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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 -
Journal of Endovascular Therapy : An... Nov 2023The article aimed to compare the efficiency and safety of atherectomy plus balloon angioplasty (BA) with BA alone for the treatment of infrapopliteal arterial disease. (Review)
Review
OBJECTIVE
The article aimed to compare the efficiency and safety of atherectomy plus balloon angioplasty (BA) with BA alone for the treatment of infrapopliteal arterial disease.
METHODS
According to the inclusion and exclusion criteria, PubMed, Embase, and Cochrane Library database were searched for studies comparing atherectomy plus angioplasty and angioplasty alone in treating infrapopliteal artery lesions until November 2022. The endpoints included technical success, primary patency, clinically-driven target lesion revascularization (CD-TLR), periprocedural complications, distal embolization, target limb major amputation, and all-cause mortality.
RESULTS
Ten studies met the requirements of our meta-analysis, including 7723 patients in the atherectomy plus BA group and 2299 patients in the BA alone group. The meta-analysis showed that atherectomy plus BA was associated with reduced CD-TLR (odds ratio [OR]: 0.51, 95% confidence interval [CI]: 0.34, 0.78, p=0.002) and target limb major amputation (OR: 0.43, 95% CI: 0.19, 1.01, p=0.05) at 12-month follow-up. No statistically significant difference was found in technical success, primary patency, periprocedural complications, distal embolization, or all-cause mortality. Subgroup analysis found a higher rate of primary patency at 6 and 12 months (6 months: OR: 2.26, 95% CI: 1.11, 4.60, p=0.02; 12 months: OR: 2.38, 95% CI: 1.16, 4.86, p=0.02), and lower rates of CD-TLR (OR: 0.45, 95% CI: 0.25, 0.82, p=0.009) and target limb major amputation (OR: 0.43, 95% CI: 0.19, 1.01, p=0.05) at 12 months in patients treated with atherectomy plus drug-coated balloon (DCB) but not in patients treated with atherectomy plus plain old balloon angioplasty (POBA).
CONCLUSIONS
This meta-analysis suggests that compared with BA alone, atherectomy plus BA may reduce the need for CD-TLR and the incidence of target limb major amputation at 12-month follow-up in the treatment of infrapopliteal artery occlusive lesions, even though there are no significant advantages in technical success, primary patency, periprocedural complications, distal embolization, or all-cause mortality. To go further, atherectomy plus DCB shows significant benefits in primary patency, CD-TLR, and target limb major amputation rate but atherectomy plus POBA does not'. However, due to the limitations of this article, more randomized controlled trials (RCTs) are needed to confirm these conclusions.
CLINICAL IMPACT
According to our research, atherectomy combined with BA has the advantages of higher primary patency rate, lower CD-TLR and target limb significant amputation rate in treating infrapopliteal artery occlusive lesions, which may replace the current mainstream surgical method ---BA alone. For the clinician, although the surgery may take longer, it will significantly improve the prognosis and quality of life of patients and hold considerable significance for the management of patients with infrapopliteal arterial disease. Based on the characteristics of infrapopliteal artery disease, this study explored the feasibility of atherectomy combined with BA for infrapopliteal artery disease. Moreover, we found that atherectomy combined with DCB had better clinical efficacy, which should be the innovation of this study.
PubMed: 37933456
DOI: 10.1177/15266028231209236 -
International Journal of Cardiology Mar 2020Coronary artery calcification is associated with poor outcomes in patients undergoing percutaneous coronary intervention (PCI). Atheroablative techniques such as orbital... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Coronary artery calcification is associated with poor outcomes in patients undergoing percutaneous coronary intervention (PCI). Atheroablative techniques such as orbital atherectomy (OA) and rotational atherectomy (RA) are routinely utilized to treat these calcified lesions in order to optimize lesion preparation and facilitate stent delivery.
OBJECTIVES
The purpose of this systematic review and meta-analysis is to compare the performance of OA versus RA in patients with calcified coronary artery disease (CAD) undergoing PCI.
METHODS
We conducted an electronic database search of all published data for studies that compared OA versus RA in patients with calcified coronary artery disease undergoing PCI and reported on outcomes of interest. Event rates were compared using a forest plot of odds ratios using a random-effects model assuming interstudy heterogeneity.
RESULTS
A total of five observational studies (total number of patients = 1872; OA = 535, RA = 1337) were included in the final analysis. On pooled analysis, OA compared to RA was associated with a significant reduction in fluoroscopy times (OR = -6.33; 95% CI = -9.90 to -2.76; p < .0005; I = 82). There was no difference between the two techniques in terms of contrast volume, coronary artery dissection, device induced arterial perforation, cardiac tamponade, slow flow/no reflow, periprocedural myocardial infarction (MI), in-hospital mortality, 30-day mortality, 30-day MI, 30-day target vessel revascularization (TVR), and 30-day major adverse cardiovascular events (MACE).
CONCLUSION
Except for lower fluoroscopy time with OA, there are no significant differences between OA and RA in relation to procedural, periprocedural, and thirty day outcomes among patients with calcified CAD undergoing PCI.
Topics: Atherectomy, Coronary; Coronary Artery Disease; Coronary Vessels; Humans; Risk Factors; Vascular Calcification
PubMed: 31898984
DOI: 10.1016/j.ijcard.2019.12.037 -
Cardiovascular Revascularization... Jun 2022Rotational atherectomy (RA) plays a central role in the treatment of heavily calcified coronary artery lesions. Our aim was to compare periprocedural characteristics and... (Meta-Analysis)
Meta-Analysis
BACKGROUND/PURPOSE
Rotational atherectomy (RA) plays a central role in the treatment of heavily calcified coronary artery lesions. Our aim was to compare periprocedural characteristics and outcomes of planned (PA) vs. bailout (BA) rotational atherectomy.
METHODS
We conducted a systematic review and performed a meta-analysis on studies which compared PA vs. BA strategy.
RESULTS
Five studies fulfilled the inclusion criteria, pooling a total of 2120 patients. There was no difference in procedural success, PA vs. BA risk ratio (RR) 1.03 and 95% confidence interval (95% CI) 0.99-1.07. Compared to BA, PA was associated with a shorter procedural time [mean difference (MD) -25.88 min, 95% CI -35.55 to -16.22], less contrast volume (MD -43.71 ml, 95% CI -69.17 to -18.25), less coronary dissections (RR 0.50, 95% CI 0.26-0.99), fewer stents (MD -0.20, 95% CI -0.29 to -0.11), and a trend favouring less periprocedural myocardial infarctions (MI) (RR 0.77, 95% CI 0.54-1.11). There was no difference in major adverse cardiovascular events on follow-up (RR 1.04, 95% CI 0.62-1.74), death (RR 0.98, 95% CI 0.59-1.64), MI (RR 1.16, 95% CI 0.62-2.18), target vessel revascularization (RR 1.40, 95% CI 0.83 to 2.36), stroke (RR 1.50, 95% CI 0.46-4.86) or stent thrombosis (RR 0.82, 95% CI 0.06-10.74); all PA vs. BA comparisons.
CONCLUSIONS
Compared to bailout RA, planned RA resulted in significantly shorter procedural times, less contrast use, lesser dissection rates and fewer stents used. The bailout RA approach appears to enhance periprocedural risk, but there is no difference on mid-term outcomes.
Topics: Atherectomy, Coronary; Coronary Artery Disease; Humans; Myocardial Infarction; Retrospective Studies; Stents; Treatment Outcome; Vascular Calcification
PubMed: 34627732
DOI: 10.1016/j.carrev.2021.09.013 -
The Journal of Cardiovascular Surgery Feb 2022Surgical endarterectomy represents the gold standard for the treatment of atherosclerotic lesions of the groin vessels. Endovascular treatment such as atherectomy with...
INTRODUCTION
Surgical endarterectomy represents the gold standard for the treatment of atherosclerotic lesions of the groin vessels. Endovascular treatment such as atherectomy with or without drug coated angioplasty (DCA) of the so called no stenting zones, i.e. inguinal and popliteal vessels, is gaining growing acceptance as alternative option to open surgery. This systematic review aims to scrutiny the current clinical evidence regarding atherectomy and DCA for the common artery (CFA).
EVIDENCE ACQUISITION
We conducted an exhaustive research in multiple platforms (Medline, PubMed, Cochrane, Google Scholar, Embase) on studies over atherectomy and angioplasty for inguinal atherosclerotic lesions published between 2000 and 2021. As search strategy we used a wide list of MeSH items, words, synonyms. Bibliographies of review articles were checked for further relating studies regarding atherectomy of CFA. A qualitative and quantitative data analysis was carried out.
EVIDENCE SYNTHESIS
Fifteen studies were included in the qualitative review. Not all studies were focused only on atherectomy of inguinal vessels, despite including such treatment. Hence, data regarding this treatment were not exhaustive. A fairly homogeneous data analysis was possible in 7 of 15 studies. The remaining 8 studies were qualitatively analyzed but not included in the statistical analysis. In all 7 included studies directional atherectomy and DCA under filter protection were carried out. In this subgroup, overall, 497 patients were treated with atherectomy. Sixty-eight percent of the patients were males. Rutherford class from 1-3 dominated against 4-6 (63% vs. 37%). Mean technical success rate was 96%, with a primary and secondary patency rate of 92% and 98% respectively at one year. Procedure related vascular complications ranged from 1% to 6%.
CONCLUSIONS
Current literature about atherectomy for inguinal arteries is scant, data are inhomogeneous and so are treatment modalities. Nevertheless, the results of this systematic review suggest that this endovascular strategy is feasible with good short and midterm results. Prospective trials with larger patient cohorts are necessary to confirm these preliminary results.
Topics: Animals; Atherectomy; Humans; Peripheral Arterial Disease; Plaque, Atherosclerotic; Treatment Outcome
PubMed: 35179336
DOI: 10.23736/S0021-9509.21.12172-X -
Journal of Endovascular Therapy : An... Dec 2023Balloon angioplasty (BA), including drug-coated balloons (DCBs) and percutaneous transluminal angioplasty (PTA), has traditionally been used to treat femoral-popliteal... (Review)
Review
Efficacy and Safety of Atherectomy Combined With Balloon Angioplasty vs Balloon Angioplasty Alone in Patients With Femoro-Popliteal Lesions: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
BACKGROUND
Balloon angioplasty (BA), including drug-coated balloons (DCBs) and percutaneous transluminal angioplasty (PTA), has traditionally been used to treat femoral-popliteal lesions. However, in recent years, atherectomy (ATH) has been proposed as a complementary approach. To assess the effectiveness of ATH compared with BA alone in patients with femoral-popliteal artery lesions, we conducted a systematic review and meta-analysis of randomized controlled trials (RCTs).
METHODS
We included RCTs that focused on patients with femoral-popliteal artery lesions and reported data on the use of ATH and BA therapy. Two reviewers conducted a literature search, refined the data, and assessed the risk of bias.
RESULTS
We included a total of 6 RCTs involving 399 patients with femoral-popliteal artery lesions. The use of ATH in combination with BA appeared to improve the patency rate at 12 months (odds ratio [OR]=2.04, 95% confidence interval [CI]=1.14-3.62). In addition, ATH with BA was associated with lower major amputation rates (MD=2.01, 95% CI=0.06-0.77, p=0.02) and a decreased likelihood of bailout stenting (OR=0.07, 95% CI=0.02-0.25, p=0.001). However, there were no statistically significant differences between the groups in terms of target lesion revascularization (TLR) at 12 months, major adverse cardiovascular events (MACEs), and distal embolization events. In addition, we performed subgroup analysis for different ATH devices and BA types.
CONCLUSIONS
Based on this meta-analysis, it can be concluded that the use of ATH in combination with BA is a safe and effective method for treating femoral-popliteal artery lesions. In addition, the patency rate at 1 year is superior to treatment with BA alone. Atherectomy also reduces the likelihood of amputation and bailout stenting. Clinicians should consider these findings when designing future RCTs and developing clinical practice guidelines.
CLINICAL IMPACT
This meta-analysis summarises a number of existing studies to advance understanding of the atherectomy devices and to reveal its potential. This new technique, when compared with drug coated balloon, shows the possibility of obtaining better clinical outcomes in femoro-popliteal lesions than drug-coated balloon alone, such as higher 12-month primary patency rates as shown in some studies. Currently, it is important to consider the appropriate technology applicable for individualised treatment. atherectomy devices seem to provide clinicians with additional options in clinical practice and to benefit patients in the future. This requires more high quality studies to explore the role and benefits of atherectomy devices in femoro-popliteal lesions.
PubMed: 38049942
DOI: 10.1177/15266028231215354 -
The Journal of Cardiovascular Surgery Feb 2022The aim of this paper was to evaluate the current role of atherectomy techniques (ATH) in treatment of peripheral arterial disease (PAD) at below the knee (BTK) arteries.
INTRODUCTION
The aim of this paper was to evaluate the current role of atherectomy techniques (ATH) in treatment of peripheral arterial disease (PAD) at below the knee (BTK) arteries.
EVIDENCE ACQUISITION
The PubMed and Embase were searched (last search on 11 September 2021) for studies reporting on the early and mid-term outcomes of ATH in BTK vessels. Analysis included the data from six studies, with a total of 1062 PAD patients treated with various ATH techniques. We compared them the ATH outcomes with the contemporaneous outcomes of plain balloon angioplasty alone or with bailout stenting. Early safety and efficacy were accessed with perioperative and 30-day technical success (TS) rate, which included the primary patency of the treated BTK arterial segment. Evaluation of clinical performance was based on target limb revascularization (TLR) and on major limb adverse events (MALEs) rates.
EVIDENCE SYNTHESIS
The current body of literature mainly includes retrospective observational studies, and the level of derived evidence is low. The mean perioperative and 30-day TS rate was 87.3%. The mean reported TLR and MALEs rates at 12 months were 6.6% and 4.7% respectively. The relevant rates in studies reporting at 24 months were 24.3% and 31.7% while in studies reporting at 36 months the rates were 37.0% and 23.0% respectively.
CONCLUSIONS
Based in low-quality evidence, it seems that ATH in BTK vessels has a high safety, high efficacy profile and durable outcomes at 12 months. In the mid-term, the clinical success of ATH is compromised by increased TLR and MALEs rates. Comparison of ATH with other endovascular techniques in BTK treatment of PAD shows a slight lead of ATH at 1-year and equivalent clinical performance in the mid-term. Overall, ATH has a significant and potentially predominant role in treatment of BTK vessels.
Topics: Arteries; Atherectomy; Humans; Leg; Peripheral Arterial Disease; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; Vascular Patency
PubMed: 34792313
DOI: 10.23736/S0021-9509.21.12113-5 -
The American Journal of Cardiology Oct 2023Calcified coronary plaque (CCP) represents a challenging scenario for interventional cardiologists. Stent underexpansion (SU), often associated with CCP, can predispose... (Meta-Analysis)
Meta-Analysis
Calcified coronary plaque (CCP) represents a challenging scenario for interventional cardiologists. Stent underexpansion (SU), often associated with CCP, can predispose to stent thrombosis and in-stent restenosis. To date, SU with heavily CCP can be addressed using very high-/high-pressure noncompliant balloons, off-label rotational atherectomy/orbital atherectomy, excimer laser atherectomy, and intravascular lithotripsy (IVL). In this meta-analysis, we investigated the success rate of IVL for the treatment of SU because of CCP. Studies and case-based experiences reporting on the use of IVL strategy for treatment of SU were included. The primary end point was IVL strategy success, defined as the adequate expansion of the underexpanded stent. A metanalysis was performed for the main focuses to calculate the proportions of procedural success rates with corresponding 95% confidence intervals (CIs). Random-effects models weighted by inverse variance were used because of clinical heterogeneity. This meta-analysis included 13 studies with 354 patients. The mean age was 71.3 years (95% CI 64.9 to 73.1), and 77% (95% CI 71.2% to 82.4%) were male. The mean follow-up time was 2.6 months (95% CI 1 to 15.3). Strategy success was seen in 88.7% (95% CI 82.3 to 95.1) of patients. The mean minimal stent area was reported in 6 studies, the pre-IVL value was 3.4 mm (95% CI 3 to 3.8), and the post-IVL value was 6.9 mm (95% CI 6.5 to 7.4). The mean diameter stenosis (percentage) was reported in 7 studies, the pre-IVL value was 69.4% (95% CI 60.7 to 78.2), and the post-IVL value was 14.6% (95% CI 11.1 to 18). The rate of intraprocedural complications was 1.6% (95% CI 0.3 to 2.9). In conclusion, the "stent-through" IVL plaque modification technique is a safe tool to treat SU caused by CCP, with a high success rate and a very low incidence of complications.
Topics: Humans; Male; Aged; Female; Lithotripsy; Stents; Endovascular Procedures; Atherectomy; Atherectomy, Coronary; Constriction, Pathologic
PubMed: 37611414
DOI: 10.1016/j.amjcard.2023.07.144 -
Vascular May 2024With the development of endovascular therapies, some studies have indicated a therapeutic potential for infrapopliteal arterial revascularization with atherectomy (AT).... (Review)
Review
The efficacy of atherectomy combined with percutaneous transluminal angioplasty (PTA)/drug-coated balloon (DCB) compared with PTA/DCB for infrapopliteal arterial diseases: A systematic review and meta-analysis.
OBJECTIVES
With the development of endovascular therapies, some studies have indicated a therapeutic potential for infrapopliteal arterial revascularization with atherectomy (AT). This study was designed to perform a meta-analysis to investigate the efficacy of AT combined with percutaneous transluminal angioplasty (PTA) or drug-coated balloon (DCB) compared with PTA or DCB for infrapopliteal arterial diseases.
METHODS
This is a systematic review and meta-analysis. The Pubmed, Web of Science, and Cochrane Library were systematically searched for articles published up to November 2022, reporting using atherectomy devices for infrapopliteal arterial patients. Randomized controlled trials and retrospective studies were included, and clinical characteristic outcomes were extracted and pooled. Then, we analyzed the efficacies of the AT (AT + PTA or DCB) group and the non-AT (DCB or PTA) group for infrapopliteal arterial patients.
RESULTS
We identified 6 studies with 1269 patients included in this meta-analysis. The risk ratios (RRs) of primary patency for patients treated with atherectomy group compared to non-atherectomy group at 6 months was 1.03 (95% confidence intervals (CIs) 0.86-1.23, = .74), at 12 months was 1.05 (95% CIs 0.84-1.30, = .66), in the subgroup analysis between AT combined with DCB and DCB alone, the RRs of primary patency was 1.56 (95% CIs 1.02-2.39, = .04). The RRs of freedom from target lesion revascularization (TLR) at 6 months was 1.04 (95% CIs 0.93-1.17, = .45), at 12 months was 1.20 (95% CIs 0.83-1.75, = .33). The RRs of mortality at 6 months was 0.57 (95% CIs 0.29-1.11, = .10), and at 12 months was 0.79 (95% CI 0.50-1.25, = .31). The RRs of limb salvage at 12 months was 0.99 (95% CIs 0.92-1.07, = .87). The standardized mean difference (SMD) of (Ankle-brachial index) ABI at 12 months was 0.16 (95% CIs 0.06-0.26, = .001).
CONCLUSIONS
According to this systematic review and meta-analysis, no significant advantages were found with the addition of atherectomy to balloon angioplasty in the below-the-knee segment. Only in the analysis of a small subgroup of atherectomy + DCB versus DCB alone was the primary patency rate at six months significantly higher when adding atherectomy. No further significant differences were found related to 12 months of primary patency, TLR, limb salvage, and mortality among groups.
PubMed: 38715518
DOI: 10.1177/17085381241252861 -
Frontiers in Cardiovascular Medicine 2022Severely calcified coronary lesions with reduced left ventricular (LV) function result in worse outcomes. Atherectomy is used in treating such lesions when technically...
Outcomes of atherectomy in treating severely calcified coronary lesions in patients with reduced left ventricular ejection fraction: A systematic review and meta-analysis.
BACKGROUND
Severely calcified coronary lesions with reduced left ventricular (LV) function result in worse outcomes. Atherectomy is used in treating such lesions when technically feasible. However, there is limited data examining the safety and efficacy of atherectomy without hemodynamic support in treating severely calcified coronary lesions in patients with reduced left ventricular ejection fraction (LVEF).
OBJECTIVE
To evaluate the clinical outcomes of atherectomy in patient with reduced LVEF.
METHODS
We searched PubMed, Cochrane CENTRAL Register and ClinicalTrials.gov (inception through July 21, 2021) for studies evaluating the outcomes of atherectomy in patients with severe LV dysfunction. We used random-effect model to calculate risk ratio (RR) with 95% confidence interval (CI). The endpoints were in-hospital and long term all-cause mortality, cardiac death, myocardial infarction (MI), and target vessel revascularization (TVR).
RESULTS
A total of 7 studies consisting of 2,238 unique patients were included in the analysis. The median follow-up duration was 22.4 months. The risk of in-hospital all-cause mortality using atherectomy in patients with severely reduced LVEF compared to the patients with moderate reduced or preserved LVEF was [2.4vs.0.5%; RR:5.28; 95%CI 1.65-16.84; = 0.005], the risk of long term all-cause mortality was [21 vs. 8.8%; RR of 2.84; 95% CI 1.16-6.95; = 0.02]. In-hospital TVR risk was 2.0 vs. 0.6% (RR: 4.15; 95% CI 4.15-15.67; = 0.04) and long-term TVR was [6.0 vs. 9.9%; RR of 0.75; 95% CI 0.39-1.42; = 0.37]. In-hospital MI was [7.1 vs. 5.4%; RR 1.63; 95% CI 0.91-2.93; = 0.10], long-term MI was [7.5 vs. 5.7; RR 1.74; 95%CI 0.95-3.18; = 0.07).
CONCLUSION
Our meta-analysis suggested that the patients with severely reduced LVEF when using atherectomy devices experienced higher risk of clinical outcomes in the terms of all-cause mortality and cardiac mortality. As we know that the patients with severely reduced LVEF are inherently at increased risk of adverse clinical outcomes, this information should be considered hypothesis generating and utilized while discussing the risks and benefits of atherectomy in such high risk patients. Future studies should focus on the comparison of outcomes of different atherectomy devices in such patients. Adjusting for the inherent mortality risk posed by left ventricular dysfunction may be a strategy while designing a study.
PubMed: 36204563
DOI: 10.3389/fcvm.2022.946027