000-2012) reporting procedural or short-term outcomes for revascularization of infrapopliteal atherosclerotic lesions. A random-effects metaanalysis was performed, which included post hoc comparisons among treatment groups.
RESULTS
A total of 42 studies with 52 treatment arms representing 3,660 unique patients were included. Technical success rates were higher with bare metal stents (BMSs; 98.6%) than with atherectomy (92.2%; P < .05) or percutaneous transluminal angioplasty (PTA; 91.2%; P = .01), and higher with drug-eluting stents (DESs) than with PTA (P < .001). DES use had higher primary patency rates than atherectomy (P < .05), BMS use (P < .001), and PTA (P < .01). The 30-day rate of target lesion revascularization was significantly higher with PTA (8.1%) than with BMSs (2.2%; P < .05) and DESs (1.1%; P < .05). Thirty-day rates of major unplanned amputation (range, 1.5%-4.4%) and mortality (range, 0.9%-3.3%) were comparable among treatment groups. Significant heterogeneity among studies was noted for most PTA outcomes. Publication bias was evident for most PTA and DES outcomes.
CONCLUSIONS
Early failure of percutaneous therapies in patients with infrapopliteal atherosclerotic lesions is device- and technique-dependent. Specialty devices designed to reduce technical failure rates may therefore be of benefit in this selected group of patients. Study results are confounded by inconsistent data reporting, heterogeneity of treatment effects, and publication bias.
Topics: Aged; Amputation, Surgical; Angioplasty, Balloon; Constriction, Pathologic; Drug-Eluting Stents; Endovascular Procedures; Female; Humans; Limb Salvage; Male; Metals; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Risk Factors; Stents; Time Factors; Treatment Failure; Vascular Patency
PubMed: 25130307
DOI: 10.1016/j.jvir.2014.06.018 -
The Journal of Cardiovascular Surgery Oct 2014A systematic review was performed to provide a qualitative analysis and quantitative data synthesis of randomized controlled trials (RCTs) assessing debulking... (Meta-Analysis)
Meta-Analysis Review
A systematic review was performed to provide a qualitative analysis and quantitative data synthesis of randomized controlled trials (RCTs) assessing debulking atherectomy versus balloon angioplasty for treatment of femoropopliteal artery occlusive disease. PubMed (MEDLINE), EMBASE, AMED, Scopus, online content and meeting abstracts were searched in May 2014 for eligible RCTs following the PRISMA selection process. Risk of bias was assessed using the Cochrane Collaboration's tool. Pooled risks were calculated with a random effects model to account for clinical and conceptual heterogeneity. Sensitivity analysis was employed to test the robustness of the results. Six RCTs comprising 287 patients (328 lesions) treated with either debulking atherectomy or balloon angioplasty for femoropopliteal artery disease were analyzed and synthesized. Technical success was similar between the atherectomy and the angioplasty group (93.6% vs. 96.2%, RR: 0.99. 95%CI: 0.95-1.03, P=0.57, I(2)=0%). Need for bail-out stenting and distal arterial embolization were largely similar between atherectomy and balloon angioplasty alone. After a median follow-up of 9 months the 2 groups showed similar primary patency (RR: 0.90, 95%CI: 0.56-1.46, P=0.68, I(2)=69%). Only 2 low-quality studies reported amputation and mortality rates, both of which were found significantly less in the atherectomy arms. Analysis of a limited body of low quality evidence with high risk of bias showed that debulking atherectomy of the femoropopliteal artery does not seem to confer any procedural advantage or improvement of clinical outcomes over balloon angioplasty alone.
Topics: Amputation, Surgical; Angioplasty, Balloon; Atherectomy; Chi-Square Distribution; Embolization, Therapeutic; Femoral Artery; Humans; Limb Salvage; Odds Ratio; Peripheral Arterial Disease; Popliteal Artery; Randomized Controlled Trials as Topic; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Patency
PubMed: 25008063
DOI: No ID Found -
The Cochrane Database of Systematic... Mar 2014Symptomatic peripheral arterial disease may be treated by a number of options including exercise therapy, angioplasty, stenting and bypass surgery. Atherectomy is an... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Symptomatic peripheral arterial disease may be treated by a number of options including exercise therapy, angioplasty, stenting and bypass surgery. Atherectomy is an alternative technique where atheroma is excised by a rotating cutting blade.
OBJECTIVES
The objective of this review was to analyse randomised controlled trials comparing atherectomy against any established treatment for peripheral arterial disease in order to evaluate the effectiveness of atherectomy.
SEARCH METHODS
The Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched November 2013) and CENTRAL (2013, Issue 10). Trials databases were searched for details of ongoing or unpublished studies.
SELECTION CRITERIA
Randomised controlled trials (RCTs) comparing atherectomy and other established treatments were selected for inclusion. All participants had symptomatic peripheral arterial disease with either claudication or critical limb ischaemia and evidence of lower limb arterial disease.
DATA COLLECTION AND ANALYSIS
Two review authors (GA and CT) screened studies for inclusion, extracted data and assessed the quality of the trials. Any disagreements were resolved through discussion.
MAIN RESULTS
Four trials were included with a total of 220 participants (118 treated with atherectomy, 102 treated with balloon angioplasty) and 259 treated vessels (129 treated with atherectomy, 130 treated with balloon angioplasty). All studies compared atherectomy with angioplasty. No study was properly powered or assessors blinded to the procedures and there was a high risk of selection, attrition, detection and reporting biases.The estimated risk of success was similar between the treatment modalities although the confidence interval (CI) was compatible with small benefits of either treatment for the initial procedural success rate (Mantel-Haenszel risk ratio (RR) 0.92, 95% CI 0.44 to 1.91, P = 0.82), patency at six months (Mantel-Haenszel RR 0.92, 95% CI 0.51 to 1.66, P = 0.79) and patency at 12 months (Mantel-Haenszel RR 1.17, 95% CI 0.72 to 1.90, P = 0.53) following the procedure. The reduction in all-cause mortality with atherectomy was most likely due to an unexpectedly high mortality in the balloon angioplasty group in one of the two trials that reported mortality (Mantel-Haenszel RR 0.24, 95% CI 0.06 to 0.91, P = 0.04). Cardiovascular events were not reported in any study. There was a reduction in the rate of bailout stenting following atherectomy (Mantel-Haenszel RR 0.45, 95% CI 0.24 to 0.84, P = 0.01), and balloon inflation pressures were lower following atherectomy (mean difference -2.73 mmHg, 95% CI -3.48 to -1.98, P < 0.00001). Complications such as embolisation and vessel dissection were reported in two trials indicating more embolisations in the atherectomy group and more vessel dissections in the angioplasty group, but the data could not be pooled. From the limited data available, there was no clear evidence of different rates of adverse events between the atherectomy and balloon angioplasty groups for target vessel revascularisation and above-knee amputation. Quality of life and clinical and symptomatic outcomes such as walking distance or symptom relief were not reported in the studies.
AUTHORS' CONCLUSIONS
This review has identified poor quality evidence to support atherectomy as an alternative to balloon angioplasty in maintaining primary patency at any time interval. There was no evidence for superiority of atherectomy over angioplasty on any outcome, and distal embolisation was not reported in all trials of atherectomy. Properly powered trials are recommended.
Topics: Angioplasty, Balloon; Atherectomy; Humans; Peripheral Arterial Disease; Randomized Controlled Trials as Topic; Stents
PubMed: 24638972
DOI: 10.1002/14651858.CD006680.pub2 -
The Cochrane Database of Systematic... Dec 2012This is an update of the review on 'Percutaneous transluminal rotational atherectomy for coronary artery disease' first published in The Cochrane Library Issue 4, 2003.... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
This is an update of the review on 'Percutaneous transluminal rotational atherectomy for coronary artery disease' first published in The Cochrane Library Issue 4, 2003. Percutaneous transluminal coronary rotational atherectomy (PTCRA) debulks atherosclerotic plaque from coronary arteries using an abrasive burr. On rotation, the burr selectively removes hard tissue. PTCRA has been used both as an alternative to and in conjunction with balloon angioplasty to open up blocked coronary arteries. Its ongoing effectiveness and safety compared with other modes of removing atherosclerotic plaques is reviewed.
OBJECTIVES
To assess the effects of PTCRA for coronary artery disease in patients with non-complex and complex lesions (e.g. ostial, long or diffuse lesions or those arising from in-stent re-stenosis) of the coronary arteries.
SEARCH METHODS
For the original review, we searched the Heart Group Specialised Register; The Cochrane Library to Issue 2, 2001; and MEDLINE, CINAHL, EMBASE and Current Contents to December 2002 and reviewed reference lists for relevant articles. For the current review, we searched the same registries from 2002 to 2012 and reviewed reference lists for relevant articles.
SELECTION CRITERIA
We included randomised and quasi-randomised controlled trials of PTCRA compared with placebo, no treatment or another intervention and excluded cross-over trials.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted data and assessed the risk of bias of the studies identified. Data were extracted independently by two review authors. We asked authors of trials to provide information when missing data were encountered. Statistical summaries used risk ratios (RR) and weighted mean differences.
MAIN RESULTS
We included 12 trials enrolling 3474 patients. The overall risk of bias was unclear for the majority of articles due to a lack of reported data; however, the authors determined that this would be unlikely to impact negatively as most data outcomes were objective (e.g. death vs. no death). There was no evidence of the effectiveness in improving patient outcomes of PTCRA in non-complex lesions. In complex lesions, there were no statistically significant differences in re-stenosis rates at six months (RR 1.05; 95% confidence interval (CI) 0.83 to 1.33) and at one year (RR 1.21; 95% CI 0.95 to 1.55) in those receiving PTCRA with adjunctive balloon angioplasty (PTCA) (PTCRA/PTCA) compared to those receiving PTCA alone. Morphological characteristics distinguishing complex lesions have not been examined in parallel-arm randomised controlled trials. The evidence for the effectiveness of PTCRA in in-stent re-stenosis is unclearCompared to angioplasty alone, PTCRA/PTCA did not result in a statistically significant increase in the risk of major adverse cardiac events (myocardial infarction (MI), emergency cardiac surgery or death) during the in-hospital period (RR 1.27; 95% CI 0.86 to 1.90). Compared to angioplasty, PTCRA was associated with nine times the risk of an angiographically detectable vascular spasm (RR 9.23; 95% CI 4.61 to 18.47), four times the risk of perforation (RR 4.28; 95% CI 0.92 to 19.83) and about twice the risk of transient vessel occlusions (RR 2.49; 95% CI 1.25 to 4.99) while angiographic dissections (RR 0.48; 95% CI 0.34 to 0.68) and stents used as a bailout procedure (RR 0.29; 95% CI 0.09 to 0.87) were less common.
AUTHORS' CONCLUSIONS
When conventional PTCA is feasible, PTCRA appears to confer no additional benefits. There is limited published evidence and no long-term data to support the routine use of PTCRA in in-stent re-stenosis. Compared to angioplasty alone, PTCRA/PTCA did not result in a higher incidence of major adverse cardiac events, but patients were more likely to experience vascular spasm, perforation and transient vessel occlusion. In certain circumstances (e.g. patients ineligible for cardiac surgery, those with architecturally complex lesions, or those with lesions that fail PTCA), PTCRA may achieve satisfactory re-vascularisation in subsequent procedures.
Topics: Angioplasty, Balloon, Coronary; Atherectomy, Coronary; Coronary Artery Disease; Coronary Restenosis; Humans; Randomized Controlled Trials as Topic; Stents
PubMed: 23235596
DOI: 10.1002/14651858.CD003334.pub2