Drug-Coated Balloon for de-novo Coronary Artery Lesions Exceeding 2.5 mm in Diameter: Optical Coherence Tomography Analysis and Clinical Follow-Up
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SUBMITTER: Liu Y
PROVIDER: S-EPMC10812136 | biostudies-literature | 2024 Jan
REPOSITORIES: biostudies-literature
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Project description:PurposeThe combined use of drug coated balloon (DCB) and optical coherence tomography (OCT) for the treatment of non-small coronary de novo lesion remains to be evaluated. We investigated the safety and efficacy of OCT-guided DCB in non-small coronary de novo lesion patients with predilation of cutting balloon.Methodshttps://clinicaltrials.gov/, ClinicalTrials.gov Identifier: NCT04795144. This study was a prospective, and open-label study. We enrolled patients with non-small de novo lesions treated with OCT-guided DCB. The non-small de novo lesions indicated vessel lesions with a diameter ≥ 2.5 mm. The primary endpoints were the success rate of the procedure and the occurrence of target lesion revascularization. The secondary endpoints were myocardial infarction, cardiac death, and major adverse cardiac events (MACE) within 3 months after the procedure.ResultsAt the Second Hospital of Jilin University, we enrolled 54 patients (54 lesions) with non-small de novo lesions who were treated with OCT-guided DCB from October 2018 to June 2019. A total of 52 patients were successfully treated with DCB-only strategy, while 2 patients turned to bailout stenting. A total of 21 patients had undergone angiography 3 months after the procedure with the late lumen loss of 0.24±0.57 mm. There was no statistically significant difference in minimal lumen diameter (MLD) between post-DCB and at 3-month angiographic follow-up (2.25±0.40 mm vs 2.04±0.54 mm; P = 0.110). Only 1 patient developed restenosis with the incidence of MACE rate of only 1.92% (n = 1). There was no significant difference in the stenosis of the lumen diameter of the target lesion vessel between 3 months after operation and immediately after operation.ConclusionsOur study showed that OCT-guided DCB with cutting balloon under guidance may be a novel approach in non-small de novo coronary artery disease.
| S-EPMC8581893 | biostudies-literature
Project description: Not available
| S-EPMC10011222 | biostudies-literature
Project description:PurposeData are limited on the long-term efficacy and safety of drug-coated balloon (DCB) treatment in comparison to drug-eluting stent (DES) for de novo coronary lesions. We investigated the long-term clinical outcomes of DCB treatment in percutaneous coronary intervention (PCI) for de novo coronary lesions.Materials and methodsA total of 103 patients scheduled for elective PCI for de novo non-small coronary lesions (≥2.5 mm) who were successfully treated with DCB alone were retrospectively compared with 103 propensity-matched patients treated with second-generation DES from the PTRG-DES registry (n=13160). All patients were followed for 5 years. The primary endpoint was major adverse cardiac events [MACE; cardiac death, myocardial infarction, stroke, target lesion thrombosis, target vessel revascularization (TVR), and major bleeding] at 5 years.ResultsAt 5-year clinical follow-up, Kaplan-Meier estimates of the rate of MACE were significantly lower in the DCB group [2.9% vs. 10.7%; hazard ratio (HR): 0.26; 95% confidence interval (CI): 0.07-0.96; log-rank p=0.027]. There was a significantly lower incidence of TVR in the DCB group (1.0% vs. 7.8%; HR: 0.12; 95% CI: 0.01-0.98; long-rank p=0.015), and there was major bleeding only in the DES group (0.0% vs. 1.9%; log-rank p=0.156).ConclusionAt 5-year follow-up, DCB treatment was significantly associated with reduced incidences of MACE and TVR, compared with DES implantation, for de novo coronary lesions.
| S-EPMC10232998 | biostudies-literature
Project description:BackgroundIn percutaneous coronary intervention (PCI) of de novo lesions, drug-coated balloons (DCB) have been shown to be a promising strategy to improve clinical outcomes of patients with small vessel disease. Evidence of this strategy in PCI of de novo coronary lesions in a real-world setting is limited. The objective of this study was to compare the 12-month outcomes of 2 paclitaxel-coated balloon systems for the treatment of all de novo coronary artery lesions.MethodsAll patients who were treated for de novo coronary artery stenosis with either SeQuent Please or In.Pact Falcon DCB at a single center from January 2014 to December 2018 were included. The primary end point was the composite of cardiac death, nonfatal myocardial infarction, and target vessel revascularization (3-point major adverse cardiovascular events) at 12 months.ResultsA total of 496 patients with 623 lesions, of which 144 were treated with SeQuent Please and 352 were treated with In.Pact Falcon were included in the study. Baseline patient, lesion and procedural characteristics at baseline were similar between groups. At 12-month follow-up, 3-point major adverse cardiovascular event outcomes were similar (4.2% vs 2.3% respectively; P = .272). Deaths due to cardiovascular events were few and similar between groups (2.7% vs 1.1% respectively; P = .20).ConclusionsBoth paclitaxel DCB systems have similar efficacy and safety outcomes, suggesting that both may be an appropriate treatment choice for patients with de novo lesions. However, a larger randomized controlled study is needed to confirm these findings.
| S-EPMC11308760 | biostudies-literature
Project description:Balloon-injured coronary segments are known to harbor abnormal vasomotion. We evaluated whether de novo coronary lesions treated using drug-coated balloon (DCB) are prone to vasospasm and how they respond to ergonovine and nitrate. Among 132 DCB angioplasty recipients followed, 89 patients underwent ergonovine provocation test at 6-9 months follow-up. Within-subject ergonovine- and nitrate-induced diameter changes were compared among three different sites: DCB-treated vs. angiographically normal vs. segment showing prominent vasoreactivity (spastic). No patient experienced clinically refractory vasospastic angina or symptom-driven revascularization during follow-up. Ergonovine induced vasospasm in seven patients; all were multifocal spasm either involving (n = 2) or rather sparing DCB-treated segments (n = 5). None showed focal spasm that exclusively involved DCB-treated lesions. Among 27 patients with vasospastic features, DCB-treated segments showed less vasoconstriction than spastic counterparts (p < 0.001). A total of 110 DCB-treated lesions were analyzed to assess vasomotor function. Vasomotor function, defined as a combined constrictor and dilator response, was comparable between DCB-treated and angiographically normal segments (p = 0.173), while significant differences were observed against spastic counterparts (p < 0.001). In our study, DCB-treated lesions were not particularly vulnerable to vasospasm and were found to have vasomotor function similar to angiographically normal segments, supporting safety of DCB-only strategy in treating de novo native coronary lesions.
| S-EPMC8779419 | biostudies-literature
Project description:PurposeDissection after plain balloon angioplasty is required to achieve adequate luminal area; however, it is associated with a high risk of vascular events. This study aimed to examine the relationship between non-flow limiting coronary dissections and subsequent lumen loss and long-term clinical outcomes following successful drug-coated balloon (DCB) treatment of de novo coronary lesions.Materials and methodsA total of 227 patients with good distal flow (Thrombolysis in Myocardial Infarction flow grade 3) following DCB treatment were retrospectively enrolled and stratified according to the presence or absence of a non-flow limiting dissection. The primary endpoint was late lumen loss (LLL) at 6-month angiography, and the secondary endpoint was target vessel failure (TVF, a composite of cardiac death, target vessel myocardial infarction, target vessel revascularization, and target vessel thrombosis).ResultsThe cohort consisted of 95 patients with and 132 patients without a dissection. There were no between-group differences in LLL (90.8%) returning for angiography at 6 months (0.05±0.19 mm in non-dissection and 0.05±0.30 mm in dissection group, p=0.886) or in TVF (6.8% in non-dissection and 8.4% in dissection group, p=0.799) at a median follow-up of 3.4 years. In a multivariate analysis, the presence of dissection and its severity were not associated with LLL or TVF. Almost dissections (93.9%) were completely healed, and there was no newly developed dissection at 6-month angiography.ConclusionThe presence of a dissection following successful DCB treatment of a de novo coronary lesion may not be associated with an increased risk of LLL or TVF (Impact of Drug-coated Balloon Treatment in de Novo Coronary Lesion; NCT04619277).
| S-EPMC7700881 | biostudies-literature
Project description:We aimed to investigate the safety of drug-coated balloon (DCB)-only percutaneous coronary intervention compared to drug-eluting stent (DES) for de novo lesions in large vessels. To pursue this goal, we conducted a systematic review and meta-analysis following the PRISMA guidelines. The analysis included studies that utilized DCB-only or hybrid angioplasty for de novo lesions in large coronary vessel (> 2.75 mm). The primary outcome was to assess the target lesion revascularization (TLR) rate, while secondary outcomes included cardiac death, myocardial infarction (MI), and the composite of these. A total of 15 studies, comprising 3975 patients (of whom 2114 treated with DCB) were included. Median age was 62 ± 1.5 years, with 77.4% being male. Overall, 26.9% had diabetes, and 67.6% were diagnosed with acute coronary syndrome. Over a pooled follow-up of 20.6 ± 1.9 months, the incidence of TLR was 4% in the pooled DBC group. Additionally, over a pooled follow-up of 25.8 ± 2.7 months, no significant differences were observed in incidence of TLR between the DCB group and the DES group (4.3% vs. 6.9%, odds ratio 0.71, 95% confidence interval 0.50-1.01, p = 0.059). Furthermore, there were no differences in incidence of cardiac death and MI. DCB angioplasty treatment of de novo lesions in large coronary vessels could be a safe and effective strategy in both acute and chronic coronary settings. The incidence of target lesion revascularization appears to be similar to that of contemporary DES.
| S-EPMC11811268 | biostudies-literature
Project description:AimsTo assess the serial changes of de novo coronary lesions treated with paclitaxel-coated balloon (PCB) using intravascular ultrasound virtual histology (IVUS-VH) and fractional flow reserve (FFR).Method and resultsThis prospective observational study enrolled 27 patients with coronary artery disease treated with PCB who underwent coronary angiography, IVUS-VH and FFR before, immediately after intervention and at 9 months. 28 de novo lesions were successfully treated with PCB. Angiographic late luminal loss was 0.02 ± 0.27 mm. Mean vessel and lumen areas showed increase at 9 months (12.0 ± 3.5 mm(2) to 13.2 ± 3.9 mm(2), p <0.001; and 5.4 ± 1.2 mm(2) to 6.5 ± 1.8 mm(2), p <0.001, respectively). Although mean plaque area was unchanged (6.6 ± 2.6 mm2 to 6.6 ± 2.4 mm(2), p = 0.269), percent atheroma volume decreased significantly (53.4 ± 7.9% to 49.5 ± 6.4%, p = 0.002). The proportion of plaque compositions including fibrous, fibrofatty, dense calcium and necrotic core by IVUS-VH was unchanged at 9 months. The FFR of the treated lesion was 0.71 ± 0.13 pre-procedure, 0.87 ± 0.06 post-procedure and 0.84 ± 0.06 at follow-up.ConclusionsDe novo coronary lesions treated with PCB showed persistent anatomical and physiological patency with plaque redistribution and vessel remodeling without chronic elastic recoil or plaque compositional change during follow-up.
| S-EPMC4733051 | biostudies-literature
Project description:BackgroundDermal blood vessels beneath the epidermis play critical roles in epidermal homeostasis and are functionally divided into several types, such as capillaries. Optical coherence tomography angiography (OCTA) is a powerful tool for the non-invasive assessment of dermal vasculature. However, the classification of vessel types has been limited. To address this issue, we proposed an algorithm for diameter-dependent classification that preserves three-dimensional (3D) information using OCTA.MethodsOCTA data were acquired by a prototype swept-source-type optical coherence tomography (OCT) system, which was processed through several imaging filters: an optical microangiography (OMAG) imaging filter, a vesselness imaging filter, and a diameter map filter. All vessels were visually classified into three types based on their diameters, as micro-vessels, intermediate vessels, and thick vessels. Aging-related alterations and their association with the epidermis were investigated for each vessel type. The measurements were conducted on the cheeks of 124 female subjects aged 20-79 years.ResultsThe 3D vascular structure was visualized by applying our proposed post-processing filters. Based on visual assessment, the thresholds for the diameters of the micro, intermediate and thick vessels were set at 80 and 160 µm. It was found that micro-vessels were predominantly located in the upper layer of the dermis and thick vessels in the deeper layer. Analysis of vessel metrics revealed that the volume density of the micro-vessels decreased significantly with age (r=-0.36, P<0.001) and was positively correlated with epidermal thickness (r=0.50, P<0.001). In contrast, the volume density of thick vessels significantly increased with age (r=0.2, P<0.05) and was not significantly correlated with epidermal thickness (r=0.13, P≥0.05).ConclusionsIn this study, we proposed a 3D quantification method using OCTA for dermal blood vessels and various vessel metrics, such as vessel volume density. This proposed classification will be beneficial for determining the function of the dermal vasculature and its diagnostic applications.
| S-EPMC11400647 | biostudies-literature
Project description:BackgroundPeripheral arterial disease (PAD) is a common and highly morbid disease. Although there have been recent advancements in the endovascular modalities to treat PAD, comparisons of these strategies, especially in the popliteal region, remain underinvestigated. The objective of this study was to compare midterm outcomes in patients with PAD undergoing treatment with both novel and SS compared with drug-coated balloon (DCB) angioplasty.MethodsAll patients at a multi-institution health system treated for PAD in the popliteal region from 2011 to 2019 were identified. Presenting features, operative details, and outcomes were included in the analysis. Patients who underwent popliteal revascularization with stents were compared with DCB. SS were compared separately with novel dedicated stents. Two-year primary patency was the primary outcome.ResultsWe included 408 patients (72.7 ± 11.8 years old; 57.1% men) in the analysis. There were 221 (54.7%) patients who underwent popliteal stenting and 187 (45.3%) who underwent popliteal DCB. There were high rates of tissue loss in both groups (57.9% vs 50.8%; P = .14). Stented patients had longer lesions (112.4 ± 3.2 vs 100.2 ± 5.8 mm; P = .03) and higher rates of concomitant superficial femoral artery treatment (88.2% vs 39.6%; P < .01). Chronic total occlusions accounted for the majority of lesions treated (stent 62.4%, DCB 64.2%). Perioperative complications were similar between groups. Primary patency for the stented group was higher at two years than the DCB group (61.0% vs 46.1%; P = .03). When evaluating stented patients only, SS had higher 2-year patency than novel stents in the popliteal segment (69.6% vs 51.4%; P = .04). On multivariable analysis, stenosis, as opposed to chronic total occlusion, was associated with improved patency (hazard ratio, 0.49; 95% confidence interval, 0.25-0.96; P = .04), whereas novel stents were associated with worse primary patency (hazard ratio, 2.01; 95% confidence interval, 1.09-3.73; P = .03).ConclusionsIn a population of patients with severe vascular disease, stents do not have inferior patency and limb salvage rates compared with DCB angioplasty when treating the popliteal region. For patients with advanced vascular disease, and especially tissue loss, stents and DCB are both beneficial when treating popliteal lesions.
| S-EPMC10849680 | biostudies-literature