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Journal of Endovascular Therapy : An... Mar 2024The femoropopliteal arteries are commonly affected by atherosclerotic lesions. The use of atherectomy may increase the benefit of definitive therapy, such as drug-coated...
BACKGROUND
The femoropopliteal arteries are commonly affected by atherosclerotic lesions. The use of atherectomy may increase the benefit of definitive therapy, such as drug-coated balloon (DCB) angioplasty.
PURPOSE
To analyze the 2-year safety and efficacy of atherectomy in general and stratified by directional atherectomy (DA) and front-cutting atherectomy (FA) for the treatment of atherosclerotic lesions of the femoropopliteal arteries.
METHODS
A retrospective analysis was performed including patients who underwent vessel preparation with atherectomy. The primary endpoint was the 2-year incidence of target lesion revascularization (TLR). Secondary endpoints included primary patency, changes in ankle-brachial index (ABI) and Rutherford-Becker class (RBC), and amputation rate up to 2 years.
RESULTS
Nine hundred and fifty-five patients (37.8% female; mean age: 69.7±9.6 years) were included in this analysis. Eight hundred and twenty-one patients (86%) were claudicants, 134 patients (14%) had critical limb-threatening ischemia. Six hundred and forty-four lesions (67.4%) were in a native artery and 145 lesions (15.2%) were in-stent restenoses. In 166 patients (17.4%), atherectomy was performed in native and in-stent segments. Eight hundred and thirty-seven patients were treated with DA and 118 patients with FA. Five-hundred and seventy-four procedures (60.1%) were followed by DCB angioplasty, provisional stent rate was 20% overall. One hundred and fifty-four procedure-related adverse events (16.1%) were documented, four complications (0.4%) required surgical intervention. At 2 years, 279 patients (34.3%) required TLR. After DA, TLR rates were 9%, 19.5%, and 32.2% at 6, 12, and 24 months, respectively, and 14.2%, 29.4%, and 49%, at 6, 12, and 24 months after FA. After DA, primary patency rates were 75.9%, 57.4%, and 40.3% at 6, 12, and 24 months, respectively, and 64.9%, 44.8%, and 26%, at 6, 12, and 24 months, respectively, after FA. Mean ABI and mean RBC improved significantly during follow-up (p<0.001), 17 patients required amputation, 13 minor (1.6%) and four major (0.5%). Regression analysis shows that more calcified lesions are more likely to have a TLR. Compared with a vessel diameter of 4 mm or smaller, larger diameters are associated with fewer TLRs.
CONCLUSION
In this retrospective analysis, atherectomy of femoropopliteal lesions shows satisfactory mid-term results.
CLINICAL TRIAL REGISTRATION
German Clinical Trials Register: DRKS00031245.
CLINICAL IMPACT
The results of this analysis could influence the daily practice of the interventionalists. A combination of atherectomy as vessel preparation followed by drug coated balloon angioplasty appears to be promising, but would need to be investigated in randomised trials.
PubMed: 38546131
DOI: 10.1177/15266028241240898 -
Journal of Clinical Medicine Mar 2024Endovascular techniques have gained preference over peripheral arterial bypass surgery due to their minimally invasive nature; however, endovascular treatments often...
Endovascular techniques have gained preference over peripheral arterial bypass surgery due to their minimally invasive nature; however, endovascular treatments often show limited efficacy in arterial segments with a high atherosclerotic load. The use of atherectomy devices enables the removal of calcified plaque material and may promote arterial wall remodeling. This study assessed the technical success, safety, and feasibility of the BYCROSS atherectomy device in femoropopliteal lesions. This single-center, retrospective cohort study analyzed elective patients undergoing BYCROSS atherectomy for chronic peripheral arterial disease from March 2022 to May 2023. Patient data, procedural details, and outcomes were retrospectively collected from electronic patient records. The primary performance endpoints of this study were technical success, complications, and patency rates. Primary safety endpoints included 30-day and short-term major adverse limb events (MALEs), major adverse cardiovascular events (MACEs), and mortality rate. The study included 19 patients (median age, 71 years; 63% male) with Fontaine class IIb (26%), III (21%), or IV (53%). The BYCROSS atherectomy device was used to treat 22 limbs in the femoropopliteal tract, of which 11 lesions (50%) were occlusions and 11 were stenoses, with a median length of 24 cm (interquartile range: 17-38). Technical success was achieved in all cases: 4.5% required atherectomy only, 50% required additional balloon angioplasties, 41% required balloon angioplasties and stenting, and 4.5% required segments only stenting. Additional treatment of below-the-knee arteries was performed in 12 patients. Procedurally related complications (not limited to the use of the BYCROSS device) occurred in 23% of limbs, including distal embolization and laceration. At 30 days, mortality was 5%, the MACE rate was 11%, and the MALE rate was 0%. The observed mortality rate was not directly related to the procedure. Patency (<50% restenosis at duplex ultrasound) was 83% at 30 days. The use of the BYCROSS atherectomy device for the treatment of femoropopliteal lesions appears to be safe and feasible, with high technical success and low MALE and MACE rates in a challenging population with long-segment femoropopliteal lesions. Long-term follow-up in larger patient series is needed to confirm these findings and to determine the durability of this technique.
PubMed: 38542032
DOI: 10.3390/jcm13061809 -
American Heart Journal Plus :... Dec 2023Chronic total occlusion rotational atherectomy (CTO RA) is an emerging intervention in coronary artery disease (CAD), although data comparing its outcomes and...
BACKGROUND
Chronic total occlusion rotational atherectomy (CTO RA) is an emerging intervention in coronary artery disease (CAD), although data comparing its outcomes and complications with non-CTO RA are scarce. We sought to evaluate the outcomes of RA in CTO lesions compared to those in non-CTO lesions by performing a meta-analysis.
METHODS
We conducted a systematic review and meta-analysis of studies comparing the clinical outcomes and complications between CTO RA and non-CTO RA in patients with CAD. We searched PUBMED, CINAHL, EMBASE and Cochrane Central Register of Clinical Trials for any studies that compared the outcomes of RA in CTO and non-CTO lesions. The outcomes analyzed included in-hospital major adverse cardiovascular events (MACE), target vessel revascularization (TVR), angiographic success, procedural success, periprocedural complications, coronary perforation, and all-cause mortality.
RESULTS
Four studies with a total of 1868 patients were included, spanning from 2018 to 2022, from Germany, Taiwan, and Korea. The median age of included patients was 71. The rate of the pooled results indicated a moderate, non-significant increase in in-hospital MACE and TVR for CTO RA compared to non-CTO RA. There was a small, non-significant decrease in angiographic and procedural success in CTO RA compared to non-CTO RA. CTO RA was associated with a non-significant increase in periprocedural complications and a significant increase in coronary perforation compared to non-CTO RA. All-cause mortality showed a non-significant increase in the CTO RA group.
CONCLUSION
This meta-analysis provides evidence that while CTO RA may be associated with a higher risk of coronary perforation, the risk of other outcomes including MACE, TVR, and all-cause mortality is not significantly different compared to non-CTO RA. More research is needed to further understand these relationships and to optimize treatment strategies in patients with CAD undergoing CTO RA.
PubMed: 38510099
DOI: 10.1016/j.ahjo.2023.100345 -
Circulation. Cardiovascular... Mar 2024
Topics: Humans; Atherectomy, Coronary; Treatment Outcome; Angioplasty, Balloon, Coronary; Coronary Occlusion; Lasers
PubMed: 38502724
DOI: 10.1161/CIRCINTERVENTIONS.124.013996 -
Circulation. Cardiovascular... Mar 2024
Topics: Humans; Atherectomy, Coronary; Treatment Outcome; Angioplasty, Balloon, Coronary; Coronary Occlusion; Lasers; Coronary Angiography
PubMed: 38502721
DOI: 10.1161/CIRCINTERVENTIONS.123.013954 -
Kardiologia Polska 2024
Topics: Humans; Female; Atherectomy, Coronary; Coronary Aneurysm; Lithotripsy; Adult; Vascular Calcification; Treatment Outcome; Coronary Angiography
PubMed: 38493463
DOI: 10.33963/v.phj.99399 -
Vascular Medicine (London, England) Mar 2024This study aimed to assess the peri- and postprocedural outcomes of atherectomy-assisted endovascular treatment of the common femoral (CFA) and popliteal arteries....
This study aimed to assess the peri- and postprocedural outcomes of atherectomy-assisted endovascular treatment of the common femoral (CFA) and popliteal arteries. Phoenix atherectomy was used for the treatment of 73 and 53 de novo CFA and popliteal artery lesions, respectively, in 122 consecutive patients. Safety endpoints encompassed perforation and peripheral embolization. Postprocedural endpoints included freedom from clinically driven target lesion revascularization (CD-TLR) and clinical success (an improvement of ⩾ 2 Rutherford category [RC]). In addition, 531 patients treated for popliteal artery stenosis or occlusion without atherectomy were used as a comparator group. Procedural success (residual stenosis < 30% after treatment) was 99.2%. The need for bail-out stenting was 2 (2.7%) and 3 (5.7%) in CFA and popliteal artery lesions, respectively. Only one (1.4%) embolization occurred in the CFA, which was treated by catheter aspiration. No perforations occurred. After 1.50 (IQR = 1.17-2.20) years, CD-TLR occurred in seven (9.2%) and six (14.6%) patients with CFA and popliteal artery lesions, respectively, whereas clinical success was achieved in 62 (91.2%) and 31 (75.6%), respectively. Patients treated with atherectomy and DCB in the popliteal artery after matching for baseline RC, lesion calcification, length, and the presence of chronic total occlusion, exhibited higher freedom from CD-TLR compared to the nondebulking group (HR = 3.1; 95% CI = 1.1-8.5, = 0.03). Atherectomy can be used safely and is associated with low rates of bail-out stenting in CFA and popliteal arteries. CD-TLR and clinical success rates are clinically acceptable. In addition, for the popliteal artery, atherectomy combined with DCB demonstrates lower CD-TLR rates compared to a DCB alone strategy. ().
PubMed: 38493349
DOI: 10.1177/1358863X241231943 -
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 -
Annals of Vascular Surgery Jul 2024This Bayesian network meta-analysis (NMA) sought to evaluate the efficacy of different endovascular treatments for femoropopliteal artery in-stent restenosis (FP-ISR). (Meta-Analysis)
Meta-Analysis
BACKGROUND
This Bayesian network meta-analysis (NMA) sought to evaluate the efficacy of different endovascular treatments for femoropopliteal artery in-stent restenosis (FP-ISR).
METHODS
PubMed, Embase, Cochrane Central Register of Controlled Trials, and Web of science for clinical trials from database inception to March 31, 2023, with no language restrictions to retrieve randomized controlled trials or cohort studies evaluating the impact of any kind of endovascular treatments for FP-ISR. Pair-wise meta-analysis and Bayesian NMA were performed to pool the outcome estimates different endovascular treatments. The primary end points under consideration were primary patency rates at both 6-month and 12-month follow-up.
RESULTS
A total of 15 studies with 1,424 patients were ultimately enrolled to be analyzed, 7 types of endovascular treatment were identified for comparison. In terms of primary patency and freedom from target lesion revascularization (TLR) at 6-month and12-month follow-up, the direct meta-analysis findings showed that drug-coated balloons (DCB) and covered stent (CS) are considerably superior to plain old balloon angioplasty (POBA), Excimer laser atherectomy (ELA) + DCB is significantly better than DCB. According to the meta-analysis based on Bayesian theory, during the 6-month and 12-months follow-up, we could not find significant difference between the different treatments in terms of the primary patency and the freedom from TLR, based on the surface values under the cumulative ranking curve (SUCRA), CS was considered the best treatment in terms of primary patency (6 months SUCRA = 85.2; 12 months SUCRA = 78.9) and freedom from TLR (6 months SUCRA = 84.9; 12 months SUCRA = 70.9); directional atherectomy + POBA may lead to higher survival rate at 12 months (SUCRA = 89.1) than others treatments; in addition, both ELA + POBA and ELA + DCB have higher limb salvage than POBA.
CONCLUSIONS
The findings of this NMA suggest that CS showed positive encouraging results in primary patency and TLR in FP-ISR at 6 and 12 months. However, due to the potential influence of certain confounding factors, the long-term results necessitate validation through numerous randomized controlled trials.
Topics: Aged; Female; Humans; Male; Middle Aged; Angioplasty, Balloon; Bayes Theorem; Coated Materials, Biocompatible; Endovascular Procedures; Femoral Artery; Network Meta-Analysis; Peripheral Arterial Disease; Popliteal Artery; Recurrence; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Patency
PubMed: 38492725
DOI: 10.1016/j.avsg.2023.12.081 -
Clinical Research in Cardiology :... Jul 2024In the PREPARE-CALC trial, severely calcified lesion preparation with rotational atherectomy (RA) before biodegradable polymer sirolimus-eluting stent (SES) implantation... (Randomized Controlled Trial)
Randomized Controlled Trial Comparative Study
Lower revascularization rates after high-speed rotational atherectomy compared to modified balloons in calcified coronary lesions: 5-year outcomes of the randomized PREPARE-CALC trial.
BACKGROUND
In the PREPARE-CALC trial, severely calcified lesion preparation with rotational atherectomy (RA) before biodegradable polymer sirolimus-eluting stent (SES) implantation demonstrated higher procedural success and comparable rates of acute lumen gain and late lumen loss compared to modified balloons (MB) (scoring/cutting). We aimed to analyze the 5-year outcomes of both lesion preparation strategies.
METHODS
PREPARE-CALC randomly assigned 200 patients 1:1 to MB or RA, followed by SES implantation. The principal endpoint of the current analysis was target vessel failure (TVF) at 5 years.
RESULTS
At 5 years, MB had comparable rates of TVF to RA (19% vs. 21%, HR 1.14, 95% CI 0.60-2.16, p = 0.687). Subgroup analysis showed a lesion length treatment interaction, favoring MB for short lesions and RA for long ones (p for interaction = 0.042). Target lesion revascularization (TLR) was significantly less common with RA (12 vs. 3%, HR 0.28, 95% CI 0.08-0.98, p = 0.048). In a multivariate analysis, RA was independently protective against TLR (adj. HR 0.17, 95% CI 0.04-0.78, p = 0.022), while ostial lesions were associated with higher TLR independent of treatment strategy (adj. HR 11.3, 95% CI 2.98-42.6, p < 0.001).
CONCLUSION
In patients with severely calcified coronary lesions, using MB or RA for lesion preparation followed by biodegradable polymer SES implantation was associated with comparable rates of TVF at 5 years. However, a significant reduction of TLR was observed after RA. PREPARE-CALC is the first randomized trial showing potential clinical advantages of RA over MB during long-term follow-up.
CLINICAL TRIAL REGISTRATION
URL: https://www.
CLINICALTRIALS
gov . Unique identifier: NCT02502851.
Topics: Humans; Atherectomy, Coronary; Male; Female; Aged; Coronary Artery Disease; Treatment Outcome; Drug-Eluting Stents; Vascular Calcification; Angioplasty, Balloon, Coronary; Time Factors; Coronary Angiography; Follow-Up Studies; Middle Aged; Coronary Vessels; Absorbable Implants
PubMed: 38483633
DOI: 10.1007/s00392-024-02434-1