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1.
Int J Cardiovasc Imaging ; 36(2): 171-178, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31919705

RESUMO

Although drug-coated balloon (DCB) angioplasty is an effective therapy for drug-eluting stent- in stent restenosis (DES-ISR) after coronary stenting, recurrent ISR after DCB angioplasty still occurs. Different patterns of DES-ISR responding to DCB are largely unknown. This study sought to assess outcomes of different patterns of DES-ISR treated with DCB. From December 2014 to December 2016, a total of 160 DES-ISR lesions treated with DCB were retrospectively evaluated. Restenosis patterns were classified into two groups according to Mehran classification: focal, defined as < 10 mm, 58 lesions (36.3%); non-focal, which were diffuse, proliferative, or obstructive, 102 lesions (63.7%). The primary endpoint was binary restenosis rate at 9-month angiographic follow-up. Secondary endpoint was major adverse cardiac events (MACE) at 24-month follow-up. Baseline characteristics were comparable between the two groups. Angiographic follow-up rate was 93.7% (93.1% in the focal group and 94.1% in the non-focal group). The focal group had a lower recurrent restenosis rate compared to the non-focal group (3.7% vs. 33.3%, respectively; P = 0.003) at an average angiographic follow-up of 10 (10.4 ± 6.2) months. There was no difference in MACE between the two groups (6.9% vs. 11.8%, respectively; P = 0.70) at (22.7 ± 9.1) months clinical follow-up. On multivariate logistic regression analysis, focal pattern (OR 13.033; 95% CI 2.441-69.573, P = 0.003) and post-procedure DS% (OR 1.142; 95% CI 1.070-1.218, P = 0.000) were predictive factors of binary restenosis after DCB angioplasty. On multivariate analysis, focal pattern of ISR was a predictive factor of MACE (OR 0.260; 95% CI 0.071-0.959, P = 0.043), and diabetes mellitus (DM) was an independent predictor of MACE after DCB angioplasty (OR 5.045; 95% CI 1.179-21.590, P = 0.029). The present study suggests that DCB provides much better clinical, angiographic outcomes in patients with focal DES-ISR than non-focal DES-ISR.


Assuntos
Angioplastia Coronária com Balão/instrumentação , Cateteres Cardíacos , Materiais Revestidos Biocompatíveis , Reestenose Coronária/terapia , Stents Farmacológicos , Intervenção Coronária Percutânea/instrumentação , Idoso , Angioplastia Coronária com Balão/efeitos adversos , Angiografia Coronária , Reestenose Coronária/diagnóstico por imagem , Reestenose Coronária/etiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Intervalo Livre de Progressão , Desenho de Prótese , Recidiva , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo
2.
J Interv Cardiol ; 2019: 3270132, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31772522

RESUMO

Objectives: The aim of our study was to investigate the predictors of target lesion revascularization (TLR) and to compare the in-stent restenosis (ISR) progression rates of different 2nd-generation drug-eluting stents (DES). Background: The predictors of early and late TLR after 2nd-generation DES implantation have not been fully evaluated. Methods: We analyzed 944 stented lesions from 394 patients who had at least two serial follow-up angiograms, using quantitative coronary angiography (QCA) analysis. The study endpoints were TLR and the velocity of diameter stenosis (DS) progression. Results: TLR occurred in 58 lesions (6.1%) during the first angiographic follow-up period and 23 de novo lesions (2.4%) during the following second interval. Independent predictors for early TLR were diabetes mellitus (DM) (HR 2.58, 95% CI 1.29-5.15, p=0.007), previous percutaneous coronary intervention (PCI) (HR 2.41, 95% CI 1.03-5.65, p=0.043), and postprocedure DS% (HR 1.08, 95% CI 1.05-1.11, p<0.001, per 1%), while predictors of late TLR were previous PCI (HR 9.43, 95% CI 2.58-34.52, p=0.001) and serum C-reactive protein (CRP) (HR 1.60, 95% CI 1.28-2.00, p<0.001). The ISR progression velocity (by DS%) was 12.1 ±21.0%/year and 3.7 ±10.1%/year during the first and second follow-up periods, respectively, which had no significant difference (p>0.05) between the four types of DESs. Conclusions: Our data showed that predictors for TLR may be different at different time intervals. DM, pervious PCI, and postprocedure DS could predict early TLR, while previous PCI and CRP level could predict late TLR. Contemporary DESs had similar rates of ISR progression rates. Trial Registration: This study was retrospectively registered and approved by the institutional review board of Seoul National University Hospital (no. 1801-138-918).


Assuntos
Reestenose Coronária/terapia , Stents Farmacológicos/efeitos adversos , Intervenção Coronária Percutânea , Idoso , Proteína C-Reativa/análise , Angiografia Coronária , Reestenose Coronária/diagnóstico por imagem , Diabetes Mellitus/epidemiologia , Progressão da Doença , Feminino , Seguimentos , Humanos , Masculino , Retratamento/estatística & dados numéricos
3.
Int Heart J ; 60(5): 1070-1076, 2019 Sep 27.
Artigo em Inglês | MEDLINE | ID: mdl-31484856

RESUMO

The efficacy of drug-coated balloons (DCB) for in-stent restenosis (ISR) in hemodialysis (HD) patients remains unclear.We retrospectively evaluated 153 consecutive patients who underwent DCB for ISR with follow-ups for up to 3 years after the procedure between February 2014 and June 2017. Patients were divided into an HD group (n = 39) and a non-HD group (n = 114). The primary endpoint was target lesion revascularization (TLR). The secondary endpoints were all revascularizations and major adverse cardiac events (MACE) defined as cardiac death, myocardial infarction and cerebral infarction. Kaplan-Meier curves of survival free from TLR were compared between the two groups. We also performed propensity score matching and then compared the two matched groups (n = 27 in each group). The acute procedure success rate was similar for the two groups (100% versus 99.1%, P = 0.56). The incidence of TLR was higher in the HD group than in the non-HD group (41.0% versus 9.6%, P < 0.0001). The rate of revascularizations and MACE combined was significantly higher in the HD group than in the non-HD group (64.1% versus 17.5%, P < 0.0001). Kaplan-Meier analyses showed that survival free from TLR was significantly lower in the HD group than in the non-HD group both before and after propensity score matching (P < 0.0001 and P = 0.005, respectively; log-rank test).Contrary to the similar acute procedure success, recurrent ISR and MACE occurred more frequently in HD patients than in non-HD patients after DCB, which indicates poorer long-term efficacy of DCB in HD patients.


Assuntos
Angioplastia Coronária com Balão/efeitos adversos , Cateteres Cardíacos/efeitos adversos , Reestenose Coronária/terapia , Estenose Coronária/terapia , Stents Farmacológicos/efeitos adversos , Diálise Renal/métodos , Idoso , Angioplastia Coronária com Balão/instrumentação , Angioplastia Coronária com Balão/métodos , Estudos de Casos e Controles , Causas de Morte , Materiais Revestidos Biocompatíveis , Reestenose Coronária/diagnóstico por imagem , Reestenose Coronária/mortalidade , Estenose Coronária/diagnóstico por imagem , Feminino , Seguimentos , Hospitais Universitários , Humanos , Estimativa de Kaplan-Meier , Falência Renal Crônica/terapia , Masculino , Pessoa de Meia-Idade , Revascularização Miocárdica/métodos , Revascularização Miocárdica/mortalidade , Paclitaxel/farmacologia , Pontuação de Propensão , Diálise Renal/estatística & dados numéricos , Estudos Retrospectivos , Medição de Risco , Análise de Sobrevida , Fatores de Tempo , Resultado do Tratamento
4.
Yonsei Med J ; 60(9): 824-831, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31433580

RESUMO

PURPOSE: We evaluated the incidence, predictors, and prognosis of coronary artery aneurysm (CAA) after second-generation drug-eluting stent (DES) implantation. MATERIALS AND METHODS: A total of 976 consecutive patients (1245 lesions) who underwent follow-up angiography after second-generation DES implantation were analyzed. Incidence and predictors of CAA were assessed, and clinical prognosis was compared with 34 cases of CAA after first-generation DES implantation using previous CAA registry data. RESULTS: All 10 cases of CAA (0.80% per lesion) in 10 patients (1.02% per patient) were detected at follow up. Compared to lesions without CAA, those with CAA had greater involvement of the proximal segment (90% vs. 51%, p=0.014), a higher proportion of pre-intervention, a Thrombolysis in Myocardial Infarction score of 0 or 1 flow (80% vs. 16%, p<0.001), more chronic total occlusions (40% vs. 10%, p<0.001), and longer implanted stents (41.9±23.2 mm vs. 28.8±14.8 mm, p=0.006). As for CAA morphology, instances of CAA after second-generation DES were predominantly the single fusiform type (90%), whereas instances of CAA after first-generation DES were multiple saccular (47%) and single saccular (35%) types (p<0.001). Myocardial infarction with stent thrombosis occurred in 5 patients with CAA after first-generation DES (15%), and no adverse events were observed in patients with CAA after second-generation DES over a median follow-up duration of 4.3 years (p=0.047, log-rank). CONCLUSION: Although CAAs after second-generation DES implantation were detected at a similar incidence to that for CAAs after first-generation DES implantation, second-generation DES-related CAAs had different morphologies and more benign clinical outcomes versus first-generation DES-related CAAs.


Assuntos
Aneurisma Coronário/epidemiologia , Stents Farmacológicos/efeitos adversos , Infarto do Miocárdio/cirurgia , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/métodos , Idoso , Aneurisma Coronário/diagnóstico por imagem , Aneurisma Coronário/terapia , Angiografia Coronária , Reestenose Coronária/terapia , Vasos Coronários , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio/etiologia , Prognóstico , Sistema de Registros , Trombose/complicações , Fatores de Tempo , Resultado do Tratamento
6.
Heart Vessels ; 34(10): 1639-1649, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-30997558

RESUMO

Pathological studies have suggested the different process of in-stent restenosis (ISR) of bare-metal stents (BMS) and drug-eluting stents (DES). Here, we evaluated the components of neointimal tissue using integrated backscatter intravascular ultrasound (IB-IVUS) and focused on the time course after stent implantation and tissue signal distribution. We evaluated 125 lesions of 125 patients who underwent target lesion revascularization for ISR (BMS: n = 73, DES: n = 52). Volume analysis of a 4-mm length centered on a minimum lumen area in every 1-mm cross-sectional area was performed. For IB-IVUS analysis, color-coded maps were constructed from the default setting based on the integrated backscatter (IB) values (middle-IB value, green: fibrous and low-IB value, blue: lipid pool). For the neointimal tissue volume, we evaluated the ratios of the green (%G) and blue (%B) areas. Tissue signal distribution (TD) was also obtained from the default setting based on IB values in each pixel of IB-IVUS imaging. We compared values of neointimal tissues measured by IB-IVUS between the DES and BMS and time course. The observed period was longer after BMS implantation than after DES implantation (BMS: 2545 days, DES: 1233 days, p < 0.001). Overall, %G and %B were similar between the BMS and DES groups (%G: 55% and 51%, respectively, p = 0.10; %B: 36% and 38%, respectively, p = 0.51); however, TD was significantly higher in the DES group than in the BMS group (1091 vs. 1367, p < 0.001). TD in the DES group remained high during the follow-up periods. However, TD in the BMS group was low in the early phase and significantly increased over time (r = 0.56, p < 0.001). When analyzing the ISR within 2 years after stent implantation, the BMS was distinguished with a sensitivity of 66% and a specificity of 90% (cut-off value: TD = 1135, area under the curve 0.83, 95% confidence interval 0.74-0.92). TD could differentiate neointimal tissue after BMS implantation in the early phase. TD can be a useful index in the observation of neoatherosclerosis.


Assuntos
Angioplastia Coronária com Balão/instrumentação , Reestenose Coronária/diagnóstico por imagem , Stents Farmacológicos/efeitos adversos , Metais , Neointima/patologia , Ultrassonografia de Intervenção , Idoso , Angiografia Coronária , Reestenose Coronária/etiologia , Reestenose Coronária/terapia , Feminino , Humanos , Modelos Lineares , Masculino , Pessoa de Meia-Idade , Neointima/diagnóstico por imagem , Desenho de Prótese , Estudos Retrospectivos , Resultado do Tratamento
7.
J Cardiovasc Med (Hagerstown) ; 20(7): 471-476, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30994510

RESUMO

AIMS: To evaluate the angiographic performance of a novel sirolimus-coated balloon (SCB) in de novo coronary lesions. METHODS: Out of an all-comer prospective registry of patients treated with the SCB at our center from April 2016 to September 2017, we selected those treated for a de novo stenosis on a native vessel, with a scheduled angiographic control at at least 4 months after the index procedure. We performed a centralized, blinded core-lab adjudicated quantitative coronary angiography analysis. Primary endpoint was late lumen loss. Secondary endpoints were binary restenosis and target-lesion revascularization. RESULTS: A total of 27 patients with native coronary arteries treated with SCB and with angiographic follow-up entered the study; seven patients were excluded because a stent was implanted at the lesion site during the index procedure. The degree of calcification (assessed with coronary angiography) was high in six patients (30%) and the average lesion length was 20.52 ±â€Š6.88 mm. The reference vessel diameter was 2.32 ±â€Š0.44 mm and the percentage diameter stenosis was 67 ±â€Š12. Procedural success was obtained in all patients. After a median of 6.6 ±â€Š2.5 months, late lumen loss was 0.09 ±â€Š0.34 mm and the percentage diameter stenosis was 31 ±â€Š18. We observed two cases (10%) of binary restenosis which underwent subsequent target-lesion revascularization: in one a drug-eluting stent was implanted, whereas the other patient was treated with paclitaxel-coated balloon. No myocardial infarction or death was observed during follow-up. CONCLUSION: The use of a novel SCB in native coronary arteries was associated with good angiographic outcome at 6-month follow-up.


Assuntos
Angioplastia Coronária com Balão/instrumentação , Cateteres Cardíacos , Fármacos Cardiovasculares/administração & dosagem , Materiais Revestidos Biocompatíveis , Angiografia Coronária , Doença da Artéria Coronariana/terapia , Sirolimo/administração & dosagem , Idoso , Angioplastia Coronária com Balão/efeitos adversos , Fármacos Cardiovasculares/efeitos adversos , Doença da Artéria Coronariana/diagnóstico por imagem , Reestenose Coronária/diagnóstico por imagem , Reestenose Coronária/etiologia , Reestenose Coronária/terapia , Feminino , Humanos , Itália , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Estudos Prospectivos , Desenho de Prótese , Sistema de Registros , Fatores de Risco , Sirolimo/efeitos adversos , Fatores de Tempo , Resultado do Tratamento
8.
Yonsei Med J ; 60(5): 429-439, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-31016904

RESUMO

PURPOSE: To explore the effects of biodegradable magnesium alloy stents (BMAS) on remodeling of vein graft (VG) anastomotic restenosis. MATERIALS AND METHODS: To establish a VG restenosis model, seventy two New Zealand rabbits were randomly divided into three groups according to whether a stent was implanted in the graft vein or not. BMASs and 316L stainless steel stents were implanted in BMAS and 316L groups, respectively, while no stent was implanted in the no-treatment control group (NC group). Loss of lumen diameter in the graft vein was measured in all three groups. Upon harvesting VG segments to evaluate intimal proliferation and re-endothelization, the degradation and biological safety of the stents were observed to explore the effects of BMAS on VG remodeling. RESULTS: Model establishment and stent implantation were successful. The BMAS reduced lumen loss, compared with the control group (0.05±0.34 mm vs. 0.90±0.39 mm, p=0.001), in the early stage. The neointimal area was smaller in the BMAS group than the 316L group after 4 months (4.96±0.66 mm² vs. 6.80±0.69 mm², p=0.017). Re-endothelialization in the BMAS group was better than that in the 316L group (p=0.001). Within 4 months, the BMAS had degraded, and the magnesium was converted to phosphorus and calcium. The support force of the BMAS began to reduce at 2-3 months after implantation, without significant toxic effects. CONCLUSION: BMAS promotes positive remodeling of VG anastomosis and has advantages over the conventional 316L stents in the treatment of venous diseases.


Assuntos
Ligas/farmacologia , Materiais Biocompatíveis/farmacologia , Prótese Vascular , Reestenose Coronária/terapia , Magnésio/farmacologia , Stents , Animais , Implante de Prótese Vascular , Constrição Patológica , Reestenose Coronária/complicações , Feminino , Neointima/complicações , Coelhos
9.
J Invasive Cardiol ; 31(3): E49-E50, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30819979
10.
Heart Vessels ; 34(9): 1420-1428, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-30903315

RESUMO

Drug-coated balloon (DCB) angioplasty has been shown to be a promising option for the treatment of coronary in-stent restenosis (ISR). We compared the clinical outcomes of patients with ISR who were treated with two commonly used paclitaxel-containing DCBs, the Pantera Lux (PL) and SeQuent Please (SP). A total of 491 patients with 507 ISR lesions [PL-DCB in 127 (26%) patients and SP-DCB in 364 (74%) patients] underwent DCB angioplasty for ISR lesions. The major adverse cardiac events (MACEs), including cardiac death, target lesion-related myocardial infarction, and target lesion revascularization, were assessed. There were no significant differences in each occurrence of MACE and cardiac death: 16 MACEs (61 per 1000 person-years) in the PL-DCB group and 55 (60 per 1000 person-years) MACEs in the SP-DCB group, log-rank p = 0.895, and three cardiac deaths (11 per 1000 person-years) in the PL-DCB group and ten cardiac deaths (11 per 1000 person-years) in the SP-DCB group, log-rank p = 0.849. Diabetes mellitus under insulin treatment [hazard ratio (HR) 2.71; 95% confidence interval (CI) 1.31-5.60; p = 0.007], chronic kidney disease (HR 1.99; 95% CI 1.01-3.92; p = 0.045), early-onset ISR (HR 1.99; 95% CI 1.18-3.36; p = 0.010), and recurrent ISR (HR 1.89; 95% CI 1.08-3.32; p = 0.026) were associated with the occurrence of MACE after DCB angioplasty. There was no significant difference of MACE between PL-DCB and SP-DCB treatment in patients with ISR. Patients with insulin-treated diabetes, chronic kidney disease, early-onset ISR, and recurrent ISR were at a higher risk of MACE after DCB angioplasty.


Assuntos
Angioplastia Coronária com Balão/instrumentação , Cateteres Cardíacos , Doença da Artéria Coronariana/terapia , Reestenose Coronária/terapia , Stents Farmacológicos , Intervenção Coronária Percutânea/instrumentação , Idoso , Angioplastia Coronária com Balão/efeitos adversos , Fármacos Cardiovasculares/administração & dosagem , Materiais Revestidos Biocompatíveis , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/mortalidade , Reestenose Coronária/diagnóstico por imagem , Reestenose Coronária/mortalidade , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Paclitaxel/administração & dosagem , Intervenção Coronária Percutânea/efeitos adversos , Modelos de Riscos Proporcionais , Desenho de Prótese , República da Coreia , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento
11.
Angiology ; 70(8): 711-718, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-30773906

RESUMO

Major advances in coronary interventional techniques and pharmacotherapy as well as the use of drug-eluting stents (DESs) have considerably reduced the risk of in-stent restenosis (ISR). However, ISR remains a major clinical challenge. Inflammation and platelet activation are important processes that underlie the pathophysiology of ISR. Parameters related to blood cells, entailing both cell count and morphology, are useful markers of the inflammatory response and platelet activation in clinical practice. Recent studies have highlighted several new combined or derived parameters related to blood cells that independently predict ISR after DES implantation. The neutrophil/lymphocyte ratio, an inflammatory marker, is regarded as a predictor of the risk of ISR and the stability of atherosclerotic plaques. The mean platelet volume, a widely used platelet activation parameter, has been shown to be a predictor of the risk of ISR and the efficacy of antiplatelet therapy. Other markers considered include the platelet/lymphocyte ratio, red blood cell distribution width, and platelet distribution width. This review provides an overview of these parameters that may help stratify the risk of coronary angiographic and clinical outcomes related to ISR.


Assuntos
Biomarcadores/sangue , Células Sanguíneas/citologia , Reestenose Coronária/terapia , Intervenção Coronária Percutânea , Stents Farmacológicos , Humanos , Intervenção Coronária Percutânea/métodos , Fatores de Risco
12.
Catheter Cardiovasc Interv ; 93(1): 79-81, 2019 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-30244535

RESUMO

Resorbable Magnesium Scaffolds (RMS) represent an interesting alternative to current drug-eluting stents. Current data from clinical trials seems to confirm good performance of these new devices with low rates of late device failure. Little is known about mechanisms leading to RMS failure. Herein, we present the first description of an early RMS in-scaffold restenosis. Optical coherence tomography (OCT) analysis at implantation detected acute non-severe malapposition and underexpansion as main promoters of RMS failure. OCT during in-scaffold restenosis intervention confirmed early severe neointimal proliferation and RMS late recoil and dismantling as the main mechanisms of device failure. We hypothesize that the fast resorption process of RMS may lead to an early loss of radial strength, that could favor late recoil, acquired underexpansion, device dismantling and might interact with distribution of sirolimus. This case also illustrates that OCT is pivotal to unravel both acute and acquired mechanisms related to RMS failure.


Assuntos
Implantes Absorvíveis , Angioplastia Coronária com Balão/instrumentação , Doença da Artéria Coronariana/terapia , Reestenose Coronária/diagnóstico por imagem , Vasos Coronários/diagnóstico por imagem , Magnésio , Tomografia de Coerência Óptica , Angioplastia Coronária com Balão/efeitos adversos , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Reestenose Coronária/etiologia , Reestenose Coronária/terapia , Humanos , Masculino , Pessoa de Meia-Idade , Neointima , Valor Preditivo dos Testes , Desenho de Prótese , Fatores de Tempo , Resultado do Tratamento
13.
Catheter Cardiovasc Interv ; 93(2): 216-221, 2019 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-30232824

RESUMO

OBJECTIVES: To investigate the relative performance of treatment with a paclitaxel-eluting balloon (PEB) compared with an everolimus-eluting stent (EES) for in-stent restenosis (ISR) in patients with diabetes mellitus (DM). BACKGROUND: ISR remains a challenge in contemporary clinical practice, particularly in patients with DM. METHODS: In the multicenter randomized DARE trial, patients with BMS or DES ISR were randomized in a 1:1 fashion to treatment with a PEB or an EES. Patients underwent angiographic follow-up after 6 months. For the purpose of this analysis, the relative performance of PEB versus EES in diabetic patients was investigated. RESULTS: Of 278 patients enrolled in DARE, 88 (32%) had DM, of whom 46 were randomized to EES and 42 to PEB treatment. Of patients with DM, 48 (55%) had DES-ISR. Angiographic follow-up was available in 30 patients (72%) in the PEB group and 36 patients (78%) in the DES group. There were no differences in terms of 6-months minimal lumen diameter in diabetic patients treated with EES (1.46 ± 0.66 mm) versus PEB (1.78 ± 0.58 mm, P = 0.15). Adverse events at one year follow-up were similar in both groups, with Major Adverse Events (MAE, death, target vessel MI, or TVR) occurring in 17.4% in the EES group versus 11.9% in the PEB group, P = 0.44. CONCLUSIONS: In patients with ISR and DM, use of a PEB resulted in similar 6-months in-segment minimal lumen diameter and comparable rates of MAE. In-segment late loss at 6 months was significantly lower in the PEB arm. Although larger trials in DM patients with ISR are necessary, PEB is a promising treatment option obviating the need for additional stent implantation.


Assuntos
Angioplastia Coronária com Balão/instrumentação , Cateteres Cardíacos , Fármacos Cardiovasculares/administração & dosagem , Materiais Revestidos Biocompatíveis , Doença da Artéria Coronariana/terapia , Reestenose Coronária/terapia , Diabetes Mellitus , Stents Farmacológicos , Everolimo/administração & dosagem , Paclitaxel/administração & dosagem , Intervenção Coronária Percutânea/instrumentação , Idoso , Angioplastia Coronária com Balão/efeitos adversos , Fármacos Cardiovasculares/efeitos adversos , Doença da Artéria Coronariana/diagnóstico por imagem , Reestenose Coronária/diagnóstico por imagem , Reestenose Coronária/etiologia , Diabetes Mellitus/diagnóstico , Everolimo/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Países Baixos , Paclitaxel/efeitos adversos , Intervenção Coronária Percutânea/efeitos adversos , Estudos Prospectivos , Desenho de Prótese , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
15.
Circ J ; 83(2): 313-319, 2019 01 25.
Artigo em Inglês | MEDLINE | ID: mdl-30487370

RESUMO

BACKGROUND: There are few reports about the differences between drug-eluting stents (DES) and bare metal stents (BMS) in neoatherosclerosis associated with in-stent restenosis (ISR), so we compared the frequency and characteristics of neoatherosclerosis with ISR evaluated by optical coherence tomography (OCT) in the present study. Methods and Results: Between March 2009 and November 2016, 98 consecutive patients with ISR who underwent diagnostic OCT were enrolled: 34 patients had a BMS, 34 had a 1st-generation DES, and 30 had a 2nd-generation DES. Neoatherosclerosis was defined as a lipid neointima (including a thin-cap fibroatheroma [TCFA] neointima, defined as a fibroatheroma with a fibrous cap <65 µm) or calcified neointima. As a result, lipid neointima, TCFA neointima and calcified neointima were detected in 39.8%, 14.3%, and 5.1%, respectively, of all patients. The frequency of neoatherosclerosis was significantly greater with DES than BMS (48.4% vs. 23.5%, P=0.018). The minimum fibrous cap thickness was significantly thicker with DES than BMS (110.3±41.1 µm vs. 62.5±17.1 µm, P<0.001). In addition, longitudinal extension of neoatherosclerosis in the stented segment was less with DES than BMS (20.2±15.1% vs. 71.8±27.1%, respectively, P=0.001). CONCLUSIONS: OCT imaging demonstrated that neoatherosclerosis with ISR was more frequent with DES than BMS and its pattern exhibited a more focal and thick fibrous cap as compared with BMS.


Assuntos
Aterosclerose/terapia , Reestenose Coronária/etiologia , Stents Farmacológicos/normas , Neointima/patologia , Stents/normas , Idoso , Idoso de 80 Anos ou mais , Aterosclerose/diagnóstico por imagem , Reestenose Coronária/terapia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Neointima/diagnóstico por imagem , Tomografia de Coerência Óptica/métodos
16.
Herz ; 44(1): 35-39, 2019 Feb.
Artigo em Alemão | MEDLINE | ID: mdl-30569181

RESUMO

Coronary restenosis is the answer of the arterial wall to a mechanical violation through balloon angioplasty, bare-metal (BM) stent implantation or rotational atherectomy through repeated narrowing. It has great clinical and prognostic relevance and occurs in approximately 30% of non-coated stents and in 10% of coated coronary stents. The wound healing process that precedes restenosis includes inflammatory reactions, cellular proliferation and remodeling of the arterial wall, where protein synthesis of the extracellular matrix is initiated. The inflammatory reaction activates platelets, leucocytes and monocytes and stimulates smooth muscle cells. The medications on the drug-eluting stents (rapamycin, paclitaxel, sirolimus, evarolimus and zotarolimus) inhibit cell division, are cytotoxic and only these sustainably influence restenosis. Whether they play a role in neoatherosclerosis needs to be determined. The mechanism of restenosis with implantation of drug-eluting stents is heterogeneous and associated with the deposition of T­lymphocytes and fibrin. Risk factors for the development of restenosis include mechanical factors, such as incorrect apposition and expansion of stents, inflammation, diabetes mellitus, genetic factors, bypass operations, stent length and stent diameter. The restenosis rate is lower with drug-eluting stents and must be considered differently between the drug-eluting stents. Drug-eluting stents of the latest generation and drug-coated balloons (DCB) showed the best clinical and angiographic results for in-stent restenosis in randomized trials. The BM and older first-generation drug-eluting stents should be avoided. Further randomized studies are needed.


Assuntos
Angioplastia Coronária com Balão , Reestenose Coronária , Stents Farmacológicos , Angiografia Coronária , Reestenose Coronária/terapia , Humanos , Paclitaxel , Desenho de Prótese , Stents , Resultado do Tratamento
17.
Arq Bras Cardiol ; 112(1): 40-47, 2019 01.
Artigo em Inglês, Português | MEDLINE | ID: mdl-30570071

RESUMO

BACKGROUND: In multivessel disease patients with moderate stenosis, fractional flow reserve (FFR) allows the analysis of the lesions and guides treatment, and could contribute to the cost-effectiveness (CE) of non-pharmacological stents (NPS). OBJECTIVES: To evaluate CE and clinical impact of FFR-guided versus angiography-guided angioplasty (ANGIO) in multivessel patients using NPS. METHODS: Multivessel disease patients were prospectively randomized to FFR or ANGIO groups during a 5 year-period and followed for < 12 months. Outcomes measures were major adverse cardiac events (MACE), restenosis and CE. RESULTS: We studied 69 patients, 47 (68.1%) men, aged 62.0 ± 9.0 years, 34 (49.2%) in FFR group and 53 (50.7%) in ANGIO group, with stable angina or acute coronary syndrome. In FFR, there were 26 patients with biarterial disease (76.5%) and 8 (23.5%) with triarterial disease, and in ANGIO, 24 (68.6%) with biarterial and 11 (31.4%) with triarterial disease. Twelve MACEs were observed - 3 deaths: 2 (5.8%) in FFR and 1 (2.8%) in ANGIO, 9 (13.0%) angina: 4(11.7%) in FFR and 5(14.2%) in ANGIO, 6 restenosis: 2(5.8%) in FFR and 4 (11.4%) in ANGIO. Angiography detected 87(53.0%) lesions in FFR, 39(23.7%) with PCI and 48(29.3%) with medical treatment; and 77 (47.0%) lesions in ANGIO, all treated with angioplasty. Thirty-nine (33.3%) stents were registered in FFR (0.45 ± 0.50 stents/lesion) and 78 (1.05 ± 0.22 stents/lesion) in ANGIO (p = 0.0001), 51.4% greater in ANGIO than FFR. CE analysis revealed a cost of BRL 5,045.97 BRL 5,430.60 in ANGIO and FFR, respectively. The difference of effectiveness was of 1.82%. CONCLUSION: FFR reduced the number of lesions treated and stents, and the need for target-lesion revascularization, with a CE comparable with that of angiography.


Assuntos
Síndrome Coronariana Aguda/terapia , Angina Estável/terapia , Angioplastia Coronária com Balão/métodos , Angiografia Coronária/métodos , Reserva Fracionada de Fluxo Miocárdico/fisiologia , Síndrome Coronariana Aguda/economia , Síndrome Coronariana Aguda/patologia , Idoso , Angina Estável/economia , Angina Estável/mortalidade , Angioplastia Coronária com Balão/economia , Angiografia Coronária/economia , Reestenose Coronária/mortalidade , Reestenose Coronária/terapia , Análise Custo-Benefício , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Estatísticas não Paramétricas , Stents , Fatores de Tempo , Resultado do Tratamento
18.
Cardiovasc Interv Ther ; 34(2): 171-177, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30136194

RESUMO

We aimed to evaluate the impact of tissue characterization for in-stent restenosis (ISR) with optical computed tomography (OCT) during excimer laser coronary angioplasty (ELCA) in the drug-eluting stent (DES) era. The effect of ELCA for ISR according to differences in tissue characteristics is unclear. Fifty-three ISR lesions (7 bare metal stents and 46 drug-eluting stents) were treated with an ELCA catheter. After ELCA, balloon dilatation with either the scoring or non-compliant balloons was conducted. The procedure was completed by applying a drug-coated balloon. Tissue characterization and lumen measurement with OCT were performed thrice: (1) before percutaneous coronary intervention (PCI), (2) after ELCA, and (3) and after the procedure. Lesions were categorized into the homogenous, layered, and mixed groups. Follow-up angiograms were conducted 6-12 months after PCI. No significant differences in minimal lumen area (MLA) were observed before PCI. A significant difference was observed in MLA after ELCA among the three groups (homogeneous group: 1.75 ± 0.84 mm2, layered group: 1.72 ± 0.45 mm2, mixed group: 2.24 ± 0.70 mm2, P = 0.048). Final MLA was larger in the mixed group than in the homogeneous group (P = 0.028). No significant difference was observed in binary restenosis in the follow-up angiogram (homogeneous group 55.5%, layered group 33.3%, mixed group 33.3%; P = 0.311) and the target lesion revascularization rate (homogeneous 30.0%, layered 23.8%, mixed 25.0%; P = 0.923). Tissue characterization by OCT may predict the efficacy of ELCA and balloon angioplasty for ISR during the acute phase.


Assuntos
Reestenose Coronária/diagnóstico por imagem , Tomografia de Coerência Óptica , Idoso , Angiografia Coronária , Reestenose Coronária/terapia , Feminino , Humanos , Lasers de Excimer , Masculino , Intervenção Coronária Percutânea , Estudos Retrospectivos , Stents
19.
Can J Cardiol ; 34(12): 1564-1572, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30527144

RESUMO

Coronary calcification often complicates atherosclerosis. With an aging population, coinciding with lower thresholds for coronary angiography and percutaneous coronary intervention (PCI), severe calcific coronary stenoses remain a challenge for interventional cardiologists. Although advances in coronary guidewires, percutaneous balloons, and adjunctive procedural devices have improved success of PCI, recalcitrant calcified lesions not amenable to the conventional technique frequently occur. Coronary atherectomy with plaque modification provides a therapeutic alternative. As such, various modalities such as rotational, orbital or laser atherectomy, and more recently shockwave lithoplasty have become therapeutic options for PCI. We provide a summary of the principles, technique, and contemporary evidence for these currently approved devices designed to treat severe coronary calcific lesions.


Assuntos
Doença da Artéria Coronariana/terapia , Intervenção Coronária Percutânea , Calcificação Vascular/terapia , Angioplastia Coronária com Balão/métodos , Aterectomia Coronária/efeitos adversos , Aterectomia Coronária/métodos , Bloqueio Atrioventricular/etiologia , Bloqueio Atrioventricular/prevenção & controle , Reestenose Coronária/terapia , Humanos , Lasers de Excimer , Litotripsia , Fenômeno de não Refluxo , Índice de Gravidade de Doença
20.
JACC Cardiovasc Interv ; 11(23): 2368-2377, 2018 12 10.
Artigo em Inglês | MEDLINE | ID: mdl-30522665

RESUMO

OBJECTIVES: The aim of the present study was to evaluate the angiographic efficacy, clinical safety, and effectiveness of the Restore paclitaxel-coated balloon in a randomized trial designed to enable the approval of the new device in China. BACKGROUND: Drug-coated balloon (DCB) angioplasty offers an effective treatment for in-stent restenosis. Restore is a new DCB with a SAFEPAX shellac-ammonium salt excipient that can avoid drug washing off during catheter delivery to the target lesion site. METHODS: In the noninferiority RESTORE ISR China (Compare the Efficacy and Safety of RESTORE DEB and SeQuent Please in Chinese Patient With Coronary In-stent Restenosis) trial, eligible patients with first occurrence of drug-eluting stent ISR were randomized to the Restore DCB or SeQuent Please DCB in a 1:1 ratio stratified by diabetes. Angiographic and clinical follow-up was planned at 9 months and 1 year, respectively, in all patients. The study was powered for the primary endpoint of 9-month in-segment late loss. RESULTS: Between May 2016 and July 2017, a total of 240 subjects at 12 sites were randomized to either the Restore group (n = 120) or the SeQuent Please group (n = 120). Nine-month in-segment late loss was 0.38 ± 0.50 mm with Restore versus 0.35 ± 0.47 mm with SeQuent Please; the 1-sided 97.5% upper confidence limit of the difference was 0.17 mm, achieving noninferiority of Restore compared with SeQuent Please (p for noninferiority = 0.02). Both DCBs had similar 1-year rates of target lesion failure (13.3% vs. 12.6%; p = 0.87). CONCLUSIONS: In this head-to-head randomized trial, the Restore DCB was noninferior to the SeQuent Please DCB for the primary endpoint of 9-month in-segment late loss. (Compare the Efficacy and Safety of RESTORE DEB and SeQuent Please in Chinese Patient With Coronary In-stent Restenosis; NCT02944890).


Assuntos
Angioplastia Coronária com Balão/instrumentação , Cateteres Cardíacos , Fármacos Cardiovasculares/administração & dosagem , Materiais Revestidos Biocompatíveis , Doença da Artéria Coronariana/terapia , Reestenose Coronária/terapia , Stents Farmacológicos , Paclitaxel/administração & dosagem , Intervenção Coronária Percutânea/instrumentação , Idoso , Angioplastia Coronária com Balão/efeitos adversos , Fármacos Cardiovasculares/efeitos adversos , China , Constrição Patológica , Doença da Artéria Coronariana/diagnóstico por imagem , Reestenose Coronária/diagnóstico por imagem , Reestenose Coronária/etiologia , Desenho de Equipamento , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Paclitaxel/efeitos adversos , Intervenção Coronária Percutânea/efeitos adversos , Estudos Prospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
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