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BioMed Research International 2020The purpose of this article was to compare the efficiency and safety of drug-coated balloon angioplasty (DCB) and atherectomy with percutaneous transluminal angioplasty... (Meta-Analysis)
Meta-Analysis
The purpose of this article was to compare the efficiency and safety of drug-coated balloon angioplasty (DCB) and atherectomy with percutaneous transluminal angioplasty (PTA) in patients with femoropopliteal in-stent restenosis (ISR). Pubmed, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) (all up to March 2019) were searched systematically. Trial sequential analysis (TSA) was conducted. 5 studies with 599 participants were included. Compared with PTA, DCB significantly increased the rate of patency (6 months: RR 1.65, 95% CI 1.30 to 2.09, < 0.01; 12 months: RR 2.38, 95% CI 1.71 to 3.30, < 0.01) and the rate freedom from target lesion revascularization (TLR) (6 months: RR 1.18, 95% CI 1.09 to 1.28, < 0.01; 12 months: RR 1.56, 95% CI 1.33 to 1.82, < 0.01) at 6 and 12 months follow-up, and the TSA results showed these outcomes were reliable. The rate of clinical improvement by ≥1 Rutherford category in the DCB group was higher than that in the PTA group (6 months: RR 1.35, 95% CI 1.03 to 1.75, = 0.03; 12 months: RR 1.46, 95% CI 1.17 to 1.82, < 0.01) at 6 and 12 months. There is no statistically difference of ABI, all-cause mortality, and incidence of amputation between DCB group and PTA group (MD 0.03, 95% CI -0.03 to 0.08, = 0.40; RR 1.24, 95% CI 0.46 to 3.34, = 0.67; RR 0.32, 95% CI 0.01 to 7.61, = 0.48). Compared with PTA, the rate of patency and freedom from TLR in the laser atherectomy (LD) group was higher than that in the PTA group (patency: 6 months: RR 1.28, 95% CI 1.01 to 1.64, < 0.05, 12 months: RR 2.25, 95% CI 1.14 to 4.44, < 0.05; freedom from TLR: 6 months: RR 1.27, 95% CI 1.05 to 1.53, = 0.01, 12 months: RR 1.59, 95% CI 1.12 to 2.25, = 0.01) at 6 and 12 months follow-up. In conclusion, DCB and LD had superior clinical (freedom from TLR and clinical improvement) and angiographic outcomes (patency rate) compared with PTA for the treatment of femoropopliteal ISR. Moreover, DCB and LD had a low incidence of amputation and mortality and were relatively safe methods.
Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Atherectomy; Coated Materials, Biocompatible; Cytoreduction Surgical Procedures; Female; Femoral Artery; Humans; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Recurrence; Reoperation; Stents
PubMed: 32596293
DOI: 10.1155/2020/3076346 -
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 -
Journal of Community Hospital Internal... Mar 2021: Coronary artery calcification (CAC) is a pathological deposition of calcium in the intimal and medial layer of the arterial wall. A plethora of therapeutic calcium... (Review)
Review
: Coronary artery calcification (CAC) is a pathological deposition of calcium in the intimal and medial layer of the arterial wall. A plethora of therapeutic calcium debulking techniques is available for the treatment of CAC, including orbital or rotational atherectomy, excimer lasers, cutting, and scoring balloons, which are associated with a soaring rate of complication and low efficacy. To this end, in 2016, the Food and Drug Administration (FDA) posited that shockwave intravascular lithotripsy (S-IVL) technique can be employed with minimal complication. : A retrospective review of cases received lithotripsy for calcified coronary artery disease was performed by using online data from PubMed, Embase, and the Cochrane Central Register of Controlled Trials. The available search results were downloaded into an Endnote library and analyzed into two phases. : Out of 24 participants from case reports and series, Majority were found to be Male. There was no significant difference found in the mortality of patients undergoing IVL for the stenosis of the left main stem, left anterior descending, left circumflex artery, or diagonal branch. The mortality was found to be high among 6 patients with prior comorbidities and underwent more than 3 cycles of IVL (OR 37,95% Cl 1.54-886.04, P 0.02). Out of 24 patients, 2 (8.33%) patients developed complications such as vessel dissection (OR 3.4, 95% Cl 17.87-64.68, P 0.4). : Shockwave intravascular lithotripsy (S-IVL) may be used in cases of the calcified disease to gain vessel lumen in order to deploy drug-eluting stents with PCI. The success of the DES implantation of IVL can be 100% with a minimal complication rate.
PubMed: 33889320
DOI: 10.1080/20009666.2021.1883219 -
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 -
Cureus Dec 2023The optimal approach to deal with severe coronary artery calcification (CAC) in people with diabetes remains ill-defined. People with diabetes have a significant risk of... (Review)
Review
The optimal approach to deal with severe coronary artery calcification (CAC) in people with diabetes remains ill-defined. People with diabetes have a significant risk of developing severe vessel calcification and coronary artery disease (CAD). CAD is the leading cause of death in people with diabetes. Individuals with diabetes mainly present with severe multivessel stenosis, diffuse coronary calcification, and severe atherosclerosis, which are poor prognostic factors of revascularization procedures. Studies have shown that the revascularization of arteries in people with diabetes often results in worse outcomes than in people without diabetes. Coronary artery bypass grafting (CABG) has been recommended as the standard of care for people with DM and complex anatomic diseases, including left main CAD. However, percutaneous coronary intervention (PCI) is more acceptable to patients in clinical practice because of decreased trauma and rapid recovery. Severe CAC has traditionally been challenging for PCI and a frequent indication for surgical revascularization. This study aims to determine the effectiveness of orbital atherectomy (OA) in improving PCI outcomes in patients with diabetes and identify possible adverse effects that preclude its use. The study is reported according to PRISMA and analyzed according to Cochrane guidelines on synthesis without meta-analysis. A comprehensive literature search of EMBASE, Scopus, Web of Science, Cochrane Library, CINAHL, and MEDLINE was conducted for studies that utilized OA before PCI in people with diabetes. A reference list of the eligible articles was also screened. A narrative synthesis was done by representing the data on the effect direction plot, followed by vote counting. Eighteen studies were included in the analysis. Success rate/successful stent delivery was >90%, while freedom from angiographic complication and major adverse cardiovascular and cerebrovascular events (MACCE) were both >80% on the effect direction plot for people with diabetes and those without diabetes. People with diabetes had low event rates similar to those without diabetes. OA appears to be a viable treatment approach for people with diabetes. However, RCTs with a longer duration of follow-up are required to establish the appropriate treatment strategy for severe CAC in people with diabetes.
PubMed: 38186553
DOI: 10.7759/cureus.50153 -
Journal of Endovascular Therapy : An... Feb 2020To report the results of a network meta-analysis of randomized controlled trials (RCTs) comparing multiple endovascular treatments for de novo femoropopliteal lesions.... (Meta-Analysis)
Meta-Analysis
To report the results of a network meta-analysis of randomized controlled trials (RCTs) comparing multiple endovascular treatments for de novo femoropopliteal lesions. The MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials databases were systematically searched on June 1, 2019, for prospective RCTs comparing 14 treatments [ie, atherectomy, brachytherapy, cryoplasty, cutting balloons, drug-coated balloons, bare nitinol stents, drug-eluting stents (DES), covered stents (CS), and combinations] in the treatment of de novo femoropopliteal lesions. Outcomes were technical success; binary restenosis and target lesion revascularization (TLR) at 6, 12, and/or 24 months; and all-cause mortality at 12 months. Ultimately, 53 articles reporting on 45 studies (91 study arms; 5565 patients) were selected. For the technical success outcome, all types of stents, all balloons, and all atherectomy devices were aggregated in stent, balloon, and atherectomy technology groups, respectively. In terms of technical success for aggregated treatment types, stent technology was the most effective treatment and was better than balloon and atherectomy technologies. In terms of binary restenosis, DES was the most effective single treatment at the 6- and 12-month follow-up and CS at the 24-month follow-up. Both DES and CS were better than the majority of other single treatments, including balloon angioplasty, cutting balloon, cryoplasty, directional atherectomy, and bare nitinol stent during all follow-up periods. In terms of TLR, DES was the second most effective single treatment and the most effective single treatment at the 6- and 12-month follow-up intervals; CS was the most effective single treatment at the 24-month follow-up. Both DES and CS were better than the majority of other single treatments. The 12-month all-cause mortality of both DES and CS were similar to other treatments, whereas cryoplasty seemed to be the least effective treatment with regard to binary restenosis and TLR. Both DES and CS had substantial advantages in terms of restenosis and TLR in femoropopliteal lesions and were similar to aggregate stent technology in terms of technical success. DES performed better within 12 months after operation and CS at ~24 months, but neither had much advantage in terms of mortality. In contrast, cryoplasty seemed to be a less effective treatment.
Topics: Aged; Comparative Effectiveness Research; Endovascular Procedures; Female; Femoral Artery; Humans; Male; Middle Aged; Network Meta-Analysis; Peripheral Arterial Disease; Popliteal Artery; Randomized Controlled Trials as Topic; Recurrence; Risk Factors; Time Factors; Treatment Outcome; Vascular Patency
PubMed: 31948375
DOI: 10.1177/1526602819895996 -
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 -
Journal of Vascular and Interventional... Oct 2019Systematic literature searches using Embase, PubMed, and Cochrane Library for directional atherectomy with antirestenotic therapy (DAART) in femoropopliteal artery... (Meta-Analysis)
Meta-Analysis
Systematic literature searches using Embase, PubMed, and Cochrane Library for directional atherectomy with antirestenotic therapy (DAART) in femoropopliteal artery disease (FPAD) from January 2003 to February 2018 were conducted to evaluate clinical safety and effectiveness. A meta-analysis was conducted using Stata software for the event rate of technical success, bailout stent placement, primary patency, and target lesion revascularization (TLR) at 12 months. Five studies with 189 patients who received DAART were included in the meta-analysis. Pooled rates of technical success and bailout stent placement were 90.4% (95% confidence interval [CI] 86.3%-94.6%) and 4.8% (95% CI 0.7%-8.9%), respectively. Primary patency and TLR at 12 months were 85.3% (95% CI 79.6%-91.1%) and 5.5% (95% CI 1.9%-9.1%), respectively. Meta-analysis of 3 comparative studies demonstrated that DAART was not superior in performance in clinical endpoints, including technical success, bailout stent placement, primary patency, and TLR at 12 months (relative risk [RR] 1.111, 95% CI 0.896-1.377, P = .337; RR 0.400, 95% CI 0.120-1.332, P = .135; RR 1.136, 95% CI 0.841-1.535, P = .405; and RR 0.722, 95% CI 0.291-1.789, P = .482). The data did not suggest that DAART was an improvement over paclitaxel-coated balloon angioplasty for FPAD. The theoretical advantages of DAART still require further confirmation.
Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Atherectomy; Cardiovascular Agents; Coated Materials, Biocompatible; Female; Femoral Artery; Humans; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Recurrence; Risk Factors; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency
PubMed: 31471198
DOI: 10.1016/j.jvir.2019.06.012 -
The American Journal of Cardiology May 2024Rotational atherectomy (RA) is used to address complex calcified coronary lesions but data regarding the association between gender and outcomes of patients who... (Meta-Analysis)
Meta-Analysis
Rotational atherectomy (RA) is used to address complex calcified coronary lesions but data regarding the association between gender and outcomes of patients who underwent RA remain uncertain. We aimed to investigate the short- and long-term outcomes of patients who underwent RA based on gender. A systematic literature search was performed in PubMed, Embase, and Cochrane databases from its inception until August 2023 for relevant studies. Endpoints were pooled using the DerSimonian and Laird random-effects model as odd ratios (OR) with 95% confidence intervals (CIs). A total of 7 studies with 8,490 patients (2,565 women and 5,925 men) who underwent RA were included in the study. In terms of periprocedural outcomes, women had a higher risk of in-hospital mortality (OR 2.00, 95% CI 1.08 to 3.68, p = 0.03), coronary dissection (OR 1.80, 95% CI 1.05 to 3.10, p = 0.03), coronary perforation (OR 1.96, 95% CI 1.19 to 3.23, p = 0.01), and stroke (OR 4.22, 95% CI 1.06 to 16.82, p = 0.04) than men. There were no significant differences between women and men in terms of major adverse cardiovascular events (OR 1.43, 95% CI 0.69 to 2.94, p = 0.33), myocardial infarction (OR 1.35, 95% CI 0.87 to 2.08, p = 0.18), bleeding (OR 1.71, 95% CI 0.88 to 3.30, p = 0.11), and cardiac tamponade (OR 2.30, 95% CI 0.45 to 11.68, p = 0.32). Over a follow-up period of 3 years, the results of meta-analysis showed that women had a higher risk of all-cause mortality (OR 1.45, 95% CI 1.19 to 1.77, p <0.001), long-term major adverse cardiovascular events (OR 1.38, 95% CI 1.10 to 1.74, p = 0.01), and long-term stroke (OR 3.41, 95% CI 1.63 to 7.17, p <0.001). The risk of long-term myocardial infarction was found to be similar between both genders (OR 1.45, 95% CI 0.95 to 2.22, p = 0.09). In conclusion, female gender is associated with adverse periprocedural and long-term outcome after RA. Women consistently demonstrated higher risk of in-hospital mortality, coronary dissection, coronary perforation, and stroke in the periprocedural period. Long-term follow-up further highlighted a heightened risk for women in terms of all-cause mortality and stroke.
Topics: Humans; Atherectomy, Coronary; Coronary Artery Disease; Female; Sex Factors; Male; Postoperative Complications; Hospital Mortality; Treatment Outcome
PubMed: 38492788
DOI: 10.1016/j.amjcard.2024.03.012 -
Catheterization and Cardiovascular... Nov 2021The optimal approach to deal with severe coronary artery calcification (CAC) during percutaneous coronary intervention (PCI) remains ill-defined. (Meta-Analysis)
Meta-Analysis
INTRODUCTION
The optimal approach to deal with severe coronary artery calcification (CAC) during percutaneous coronary intervention (PCI) remains ill-defined.
METHODS
We conducted an electronic database search of all published studies comparing Orbital versus Rotational Atherectomy in patients undergoing PCI.
RESULTS
Eight observational studies were included in the analysis. Overall, there were no significant differences in Major-adverse-cardiac-events/MACE (OR: 0.81, CI: 0.63-1.05, p = .11), myocardial-infarction/MI (OR: 0.75, CI: 0.56-1.00, p = .05), all-cause mortality (OR: 0.82, CI: 0.25-2.64, p = .73) or Target-vessel-revascularization/TVR (OR: 0.72, CI: 0.38-1.36, p = .31). However, OA was associated with lower long-term MACE (1-year), (OR: 0.66, CI: 0.44-0.99, p = .04), long-term TVR (OR: 0.40, CI: 0.18-0.89, p = .03), and short-term MI (in-hospital and 30-day) (OR: 0.64, CI: 0.44-0.94, p = .02). OA was associated with more coronary artery dissections (OR: 2.61, CI: 1.38-4.92, p = .003) and device-related coronary perforations (OR: 2.79, CI: 1.08-7.19, p = .03). There were no differences in cardiac tamponade (OR: 1.78, CI: 0.37-8.69, p = .47). OA was noted to have significantly lower fluoroscopy time (MD: -3.96 min, CI: -7.67, -0.25; p = .04) compared to RA. No significant difference was noted in terms of contrast volume between the two groups (OR: -4.35 ml, CI: -14.52, 23.22; p = .65).
CONCLUSION
Although there was no difference in overall MACE, MI, all-cause mortality and TVR, OA was associated with lower long-term MACE and short-term MI. OA is associated with lower fluoroscopy time but higher rates of coronary artery dissection and coronary perforation.
Topics: Atherectomy; Atherectomy, Coronary; Coronary Artery Disease; Coronary Stenosis; Humans; Percutaneous Coronary Intervention; Retrospective Studies; Risk Factors; Treatment Outcome; Vascular Calcification
PubMed: 33325587
DOI: 10.1002/ccd.29430