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Angioplastia Coronaria con Balón , Humanos , Angioplastia Coronaria con Balón/instrumentación , Angioplastia Coronaria con Balón/métodos , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/cirugía , Stents Liberadores de Fármacos , Resultado del Tratamiento , Masculino , Angiografía Coronaria , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/cirugíaAsunto(s)
Angioplastia Coronaria con Balón , Humanos , Angioplastia Coronaria con Balón/instrumentación , Angioplastia Coronaria con Balón/efectos adversos , Angioplastia Coronaria con Balón/métodos , Stents Liberadores de Fármacos , Resultado del Tratamiento , Vasos Coronarios/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia , Materiales Biocompatibles RevestidosRESUMEN
BACKGROUND: Drug-coated balloon (DCB) angioplasty and drug-eluting stents (DES) are two widely used treatments for in-stent restenosis (ISR). Focal and non-focal types of ISR affect the clinical outcomes. The present study aims to compare DES reimplantation versus DCB angioplasty in acute coronary syndrome (ACS) patients with focal ISR and non-focal ISR lesions. METHODS: Patients with ISR lesions underwent percutaneous coronary intervention (PCI) were retrospectively evaluated and divided into DES group and DCB group. The primary endpoint was the incidence of target lesion failure (TLF) at 24 months follow up. Propensity score matching (PSM) was conducted to balance the baseline characteristics. RESULTS: For focal ISR, TLF was comparable in the DES and DCB groups at 24 months of follow-up (Before PSM, hazard ratio [HR]: 0.70; 95% confidence interval [CI]: 0.39-1.27; p = 0.244; After PSM, HR: 0.83; 95% CI: 0.40-1.73; p = 0.625). For non-focal ISR, TLF was significantly decreased in DES compared with DCB group (Before PSM, HR: 0.43; 95% CI: 0.29-0.63; p < 0.001; After PSM, HR: 0.33; 95% CI: 0.19-0.59; p < 0.001), which was mainly attributed to the lower incidence of clinically indicated target lesion revascularization (CD-TLR) (Before PSM, HR: 0.39; 95% CI: 0.26-0.59; p < 0.001; After PSM, HR: 0.28; 95% CI: 0.15-0.54; p < 0.001). CONCLUSIONS: The clinical outcomes for DES and DCB treatment are similar in focal type of ISR lesions. For non-focal ISR, the treatment of DES showed a significant decrease in TLF which was mainly attributed to a lower incidence of CD-TLR.
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Síndrome Coronario Agudo , Angioplastia Coronaria con Balón , Angiografía Coronaria , Reestenosis Coronaria , Stents Liberadores de Fármacos , Humanos , Masculino , Femenino , Persona de Mediana Edad , Estudios Retrospectivos , Reestenosis Coronaria/diagnóstico por imagen , Reestenosis Coronaria/epidemiología , Reestenosis Coronaria/etiología , Anciano , Síndrome Coronario Agudo/diagnóstico por imagen , Síndrome Coronario Agudo/cirugía , Síndrome Coronario Agudo/terapia , Angioplastia Coronaria con Balón/métodos , Angioplastia Coronaria con Balón/instrumentación , Angiografía Coronaria/métodos , Estudios de Seguimiento , Materiales Biocompatibles Revestidos , Resultado del Tratamiento , Intervención Coronaria Percutánea/métodos , Intervención Coronaria Percutánea/instrumentaciónRESUMEN
INTRODUCTION: Percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in complex coronary artery disease (CAD) has been established as the standard of care, but stent-related events are not uncommon. Sirolimus-Coated Balloon (SCB)-based angioplasty is an emerging technology, although it needs to be thoroughly evaluated compared with DES in the complex PCI setting. This study aimed to investigate the safety and efficacy of SCB-based angioplasty compared with new-generation DES in complex PCI. METHODS: Net adverse cardiovascular events (NACE: all-cause death, target lesion revascularization, non-fatal myocardial infarction, and major bleedings according to BARC classification), as a primary study endpoint was compared between SCB and new-generation DES for complex coronary lesions. RESULTS: Among 1782 patients with complex CAD, 1076 were treated with a sirolimus-coated balloon (EASTBOURNE Registry) and 706 with new-generation DES (COMPLEX Registry). After propensity score matching, a total of 512 patients in both groups were analyzed. NACE occurred more significantly in the DES group during the 1-year follow-up (10.5% vs. 3.9%, p = 0.003), mainly due to a higher risk of bleeding (6.6% vs. 0.4%, p = 0.001). The Cox model adjusted for lesion length showed a significantly lower hazard of NACE (HR: 0.23, CI [0.10, 0.52], p < 0.001) and all-cause mortality (HR: 0.07, CI [0.01, 0.66], p = 0.020) in SCB compared to DES group. CONCLUSIONS: SCB angioplasty has an advantage over DES for the treatment of complex CAD regarding NACE, significantly reducing the incidence of major bleeding without increasing ischemic endpoints. SCB may be an alternative to DES in selected patients with complex coronary lesions.
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Angioplastia Coronaria con Balón , Enfermedad de la Arteria Coronaria , Stents Liberadores de Fármacos , Puntaje de Propensión , Sirolimus , Humanos , Sirolimus/administración & dosificación , Masculino , Femenino , Anciano , Persona de Mediana Edad , Enfermedad de la Arteria Coronaria/cirugía , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Angioplastia Coronaria con Balón/métodos , Angioplastia Coronaria con Balón/instrumentación , Angioplastia Coronaria con Balón/efectos adversos , Sistema de Registros , Estudios de Seguimiento , Resultado del Tratamiento , Materiales Biocompatibles RevestidosAsunto(s)
Diseño de Prótesis , Stents , Humanos , Resultado del Tratamiento , Masculino , Intervención Coronaria Percutánea/instrumentación , Intervención Coronaria Percutánea/efectos adversos , Anciano , Lesiones del Sistema Vascular/diagnóstico por imagen , Lesiones del Sistema Vascular/cirugía , Lesiones del Sistema Vascular/etiología , Lesiones del Sistema Vascular/terapia , Angioplastia Coronaria con Balón/instrumentación , Stents Liberadores de FármacosRESUMEN
BACKGROUND: In-stent restenosis (ISR) remains a significant challenge in interventional cardiology despite advancements in stent technology. Drug-coated balloons (DCBs), which deliver antiproliferative agents directly to the vessel wall, have emerged as a promising alternative to plain balloon angioplasty for ISR treatment. This meta-analysis evaluates the efficacy of DCBs compared to plain balloon angioplasty in patients with coronary ISR. METHODS: A comprehensive search of PubMed and Embase was conducted on June 27, 2024. The search identified randomized controlled trials comparing DCBs and plain balloon angioplasty for ISR treatment. Six trials involving 1,322 patients met the inclusion criteria. Quality was assessed with the Cochrane Risk of Bias tool. Data extraction and statistical analysis were performed using RevMan software, assessing heterogeneity with the I2 statistic and publication bias using funnel plots. RESULTS: The analysis showed that DCBs significantly reduced late in-stent and in-segment luminal loss (P < 0.001) and target lesion revascularization (P = 0.02) compared to plain balloon angioplasty. Major adverse cardiovascular events and the combined endpoint of target lesion revascularization, myocardial infarction, and death also showed highly significant improvements with DCB treatment (P < 0.00001 and P = 0.0002, respectively). However, no significant effect was observed on myocardial infarction and mortality rates. CONCLUSION: DCBs significantly reduce in-stent late luminal loss, target lesion revascularization, and major adverse cardiovascular events compared to plain balloon angioplasty.
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Angioplastia Coronaria con Balón , Materiales Biocompatibles Revestidos , Reestenosis Coronaria , Humanos , Angioplastia Coronaria con Balón/instrumentación , Angioplastia Coronaria con Balón/métodos , Materiales Biocompatibles Revestidos/administración & dosificación , Materiales Biocompatibles Revestidos/efectos adversos , Reestenosis Coronaria/terapia , Reestenosis Coronaria/diagnóstico , Stents Liberadores de Fármacos/efectos adversos , Ensayos Clínicos Controlados Aleatorios como Asunto , Stents/efectos adversos , Resultado del TratamientoRESUMEN
Coronary intervention involving the region of bifurcation remains a challenging issue for the cardiologist as well as a complication. A number of factors including the angulation of side branch with the main branch determines the success. Though provisional strategy remains the best option in bifurcation intervention, at times a two-stent strategy cannot be avoided. We report a case in which percutaneous coronary intervention was performed on the left anterior descending artery (LAD) at its bifurcation with a major diagonal branch (> 2.5 mm). The ostium of the diagonal was diseased, and the branch took off from the LAD at an unfavorable angle (> 120°). We describe the use of the "shepherd's crook wire curve" approach, a modification of the reverse wire technique, which allowed us to successfully wire, dilate, and protect the diagonal and so named to reflect its resemblance to the shape of a shepherd's crook.
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Angioplastia Coronaria con Balón , Angiografía Coronaria , Enfermedad de la Arteria Coronaria , Humanos , Resultado del Tratamiento , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/cirugía , Angioplastia Coronaria con Balón/instrumentación , Masculino , Stents Liberadores de Fármacos , Catéteres Cardíacos , AncianoRESUMEN
BACKGROUND: To treat stenosed coronary arteries, percutaneous transluminal coronary angioplasty (PTCA) balloon catheters must combine pushability, trackability, crossability, and rewrap behavior. The existing anatomic track model (ASTM F2394) for catheter testing lacks 3D morphology, vessel tortuosity, and compliance, making evaluating performance characteristics difficult. This study aimed to develop a three-dimensional patient-specific phantom (3DPSP) for device testing and safe training for interventional cardiologists. METHODS: A range of silicone materials with different shore hardnesses (00-30-45 A) and wall thicknesses (0.5 mm, 1 mm, 2 mm) were tested to determine compliance for creating coronary vessel phantoms. Compliance was assessed using optical coherence tomography (OCT) and compared to values in the literature. Stenosis was induced using multilayer casting and brushing methods, with gypsum added for calcification. The radial tensile properties of the samples were investigated, and the relationship between Young's modulus and compliance was determined. Various methods have been introduced to approximate the friction between silicone and real coronary vessel walls. Computerized tomography (CT) scans were used to obtain patient-specific anatomy from the femoral artery to the coronary arteries. Artery lumens were segmented from the CT scans to create dissolvable 3D-printed core models. RESULTS: A 15A shore hardness silicone yielded an experimental compliance of 12.3-22.4 m m 2 mmHg · 10 3 for stenosed tubes and 14.7-57.9 m m 2 mmHg · 10 3 for uniform tubes, aligning closely with the literature data (6.28-40.88 m m 2 mmHg · 10 3 ). The Young's modulus ranged from 43.2 to 75.5 kPa and 56.6-67.9 kPa for the uniform and calcified materials, respectively. The dependency of the compliance on the wall thickness, Young's modulus, and inner diameter could be shown. Introducing a lubricant reduced the silicone friction coefficient from 0.52 to 0.13. The 3DPSP was successfully fabricated, and comparative analyses were conducted among eight commercially available catheters. CONCLUSION: This study presents a novel method for crafting 3DPSPs with realistic mechanical and frictional properties. The proposed approach enables the creation of comprehensive and anatomically precise setups spanning the right femoral artery to the coronary arteries, highlighting the importance of such realistic environments for advancing medical device development and fostering safe training conditions.
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Angioplastia Coronaria con Balón , Vasos Coronarios , Humanos , Vasos Coronarios/diagnóstico por imagen , Angioplastia Coronaria con Balón/instrumentación , Siliconas/química , Modelación Específica para el Paciente , Fantasmas de Imagen , Ensayo de Materiales , Tomografía de Coherencia Óptica , Modelos AnatómicosAsunto(s)
Angioplastia Coronaria con Balón , Paclitaxel , Sirolimus , Animales , Paclitaxel/administración & dosificación , Paclitaxel/uso terapéutico , Sirolimus/administración & dosificación , Sirolimus/uso terapéutico , Conejos , Angioplastia Coronaria con Balón/instrumentación , Angioplastia Coronaria con Balón/métodos , Modelos Animales de Enfermedad , Stents Liberadores de Fármacos , Materiales Biocompatibles Revestidos , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/efectos de los fármacosAsunto(s)
Paclitaxel , Sirolimus , Animales , Paclitaxel/administración & dosificación , Paclitaxel/uso terapéutico , Sirolimus/administración & dosificación , Conejos , Angioplastia Coronaria con Balón/instrumentación , Angioplastia Coronaria con Balón/métodos , Stents Liberadores de Fármacos , Modelos Animales de Enfermedad , Materiales Biocompatibles RevestidosRESUMEN
BACKGROUND: In patients with in-stent restenosis (ISR) bioresorbable vascular scaffolds (BVS) provide similar results to drug-coated balloons (DCBs) but are inferior to drug-eluting stents (DES) at 1 year. However, the long-term efficacy of BVS in these patients remains unknown. OBJECTIVES: This study sought to assess the long-term safety and efficacy of BVS in patients with ISR. METHODS: RIBS VI (Restenosis Intrastent: Bioresorbable Vascular Scaffolds Treatment; NCT02672878) and RIBS VI Scoring (Restenosis Intrastent: Bioresorbable Vascular Scaffolds Treatment With Scoring Balloon; NTC03069066) are prospective multicenter studies designed to evaluate the results of BVS in patients with ISR (N = 220). The inclusion and exclusion criteria were identical to those used in the RIBS IV (ISR of DES) (Restenosis Intra-stent of Drug-eluting Stents: Drug-eluting Balloon vs Everolimus-eluting Stent; NCT01239940) and RIBS V (ISR of bare-metal stents) (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting Balloon vs Everolimus-eluting Stent; NCT01239953) randomized trials (including 249 ISR patients treated with DCBs and 249 ISR patients treated with DES). A prespecified comparison of the long-term results obtained with these treatment modalities (ie, DES, DCBs, and BVS) was performed. RESULTS: Clinical follow-up at 3 years was obtained in all (100%) 718 patients. The 3-year target lesion revascularization rate after BVS was 14.1% (vs 12.9% after DCBs [not significant], and 5.2% after DES [HR: 2.80; 95% CI: 1.47-5.36; P = 0.001]). In a landmark analysis (>1 year), the target lesion revascularization rate after BVS was higher than after DES (adjusted HR: 3.41; 95% CI: 1.15-10.08) and DCBs (adjusted HR: 3.33; 95% CI: 1.14-9.70). Very late vessel thrombosis was also more frequent with BVS (BVS: 1.8%, DCBs: 0.4%, DES: 0%; P = 0.03). CONCLUSIONS: In patients with ISR, late clinical results of DES are superior to those obtained with DCBs and BVS. Beyond the first year, DCBs are safer and more effective than BVS.
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Implantes Absorbibles , Reestenosis Coronaria , Diseño de Prótesis , Humanos , Factores de Tiempo , Masculino , Resultado del Tratamiento , Femenino , Estudios Prospectivos , Reestenosis Coronaria/etiología , Reestenosis Coronaria/diagnóstico por imagen , Reestenosis Coronaria/terapia , Persona de Mediana Edad , Anciano , Factores de Riesgo , Angioplastia Coronaria con Balón/instrumentación , Angioplastia Coronaria con Balón/efectos adversos , Fármacos Cardiovasculares/administración & dosificación , Fármacos Cardiovasculares/efectos adversos , Stents , Intervención Coronaria Percutánea/instrumentación , Intervención Coronaria Percutánea/efectos adversos , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Materiales Biocompatibles Revestidos , Stents Liberadores de Fármacos , Ensayos Clínicos Controlados Aleatorios como AsuntoAsunto(s)
Angioplastia Coronaria con Balón , Materiales Biocompatibles Revestidos , Humanos , Angioplastia Coronaria con Balón/instrumentación , Angioplastia Coronaria con Balón/efectos adversos , Resultado del Tratamiento , Catéteres Cardíacos , Diseño de Equipo , Stents Liberadores de Fármacos , Fármacos Cardiovasculares/administración & dosificación , Fármacos Cardiovasculares/uso terapéutico , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/diagnóstico por imagenRESUMEN
A 32-year-old man, who was treated for T-cell lymphoma, presented in cardiac arrest. He had been treated for heart failure with reduced ejection fraction. Veno-arterial extracorporeal membrane oxygenation was initiated immediately. We diagnosed him as non-ST elevated myocardial infarction. Coronary angiography demonstrated the occlusion of the trifurcation in the proximal left anterior descending artery (LAD). We failed to advance the first guidewire into the distal LAD by angio-based conventional wiring. Intravascular ultrasonography (IVUS) of the proximal diagonal branch revealed two diaphragms separating the distal lumen without connection, which looks like lotus root-like appearance. We quickly penetrated the plaque using IVUS-based real-time 3D wiring using the tip detection method. The contrast injection via the microcatheter showed the distal diagonal branch (D2). After the balloon dilation in D2, IVUS image revealed a torn plaque between D2 and the distal LAD. Subsequently we advanced the guidewire to the distal LAD using IVUS-based real-time 3D wiring using the tip detection method through the tear of the plaque. Finally, we successfully performed the revascularization of LAD in a preferable procedure time. The patient recovered well and was discharged 39 days after cardiac arrest. This case highlights the efficacy of IVUS-based real-time 3D wiring using the tip detection method even in the emergent and challenging situation.
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Angiografía Coronaria , Oclusión Coronaria , Paro Cardíaco , Placa Aterosclerótica , Ultrasonografía Intervencional , Humanos , Masculino , Adulto , Paro Cardíaco/terapia , Paro Cardíaco/etiología , Paro Cardíaco/fisiopatología , Resultado del Tratamiento , Oclusión Coronaria/diagnóstico por imagen , Oclusión Coronaria/terapia , Oclusión Coronaria/fisiopatología , Imagenología Tridimensional , Angioplastia Coronaria con Balón/instrumentación , Valor Predictivo de las PruebasRESUMEN
BACKGROUND: Debulking devices are often followed by a scoring or cutting balloon in percutaneous coronary intervention (PCI) for severely calcified lesions. However, there are limited data on balloon preparation after orbital atherectomy (OA) assessed using optical coherence tomography (OCT). AIM: We aimed to compare the effects of a novel scoring and cutting balloon on calcified coronary lesions with OCT. METHODS: We retrospectively examined 38 patients (38 lesions) who underwent PCI with a scoring or a cutting balloon after OA. All patients underwent pre-PCI, preballooning, postballooning, and post-PCI OCT imaging. We divided the patients into novel scoring-balloon (group A: n = 22) and cutting-balloon (group B: n = 16) groups and compared the OCT findings, including minimum lumen area (MLA) and expansion ratio (MLA divided by mean reference lumen area). RESULTS: The mean patient age was 76.1 ± 8.7 years; 71.5% were male. There were no significant differences in patient background between both groups. Regarding procedural characteristics, the maximum balloon pressure was significantly higher in group A (median 23 atm, interquartile range [IQR] 18-24 vs. 12 atm [IQR: 10-12], p < 0.01). Although a calcium score of 4 was more frequently observed in group A (86.4% vs. 62.5%, p = 0.12), post-PCI MLA was comparable between both groups (3.95 mm2 [IQR: 3.27-4.41] vs. 3.43 mm2 [IQR: 2.90-4.82], p = 0.63). Furthermore, the expansion ratio was significantly greater in group A (0.83 ± 0.20 vs. 0.68 ± 0.14, p < 0.01). CONCLUSION: Despite a higher calcium score, a larger expansion ratio was achieved in patients with a novel scoring balloon than in those with a cutting balloon after OA.
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Angioplastia Coronaria con Balón , Aterectomía Coronaria , Enfermedad de la Arteria Coronaria , Vasos Coronarios , Valor Predictivo de las Pruebas , Índice de Severidad de la Enfermedad , Tomografía de Coherencia Óptica , Calcificación Vascular , Humanos , Masculino , Femenino , Estudios Retrospectivos , Calcificación Vascular/diagnóstico por imagen , Calcificación Vascular/terapia , Aterectomía Coronaria/efectos adversos , Anciano , Resultado del Tratamiento , Vasos Coronarios/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia , Anciano de 80 o más Años , Angioplastia Coronaria con Balón/instrumentación , Angioplastia Coronaria con Balón/efectos adversos , Catéteres Cardíacos , Diseño de Equipo , Angiografía CoronariaRESUMEN
BACKGROUND: Evidence suggests that drug-coated balloons may benefit in-stent restenosis (ISR) treatment. However, the efficacy of new-generation sirolimus-coated balloon (SCB) compared with the latest generation drug-eluting stents (DESs) has not been studied in this setting. METHODS: All patients in the EASTBORNE (The All-Comers Sirolimus-Coated Balloon European Registry) and DEB-DRAGON (DEB vs Thin-DES in DES-ISR: Long Term Outcomes) registries undergoing percutaneous coronary intervention for DES-ISR were included in the study. The primary study end point was target lesion revascularization at 24 months. Secondary end points were major adverse cardiovascular events, all-cause death, myocardial infarction, and target vessel revascularization at 24 months. Our goal was to evaluate the efficacy and safety of SCB versus thin-struts DES in ISR at long-term follow-up. RESULTS: A total of 1545 patients with 1679 ISR lesions were included in the pooled analysis, of whom 621 (40.2%) patients with 621 lesions were treated with thin-strut DES and 924 (59.8%) patients with 1045 lesions were treated with SCB. The unmatched cohort showed no differences in the incidence of target lesion revascularization (10.8% versus 11.8%; P=0.568); however, there was a trend toward lower rates of myocardial infarction (7.4% versus 5.0%; P=0.062) and major adverse cardiovascular events (20.8% versus 17.1%; P=0.072) in the SCB group. After propensity score matching (n=335 patients per group), there were no significant differences in the rates of target lesion revascularization (11.6% versus 11.8%; P=0.329), target vessel revascularization (14.0% versus 13.1%; P=0.822), myocardial infarction (7.2% versus 4.5%; P=0.186), all-cause death (5.7% versus 4.2%; P=0.476), and major adverse cardiovascular event (21.5% versus 17.6%; P=0.242) between DES and SCB treatment. CONCLUSIONS: In patients with ISR, angioplasty with SCB compared with thin-struts DES is associated with comparable rates of target lesion revascularization, target vessel revascularization, myocardial infarction, all-cause death, and major adverse cardiovascular events at 2 years.