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European Heart Journal Mar 2023Optimal endovascular management of intermittent claudication (IC) remains disputed. This systematic review and meta-analysis compares efficacy and safety outcomes for... (Meta-Analysis)
Meta-Analysis
AIMS
Optimal endovascular management of intermittent claudication (IC) remains disputed. This systematic review and meta-analysis compares efficacy and safety outcomes for balloon angioplasty (BA), bare-metal stents (BMS), drug-coated balloons (DCB), drug-eluting stents (DES), covered stents, and atherectomy.
METHODS AND RESULTS
Electronic databases were searched for randomized, controlled trials (RCT) from inception through November 2021. Efficacy outcomes were primary patency, target-lesion revascularization (TLR), and quality-of-life (QoL). Safety endpoints were all-cause mortality and major amputation. Outcomes were evaluated at short-term (<1 year), mid-term (1-2 years), and long-term (≥2 years) follow-up. The study was registered on PROSPERO (CRD42021292639). Fifty-one RCTs enrolling 8430 patients/lesions were included. In femoropopliteal disease of low-to-intermediate complexity, DCBs were associated with higher likelihood of primary patency [short-term: odds ratio (OR) 3.21, 95% confidence interval (CI) 2.44-4.24; long-term: OR 2.47, 95% CI 1.93-3.16], lower TLR (short-term: OR 0.33, 95% CI 0.22-0.49; long-term: OR 0.42, 95% CI 0.29-0.60) and similar all-cause mortality risk, compared with BA. Primary stenting using BMS was associated with improved short-to-mid-term patency and TLR, but similar long-term efficacy compared with provisional stenting. Mid-term patency (OR 1.64, 95% CI 0.89-3.03) and TLR (OR 0.50, 95% CI 0.22-1.11) estimates were comparable for DES vs. BMS. Atherectomy, used independently or adjunctively, was not associated with efficacy benefits compared with drug-coated and uncoated angioplasty, or stenting approaches. Paucity and heterogeneity of data precluded pooled analysis for aortoiliac disease and QoL endpoints.
CONCLUSION
Certain devices may provide benefits in femoropopliteal disease, but comparative data in aortoiliac arteries is lacking. Gaps in evidence quantity and quality impede identification of the optimal endovascular approach to IC.
Topics: Humans; Popliteal Artery; Vascular Patency; Peripheral Arterial Disease; Treatment Outcome; Femoral Artery; Angioplasty, Balloon; Risk Factors
PubMed: 36721954
DOI: 10.1093/eurheartj/ehac722 -
Frontiers in Cardiovascular Medicine 2022Endovascular treatment has become the first-line therapy for infrapopliteal artery occlusive disease (IPOD), while the optimal endovascular method remains to be...
BACKGROUND
Endovascular treatment has become the first-line therapy for infrapopliteal artery occlusive disease (IPOD), while the optimal endovascular method remains to be determined. We performed a network meta-analysis (NWM) of randomized controlled trials (RCTs) to simultaneously compare the outcomes of different endovascular modalities for IPOD.
METHODS AND RESULTS
The Pubmed, Embase, and Cochrane databases were used as data sources. The NWM approach used random-effects models based on the frequentist framework. In total, 22 eligible RCTs (44 study arms; 1,348 patients) involving nine endovascular modalities or combinations [balloon angioplasty (BA), drug-coated balloon (DCB), drug-eluting stent (DES), atherectomy device + BA (AD + BA), AD + DCB, balloon-expandable bare metal stent (BMS), self-expanding stent (SES), absorbable metal stents (AMS), and inorganics-coated stent (ICS)] were included. BA had a lower 12-month primary patency rate than DCB (RR 0.50, CI 0.27, 0.93) and AD + DCB (RR 0.34, CI 0.12, 0.93). AD + DCB decreased 6-month TLR compared with AMS (RR 0.15, CI 0.03, 0.90), and DES decreased it compared with BMS (RR 0.25, CI 0.09, 0.71). DCB had a lower 6-month TLR rate than AMS (RR 0.26, CI 0.08, 0.86) and BA (RR 0.51, CI 0.30, 0.89). BA had a higher 12-month TLR rate than DCB (RR 1.76, CI 1.07, 2.90). According to the value of the surface under the cumulative ranking curve (SUCRA), AD + DCB was considered the best treatment in terms of primary patency at 6 months (SUCRA = 87.5) and 12 months (SURCA = 91). AD + BA was considered the best treatment in terms of 6-month TLR (SUCRA = 83.1), 12-month TLR (SURCA = 75.8), and 12-month all-cause mortality (SUCRA = 92.5). In terms of 12-month major amputation, DES was considered the best treatment (SUCRA = 78.6), while AD + DCB was considered the worst treatment (SUCRA = 28.8). Moreover, AD + BA always ranks higher than AD + DCB in the comparison including these two combinations. Subgroup analyses of modalities without stenting did not significantly change the primary outcomes.
CONCLUSION
ADs showed noteworthy advantages in multiple terms for IPOD except for 12-month major amputation. AD + BA may be a better method for IPOD than AD + DCB. The efficacy and safety of ADs are worthy of further investigation.
SYSTEMATIC REVIEW REGISTRATION
[https://www.crd.york.ac.uk/prospero/], identifier [CRD42022331626].
PubMed: 36439998
DOI: 10.3389/fcvm.2022.993290 -
Coronary Artery Disease Dec 2022Rotational and orbital coronary atherectomy (CA) are commonly utilized to treat complex calcified coronary lesions. We conducted a meta-analysis to evaluate sex... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Rotational and orbital coronary atherectomy (CA) are commonly utilized to treat complex calcified coronary lesions. We conducted a meta-analysis to evaluate sex differences in procedural complications and clinical outcomes after CA.
METHODS
PubMed, Google Scholar, and Cochrane databases were searched for all studies comparing sex differences in procedural and clinical outcomes following CA. The outcomes of interest were procedural complications (coronary dissection, stroke, major bleeding, coronary perforation, cardiac tamponade, and slow or no flow in target vessel) and the clinical outcomes (including early mortality, mid-term all-cause mortality, stroke, myocardial infarction, and target vessel revascularization). Pooled risk ratios (RRs) with their corresponding 95% confidence intervals (CIs) were calculated using the Mantel-Haenszel random-effects model.
RESULTS
Six observational studies with 3517 patients (2420 men and 1035 women) were included in this meta-analysis. While there was no significant difference in the early mortality (RR, 1.14; 95% CI, 0.37-3.53; P = 0.83) between men and women, at a mean follow-up of 2.9 years, all-cause mortality was significantly higher in women (RR, 1.29; 95% CI, 1.11-1.49; P = 0.0009). Women had an increased risk of procedure-related stroke (RR, 3.98; 95% CI, 1.06-14.90; P = 0.04), coronary dissection (RR, 2.10; 95% CI, 1.23-3.58; P = 0.006), and bleeding (RR, 2.26; 95% CI, 1.30-3.93; P = 0.004), whereas the rates of coronary perforation, cardiac tamponade, and the risk of slow or no flow in the revascularized artery were similar in both.
CONCLUSION
In our analysis, women undergoing CA are at increased risk of mid-term mortality and procedure-related complications including stroke, coronary dissection, and major bleeding.
Topics: Female; Humans; Male; Atherectomy, Coronary; Cardiac Tamponade; Sex Characteristics; Heart Injuries; Hemorrhage; Treatment Outcome; Stroke; Percutaneous Coronary Intervention; Coronary Artery Disease; Observational Studies as Topic
PubMed: 36238981
DOI: 10.1097/MCA.0000000000001187 -
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 -
Journal of Endovascular Therapy : An... Apr 2024Infrapopliteal lesions are generally complex to treat due to small vessel diameter, long lesion length, multilevel disease, and severe calcification. Therefore,... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
Infrapopliteal lesions are generally complex to treat due to small vessel diameter, long lesion length, multilevel disease, and severe calcification. Therefore, different vessel preparation devices have been developed to contribute to better peri- and postprocedural outcomes. This systematic review aims to compare different vessel preparation techniques prior to plain old balloon angioplasty (POBA) or drug-coated balloon (DCB) angioplasty with POBA or DCB alone in infrapopliteal arterial disease.
METHODS
Medline, EMBASE, and Cochrane databases were searched for studies published between 2000 and 2022 assessing the value of adjunctive vessel preparation in infrapopliteal arterial disease. The primary outcomes were 12-month primary patency and limb salvage.
RESULTS
A total of 1685 patients with 1913 lesions were included in 11 POBA studies. Methodological quality was assessed as poor to moderate in these studies. Only 2 studies with 144 patients assessed vessel preparation in conjunction with DCB angioplasty. These randomized trials were assessed as high quality and found no significant benefit of adjunctive atherectomy to DCB angioplasty. The pooled Kaplan-Meier estimates of 12-month primary patency and limb salvage in the POBA studies were 67.8% and 80.9% for POBA, 62.1% and 86.4% for scoring balloons, 67.9% and 79.6% for mechanical atherectomy (MA), and 79.7% and 82.6% for laser atherectomy, respectively. Within the pooled data only scoring balloons and MA demonstrated significantly improved 12-month limb salvage compared to POBA.
CONCLUSIONS
Different forms of adjunctive vessel preparation demonstrate similar 12-month outcomes compared to POBA and DCB angioplasty alone in infrapopliteal disease, with the exception of improved 12-month limb salvage in scoring balloons and MA. However, since the included studies were heterogeneous and assessed as poor to moderate methodological quality, selection bias may have played an important role. Main conclusion is that this systematic review found no additional value of standard use of vessel preparation.
CLINICAL IMPACT
Infrapopliteal arterial disease is associated with chronic limb-threatening ischemia (CLTI) and generally complex to treat due to small vessel diameter, long lesion length, multilevel disease and severe calcification. A wide range of vessel preparation devices have been developed to contribute to improved peri- and postprocedural outcomes in these complex lesions. This systematic review aims to compare different vessel preparation techniques prior to plain old balloon angioplasty (POBA) or drug coated balloon (DCB) angioplasty with POBA or DCB angioplasty alone in infrapopliteal arterial disease. Different forms of adjunctive vessel preparation demonstrate similar 12-month outcomes compared to POBA and DCB angioplasty alone in infrapopliteal disease, with the exception of improved 12-month limb salvage in scoring balloons and mechanical atherectomy (MA). However, since the included studies were heterogeneous and assessed as poor to moderate methodological quality, selection bias may have played an important role. Main conclusion is that this systematic review found no additional value of standard use of vessel preparation.
Topics: Humans; Femoral Artery; Popliteal Artery; Peripheral Arterial Disease; Risk Factors; Treatment Outcome; Angioplasty, Balloon; Coated Materials, Biocompatible; Vascular Patency
PubMed: 36062761
DOI: 10.1177/15266028221120752 -
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 -
European Journal of Vascular and... Mar 2022Intravascular lithotripsy (IVL) is a novel technique for plaque modification during endovascular revascularisation for peripheral artery disease (PAD) with severe... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
Intravascular lithotripsy (IVL) is a novel technique for plaque modification during endovascular revascularisation for peripheral artery disease (PAD) with severe calcification. The aim of this paper was to perform a systematic review and meta-analysis of contemporary data to elucidate the efficacy and safety of IVL in lower extremity PAD.
DATA SOURCES
A systematic literature search with pre-defined search terms was performed using PubMed, Web of Sciences, OvidSP, and EMBASE.
REVIEW METHODS
A meta-analysis was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Patient characteristics, lesion calcification, pre-IVL and post-IVL diameter stenosis, complications, and stent rates were evaluated.
RESULTS
Nine studies were included, encompassing a total of 681 patients (769 lesions) with IVL performed for PAD, of which 75.53% (95% confidence interval [CI] 66.08% - 83.03%) of the lesions were reported to have severe calcification. Comparison between pre-IVL and post-IVL diameter stenosis demonstrated a diameter stenosis reduction of 59.3% (95% CI 53.30% - 65.31%). Vascular complications were rare, with flow limiting or type D/E/F dissection occurring in only 1.25% (95% CI 0.60% - 2.61%) of cases. The overall pooled event rate for stent placement was 15.89% (95% CI 5.22% - 39.34%).
CONCLUSION
This meta-analysis supports IVL as an effective and safe approach for calcified plaque modification in lower extremity PAD, achieving a diameter stenosis reduction of 59.3% (95% CI 53.30% - 65.31%) with minimal vascular complications. Routine use of this device is not recommended; further high quality evidence is required to elucidate the efficacy of IVL with respect to different clinical characteristics such as lesion location and length, and in comparison with other treatment modalities such as atherectomy.
Topics: Humans; Lithotripsy; Lower Extremity; Peripheral Arterial Disease; Treatment Outcome; Vascular Calcification
PubMed: 34887206
DOI: 10.1016/j.ejvs.2021.10.035 -
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 -
Minerva Cardiology and Angiology Dec 2023Coronary artery calcification remains a challenge in percutaneous coronary interventions, due to the higher risk of suboptimal result with subsequent poor clinical...
INTRODUCTION
Coronary artery calcification remains a challenge in percutaneous coronary interventions, due to the higher risk of suboptimal result with subsequent poor clinical outcomes. Intravascular lithotripsy is a novel way of treating severe coronary calcification as it has the ability to modify calcium both circumferentially as well as transmurally, facilitating stent expansion and apposition. We conducted a systematic overview of the published literature on intravascular lithotripsy (IVL) assessing the efficacy and feasibility of IVL in treating severe coronary calcification.
EVIDENCE ACQUISITION
Of the retrieved publications, 62 met our inclusion criteria and were included. A total of 1389 patients (1414 lesions) with significant coronary calcification or under-expanded stents underwent IVL.
EVIDENCE SYNTHESIS
The mean age was 72.03 years (74.7% male). There was a significant improvement in acute and sustained vessel patency, with mean minimal lumen diameter of 2.78±0.46 mm, resulting in acute gain of 1.72±0.51 mm. The acute procedural success rate was 78.2 to 100% with in-hospital complication rate of 5.6 to 7.0%. The majority of the studies reported 30-day MACE, which was between 2.2 to 7.8%.
CONCLUSIONS
The recent studies have highlighted that the use of IVL with adjuvant intracoronary imaging has revolutionized the way of treating heavily calcified, non-dilatable coronary lesions and is likely to succeed the conventional ways of treating these complex lesions. We need further studies to gauge the long-term efficacy and safety of IVL against techniques currently available for calcium modification including conventional balloons, cutting or scoring balloons, rotational atherectomy and laser atherectomy.
Topics: Humans; Male; Aged; Female; Calcinosis; Calcification, Physiologic; Heart; Adjuvants, Immunologic; Adjuvants, Pharmaceutic; Calcium, Dietary
PubMed: 34713678
DOI: 10.23736/S2724-5683.21.05776-8 -
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