RESUMO
BACKGROUND: The 1-year clinical outcomes of the Absorb GT1 Japan post-market surveillance (PMS) suggested that an appropriate intracoronary imaging-guided bioresorbable vascular scaffold (BVS) implantation technique may reduce the risk of target lesion failure (TLF) and scaffold thrombosis (ST) associated with the Absorb GT1 BVS. The long-term outcomes through 5 years are now available. METHODSâANDâRESULTS: This study enrolled 135 consecutive patients (n=139 lesions) with ischemic heart disease in whom percutaneous coronary intervention (PCI) with the Absorb GT1 BVS was attempted. Adequate lesion preparation, imaging-guided appropriate sizing, and high-pressure post-dilatation using a non-compliant balloon were strongly encouraged. All patients had at least 1 Absorb GT1 successfully implanted at the index procedure. Intracoronary imaging was performed in all patients (optical coherence tomography: 127/139 [91.4%] lesions) and adherence to the implantation technique recommendations was excellent: predilatation, 100% (139/139) lesions; post-dilatation, 98.6% (137/139) lesions; mean (±SD) post-dilatation pressure, 18.8±3.5 atm. At 5 years, the follow-up rate was 87.4% (118/135). No definite/probable ST was reported through 5 years. The cumulative TLF rate was 5.1% (6/118), including 2 cardiac deaths, 1 target vessel-attributable myocardial infarction, and 3 ischemia-driven target lesion revascularizations. CONCLUSIONS: Appropriate intracoronary imaging-guided BVS implantation, including the proactive use of pre- and post-balloon dilatation during implantation may be beneficial, reducing the risk of TLF and ST through 5 years.
Assuntos
Implantes Absorvíveis , Vigilância de Produtos Comercializados , Humanos , Japão , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Intervenção Coronária Percutânea/efeitos adversos , Tomografia de Coerência Óptica , Seguimentos , Alicerces Teciduais , Isquemia Miocárdica , Doença da Artéria Coronariana/terapia , Doença da Artéria Coronariana/diagnóstico por imagemRESUMO
OBJECTIVES: The aim of this study was to investigate the vascular responses and fates of the scaffold after bioresorbable vascular scaffold (BVS) implantation using multimodality imaging. BACKGROUND: Serial comprehensive image assessments after BVS implantation in the context of a randomized trial have not yet been reported. METHODS: In the ABSORB Japan trial, 400 patients were randomized to a BVS (n = 266) or a cobalt-chromium everolimus-eluting stent (n = 134). Through 3 years, patients underwent serial angiography and intravascular ultrasound or optical coherence tomography (OCT). RESULTS: Luminal dimension at 3 years was consistently smaller with the BVS than with the cobalt-chromium everolimus-eluting stent (mean angiographic minimal luminal diameter 2.04 ± 0.63 mm vs. 2.40 ± 0.56 mm, mean difference -0.37 mm [95% confidence interval: -0.50 to -0.24 mm]; p < 0.001), mainly because of smaller device area (6.13 ± 2.03 mm2 vs. 7.15 ± 2.16 mm2, mean difference -1.04 mm2 [95% confidence interval: -1.66 to -0.42 mm2]; p < 0.001), and larger neointimal area (2.10 ± 0.61 mm2 vs. 1.86 ± 0.64 mm2, mean difference 0.24 mm2 [95% confidence interval: 0.06 to 0.43 mm2]; p = 0.01) by OCT. BVS-treated vessels did not show previously reported favorable vessel responses, such as positive vessel remodeling, late luminal enlargement, and restoration of vasomotion, although the OCT-based healing score was on average zero (interquartile range: 0.00 to 0.00). At 3 years, intraluminal scaffold dismantling (ISD) was observed in 14% of BVS. On serial OCT, ISD was observed in 6 lesions at 2 years, where the struts had been fully apposed at post-procedure, while ISD was observed in 12 lesions at 3 years, where 8 lesions were free from ISD on 2-year OCT. In 5 cases of very late scaffold thrombosis, strut discontinuities were detected in all 4 cases with available OCT immediately before reintervention. CONCLUSIONS: In this multimodality serial imaging study, luminal dimension at 3 years was smaller with the BVS than with the cobalt-chromium everolimus-eluting stent. ISD, suspected to be one of the mechanisms of very late BVS thrombosis, was observed in a substantial proportion of cases at 3 years, which developed between post-procedure and 2 years and even beyond 2 years. (AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 [Absorb™ BVS] in Japanese Population [ABSORB JAPAN]; NCT01844284).
Assuntos
Implantes Absorvíveis , Fármacos Cardiovasculares/administração & dosagem , Ligas de Cromo , Doença da Artéria Coronariana/terapia , Vasos Coronários/diagnóstico por imagem , Stents Farmacológicos , Everolimo/administração & dosagem , Imagem Multimodal , Intervenção Coronária Percutânea/instrumentação , Stents , Fármacos Cardiovasculares/efeitos adversos , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Trombose Coronária/diagnóstico por imagem , Trombose Coronária/etiologia , Everolimo/efeitos adversos , Humanos , Japão , Intervenção Coronária Percutânea/efeitos adversos , Valor Preditivo dos Testes , Estudos Prospectivos , Desenho de Prótese , Método Simples-Cego , Fatores de Tempo , Tomografia de Coerência Óptica , Resultado do Tratamento , Ultrassonografia de IntervençãoRESUMO
BACKGROUND: Analysis of pooled clinical data has shown the safety of 3 months of dual antiplatelet therapy with everolimus-eluting cobalt-chromium stents (Co-Cr EESs). This study evaluated early and mid-term vascular responses to Co-Cr EESs in patients with stable coronary artery disease. METHODS: The Multicenter Comparison of Early and Late Vascular Responses to Everolimus-Eluting Cobalt-Chromium Stent and Platelet Aggregation Studies in Patients With Stable Angina Managed as Elective Case (MECHANISM-Elective) study (NCT02014818) is a multicenter optical coherence tomography (OCT) registry. Enrolled patients were evaluated by OCT immediately after everolimus-eluting stent implantation were prospectively allocated to 1 month (n = 50) or 3 months (n = 50) OCT follow-up and then received a 12-month OCT evaluation. The incidences of intrastent thrombus (IS-Th) and irregular protrusion (IRP) were also assessed. RESULTS: The percentage of uncovered struts was 6.4% ± 10.3% at 1 month (P < 0.001 vs. postprocedure) and 0.5% ± 0.9% at 12 months (P < 0.001 vs. 1 month). The corresponding values in the 3-month cohort were 2.0% ± 2.5% (P < 0.001 vs. postprocedure) and 0.5% ± 1.5% (P < 0.001 vs. 3 months). The incidence of IS-Th was 32.7% at 1 month, 5.4% at 3 months, and 2.0% at 12 months. IRP was observed in 21.8% of patients post-EES but had totally resolved at 1, 3, and 12 months. CONCLUSION: Early and mid-term vascular reactions after Co-Cr EES implantation in stable patients with coronary artery disease in the MECHANISM-Elective included dynamic resolution of IS-Th and IRP and rapid decrease in uncovered struts. Thus, EES may allow shortening of dual antiplatelet therapy duration less than 3 months in this patient subset.
Assuntos
Doença da Artéria Coronariana/cirurgia , Vasos Coronários/diagnóstico por imagem , Stents Farmacológicos , Everolimo/farmacologia , Revascularização Miocárdica/métodos , Cirurgia Assistida por Computador/métodos , Tomografia de Coerência Óptica/métodos , Idoso , Doença da Artéria Coronariana/diagnóstico , Vasos Coronários/cirurgia , Feminino , Seguimentos , Humanos , Imunossupressores/farmacologia , Masculino , Estudos Retrospectivos , Fatores de Tempo , Resultado do TratamentoRESUMO
RATIONALE AND OBJECTIVES: We have developed a new contrast enhancement protocol for subtraction coronary computed tomography (SCCTA) requiring a short breath-holding time. In the protocol, test and main boluses were sequentially and automatically injected, and correct timings for pre-contrast and contrast-enhanced scans for main bolus were automatically determined only by the test bolus tracking. Combined with a fixed short main bolus injection for 7 seconds, the breath-holding time was shortened as possible. The purpose of this study was to evaluate whether use of this new protocol produced adequate quality images, taking into account calcified lesions and in-stent lumens. MATERIALS AND METHODS: Patients (n = 127) with calcium scores of >400 Agatston units or a history of stent placement were enrolled. Breath-holding times were recorded, and image quality was visually evaluated by two observers. RESULTS: The mean ± standard deviation breath-holding time was 13.2 ± 0.6 seconds. The mean ± SD computed tomography (CT) number of coronary arteries for the pre-contrast scan was sufficiently low [99.2 ± 32.2 Hounsfield units (HU)] and, simultaneously, that for SCCTA was 367.0 ± 77.2 HU. The rate of segments evaluated as unreadable was sufficiently low (3.8%). CONCLUSIONS: Use of the SCCTA protocol was efficient and allowed for a shorter breath-holding time and adequate diagnostic accuracy of SCCTA images, including images of calcified and stent implantation segments.
Assuntos
Angiografia por Tomografia Computadorizada/métodos , Doença da Artéria Coronariana/diagnóstico por imagem , Calcificação Vascular/diagnóstico por imagem , Adulto , Idoso , Idoso de 80 Anos ou mais , Suspensão da Respiração , Meios de Contraste , Angiografia Coronária/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Variações Dependentes do Observador , Intensificação de Imagem Radiográfica/métodos , Reprodutibilidade dos Testes , Sensibilidade e Especificidade , StentsRESUMO
AIMS: We sought to investigate two-year clinical and serial optical coherence tomography (OCT) outcomes after implantation of a fully bioresorbable vascular scaffold (BVS) or a cobalt-chromium everolimus-eluting stent (CoCr-EES). METHODS AND RESULTS: In the ABSORB Japan trial, 400 patients were randomised in a 2:1 ratio to BVS (N=266) or CoCr-EES (N=134). A pre-specified OCT subgroup (N=125, OCT-1 group) underwent angio-graphy and OCT post procedure and at two years. Overall, the two-year TLF rates were 7.3% and 3.8% in the BVS and CoCr-EES arms (p=0.18), respectively. Very late scaffold thrombosis (VLST) beyond one year was observed in 1.6% (four cases: all in non-OCT-1 subgroups) of the BVS arm, while there was no VLST in the CoCr-EES arm. In three cases, OCT at the time of or shortly after VLST demonstrated strut discontinuities, malapposition and/or uncovered struts. However, the vessel healing by two-year OCT was nearly complete in both BVS and CoCr-EES arms with almost fully covered struts, and minimal malapposition. The flow area by two-year OCT was smaller in the BVS arm than in the CoCr-EES arm, mainly due to tissue growth inside the device. However, there were no differences between the BVS and CoCr-EES with regard to the quality of homogenous tissues growing inside the devices. CONCLUSIONS: The rate of TLF was numerically higher in the BVS arm than in the CoCr-EES arm, although this difference was not statistically significant. VLST was observed only in the BVS arm at a rate of 1.6% between one and two years. Further studies are mandatory to investigate the risk of BVS relative to metallic stents for VLST, and the underlying mechanisms of BVS VLST.
Assuntos
Implantes Absorvíveis , Antineoplásicos/administração & dosagem , Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos , Everolimo/administração & dosagem , Intervenção Coronária Percutânea , Alicerces Teciduais , Idoso , Doenças Cardiovasculares/mortalidade , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Feminino , Seguimentos , Oclusão de Enxerto Vascular/epidemiologia , Humanos , Japão , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , Revascularização Miocárdica/estatística & dados numéricos , Complicações Pós-Operatórias/epidemiologia , Método Simples-Cego , Trombose/epidemiologia , Tomografia de Coerência Óptica , Resultado do TratamentoRESUMO
BACKGROUND: There have been no reports about the diagnostic ability of coronary computed tomography angiography (CTA) in evaluating collateral channels used for retrograde chronic total occlusion (CTO) percutaneous coronary intervention (PCI). OBJECTIVE: We investigated the ability and diagnostic accuracy of coronary CTA compared with invasive coronary angiography to detect collaterals used in retrograde CTO PCI and to compared the success rates for wire crossing between collaterals that are detectable and not detectable in coronary CTA. METHODS: We retrospectively reviewed data from 43 patients (55 collaterals) who underwent coronary CTA and PCI for CTO with the retrograde approach. We compared the ability of coronary CTA to visualize collaterals to invasive coronary angiography and evaluated the rates of successful wire crossing between CTA-visible and invisible collaterals. RESULTS: The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of coronary CTA for detecting collaterals which were used for the retrograde approach was 100.0%, 50.0%, 65.9%, 100.0%, and 74.5%, respectively. Guidewire collateral crossing was more successful in CT-visible collaterals than those not detectable in CT (74.1% vs. 46.4%, p = 0.034). There were fewer collateral vessel injuries in CTA-visible collaterals (11.1% vs. 32.1%, p = 0.041). CONCLUSION: Coronary CTA provides good visualization of collaterals used in retrograde CTO PCI. For retrograde guidewire crossing, a higher success rate with fewer complications was observed in CTA-visible collaterals than in those not detectable in coronary CTA.
Assuntos
Circulação Colateral , Angiografia por Tomografia Computadorizada , Angiografia Coronária/métodos , Circulação Coronária , Oclusão Coronária/diagnóstico por imagem , Oclusão Coronária/terapia , Vasos Coronários/diagnóstico por imagem , Tomografia Computadorizada Multidetectores , Intervenção Coronária Percutânea/métodos , Idoso , Doença Crônica , Oclusão Coronária/fisiopatologia , Vasos Coronários/fisiopatologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Valor Preditivo dos Testes , Reprodutibilidade dos Testes , Estudos Retrospectivos , Resultado do TratamentoRESUMO
The early phase arterial reaction after implantation of second-generation drug-eluting stents (2nd DES) and baremetal stents (BMS) in patients with ST-segment elevation myocardial infarction (STEMI) remains unclear.The MECHANISM pilot study is a multi-center prospective registry that enrolled 24 STEMI patients (from 11 centers) who had undergone implantation of everolimus-eluting (n = 6), biolimus A9-eluting (n = 6) or zotarolimus-eluting stents (n = 6), or BMS (n = 6). Scheduled optical coherence tomography (OCT) was performed 2 weeks after implantation, and images were independently analyzed at a core laboratory in a blinded fashion. Intra-stent thrombus was quantitatively analyzed in terms of the maximal area and the percentage of cross-sections with thrombus (the numbers of cross-section with thrombus × 100 divided by total number of cross-sections within the stented segment). More than 90% of struts were already covered 2 weeks after the index procedure, regardless of the stent type. There were no differences in stent diameter, minimal lumen diameter, minimal lumen area, neointimal thickness, or the frequencies of malapposed and uncovered struts among the 4 groups. The quantity of intra-stent thrombus also did not differ among the 4 groups.The results of this pilot study suggest that the 2-week vascular responses seem to be similar among 2nd DES and BMS in STEMI patients. Considering the possible advantage of 2nd DES in the prevention of restenosis, 2nd DES are a feasible option for the treatment of patients with STEMI.
Assuntos
Angioplastia Coronária com Balão , Stents Farmacológicos , Infarto do Miocárdio/terapia , Neointima , Sirolimo , Trombose , Idoso , Angioplastia Coronária com Balão/efeitos adversos , Angioplastia Coronária com Balão/métodos , Antineoplásicos/farmacologia , Stents Farmacológicos/efeitos adversos , Stents Farmacológicos/classificação , Feminino , Humanos , Imunossupressores/farmacologia , Masculino , Pessoa de Meia-Idade , Neointima/diagnóstico , Neointima/etiologia , Projetos Piloto , Estudos Prospectivos , Sirolimo/análogos & derivados , Sirolimo/farmacologia , Trombose/diagnóstico , Trombose/etiologia , Fatores de Tempo , Tomografia de Coerência Óptica/métodosRESUMO
A 52-year-old woman presented with a one-week history of low-grade fever and dyspnea. A CT scan showed multiple pulmonary nodules with cavitation, as well as bilateral pleural thickenings with effusions. A specimen resected by video-assisted thoracoscopic surgery showed multiple confluent granulomas with central necrosis and granulomatous vasculitis. These findings were consistent with necrotizing sarcoid granulomatosis. An elevated serum soluble interleukin-2 receptor level became normal following clinical and radiological improvement. This indicates that the serum soluble interleukin-2 receptor can be a useful marker for the clinical management of necrotizing sarcoid granulomatosis.