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The New England Journal of Medicine Jan 2024Among patients with chronic limb-threatening ischemia (CLTI) and infrapopliteal artery disease, angioplasty has been associated with frequent reintervention and adverse... (Comparative Study)
Comparative Study Randomized Controlled Trial
BACKGROUND
Among patients with chronic limb-threatening ischemia (CLTI) and infrapopliteal artery disease, angioplasty has been associated with frequent reintervention and adverse limb outcomes from restenosis. The effect of the use of drug-eluting resorbable scaffolds on these outcomes remains unknown.
METHODS
In this multicenter, randomized, controlled trial, 261 patients with CLTI and infrapopliteal artery disease were randomly assigned in a 2:1 ratio to receive treatment with an everolimus-eluting resorbable scaffold or angioplasty. The primary efficacy end point was freedom from the following events at 1 year: amputation above the ankle of the target limb, occlusion of the target vessel, clinically driven revascularization of the target lesion, and binary restenosis of the target lesion. The primary safety end point was freedom from major adverse limb events at 6 months and from perioperative death.
RESULTS
The primary efficacy end point was observed (i.e., no events occurred) in 135 of 173 patients in the scaffold group and 48 of 88 patients in the angioplasty group (Kaplan-Meier estimate, 74% vs. 44%; absolute difference, 30 percentage points; 95% confidence interval [CI], 15 to 46; one-sided P<0.001 for superiority). The primary safety end point was observed in 165 of 170 patients in the scaffold group and 90 of 90 patients in the angioplasty group (absolute difference, -3 percentage points; 95% CI, -6 to 0; one-sided P<0.001 for noninferiority). Serious adverse events related to the index procedure occurred in 2% of the patients in the scaffold group and 3% of those in the angioplasty group.
CONCLUSIONS
Among patients with CLTI due to infrapopliteal artery disease, the use of an everolimus-eluting resorbable scaffold was superior to angioplasty with respect to the primary efficacy end point. (Funded by Abbott; LIFE-BTK ClinicalTrials.gov number, NCT04227899.).
Topics: Humans; Absorbable Implants; Angioplasty; Angioplasty, Balloon; Blood Vessel Prosthesis Implantation; Chronic Disease; Chronic Limb-Threatening Ischemia; Drug-Eluting Stents; Everolimus; Immunosuppressive Agents; Ischemia; Peripheral Arterial Disease; Popliteal Artery; Tissue Scaffolds; Treatment Outcome
PubMed: 37888915
DOI: 10.1056/NEJMoa2305637 -
Progress in Cardiovascular Diseases 2021Symptomatic vertebral artery stenosis is associated with high risk of early recurrent stroke. Vertebral artery stenosis can be treated with angioplasty and stenting with... (Review)
Review
Symptomatic vertebral artery stenosis is associated with high risk of early recurrent stroke. Vertebral artery stenosis can be treated with angioplasty and stenting with good technical results. In this review we outline the framework for the diagnosis and management of vertebral artery disease with focus on the emerging benefits of angiography and endovascular interventions.
Topics: Angioplasty; Endarterectomy; Humans; Recurrence; Risk Factors; Stents; Treatment Outcome; Vascular Grafting; Vascular Patency; Vertebral Artery; Vertebrobasilar Insufficiency
PubMed: 33592207
DOI: 10.1016/j.pcad.2021.02.006 -
JACC. Cardiovascular Interventions Sep 2022The comparative efficacy of percutaneous techniques for the preparation of calcified lesions before stenting remains poorly studied. (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
The comparative efficacy of percutaneous techniques for the preparation of calcified lesions before stenting remains poorly studied.
OBJECTIVES
This study sought to compare the performance of up-front rotational atherectomy (RA) or balloon-based techniques before drug-eluting stent implantation in severely calcified coronary lesions as assessed by angiography and optical coherence tomography (OCT).
METHODS
Patient-level data from the PREPARE-CALC (Comparison of Strategies to Prepare Severely Calcified Coronary Lesions) and ISAR-CALC (Comparison of Strategies to Prepare Severely Calcified Coronary Lesions) randomized trials were pooled. The primary endpoint was stent expansion as assessed by OCT imaging. The secondary endpoints included stent eccentricity, stent asymmetry, angiographic acute lumen gain, strategy success and in-hospital occurrence of cardiac death, target vessel myocardial infarction, and repeat revascularization.
RESULTS
Among 274 patients originally randomized, 200 participants with available OCT data after lesion preparation with RA (n = 63), a modified balloon (MB, n = 103), or a super high-pressure balloon (n = 34) before stenting were analyzed. The use of RA versus MB or a super high-pressure balloon led to comparable stent expansion (73.2% ± 11.6% vs 70.8% ± 13.6% vs 71.8% ± 12.2%, P = 0.49) and stent asymmetry (P = 0.83). Compared with RA or MB, a super high-pressure balloon was associated with less stent eccentricity (P = 0.03) with a numerically higher acute lumen gain, albeit not significantly different (P = 0.08). Strategy success was more frequent with RA versus MB (P = 0.002) and numerically more frequent with RA versus a super high-pressure balloon (P = 0.06). Clinical outcomes did not differ between groups.
CONCLUSIONS
In patients with severely calcified lesions undergoing drug-eluting stent implantation, lesion preparation with RA, MB, or a super high-pressure balloon was associated with comparable stent expansion. A super high-pressure balloon is associated with less stent eccentricity, whereas strategy success is more frequent with RA.
Topics: Angioplasty, Balloon, Coronary; Atherectomy, Coronary; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Humans; Treatment Outcome; Vascular Calcification
PubMed: 36137691
DOI: 10.1016/j.jcin.2022.07.034 -
The Journal of Invasive Cardiology May 2020Accordion effect or concertina effect - also known as "crumpled coronary" - is an uncommon occurrence during coronary angioplasty. It usually has no major clinical...
Accordion effect or concertina effect - also known as "crumpled coronary" - is an uncommon occurrence during coronary angioplasty. It usually has no major clinical sequelae and should be differentiated from spasm, dissection, and thrombosis, which require special management.
Topics: Angioplasty, Balloon, Coronary; Coronary Angiography; Humans
PubMed: 32357138
DOI: No ID Found -
Journal of Visualized Experiments : JoVE Aug 2022Coronary artery disease is a major contributor to morbidity and mortality worldwide. While lifestyle changes and medication are the cornerstones of treatment, coronary...
Coronary artery disease is a major contributor to morbidity and mortality worldwide. While lifestyle changes and medication are the cornerstones of treatment, coronary artery balloon angioplasty and stenting are routinely performed on patients with acute coronary syndromes and chronic coronary artery disease who remain symptomatic with optical medical treatment. Several generations of coronary stents have been developed over recent decades. Balloon angioplasty and stenting are supported by the use of pharmaceutical agents applied onto balloons and the stent surface, either to advance the healing properties of the artery post-intervention or to prevent the formation of restenosis. New devices need to be rigorously tested for safety and efficacy before acceptance into clinical practice; thus, there is a continuing need for reliable and reproducible preclinical methods of stent evaluation. We describe here a pig coronary artery model as well as an atherosclerotic rabbit model for coronary artery stent research and describe basic steps in intravascular imaging and stent histology.
Topics: Angioplasty, Balloon; Angioplasty, Balloon, Coronary; Animals; Coronary Artery Disease; Rabbits; Stents; Swine
PubMed: 36094257
DOI: 10.3791/64038 -
Current Problems in Cardiology Jun 2023This review of the literature analyzes publications over the past five years on various problems associated with carotid endarterectomy: 1. Is the eversion or classical... (Review)
Review
This review of the literature analyzes publications over the past five years on various problems associated with carotid endarterectomy: 1. Is the eversion or classical technique of surgery with plastic repair of the reconstruction area with a patch more effective? 2. Carotid endarterectomy or carotid angioplasty with stenting is more optimal? 3. When should brain revascularization be performed after the development of ischemic stroke? 4. Should a temporary shunt be used to protect the brain during carotid endarterectomy? 5. How to prevent and treat different types of intraoperative ischemic strokes? 6. What tactics of treatment of patients with combined lesions of the carotid and coronary arteries is more effective? 7. What are the causes and methods of elimination of restenosis of the internal carotid artery known? 8. Is carotid endarterectomy safe in old age?
Topics: Humans; Carotid Stenosis; Treatment Outcome; Endarterectomy, Carotid; Angioplasty; Stents; Stroke
PubMed: 36828045
DOI: 10.1016/j.cpcardiol.2023.101676 -
Current Cardiology Reviews 2023Patients with posterior circulation ischemia due to vertebral artery stenosis account for 20 to 25% of ischemic strokes and have an increased risk of recurrent stroke.... (Review)
Review
Patients with posterior circulation ischemia due to vertebral artery stenosis account for 20 to 25% of ischemic strokes and have an increased risk of recurrent stroke. In patients treated with medical therapy alone, the risk of recurrence is particularly increased in the first few weeks after symptoms occur, with an annual stroke rate of 10 to 15%. Additionally, obstructive disease of the vertebrobasilar system carries a worse prognosis, with a 30% mortality at 2-years if managed medically without additional surgical or endovascular intervention. Percutaneous transluminal angioplasty and stenting of symptomatic vertebral artery stenosis are promising options widely used in clinical practice with good technical results; however, the improved clinical outcome has been examined in various clinical trials without a sufficient sample size to conclusively determine whether stenting is better than medical therapy. Surgical revascularization is an alternative approach for the treatment of symptomatic vertebral artery stenosis that carries a 10-20% mortality rate. Despite the advances in medical therapy and endovascular and surgical options, symptomatic vertebral artery stenosis continues to impose a high risk of stroke recurrence with associated high morbidity and mortality. This review aims to provide a focused update on the percutaneous treatment of vertebral artery stenosis, its appropriate diagnostic approach, and advances in medical therapies.
Topics: Humans; Vertebral Artery; Vertebrobasilar Insufficiency; Angioplasty; Stroke; Treatment Outcome; Stents
PubMed: 35301953
DOI: 10.2174/1573403X18666220317093131 -
Journal of the American College of... Apr 2022Percutaneous transluminal pulmonary angioplasty (PTPA) is a treatment modality for chronic thromboembolic pulmonary hypertension, but whether it can be applied to...
BACKGROUND
Percutaneous transluminal pulmonary angioplasty (PTPA) is a treatment modality for chronic thromboembolic pulmonary hypertension, but whether it can be applied to Takayasu arteritis-associated pulmonary hypertension (TA-PH), another chronic obstructive pulmonary vascular disease, remains unclear.
OBJECTIVES
This study sought to investigate the efficacy and safety of PTPA for TA-PH.
METHODS
Between January 1, 2016, and December 31, 2019, a total of 50 patients with TA-PH who completed the PTPA procedure (the PTPA group) and 21 patients who refused the PTPA procedure (the non-PTPA group) were prospectively enrolled in this cohort study. The primary outcome was all-cause mortality. The safety outcomes included PTPA procedure-related complications.
RESULTS
Baseline characteristics and medical therapies were similar between the PTPA group and the non-PTPA group. During a mean follow-up time of 37 ± 14 months, deaths occurred in 3 patients (6.0%) in the PTPA group and 6 patients (28.6%) in the non-PTPA group, contributing to the 3-year survival rate of 93.7% in the PTPA group and 76.2% in the non-PTPA group (P = 0.0096 for log-rank test). The Cox regression model showed that PTPA was associated with a significantly reduced hazard of all-cause mortality in TA-PH patients (HR: 0.18; 95% CI: 0.05-0.73; P = 0.017). No periprocedural death occurred. Severe complications requiring noninvasive positive pressure ventilation occurred in only 1 of 150 total sessions (0.7%).
CONCLUSIONS
PTPA tended to be associated with a reduced risk of all-cause mortality with acceptable safety profiles and seemed to be a promising therapeutic option for TA-PH patients.
Topics: Angioplasty; Cohort Studies; Humans; Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Retrospective Studies; Takayasu Arteritis; Treatment Outcome
PubMed: 35422244
DOI: 10.1016/j.jacc.2022.01.052 -
International Journal of Cardiology Jan 2021
Topics: Angioplasty, Balloon; Coronary Vessels; Humans; Paclitaxel; Pharmaceutical Preparations; Popliteal Artery
PubMed: 33091521
DOI: 10.1016/j.ijcard.2020.10.044 -
International Heart Journal Mar 2023Evidence on the effectiveness and comparative effectiveness of stent implantation and balloon angioplasty for native coarctation of the aorta (CoA) and recurrent CoA... (Meta-Analysis)
Meta-Analysis
Evidence on the effectiveness and comparative effectiveness of stent implantation and balloon angioplasty for native coarctation of the aorta (CoA) and recurrent CoA separately is lacking. The present meta-analysis was performed to assess the efficacy and safety of stent implantation and balloon angioplasty in native (NaCo) and recurrent (ReCo) CoA.A systematic computerized literature search was conducted to retrieve all relevant studies of stent implantation and balloon angioplasty for CoA. Both single-arm and comparative studies were included. Data on NaCo and ReCo were pooled separately.A post-procedure gradient of ≤ 20 mmHg was achieved in 97% and 92% of patients undergoing stent implantation and balloon angioplasty for NaCo, and in 98% and 90% for ReCo, respectively. A post-procedure gradient of ≤ 10 mmHg was achieved in 97% and 83% of patients undergoing stent implantation and balloon angioplasty for NaCo, and in 86% and 78% for ReCo, respectively. Comparative results confirmed that stent implantation provided a significantly higher success rate compared with balloon angioplasty (odds ratio [OR] = 2.09; 95% confidence interval [CI] = 1.13-3.86; P = 0.019) in treating NaCo. Incidences of all-cause complications, mortality, reintervention, and aneurysm formation were similar between the groups. Patients undergoing stent implantation had a significantly lower incidence of dissection (OR = 0.15; 95% CI = 0.02-0.92; P = 0.040).Current evidence indicates that stent implantation might have superior efficacy compared with balloon angioplasty for the treatment of NaCo with higher success rates and similar complication rates. However, whether this superior effect is also present in ReCo patients needs further evaluation.
Topics: Humans; Aortic Coarctation; Aorta; Angioplasty, Balloon, Coronary; Angioplasty, Balloon; Recurrence; Stents; Treatment Outcome
PubMed: 36682763
DOI: 10.1536/ihj.21-643