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1.
Artículo en Inglés | MEDLINE | ID: mdl-38816504

RESUMEN

PURPOSE: In the present trial, the 24-month safety and effectiveness of the TCD-17187 drug-coated balloon (DCB) for the treatment of atherosclerotic lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PA) were evaluated in Japanese patients. METHODS: This was a prospective, multicenter, core laboratory-adjudicated, single-arm trial. From 2019 to 2020, 121 patients with symptomatic peripheral artery disease were enrolled. The primary effectiveness outcome measure was primary patency. The safety outcome measure was the major adverse event (MAE) rate. RESULTS: Age was 74.5 ± 7.3 years, and diabetes mellitus was present in 67.5%. Lesion length and reference vessel diameter (RVD) were 106.0 ± 52.6 mm and 5.2 ± 0.8 mm, respectively. Chronic total occlusion (CTO) and bilateral calcification rate (Grade 3 and 4 by peripheral arterial calcium scoring system (PACSS)) were 17.5% and 50.8%, respectively. The 24-month primary patency rate by duplex ultrasound was 71.3%, while freedom from clinically driven target lesion revascularization (CD-TLR) was 87.0%. The MAE rate was 13.2% and all events consisted of CD-TLR. There were no instances of device- or procedure-related deaths major amputations throughout the 24 months. Multivariate Cox proportional hazards regression analysis revealed significant differences associated with loss of primary patency in the following characteristics: CTO, restenotic lesion and RVD. CONCLUSION: This trial confirmed the safety and effectiveness of TCD-17187 DCB for atherosclerotic lesions of the SFA and/or proximal PA for up to 24 months. LEVEL OF EVIDENCE: Level 3, Cohort study. CLINICAL TRIAL REGISTRATION: URL: https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000038612&type=summary&language=J:Registration ID: UMIN000034122. Registration Date: September 13, 2018.

2.
Intern Med ; 2023 Sep 15.
Artículo en Inglés | MEDLINE | ID: mdl-37722892

RESUMEN

An elderly woman showed positive conversion of myeloperoxidase (MPO)-antineutrophil cytoplasmic antibodies (ANCAs) following the diagnosis of interstitial lung disease (ILD) and glomerular hematuria and subsequently experienced slowly progressive glomerulonephritis. A kidney biopsy revealed chronic damage and necrotizing crescentic glomerulonephritis with mesangial MPO deposits. After corticosteroid treatment, the patient's urinalysis results and MPO-ANCA titers almost normalized and her renal function stabilized. This case is similar to recently reported cases of slowly progressive ANCA-associated glomerulonephritis. ILD likely triggered the production of MPO-ANCAs, and the accumulation of MPO deposits in the glomeruli may have contributed to the progression of her renal disease.

3.
J Cardiol Cases ; 27(2): 56-59, 2023 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-36788954

RESUMEN

We present the case of a 39-year-old pregnant woman who had intrauterine fetal death and imminent uterine rupture and underwent cesarean section. She also underwent catheter embolization for hemorrhagic shock due to bleeding from the uterine artery, and heparin-containing saline was used. On day 7 of hospitalization, she felt severe pain in her right lower leg, and computed tomography (CT) revealed focal nonocclusive thrombus formations in the right common and external iliac artery. After intravenous heparin administration, she suddenly developed dyspnea, her blood pressure dropped, and her platelet count decreased. We diagnosed her with heparin-induced thrombocytopenia (HIT). Although we discontinued heparin and switched to argatroban, CT after 5 days revealed subtotal occlusion of the right iliac artery by a massive thrombus. We performed surgical thrombectomy using a Fogarty catheter, but blood flow was not restored. Therefore, we administered urokinase continuously with catheter-directed thrombolysis (CDT). The thrombus in the iliac artery gradually cleared and was successfully eliminated. However, the patient developed gangrene in her right lower leg, and we decided to perform an above-knee amputation of the right leg. She was discharged with a prosthetic leg and prescribed 15 mg of rivaroxaban per day. Learning objective: HIT is a known serious side effect of heparin administration, and it can sometimes be fatal. HIT treatment using aggressive thrombectomy procedures may be ineffective since such procedures may accelerate thrombus formation when the coagulation cascade is highly activated. In this case, CDT may have to be considered as the first-line treatment before Fogarty thrombectomy when argatroban therapy fails.

4.
Heart Vessels ; 38(4): 488-496, 2023 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-36322238

RESUMEN

The incidence of lower extremity artery disease (LEAD) in patient receiving hemodialysis is remarkably higher than the general population. The treatment strategy and prognosis for LEAD patients differs depending on whether a patient has intermittent claudication (IC) or critical limb-threatening ischemia (CLTI). However, the distinction between the prognosis in HD-dependent patients with IC and CLTI has not been fully elucidated. This study is to determine whether indication of PAD has a distinct impact on major adverse cardiovascular and cerebrovascular events (MACCE) and limb events in patients receiving hemodialysis. The current study included 2321 prospectively enrolled patients from the Tokyo taMA peripheral vascular intervention research ComraDE registry (UMIN-CTR no. UMIN000015100) between September 2014 and December 2016. Out of the enrolled patients, 1644 were not receiving hemodialysis (non-HD patients) and 603 were receiving hemodialysis (HD patients). A composite of all-cause death, myocardial infarction, and stroke events defined as MACCE; while limb events were defined as a composite of unscheduled major amputation, unscheduled major lower limb surgery, acute limb ischemia, unscheduled endovascular treatment, and target lesion revascularization. Propensity score matching was applied among the non-HD and HD patients, in whole group, IC subgroup, and CLTI subgroup. Kaplan-Meier analysis was used for the analysis of outcomes for the whole group, IC subgroup, and the CLTI subgroup. CLTI accounted for 75.5% of the HD patients, whereas IC was 63.4% in the non-HD patients. The HD patients exhibited more frequent below-the-knee lesions than those in the non-HD patients in both IC (p = 0.01) and CLTI (p < 0.001) subgroups. Overall, HD patients exhibited a significantly higher rate of MACCE at 24 months. This trend was similar for limb events in whole group and CLTI subgroup. In contrast, no significant differences in outcomes for limb events were found in IC subgroup. Although, prognosis after EVT in HD patients were significantly worse than non-HD patients, comparable outcome with non-HD patients was observed in the patients treated for IC. Clinical trial registration: This study was registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR No. UMIN000015100).


Asunto(s)
Procedimientos Endovasculares , Enfermedad Arterial Periférica , Humanos , Isquemia Crónica que Amenaza las Extremidades , Procedimientos Endovasculares/efectos adversos , Claudicación Intermitente , Extremidad Inferior/irrigación sanguínea , Enfermedad Arterial Periférica/cirugía , Diálisis Renal , Factores de Riesgo , Resultado del Tratamiento
5.
Heart Vessels ; 38(2): 164-170, 2023 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-35896724

RESUMEN

Depression is a chronic illness that affects mood, physical health, and overall vitality and quality of life. Depression has been associated with an increased risk of all-cause and cardiovascular mortality among patients with peripheral arterial disease (PAD). Therefore, this study aimed to compare the incidence of depression before and after endovascular treatment in patients with lower limb PAD. This is an important clinical issue considering the worldwide increase in PAD with the aging population and the known negative impact of depression on recovery. This was a retrospective sub-analysis of data from the Tokyo Peripheral Vascular Intervention Study using the TOMA-CODE registry. The presence and extent of depressive symptoms were evaluated using the patient health questionnaire (PHQ-9), with a depressive tendency score of ≥ 5. The PHQ-9 score was evaluated before endovascular treatment (EVT) and at 4 (± 1) weeks after EVT. The study population consisted of 87 patients who completed the PHQ-9 before EVT, with 76 completing the post-EVT PHQ-9. Of these 76, 19 had a pre-EVT score ≥ 5. Overall, there was no difference in the pre- and post-EVT scores (P = 0.091). There was no significant change in the 19 patients with a pre-EVT score ≥ 5 (mean 9.2 ± 4.4); however, there was a tendency to improve in the pre- to post-EVT score (mean, 6.9 ± 5.2; P = 0.059). Diabetes was a significant negative factor for pre- to post-EVT score improvement (P = 0.023). Overall, symptoms of depression showed the tendency to improve at 30 days post-EVT. However, diabetes was associated with lower improvement in symptoms.


Asunto(s)
Procedimientos Endovasculares , Enfermedad Arterial Periférica , Humanos , Anciano , Resultado del Tratamiento , Estudios Retrospectivos , Incidencia , Calidad de Vida , Depresión/epidemiología , Factores de Riesgo , Procedimientos Endovasculares/efectos adversos , Enfermedad Arterial Periférica/diagnóstico , Enfermedad Arterial Periférica/epidemiología , Enfermedad Arterial Periférica/cirugía , Extremidad Inferior/irrigación sanguínea
6.
Catheter Cardiovasc Interv ; 100(6): 1100-1109, 2022 11.
Artículo en Inglés | MEDLINE | ID: mdl-36177551

RESUMEN

PURPOSE: The aim of this preapproval trial was to evaluate the 12-month safety and effectiveness of the TCD-17187 drug-coated balloon (DCB) for the treatment of atherosclerotic lesions in the superficial femoral artery (SFA) and/or proximal popliteal artery (PA). METHODS: This was a prospective, multicenter, core laboratory adjudicated, single-arm trial. From October 2019 to November 2020, a total of 121 symptomatic peripheral artery disease patients with SFA and/or proximal PA lesions were enrolled. The primary effectiveness endpoint was 12-month primary patency defined as freedom from restenosis as determined by duplex ultrasonography in the absence of clinically driven target lesion revascularization (CD-TLR). The safety endpoint was the major adverse event (MAE) rate defined as freedom from a composite of device- and procedure-related death within 30 days, and index limb major amputation and/or CD-TLR through follow-up. RESULTS: Average age was 74.5 ± 7.3 years and the frequency of diabetes mellitus was 67.5%. Average lesion length and vessel diameter were 106.0 ± 52.6 and 5.2 ± 0.8 mm, respectively. The frequency of chronic total occlusion and bilateral calcification was 17.5% and 50.8% of patients, respectively. The 12-month primary patency rate calculated by Kaplan-Meier analysis was 81.1%, while 12-month freedom from CD-TLR was 95.8%. The MAE rate at 30 days was 1.7% and all events comprised CD-TLR. There were no instances of device- or procedure-related deaths, major amputations, or thrombosis throughout the 12-month evaluation period. CONCLUSION: This preapproval trial confirmed the safety and effectiveness of TCD-17187 DCB in the treatment of atherosclerotic lesions in the SFA and/or proximal PA.


Asunto(s)
Aterosclerosis , Enfermedad Arterial Periférica , Humanos , Anciano , Anciano de 80 o más Años , Arteria Poplítea/diagnóstico por imagen , Arteria Femoral/diagnóstico por imagen , Estudios Prospectivos , Resultado del Tratamiento , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/terapia
8.
Ann Vasc Dis ; 14(3): 277-280, 2021 Sep 25.
Artículo en Inglés | MEDLINE | ID: mdl-34630774

RESUMEN

Although the importance of the retrieval of an optional inferior vena cava filter (o-IVCF) has gained attention because of the awareness of a high complication rate with long indwelling time, the o-IVCF retrieval rate remains low. The advanced retrieval technique of o-IVCF may increase the retrieval rate, which in turn diminishes future adverse events. Through two cases, we describe how to perform the novel approach "bidirectional sling technique with biopsy forceps." This technique will improve the retrieval rate in patients following the failure by conventional retrieval technique.

9.
Circ J ; 85(4): 377-384, 2021 03 25.
Artículo en Inglés | MEDLINE | ID: mdl-33658454

RESUMEN

BACKGROUND: It is recommended to remove retrievable inferior vena cava filters (r-IVCFs) when they are no longer needed because their presence may give rise to serious complications related to prolonged placement of the filter. An advanced filter retrieval technique may help improve the retrieval rate.Methods and Results:107 consecutive patients (mean age; 61±18 years, male 53%) in whom r-IVCF retrieval was attempted were prospectively enrolled between April 2012 and December 2018. The frequently used advanced techniques were sling technique and biopsy forceps dissection technique. Retrieval success was 75% with standard retrieval technique alone; however, the overall retrieval success rate improved to 98% with advanced techniques. We observed few serious complications related to the retrieval procedure. Logistic multivariate analysis identified prolonged indwelling time (P=0.0011) and embedded hook in the caval wall (P=0.0114) as independent predictors, and the cutoff value for the indwelling time for requirement of advanced technique was 80 days. CONCLUSIONS: Advanced retrieval techniques helped improve the retrieval rate without serious complications. We may need to consider the referral of patients to centers with expertise in advanced retrieval techniques when the indwelling time is >80 days, and pre-retrieval CT image shows a hook embedded in the vessel wall.


Asunto(s)
Remoción de Dispositivos , Filtros de Vena Cava , Adulto , Anciano , Remoción de Dispositivos/métodos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Instrumentos Quirúrgicos , Resultado del Tratamiento , Filtros de Vena Cava/efectos adversos , Vena Cava Inferior
10.
J Cardiol Cases ; 23(1): 6-9, 2021 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-33437331

RESUMEN

Central venous occlusion (CVO) remains an unresolved issue in hemodialysis patients. We herein present an interesting case of a 42-year-old hemodialysis female patient with complete vision loss in the left eye, who was at high risk of losing vision in her right eye because of neovascular glaucoma (NVG). Computed tomography (CT) showed occlusion of the right internal jugular vein (IJV) just above the junction with the right innominate vein. From the configuration and location of the lesion, it was concluded the occlusion had been caused by venous valvular degeneration. Her NVG with progressive intraocular pressure (IOP) elevation was presumably attributed to the right IJV occlusion. The extra-rigid occlusive lesion was successfully penetrated by means of a Brockenbrough needle and subsequently implanted with a balloon-expandable stent. Intravascular ultrasound (IVUS) guidance allowed us to manipulate the Brockenbrough needle safely. After stent implantation, the right IOP declined dramatically, resulting in the preservation of her eyesight. .

11.
Cardiovasc Interv Ther ; 36(2): 226-236, 2021 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-32212046

RESUMEN

The present study aimed to clarify the current status, therapeutic strategy, and 1-year outcome in acute limb ischemia (ALI) patients in Japan. The EnDOvascular treatment (Edo) registry database includes 324 patients from 10 institutes who were registered between November 2011 and October 2013. A total of 70 ALI patients (mean age 74.0 years) from the Edo registry database were enrolled in this study. Of the 70 included patients, 72.9% were male and 35.7% had embolism. Of patients, 38.6%, 42.9%, and 18.6% underwent EVT, surgery, and hybrid thrombectomy, respectively, in primary revascularization strategy. Limb ischemia was categorized into four classes at initial evaluation: SVS/ISCVS class I (n = 13, 18.6%), SVS/ISCVS class IIa (n = 36, 51.4%), SVS/ISCVS class IIb (n = 21, 30%), and SVS/ISCVS class III (n = 0, 0%). Three patients with SVS/ISCVS class IIb limb ischemia developed myonephropathic metabolic syndrome. No catheter-directed thrombolysis was employed as a primary revascularization strategy. The 1-year rates of all-cause death, major amputation, and a composite of perioperative death or major adverse limb event were 28.6%, 5.7%, and 40.0%, respectively. Lower age, male sex, dyslipidemia, high estimated glomerular filtration rate, high albumin level, and low C-reactive protein level were independent positive predictors of all-cause death. In this registry, SVS/ISCVS class IIa ALI was predominant. Approximately 40% of primary revascularization strategy was surgery and EVT, followed by hybrid therapy. All-cause death and major amputation rates at 1 year were less than 30% and 6%, respectively.


Asunto(s)
Procedimientos Endovasculares/métodos , Enfermedad Arterial Periférica/cirugía , Sistema de Registros , Trombectomía/métodos , Anciano , Bases de Datos Factuales , Femenino , Humanos , Japón/epidemiología , Recuperación del Miembro , Masculino , Enfermedad Arterial Periférica/mortalidad , Estudios Retrospectivos , Factores de Riesgo , Tasa de Supervivencia/tendencias , Factores de Tiempo , Resultado del Tratamiento
12.
Cardiovasc Interv Ther ; 36(2): 237-245, 2021 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-32219735

RESUMEN

Post-thrombotic syndrome (PTS) occurs in 20-50% of patients with proximal deep vein thrombosis (DVT). In this study, we aimed to identify potential markers of thrombolysis success at the early stage and to clarify the relationship between early thrombolysis success and subsequent PTS development in patients with acute DVT in the iliac vein. Fifty-two consecutive patients with acute iliofemoral DVT who were treated with catheter-directed thrombolysis (CDT) within 21 days of onset were enrolled. An infusion catheter with multiple side holes was placed to cover the thrombosed vessel entirely. Urokinase solution was administered either continuously or with the pulse-spray method at a dose of 480,000-720,000 IU/day over the course of 2-7 days. During CDT, unfractionated heparin (UFH) was infused simultaneously via the access sheath to prevent thrombus formation. Early success was defined as lysis grade ≥ 50% and restoration of forward flow. PTS was diagnosed based on the Villalta scale. Based on the lysis grading method, complete lysis (grade III) was achieved in 8 of 52 (16%) limbs. Lysis grade II (50-99%) was achieved in 35 of 52 (67%) limbs. Lysis grade I (< 50%) was achieved in 9 of 52 (17%) limbs. Therefore, grade II and grade III lytic outcomes (early success) were observed in 43 patients (83%). One-year clinical follow-up was performed for 43 patients (83%). PTS occurred in seven (16%) patients. Early success was more frequently observed in patients without PTS than in those with PTS (92% vs. 43%; P < 0.01). Early success was only significantly associated with PTS in the multivariate analysis. Patients with acute symptomatic iliofemoral DVT who had early success from CDT treatment during the acute phase less frequently progressed to PTS. Patients with early success tended to undergo the pulse-spray method and had a shorter interval from symptom onset to CDT. The use of pulse-spray method and early initiation of CDT since DVT onset were potential markers of thrombolysis success.


Asunto(s)
Heparina/uso terapéutico , Síndrome Postrombótico/tratamiento farmacológico , Terapia Trombolítica/métodos , Trombosis de la Vena/terapia , Enfermedad Aguda , Anticoagulantes/uso terapéutico , Femenino , Humanos , Vena Ilíaca , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Resultado del Tratamiento
13.
J Cardiol ; 77(2): 109-115, 2021 02.
Artículo en Inglés | MEDLINE | ID: mdl-32888832

RESUMEN

BACKGROUND: Malnutrition measured by the geriatric nutritional risk index (GNRI) was reported to be associated with poor prognosis for patients with peripheral artery disease (PAD). However, the optimal cut-off value of preprocedural GNRI for critical limb ischemia (CLI) and intermittent claudication (IC) is unknown. We aimed to determine its optimal cut-off value for CLI or IC patients requiring endovascular revascularization. METHODS: We explored data of 2246 patients (CLI: n = 1061, IC: n = 1185) registered in the Tokyo-taMA peripheral vascular intervention research COmraDE (TOMA-CODE) registry, which prospectively enrolled consecutive PAD patients who underwent endovascular revascularization in 34 hospitals in Japan from August 2014 to August 2016. The optimal cut-off values of GNRI were assessed by the survival classification and regression tree (CART) analyses, and the survival curve analyses for major adverse cardiovascular and limb events (MACLEs) were performed for these cut-off values. RESULTS: In addition to the first cut-off value of 96.2 in CLI and 85.6 in IC, the survival CART provided an additional cut-off value of 78.2 in CLI and 106.0 in IC for further risk stratification. The survival curve was significantly stratified by the GNRI-based malnutrition status in both CLI [high risk: 47.7% (51/107), moderate: 30.1% (118/392), and low: 10.2% (53/520), log-rank p < 0.001] and IC [high risk: 14.3% (7/49), moderate: 4.5% (29/646), and low: 0.5% (2/407), log-rank p < 0.001]. The multivariate Cox-proportional hazard analysis showed that a higher GNRI was significantly associated with a better outcome in both CLI [hazard ratio (HR) per 1-point increase: 0.97, 95% CI: 0.96-0.98, p < 0.001] and IC (HR: 0.94, 95% CI: 0.91-0.97, p < 0.001). CONCLUSIONS: Preprocedural nutritional status significantly stratified future events in patients with PAD. Given that the optimal cut-off value of GNRI in CLI was almost 10-points lower than that of IC, using a disease-specific cut-off value is important for risk stratification.


Asunto(s)
Procedimientos Endovasculares/mortalidad , Evaluación Geriátrica/estadística & datos numéricos , Desnutrición/diagnóstico , Evaluación Nutricional , Enfermedad Arterial Periférica/fisiopatología , Anciano , Anciano de 80 o más Años , Femenino , Evaluación Geriátrica/métodos , Humanos , Japón , Masculino , Desnutrición/complicaciones , Persona de Mediana Edad , Estado Nutricional , Enfermedad Arterial Periférica/complicaciones , Enfermedad Arterial Periférica/cirugía , Valor Predictivo de las Pruebas , Periodo Preoperatorio , Modelos de Riesgos Proporcionales , Valores de Referencia , Sistema de Registros , Medición de Riesgo , Factores de Riesgo , Análisis de Supervivencia
14.
Circ J ; 85(1): 27-36, 2020 12 25.
Artículo en Inglés | MEDLINE | ID: mdl-33162490

RESUMEN

BACKGROUND: The risks of bleeding and cardiovascular events in high bleeding risk (HBR) Japanese patients undergoing percutaneous coronary intervention (PCI) while receiving single-antiplatelet therapy (SAPT) remains unknown. We aimed to evaluate the frequency of bleeding and cardiovascular events associated with prasugrel monotherapy after short-term dual-antiplatelet therapy (DAPT) in Japanese HBR patients after PCI.Methods and Results:The PENDULUM mono study was a multicenter, non-interventional, prospective registry (n=1,173). The primary endpoint was the cumulative incidence of clinically relevant bleeding (CRB; Bleeding Academic Research Consortium types 2, 3, and 5) from 1 to 12 months after PCI. Secondary endpoints included major adverse cardiac and cerebrovascular events (MACCE). The proportion of patients who received prasugrel monotherapy at 12 months after PCI was 79.7%, and no cases of stent thrombosis were observed among these patients. The cumulative incidence of CRB was 3.2% from 1 to 12 months after PCI; that of MACCE was 3.8%. Severe anemia, chronic kidney disease, oral anticoagulant use at discharge, and heart failure were significantly associated with CRB. CONCLUSIONS: Among HBR patients undergoing PCI who were not suitable for concomitant aspirin and were scheduled for prasugrel monotherapy, most patients were on prasugrel monotherapy after DAPT. Cumulative incidences of CRB and MACCE after periprocedural period were 3.2% and 3.8%, respectively, and no cases of stent thrombosis were reported. SAPT might be a suitable alternative to DAPT.


Asunto(s)
Intervención Coronaria Percutánea , Inhibidores de Agregación Plaquetaria , Clorhidrato de Prasugrel , Hemorragia/inducido químicamente , Hemorragia/epidemiología , Humanos , Japón/epidemiología , Inhibidores de Agregación Plaquetaria/uso terapéutico , Clorhidrato de Prasugrel/uso terapéutico , Estudios Prospectivos , Trombosis , Resultado del Tratamiento
15.
Catheter Cardiovasc Interv ; 96(4): E467-E478, 2020 10 01.
Artículo en Inglés | MEDLINE | ID: mdl-32691953

RESUMEN

OBJECTIVES: We aimed to evaluate whether paclitaxel eluting devices increased the risk of death in patients undergoing revascularization for infrainguinal peripheral artery disease using network meta-analyses. METHODS: PUBMED and EMBASE were searched through April 2020 for randomized trials in patients with infrainguinal peripheral artery disease who underwent revascularization with or without a paclitaxel eluting device (balloon/stent). Short-term mortality defined as death at 6-12 months, and long-term mortality defined as death at >12 months after revascularization. RESULTS: Our search identified 57 eligible randomized controlled studies enrolling a total of 9,362 patients comparing seven revascularization strategies (balloon angioplasty vs. bare metal stent vs. covered stent vs. paclitaxel eluting stent vs. other drug eluting stent vs. paclitaxel-coated balloon vs. bypass surgery). Overall, paclitaxel eluting stent and paclitaxel-coated balloons did not increase short-term mortality (eg, vs. balloon angioplasty: paclitaxel-coated balloon OR [95% CI] 1.21 [0.88-1.66], p = .24; paclitaxel eluting stent OR [95%CI] 1.01 [0.63-1.63], p = .97, respectively). In addition, paclitaxel eluting stent did not show significant increase in long-term mortality (eg, vs. balloon angioplasty: OR [95%CI] 1.06 [0.70-1.59], p = .79). However, paclitaxel-coated balloon showed significant increase in long-term mortality compared to balloon angioplasty and bypass (vs. balloon angioplasty: OR [95% CI] 1.48 [1.06-2.07], p = .021; vs. bypass: OR [95%CI] 1.73 [1.05-2.84], p = .031, respectively). CONCLUSIONS: In this meta-analysis of randomized trials, there was no significant increase in mortality with paclitaxel eluting stent, but there was increased risk of long-term mortality in paclitaxel-coated balloon for the treatment of infrainguinal peripheral artery disease.


Asunto(s)
Fármacos Cardiovasculares/administración & dosificación , Materiales Biocompatibles Revestidos , Stents Liberadores de Fármacos , Procedimientos Endovasculares/instrumentación , Paclitaxel/administración & dosificación , Enfermedad Arterial Periférica/terapia , Dispositivos de Acceso Vascular , Adulto , Anciano , Anciano de 80 o más Años , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/mortalidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Metaanálisis en Red , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/mortalidad , Diseño de Prótesis , Ensayos Clínicos Controlados Aleatorios como Asunto , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento
16.
J Am Heart Assoc ; 9(10): e015439, 2020 05 18.
Artículo en Inglés | MEDLINE | ID: mdl-32394794

RESUMEN

Background The balance between ischemic and bleeding events and their association with platelet reactivity in patients receiving antiplatelet therapy after percutaneous coronary intervention (PCI), which differs among regions, is not fully evaluated for East Asians. We examined ischemic/bleeding events and platelet reactivity in Japanese patients undergoing PCI and determined associations between high/low platelet reactivity and clinical outcomes. Methods and Results PENDULUM (Platelet Reactivity in Patients with Drug Eluting Stent and Balancing Risk of Bleeding and Ischemic Event) is a prospective, multicenter registry of Japanese patients with PCI. Primary end points were incidence of first major adverse cardiac and cerebrovascular events (MACCE) and first major bleeding events at 12 months post-PCI. Platelet reactivity (P2Y12 reaction unit [PRU] value) was measured at 12 to 48 hours post-PCI; patients were grouped as having high PRU (>208), optimal PRU (>85 to ≤208), and low PRU (≤85). MACCE and major bleeding occurred in 4.4% and 2.8% of 6267 patients, respectively. The mean±SD PRU value was 182.1±77.1. MACCE was significantly higher in the high PRU (5.7%; n=2227) versus the optimal PRU group (3.6%; n=3002). The hazard ratio (HR) for high PRU versus optimal PRU level was significantly higher for MACCE (adjusted HR, 1.53; 95% CI, 1.14-2.06 [P=0.004]); stent thrombosis followed the same trend. Incidence of major bleeding did not differ significantly between groups. A high PRU level was significantly associated with MACCE in both patients with and patients without acute coronary syndrome. Conclusions These real-world data suggest an association between high platelet reactivity and cardiovascular events in Japanese patients undergoing PCI. The trend was the same in both patients with and patients without acute coronary syndrome. REGISTRATION URL: https://www.umin.ac.jp/ctr. Unique identifier: UMIN 000020332.


Asunto(s)
Síndrome Coronario Agudo/terapia , Enfermedad de la Arteria Coronaria/terapia , Terapia Antiplaquetaria Doble , Intervención Coronaria Percutánea , Activación Plaquetaria/efectos de los fármacos , Inhibidores de Agregación Plaquetaria/uso terapéutico , Antagonistas del Receptor Purinérgico P2Y/uso terapéutico , Trombosis/prevención & control , Síndrome Coronario Agudo/sangre , Síndrome Coronario Agudo/mortalidad , Anciano , Anciano de 80 o más Años , Enfermedad de la Arteria Coronaria/sangre , Enfermedad de la Arteria Coronaria/mortalidad , Stents Liberadores de Fármacos , Terapia Antiplaquetaria Doble/efectos adversos , Terapia Antiplaquetaria Doble/mortalidad , Femenino , Hemorragia/inducido químicamente , Humanos , Japón , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/instrumentación , Intervención Coronaria Percutánea/mortalidad , Inhibidores de Agregación Plaquetaria/efectos adversos , Estudios Prospectivos , Antagonistas del Receptor Purinérgico P2Y/efectos adversos , Recurrencia , Sistema de Registros , Medición de Riesgo , Factores de Riesgo , Trombosis/sangre , Trombosis/mortalidad , Factores de Tiempo , Resultado del Tratamiento
17.
Cardiovasc Interv Ther ; 35(4): 393-397, 2020 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-32112238

RESUMEN

Calcified lesions still remain a technical challenge even in the treatment of infrainguinal artery disease. The aim of this retrospective, multicenter observational study was to investigate interventional outcomes of a high-speed rotational atherectomy device (Rotablator™) and to compare clinical outcomes in patients who underwent Rotablator and those who did not even after failed balloon angioplasty because of underlying calcified lesions. This study enrolled patients who underwent Rotablator (Rota group) and those who did not (Non-rota group) between January 2010 and 2014 December at 12 hospitals. A total of 67 limbs and 68 lesions in 65 patients were included (Rota group; 54 limbs and 55 lesions in 52 patients, Non-rota group; 13 limbs and 13 lesions in 13 patients). In the Rota group, a technical success rate was 94.5% with a complication rate of 1.8%, and all lesions underwent subsequent postdilatation following the adjunctive use of Rotablator, and approximately half of above-the-knee lesions underwent stent implantation. The Rota group had a significantly lower clinically driven reintervention rate at 12 months than the Non-rota group (26.5% vs. 58.3%, respectively, p = 0.046). In addition, Rota group showed a trend toward a higher amputation-free survival compared to the Non-rota group at 1 month (Rota; 98.0% vs. Non-rota; 84.6%, respectively, p = 0.10). Rotablator was used as an adjunctive device with a high technical success and a low complication rates, and Patients who underwent Rotablator yielded a significantly lower clinically driven reintervention rate at 12 months compared to those who did not even after failed balloon angioplasty.


Asunto(s)
Aterectomía/métodos , Enfermedad Arterial Periférica/cirugía , Calcificación Vascular/cirugía , Anciano , Anciano de 80 o más Años , Aterectomía/instrumentación , Femenino , Humanos , Masculino , Persona de Mediana Edad , Sistema de Registros , Estudios Retrospectivos , Resultado del Tratamiento
19.
Heart Vessels ; 35(3): 307-311, 2020 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-31473802

RESUMEN

Peripheral artery disease (PAD) is associated with high cardiovascular mortality. Which part of PAD with lower extremities is related to coronary artery disease (CAD) remains unknown. We hypothesized that PAD including infrapopliteal artery (IPA) occlusion was associated with CAD. A total of 260 patients who have no history of CAD or the anginal symptom, complain of the claudication or critical limb ischemia and underwent peripheral angiography were retrospectively analyzed. IPA occlusion was diagnosed with peripheral angiography, and CAD was diagnosed with the coronary angiography. A multivariate logistic regression analysis was performed to determine the predictors of silent CAD. Among them, a total of 146 patients (56.2%) had IPA occlusion. Baseline characteristics were significantly different between two groups as to the proportions of age, male, dyslipidemia (with vs. without IPA occlusion; 72.4 ± 10.8 vs. 69.1 ± 10.2; 62.3% vs. 75.4%; 38.6% vs. 52.6%, respectively, all comparisons P < 0.05). Notably, the prevalence of CAD was significantly higher in patients with IPA occlusion (50.7% vs. 34.2%, P = 0.008). On a multivariate analysis, IPA occlusion was an independent predictor for the presence of silent CAD (OR, 1.94; CI, 1.09-3.44, P = 0.024), but aortoiliac artery occlusion (OR, 1.16; CI, 0.53-2.56, P = 0.71) and femoropopliteal artery occlusion (OR, 1.02; CI, 0.57-1.83, P = 0.96) were not. IPA occlusion was associated with silent CAD. Vascular surgeons, interventional radiologists, as well as interventional cardiologists should recognize IPA occlusion as a risk factor of silent CAD.


Asunto(s)
Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad Arterial Periférica/diagnóstico por imagen , Arteria Poplítea/diagnóstico por imagen , Anciano , Anciano de 80 o más Años , Enfermedades Asintomáticas , Enfermedad de la Arteria Coronaria/epidemiología , Enfermedad de la Arteria Coronaria/fisiopatología , Femenino , Humanos , Japón/epidemiología , Masculino , Persona de Mediana Edad , Enfermedad Arterial Periférica/epidemiología , Enfermedad Arterial Periférica/fisiopatología , Arteria Poplítea/fisiopatología , Valor Predictivo de las Pruebas , Pronóstico , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo
20.
Kyobu Geka ; 72(11): 901-904, 2019 Oct.
Artículo en Japonés | MEDLINE | ID: mdl-31588105

RESUMEN

We report a case of a dialysis patient with severe aortic stenosis(AS) along with bilateral pheochromocytomas. A 52-year-old man presented with syncope and was diagnosed with severe AS. Although aortic valve replacement(AVR) was scheduled, bilateral pheochromocytomas were found during preoperative examination. There was a high possibility of developing hemodynamical crisis during AVR, and we planned to perform adrenalectomy prior to AVR. To avoid circulatory collapse just after adrenalectomy, balloon aortic valvuloplasty (BAV) was performed beforehand. Two weeks after the adrenalectomy, AVR was performed in a stable condition.


Asunto(s)
Neoplasias de las Glándulas Suprarrenales , Estenosis de la Válvula Aórtica , Valvuloplastia con Balón , Feocromocitoma , Válvula Aórtica , Humanos , Masculino , Persona de Mediana Edad , Recurrencia Local de Neoplasia , Diálisis Renal , Resultado del Tratamiento
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