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1.
J. Am. Coll. Cardiol. ; 74(13 supl.): 46-46, Oct., 2019.
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1024901

RESUMO

BACKGROUND: Bioresorbable vascular scaffolds (BRS) provide temporary mechanical support and may help restore normal vessel reactivity, positive remodeling, and reduce chronic inflammation. The Fantom scaffold (REVA Medical) is a sirolimus-eluting BRS, with a TyroCoreTM radiopaque tyrosine analog polymer. METHODS: FANTOM II is a prospective, multi-center, safety and performance study of patients with myocardial ischemia or a positive functional study. The study included patients with single de novo lesions in native coronary vessels ranging in diameter from 2.5 to 3.5 mm and lesion lengths up to 20 mm. The primary objective of the study is to demonstrate safety and performance of the Fantom sirolimus-eluting bioresorbable scaffold by assessing the incidence of Major Adverse Cardiac Events (MACE) and Late Lumen Loss at 6 months. RESULTS: FANTOM II enrolled 240 patients across 28 clinical centers in 8 countries. Two separate sequential cohorts followed patients with a 6-month (Cohort A, N=117) versus 9-month (Cohort B, N=123) angiographic assessment. A sub-set of Cohort A patients, returned for serial angiographic follow-up at 24-month. We report 24-month adjudicated clinical endpoints. Acute technical success, acute procedural success, and clinical procedural success were 95.8%, 99.1% and 99.6%, respectively. The primary safety endpoint of MACE at 24 months was 5.0%. Late Lumen Loss at 6 months in the Cohort A was 0.25 ± 0.35mm In-Scaffold and 0.17 ± 0.29mm In-Segment. At 24-months the subset of Cohort A patients (n=36) demonstrated stable late lumen loss values of 0.23 ± 0.49mm In-Scaffold and 0.21 ± 0.49mm In-Segment. CONCLUSION: FANTOM II demonstrates safe and stable performance of the REVA BRS at 24-months. (AU)


Assuntos
Doença da Artéria Coronariana/terapia , Tecidos Suporte , Stents Farmacológicos , Intervenção Coronária Percutânea
2.
J. Am. Coll. Cardiol. ; 74(13 supl.): 115-115, Oct., 2019.
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1024911

RESUMO

BACKGROUND: The development of bioresorbable vascular scaffold (BRS) offers a new treatment strategy for coronary artery lesion by replacement of a permanent metallic scaffold with a temporary scaffold and eradicating a nidus for very late adverse events. The first-in-human MeRes-1 trial reported favorable safety and efficacy of thin-strut (100 mm) MeRes100 sirolimus-eluting BRS (Meril Life Sciences Pvt. Ltd., India) in patients with de novo coronary artery lesions. Hence, to reaffirm the outcomes of the MeRes-1 trial, the MeRes-1 Extend trial sought to evaluate the safety and efficacy of the MeRes100 BRS in diverse patient population in Europe, Brazil, South Africa, and Asia Pacific. METHODS: The MeRes-1 Extend was a multicenter, prospective, single-arm study of MeRes100 BRS in 64 patients from Spain, Macedonia, Brazil, South Africa, Malaysia, and Indonesia. The safety endpoint was major adverse cardiac events (MACE), which composed of cardiac death, myocardial infarction (MI), and ischemia-driven target lesion revascularization (ID-TLR). Quantitative coronary angiography and optical coherence tomography (OCT) imaging was performed at baseline and 6-month follow-up. RESULTS: Among 64 enrolled patients (mean age: 58.30 _ 9.02 years), 26.56% had diabetes mellitus and 68.75% patients presented with stable angina. Of 69 target lesions, 71.01% were classified as type B2/C; average lesion length was 14.37 _ 5.89 mm and mean reference vessel diameter was 3.03 _ 0.35 mm. Procedural and device success was achieved in 64 and 62 patients, respectively. MACE was reported in 1 patient (1.61%) at 24-month follow-up in the form of ID-TLR with absence of MI, cardiac death, or scaffold thrombosis. At 6-month angiographic follow-up in a subset of 32 patients, mean in-scaffold LLL was 0.18 _ 0.31 mm. OCT analysis (n » 21) reported 97.95 _ 3.69% strut coverage with mean scaffold area of 7.56 _ 1.79 mm2 and no evidence of strut malapposition. CONCLUSION: Based on 2-year clinical and 6-month imaging outcomes, the MeRes-1 Extend trial established favorable safety and efficacy of MeRes100 sirolimus-eluting BRS in patients with de novo coronary artery lesions. (AU)


Assuntos
Doença da Artéria Coronariana , Tecidos Suporte , Stents Farmacológicos
3.
J. Am. Coll. Cardiol. ; 74(13 supl.): 176-176, Oct., 2019.
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1024953

RESUMO

BACKGROUND: The Fantom sirolimus-eluting bioresorbable coronary scaffold (BRS) (REVA Medical, San Diego, California) was previously studied with angiographic late lumen loss at 6, 9, and 24 months with clinical events being followed through 36 months. However, a functional evaluation has not previously been performed. The aim of this study was to assess serial functional changes after percutaneous coronary intervention (PCI) with the Fantom BRS implantation. METHODS: The FANTOM II trial was a prospective, multicenter, single-arm study that enrolled 240 patients with stable coronary artery disease or unstable angina and single de novo native coronary lesions, of which 235 patients received the Fantom BRS and are included in the present analysis. Serial quantitative flow ratio (QFR) analysis was performed in an independent core laboratory at baseline, after PCI, and at 6- or 9-month and 24-month follow-up. RESULTS: QFR was analyzable in 178 patients at baseline, 185 post-PCI, 178 at 6- or 9-month follow-up, and 31 at 24-month follow-up. At baseline, 59 patients (33.1%) had QFR >0.80, whereas 12 (6.5%) at post-PCI, 13 (7.3%) at 6- or 9-month followup, and 3 (9.7%) at 24-month follow-up had QFR _0.80. In the paired analyses, QFR was significantly increased from baseline to post-PCI (0.73 _ 0.12 vs. 0.94 _ 0.07; p < 0.001), while it decreased from post-PCI to 6- or 9-month follow-up (0.94 _ 0.07 vs. 0.92 _ 0.08; p < 0.001) and from 6- or 9-month to 24-month follow-up (0.93 _ 0.07 vs. 0.91 _ 0.09; p » 0.03). CONCLUSION: Serial angiographic analysis showed significant increase in QFR values between baseline and post-PCI. A slight decrease was observed in QFR values with the Fantom BRS over 24 months. (AU)


Assuntos
Angiografia/métodos , Stents Farmacológicos , Intervenção Coronária Percutânea
4.
J. Am. Coll. Cardiol. ; 74(13 supl.): 187-187, Oct., 2019.
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1024965

RESUMO

BACKGROUND: Assessment of the safety and clinical performance of the Sirolimus-Eluting Bioabsorbable Magnesium Scaffold (DREAMS 2G) from the combined analysis of BIOSOLVE- II and -III studies at 36 months. METHODS A total of 184 subjects have been enrolled in the BIOSOLVE-II and -III studies. Clinical follow-ups are scheduled at 1, 6, 12, 24, and 36 months plus 60 months for BIOSOLVE-II. Angiographies are planned at 6 months and voluntarily at 12 and 36 months in BIOSOLVE-II, and 1 angiography is mandatory at 12 months in the BIOSOLVE-III study. Dual antiplatelet therapy is recommended for a minimum of 6 months. The angiographic results are analyzed by an independent core laboratory and all clinical events were adjudicated by an independent clinical events committee. RESULTS A total of 117 men and 67 women with 189 lesions, mean age 65.5 _ 10.8 years, were enrolled at 18 sites in Europe, Brazil, and Singapore. Hypertension was presente in 79.3% of the subjects and 62% had hyperlipidemia. The mean lesion length was 12.6 _ 5.1 mm with a mean reference vessel diameter of 2.70 _ 0.43 mm. At 12 months, 97 patients had available angiographic follow-up. There was no difference in late lumen loss between the 2 studies; in the overall population, it was 0.25 _ 0.31 mm in-segment and 0.39 _ 0.34 mm in-scaffold. The target lesion failure (TLF) rate of the combined population was 3.3%, including 2 cardiac deaths (1.1%), 1 target vessel myocardial infarction (0.6%), and 3 clinically driven target lesion revascularizations (1.7%). The 36-month clinical data of BIOSOLVE- II study are available. Target lesion failure occurred in 8 patients (6.8%) and included 2 cardiac deaths (1.7%), 1 target vessel myocardial infarction (0.9%), and 5 clinically driven target lesion revascularizations (4.3%). No definite or probable scaffold thrombosis was observed. The 36- month clinical visits are ongoing for BIOSOLVE-III patients and data of the combined cohort will be available upon presentation. CONCLUSION The 36-month results of DREAMS 2G, meaning 2 years beyond the completion of resorption, are encouraging on safety and clinical performance standpoints. They will be presented for a larger population of subjects enrolled in the BIOSOLVE-II and -III studies. (AU)


Assuntos
Reestenose Coronária , Stents Farmacológicos
5.
Zhonghua Xin Xue Guan Bing Za Zhi ; 47(10): 784-789, 2019 Oct 24.
Artigo em Chinês | MEDLINE | ID: mdl-31648460

RESUMO

Objective: To evaluate the long-term efficacy of a second generation biodegradable polymer sirolimus-eluting stent (EXCEL2) in treating patients with de novo coronary artery diseases. Methods: CREDIT Ⅱ trial was a prospective, multicenter, randomized, controlled study, conducted at 15 Chinese cardiac centres from November 2013 to December 2014. In this analysis, eligible patients for coronary stenting (n=419) were randomized to receive either the EXCEL2 stent (n=208) or the EXCEL stent (n=211). The primary endpoint was target lesion failure (TLF) at 3 years after PCI defined as a composite endpoints of cardiac death, target vessel myocardial infarction (TVMI), or clinically indicated target lesion revascularization (CI-TLR). Secondary endpoints included patient-oriented composite endpoint (PoCE) including all-cause death, all MI, or any revascularization at 3 years and independent components, and stent thrombosis according to Academic Research Consortium's (ARC) definition. Results: Among 419 enrolled patients, 413 (98.6%) patients completed 3-year clinical follow-up. Compared with the EXCEL group, 3-year TLF (5.4%(11/204) vs. 11.5% (24/209), P=0.025) and PoCE (9.8% (20/204) vs. 20.1% (42/209), P=0.003) were significantly lower in the EXCEL2 group. The cumulative event rate of CI-TLR (2.0% (4/204) vs. 5.7% (12/209), P=0.042) and any revascularization (4.9% (10/204) vs. 14.4% (30/209), P=0.001) were statistically lower in the EXCEL2 group than in the EXCEL group. There were no significant difference between two groups in terms of all-cause death and all MI. Rates of stent thrombosis were low without significant difference between the two groups (EXCEL2 vs. EXCEL, 1.0% (2/204) vs. 2.9% (6/209), P=0.285). Conclusion: 3-year clinical follow-up results demonstrate that EXCEL2 stents are effective and safe in treating CAD patients with de novo coronary lesions.


Assuntos
Fármacos Cardiovasculares/administração & dosagem , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Sirolimo/administração & dosagem , Implantes Absorvíveis , Humanos , Intervenção Coronária Percutânea , Polímeros , Estudos Prospectivos , Fatores de Tempo , Resultado do Tratamento
6.
Zhonghua Xin Xue Guan Bing Za Zhi ; 47(10): 790-797, 2019 Oct 24.
Artigo em Chinês | MEDLINE | ID: mdl-31648461

RESUMO

Objective: To explore the value of SYNTAX revascularization index (SRI) on evaluating the long-term prognosis of coronary artery disease (CAD) patients implanted with biodegradable polymer drug-eluting stents (BP-DES) and define the best threshold of SRI for predicting all-cause mortality in these patients. Methods: Data used in this study derived from the I-LOVE-IT 2 trial (evaluate safety and effectiveness of the Tivoli DES and the Firebird DES for treatment of coronary). I-LOVE-IT 2 trial was a prospective, multicenter, randomized, assessor-blinded, non-inferiority study. A total of 1 829 patients implanted with BP-DES were divided into 3 groups, namely SRI=100% group (n=963), 50%≤SRI<100% group (n=527) and SRI<50% group (n=339). The primary endpoint was 48-month patient-oriented composite endpoint (PoCE), a composite of all-cause mortality, myocardial infarction(MI), stroke, and/or any revascularization. The secondary endpoints were components of PoCE and definite/probable stent thrombosis at 48 months. The receiver operating characteristic curve was used to investigate the best cut-off point of SRI for 48-month all-cause mortality. The Cox regression analysis was used to identify independent predictors of the all-cause death and PoCE at 48 months. Results: Incidence of PoCE at 48 months was significantly lower in SRI=100% group than patients with 50%≤SRI<100%(17.34% (167/963) vs. 22.20% (117/527), P<0.05) and SRI<50% (17.34% (167/963) vs. 24.78% (84/339), P<0.05). Comparing with SRI=100% group, the patients with 50%≤SRI<100% suffered higher rates of all MI (7.78% (41/527) vs. 4.26% (41/963), P<0.05) and target vessel MI (6.45% (34/527) vs. 4.26% (41/963), P<0.05); patients with SRI<50% had higher rates of all-cause mortality (5.90% (20/339) vs. 3.12% (30/963), P<0.05) and any revascularization (14.16% (48/339) vs. 3.12% (30/963), P<0.05). The receiver operating characteristic curve analysis showed that the SRI=65% was the best cut-off point to predict the all-cause mortality at 48 months (area under the curve was 0.58, sensitive was 0.47, specificity was 0.70). Meanwhile, SRI<65% was an independent predictor of 48-month all-cause mortality (HR=2.06, 95%CI 1.25-3.38) and PoCE (HR=1.34, 95%CI 1.09-1.66). Conclusions: SRI serves as a good index for predicting long-term prognosis and SRI<65% is an independent predictor of 48-month PoCE and all-cause mortality for CAD patients with BP-DES implantation. Meanwhile, SRI≥65% might be a reasonable threshold of incomplete revascularization.


Assuntos
Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Implantes Absorvíveis , Humanos , Mortalidade , Polímeros , Prognóstico , Estudos Prospectivos , Fatores de Risco , Resultado do Tratamento
7.
Orv Hetil ; 160(43): 1711-1713, 2019 Oct.
Artigo em Húngaro | MEDLINE | ID: mdl-31630552

RESUMO

A 42-year-old man is presented with acute coronary syndrome and De Winter ECG sign. The De Winter sign is a rare ECG manifestation of proximal LAD occlusion. The ECG sign was misinterpreted and the patient was transmitted to our percutan coronaria intervention centrum with 3 hours delay. The hyperacute T-waves and the precordial ST-depressions disappeared, but the biomarkers showed a marked elevation. Coronary angiography revealed LAD proximal thrombotic dissection treated with a drug-eluting stent. The authors suggest that in patients with this ECG pattern the immediate coronary intervention is the best treatment. Orv Hetil. 2019; 160(43): 1711-1713.


Assuntos
Síndrome Coronariana Aguda/diagnóstico por imagem , Angiografia Coronária/métodos , Stents Farmacológicos/efeitos adversos , Eletrocardiografia/métodos , Adulto , Coração/diagnóstico por imagem , Humanos , Masculino
8.
Medicine (Baltimore) ; 98(38): e17202, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31567970

RESUMO

A number of studies have reported on treatment outcomes of coronary stenting (PCI) for multivessel coronary artery diseases (MVD), and compared them with the conventional coronary artery bypass grafting (CABG). However, the clinical outcomes of robot-assisted CABG (R-CABG) in comparison with PCI in MVD patients have not been investigated.We recruited retrospectively MVD patients receiving R-CABG and PCI with drug-eluting stents for all vessels in one stage between January 2005 and December 2013 at our institution with at least 3 years of outcomes were retrospectively recruited and analyzed.A total of 638 MVD patients were studied. Among them, 281 received R-CABG, and 357 received PCI. Similar complete revascularizations were achieved in both groups (R-CABG: 40.2%, PCI: 41.5%, P = .751). The residual stenosis was 4.1 ±â€Š4.4 in the R-CABG group, and comparably 3.5 ±â€Š3.7 in the PCI group (P = .077). Patients in the R-CABG group were younger, with more severe coronary artery disease (CAD) and had more background risk factors. The in-hospital and long-term mortalities as well as the incidence of TLR, myocardial infarction (MI), stroke were all similar between groups. But the incidence of TVR and any revascularization were lower in the R-CABG group. The long-term mortality was predicted by age, left ventricular ejection fraction, and chronic kidney disease, but not by the revascularization modality, completeness of revascularization, nor residual SYNTAX scores. The last 3 factors were not predictors of long-term TLR, TVR, MI, and stroke.The in-hospital and long-term survival rates of MVD were similar for both the R-CABG and PCI groups. But the R-CABG group had rates of TVR and any revascularization lower than PCI. Revascularization modality, completeness of revascularization, and residual SYNTAX scores were not predictors of in-hospital and long-term mortalities, MI, and stroke in real-world practice. R-CABG was associated with lower rates of TLR and TVR, and is likely a safe and effective treatment and an alternative choice of PCI for MVD patients who have low surgical risks.


Assuntos
Implante de Prótese Vascular , Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos , Intervenção Coronária Percutânea , Procedimentos Cirúrgicos Robóticos , Idoso , Implante de Prótese Vascular/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/métodos , Estudos Retrospectivos , Procedimentos Cirúrgicos Robóticos/métodos , Resultado do Tratamento
9.
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
10.
Int Heart J ; 60(5): 1050-1060, 2019 Sep 27.
Artigo em Inglês | MEDLINE | ID: mdl-31484868

RESUMO

Edge restenosis has gained attention as a main cause of restenosis after first-generation drug-eluting stent (DES) implantation. The aim of this study was to assess the incidence of edge restenosis and identify the predictors of edge restenosis after second-generation DES implantation. Data were obtained from several postmarketing surveillance (PMS) studies on a cobalt-chromium everolimus-eluting stent (CoCr-EES; Xience V/PROMUS, Xience Prime, Xience Prime SV, and Xience Expedition SV), a second-generation DES, in Japan. Angiographic analysis was conducted at the baseline and after eight months on the following subsegments: in-stent region, proximal edge, and distal edge. Restenosis was defined as ≥ 50% diameter stenosis (DS) at follow-up. We used multivariate logistic regression (with lesions as a random effect) to compare the instances of restenosis between the proximal and the distal edges. Univariate and multivariate analyses of the risk factors for restenosis were performed for each subsegment. We analyzed 1,966 lesions in 1,687 patients. The restenosis rates at the in-stent region, proximal edge, and distal edge were 4.4%, 3.0%, and 1.1%, respectively. The risk of restenosis at the distal edge was significantly lower than that at the proximal edge, when adjusted for 13 variables. The predictors of restenosis were postprocedural % diameter stenosis (%DS), postprocedural reference diameter, ≥ 45° bending, stent overlap at the proximal edge, and postprocedural %DS at the distal edge. Our analysis of eight-month angiographic outcomes from CoCr-EES PMS demonstrated that postprocedural %DS is a major predictor of edge restenosis. Edge restenosis is more likely attributable to postprocedural angiographic results than to the patient's background.


Assuntos
Angiografia Coronária/métodos , Estenose Coronária/terapia , Stents Farmacológicos/efeitos adversos , Vigilância de Produtos Comercializados , Desenho de Prótese , Sirolimo/farmacologia , Fatores Etários , Idoso , Angioplastia Coronária com Balão/métodos , Angioplastia Coronária com Balão/mortalidade , Cromo , Cobalto , Estudos de Coortes , Reestenose Coronária/diagnóstico por imagem , Reestenose Coronária/epidemiologia , Estenose Coronária/diagnóstico por imagem , Estenose Coronária/mortalidade , Análise de Falha de Equipamento , Feminino , Hospitais Universitários , Humanos , Incidência , Japão , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Prognóstico , Sistema de Registros , Estudos Retrospectivos , Medição de Risco , Índice de Gravidade de Doença , Fatores Sexuais , Análise de Sobrevida , Resultado do Tratamento
12.
Angiol Sosud Khir ; 25(3): 63-67, 2019.
Artigo em Russo | MEDLINE | ID: mdl-31503248

RESUMO

Despite implementation of antiproliferative drug-eluting stents (DES) and intention to perform maximally full myocardial revascularization during a single hospital stay even in acute coronary syndrome (ACS) the frequency of repeat interventions after endovascular revascularization remains at a sufficiently stable level. In order to examine the causes of repeat hi-tech medical care rendered by means of endovascular myocardial revascularization for acute coronary syndrome without ST-segment elevation we carried out a retrospective single-centre study. It included a total of 93 patients suffering from ischaemic heart disease (IHD), who in 2017 endured this type of medical care twice. The cases of repeat revascularization were analysed based on medical history taking, physical examination, ECG pattern, ultrasonographic examination, laboratory findings, data of electronic case report forms and video recordings of the previous and latest coronary angiographies (CAG). The obtained findings revealed the main causes of repeat hi-tech medical care rendered within 1 year by means of endovascular myocardial revascularization for acute coronary syndrome without ST-segment elevation, which were as follows: progression of atherosclerosis in the previously non-revascularized arteries, the emergence of the clinical course of ACS in borderline stenosis; the development of acute coronary syndrome in patients with a significant lesion of the coronary bed, who were scheduled for this or that reason to undergo elective staged transcutaneous coronary intervention (TCI); restenosis in the previously implanted stents.


Assuntos
Síndrome Coronariana Aguda , Stents Farmacológicos , Infarto do Miocárdio , Síndrome Coronariana Aguda/diagnóstico , Síndrome Coronariana Aguda/terapia , Humanos , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/terapia , Estudos Retrospectivos , Resultado do Tratamento
13.
Lancet ; 394(10208): 1530-1539, 2019 10 26.
Artigo em Inglês | MEDLINE | ID: mdl-31522843

RESUMO

BACKGROUND: Insertion of a ventriculoperitoneal shunt for hydrocephalus is one of the commonest neurosurgical procedures worldwide. Infection of the implanted shunt affects up to 15% of these patients, resulting in prolonged hospital treatment, multiple surgeries, and reduced cognition and quality of life. Our aim was to determine the clinical and cost-effectiveness of antibiotic (rifampicin and clindamycin) or silver shunts compared with standard shunts at reducing infection. METHODS: In this parallel, multicentre, single-blind, randomised controlled trial, we included patients with hydrocephalus of any aetiology undergoing insertion of their first ventriculoperitoneal shunt irrespective of age at 21 regional adult and paediatric neurosurgery centres in the UK and Ireland. Patients were randomly assigned (1:1:1 in random permuted blocks of three or six) to receive standard shunts (standard shunt group), antibiotic-impregnated (0·15% clindamycin and 0·054% rifampicin; antibiotic shunt group), or silver-impregnated shunts (silver shunt group) through a randomisation sequence generated by an independent statistician. All patients and investigators who recorded and analysed the data were masked for group assignment, which was only disclosed to the neurosurgical staff at the time of operation. Participants receiving a shunt without evidence of infection at the time of insertion were followed up for at least 6 months and a maximum of 2 years. The primary outcome was time to shunt failure due the infection and was analysed with Fine and Gray survival regression models for competing risk by intention to treat. This trial is registered with ISRCTN 49474281. FINDINGS: Between June 26, 2013, and Oct 9, 2017, we assessed 3505 patients, of whom 1605 aged up to 91 years were randomly assigned to receive either a standard shunt (n=536), an antibiotic-impregnated shunt (n=538), or a silver shunt (n=531). 1594 had a shunt inserted without evidence of infection at the time of insertion (533 in the standard shunt group, 535 in the antibiotic shunt group, and 526 in the silver shunt group) and were followed up for a median of 22 months (IQR 10-24; 53 withdrew from follow-up). 32 (6%) of 533 evaluable patients in the standard shunt group had a shunt revision for infection, compared with 12 (2%) of 535 evaluable patients in the antibiotic shunt group (cause-specific hazard ratio [csHR] 0·38, 97·5% CI 0·18-0·80, p=0·0038) and 31 (6%) of 526 patients in the silver shunt group (0·99, 0·56-1·74, p=0·96). 135 (25%) patients in the standard shunt group, 127 (23%) in the antibiotic shunt group, and 134 (36%) in the silver shunt group had adverse events, which were not life-threatening and were mostly related to valve or catheter function. INTERPRETATION: The BASICS trial provides evidence to support the adoption of antibiotic shunts in UK patients who are having their first ventriculoperitoneal shunt insertion. This practice will benefit patients of all ages by reducing the risk and harm of shunt infection. FUNDING: UK National Institute for Health Research Health Technology Assessment programme.


Assuntos
Infecções Relacionadas a Cateter/prevenção & controle , Stents Farmacológicos/economia , Derivação Ventriculoperitoneal/economia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Antibacterianos/administração & dosagem , Infecções Relacionadas a Cateter/sangue , Infecções Relacionadas a Cateter/líquido cefalorraquidiano , Criança , Pré-Escolar , Análise Custo-Benefício , Stents Farmacológicos/efeitos adversos , Feminino , Humanos , Hidrocefalia/cirurgia , Lactente , Recém-Nascido , Masculino , Pessoa de Meia-Idade , Prata/economia , Método Simples-Cego , Derivação Ventriculoperitoneal/efeitos adversos , Adulto Jovem
14.
Lancet ; 394(10205): 1243-1253, 2019 10 05.
Artigo em Inglês | MEDLINE | ID: mdl-31488372

RESUMO

BACKGROUND: Newer-generation drug-eluting stents that combine ultrathin strut metallic platforms with biodegradable polymers might facilitate vascular healing and improve clinical outcomes in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention (PCI) compared with contemporary thin strut second-generation drug-eluting stents. We did a randomised clinical trial to investigate the safety and efficacy of ultrathin strut biodegradable polymer sirolimus-eluting stents versus thin strut durable polymer everolimus-eluting stents in patients with acute ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI. METHODS: The BIOSTEMI trial was an investigator-initiated, multicentre, prospective, single-blind, randomised superiority trial at ten hospitals in Switzerland. Patients aged 18 years or older with acute STEMI who were referred for primary PCI were eligible to participate. Patients were randomly allocated (1:1) to either biodegradable polymer sirolimus-eluting stents or durable polymer everolimus-eluting stents. Central randomisation was done based on a computer-generated allocation sequence with variable block sizes of 2, 4, and 6, which was stratified by centre, diabetes status, and presence or absence of multivessel coronary artery disease, and concealed using a secure web-based system. Patients and treating physicians were aware of group allocations, whereas outcome assessors were masked to the allocated stent. The experimental stent (Orsiro; Biotronik; Bülach, Switzerland) consisted of an ultrathin strut cobalt-chromium metallic stent platform releasing sirolimus from a biodegradable polymer. The control stent (Xience Xpedition/Alpine; Abbott Vascular, Abbott Park, IL, USA) consisted of a thin strut cobalt-chromium stent platform that releases everolimus from a durable polymer. The primary endpoint was target lesion failure, a composite of cardiac death, target vessel myocardial reinfarction (Q-wave and non-Q-wave), and clinically-indicated target lesion revascularisation, within 12 months of the index procedure. All analyses were done with the individual participant as the unit of analysis and according to the intention-to-treat principle. The trial was registered with ClinicalTrials.gov, number NCT02579031. FINDINGS: Between April 26, 2016, and March 9, 2018, we randomly assigned 1300 patients (1623 lesions) with acute myocardial infarction to treatment with biodegradable polymer sirolimus-eluting stents (649 patients and 816 lesions) or durable polymer everolimus-eluting stents (651 patients and 806 lesions). At 12 months, follow-up data were available for 614 (95%) patients treated with biodegradable polymer sirolimus-eluting stents and 626 (96%) patients treated with durable polymer everolimus-eluting stents. The primary composite endpoint of target lesion failure occurred in 25 (4%) of 649 patients treated with biodegradable polymer sirolimus-eluting stents and 36 (6%) of 651 patients treated with durable polymer everolimus-eluting stents (difference -1·6 percentage points; rate ratio 0·59, 95% Bayesian credibility interval 0·37-0·94; posterior probability of superiority 0·986). Cardiac death, target vessel myocardial reinfarction, clinically-indicated target lesion revascularisation, and definite stent thrombosis were similar between the two treatment groups in the 12 months of follow-up. INTERPRETATION: In patients with acute STEMI undergoing primary PCI, biodegradable polymer sirolimus-eluting stents were superior to durable polymer everolimus-eluting stents with respect to target lesion failure at 1 year. This difference was driven by reduced ischaemia-driven target lesion revascularisation in patients treated with biodegradable polymer sirolimus-eluting stents compared with durable polymer everolimus-eluting stents. FUNDING: Biotronik.


Assuntos
Implantes Absorvíveis , Prótese Vascular , Stents Farmacológicos , Everolimo/uso terapêutico , Imunossupressores/uso terapêutico , Intervenção Coronária Percutânea/métodos , Infarto do Miocárdio com Supradesnível do Segmento ST/cirurgia , Sirolimo/uso terapêutico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Polímeros , Método Simples-Cego
15.
Lancet ; 394(10206): 1325-1334, 2019 10 12.
Artigo em Inglês | MEDLINE | ID: mdl-31488373

RESUMO

BACKGROUND: The Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial was a non-inferiority trial that compared percutaneous coronary intervention (PCI) using first-generation paclitaxel-eluting stents with coronary artery bypass grafting (CABG) in patients with de-novo three-vessel and left main coronary artery disease, and reported results up to 5 years. We now report 10-year all-cause death results. METHODS: The SYNTAX Extended Survival (SYNTAXES) study is an investigator-driven extension of follow-up of a multicentre, randomised controlled trial done in 85 hospitals across 18 North American and European countries. Patients with de-novo three-vessel and left main coronary artery disease were randomly assigned (1:1) to the PCI group or CABG group. Patients with a history of PCI or CABG, acute myocardial infarction, or an indication for concomitant cardiac surgery were excluded. The primary endpoint of the SYNTAXES study was 10-year all-cause death, which was assessed according to the intention-to-treat principle. Prespecified subgroup analyses were performed according to the presence or absence of left main coronary artery disease and diabetes, and according to coronary complexity defined by core laboratory SYNTAX score tertiles. This study is registered with ClinicalTrials.gov, NCT03417050. FINDINGS: From March, 2005, to April, 2007, 1800 patients were randomly assigned to the PCI (n=903) or CABG (n=897) group. Vital status information at 10 years was complete for 841 (93%) patients in the PCI group and 848 (95%) patients in the CABG group. At 10 years, 244 (27%) patients had died after PCI and 211 (24%) after CABG (hazard ratio 1·17 [95% CI 0·97-1·41], p=0·092). Among patients with three-vessel disease, 151 (28%) of 546 had died after PCI versus 113 (21%) of 549 after CABG (hazard ratio 1·41 [95% CI 1·10-1·80]), and among patients with left main coronary artery disease, 93 (26%) of 357 had died after PCI versus 98 (28%) of 348 after CABG (0·90 [0·68-1·20], pinteraction=0·019). There was no treatment-by-subgroup interaction with diabetes (pinteraction=0·66) and no linear trend across SYNTAX score tertiles (ptrend=0·30). INTERPRETATION: At 10 years, no significant difference existed in all-cause death between PCI using first-generation paclitaxel-eluting stents and CABG. However, CABG provided a significant survival benefit in patients with three-vessel disease, but not in patients with left main coronary artery disease. FUNDING: German Foundation of Heart Research (SYNTAXES study, 5-10-year follow-up) and Boston Scientific Corporation (SYNTAX study, 0-5-year follow-up).


Assuntos
Ponte de Artéria Coronária , Doença da Artéria Coronariana/mortalidade , Doença da Artéria Coronariana/cirurgia , Intervenção Coronária Percutânea , Idoso , Doença da Artéria Coronariana/patologia , Stents Farmacológicos , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Taxa de Sobrevida , Resultado do Tratamento
16.
N Engl J Med ; 381(19): 1820-1830, 2019 11 07.
Artigo em Inglês | MEDLINE | ID: mdl-31562798

RESUMO

BACKGROUND: Long-term outcomes after percutaneous coronary intervention (PCI) with contemporary drug-eluting stents, as compared with coronary-artery bypass grafting (CABG), in patients with left main coronary artery disease are not clearly established. METHODS: We randomly assigned 1905 patients with left main coronary artery disease of low or intermediate anatomical complexity (according to assessment at the participating centers) to undergo either PCI with fluoropolymer-based cobalt-chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG group, 957 patients). The primary outcome was a composite of death, stroke, or myocardial infarction. RESULTS: At 5 years, a primary outcome event had occurred in 22.0% of the patients in the PCI group and in 19.2% of the patients in the CABG group (difference, 2.8 percentage points; 95% confidence interval [CI], -0.9 to 6.5; P = 0.13). Death from any cause occurred more frequently in the PCI group than in the CABG group (in 13.0% vs. 9.9%; difference, 3.1 percentage points; 95% CI, 0.2 to 6.1). In the PCI and CABG groups, the incidences of definite cardiovascular death (5.0% and 4.5%, respectively; difference, 0.5 percentage points; 95% CI, -1.4 to 2.5) and myocardial infarction (10.6% and 9.1%; difference, 1.4 percentage points; 95% CI, -1.3 to 4.2) were not significantly different. All cerebrovascular events were less frequent after PCI than after CABG (3.3% vs. 5.2%; difference, -1.9 percentage points; 95% CI, -3.8 to 0), although the incidence of stroke was not significantly different between the two groups (2.9% and 3.7%; difference, -0.8 percentage points; 95% CI, -2.4 to 0.9). Ischemia-driven revascularization was more frequent after PCI than after CABG (16.9% vs. 10.0%; difference, 6.9 percentage points; 95% CI, 3.7 to 10.0). CONCLUSIONS: In patients with left main coronary artery disease of low or intermediate anatomical complexity, there was no significant difference between PCI and CABG with respect to the rate of the composite outcome of death, stroke, or myocardial infarction at 5 years. (Funded by Abbott Vascular; EXCEL ClinicalTrials.gov number, NCT01205776.).


Assuntos
Ponte de Artéria Coronária , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Intervenção Coronária Percutânea , Idoso , Doença da Artéria Coronariana/mortalidade , Doença da Artéria Coronariana/cirurgia , Everolimo/administração & dosagem , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , Isquemia Miocárdica/terapia , Razão de Chances , Acidente Vascular Cerebral/epidemiologia
17.
Medicine (Baltimore) ; 98(37): e17097, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31517836

RESUMO

The relationship between preexisting atherosclerotic lesion characteristics and neointimal thickness after second-generation drug-eluting stent (DES) placement is still unknown. Thus, we evaluated that relationship using optical coherence tomography (OCT).A single-center, retrospective, observational study was conducted. Patients with stable angina or asymptomatic myocardial ischemia who received percutaneous coronary intervention for a de novo lesion using a second-generation DES under frequency domain OCT guidance and underwent follow-up coronary angiography (CAG) and OCT between December 2010 and December 2015 were included. The relationship between the neointimal thickness on the stent strut and the plaque characteristics was retrospectively evaluated using OCT immediately after stent implantation and at the time of follow-up CAG.We analyzed 3459 struts from 20 stents in 15 patients. The mean follow-up period was 264 days. In the follow-up study, no angiographic in-stent restenosis was found. Of the 3459 struts, 3315 (95.8%) were covered with neointima. The median neointimal thicknesses of the stent struts on calcified, fibrous, and lipid-rich lesions were 20 µm (interquartile range [IQR], 10-50 µm), 70 µm (40-140 µm; P < .001), and 90 µm (50-170 µm; P < .001), respectively. These differences were observed regardless of the type of second-generation DES used.Most of the stent struts were covered with neointima. The neointimal thickness after the second-generation DES implantation had a close relationship with the preexisting atherosclerotic lesion characteristics. In this study, we found differences in arterial healing processes due to underlying plaque; therefore, evaluating the lesion characteristics by OCT may predict the risk for future restenosis and thrombosis.


Assuntos
Stents Farmacológicos/normas , Neointima/classificação , Idoso , Angiografia Coronária/métodos , Stents Farmacológicos/estatística & dados numéricos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Neointima/fisiopatologia , Estudos Retrospectivos , Pesos e Medidas/instrumentação
18.
Medicine (Baltimore) ; 98(32): e16767, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31393396

RESUMO

There are limited long-term outcome data comparing BioLinx polymer (B)-zotarolimus-eluting stents (ZES) with phosphorylcholine polymer (P)-ZES. The aim of this study was to compare the efficacy and safety of B-ZES with P-ZES in patients who underwent percutaneous coronary intervention (PCI) during a 3-year follow-up period.One thousand two hundred fifty four patients who underwent PCI with P-ZES (Endeavor [ZES-E] or Endeavor sprint [ZES-S], n = 356) or B-ZES (Endeavor resolute [ZES-R] or Resolute Integrity [ZES-I], n = 889) were enrolled. The primary endpoint was major adverse cardiac events (MACE); the composite of total death, non-fatal myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), non-target vessel revascularization (Non-TVR), and the secondary endpoint was stent thrombosis (ST).After PSM, 2 propensity-matched (PSM) groups (275 pairs, n = 550, C-statistic = 0.730) were generated. During the 3-year follow-up period, the cumulative incidence of MACE (hazard ratio [HR], 1.525; 95% confidence interval [CI], 0.920-2.526; P = .101) and ST (HR, 1.248; 95% CI, 0.335-4.4649; P = .741) were similar between P-ZES and B-ZES after PSM. However, TLR rate was significantly higher in ZES-S than ZES-I (11.3% vs 3.8%, log rank P = .029) and TVR rate was higher in ZES-S than ZES-R (14.1% vs 4.8%, log rank P = .025).In this single-center, all-comer registry, despite different polymers, P-ZES, and B-ZES showed comparable safety and efficacy during a 3-year follow-up period after PCI.


Assuntos
Doenças Cardiovasculares/epidemiologia , Stents Farmacológicos/efeitos adversos , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/métodos , Fosforilcolina/administração & dosagem , Sirolimo/análogos & derivados , Idoso , Doenças Cardiovasculares/mortalidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/mortalidade , Polímeros , Pontuação de Propensão , Desenho de Prótese , Reoperação , Sirolimo/administração & dosagem
19.
Bratisl Lek Listy ; 120(8): 545-551, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31379174

RESUMO

INTRODUCTION: BVS proved safe in humans. ABSORB trials showed them performing similar to Drug Eluting Stents in simple coronary interventions. We assessed a registry of 63 patients with bifurcation lesions, treated by BVS and followed their outcomes up-to 5 years. METHODS: Patients who satisfied the inclusion criteria were included. Data about contact information, baseline characteristics, findings of coronary angiogram, details of their interventional treatment; short and long-term outcomes up till 5 years was collected. RESULTS: Acute feasibility of implantation in bifurcation was high (98 %). Rate of stent thrombosis, acute or sub-acute, was 3.1 %. Rate of re-intervention was 38 %. The average time for an event to occur was 1.6±0.8 years. Over 5 years, 56 % had developed MACE. Patients with MACE were more likely females, hypertensive, smokers, with acute presentations (p=NS), and diabetic (72 % vs 33 % non-diabetic; p=0.002). Patients treated with hybrid strategy of BVS and DES were more likely to develop MACE (64 % vs 49 % for others; P=ns). Patients treated by simple provisional stenting were less likely to develop MACE (45 % vs 60.5 %; p=ns). The average SYNTAX score of MACE patients was 27 vs 20; p=0.06). Diabetes was independently associated with MACE. Hypertension was of borderline statistical significance (2-sided Log rank for Hypertension p=0.06, for Diabetes p=0.01). DISCUSSION: The use of multiple stenting strategies to treat true bifurcation lesions using BVS is feasible with low rate of serious adverse events, albeit on the long run, the rate of re-intervention is high and stringent follow up is required (Tab. 7, Fig. 3, Ref. 37).


Assuntos
Implantes Absorvíveis , Doença da Artéria Coronariana/cirurgia , Tecidos Suporte , Angiografia Coronária , Stents Farmacológicos , Humanos , Resultado do Tratamento
20.
Zhonghua Xin Xue Guan Bing Za Zhi ; 47(7): 549-553, 2019 Jul 24.
Artigo em Chinês | MEDLINE | ID: mdl-31365996

RESUMO

Objective: To compare the efficacy and safety of active transfer of plaque (ATP) versus provisional stenting (PS) with drug-eluting stents (DES) for the treatment of coronary bifurcation lesions. Methods: A total of 1 136 patients with bifurcation lesions hospitalized in 6 selected hospitals between January 2010 and January 2014 were included in this prospective observational trial, patients were divided into either ATP (n=560) or PS group (n=576) accordingly. The primary endpoint was target lesion revascularization within 1 year, and the second endpoints were all-cause death, cardiogenic death, myocardial infarction, stent thrombosis, stroke, recurrent angina within 1 year. Results: There were no significant differences in age, sex, hypertension, diabetes, hyperlipidemia and smoking history between the two groups (P>0.05). The incidence of TIMI blood flow <3 grade in the side branch (1.6%(9/560) vs. 7.5% (43/576), P<0.01), acute occlusion of the side branch (1.3%(7/560) vs. 7.1%(41/576), P<0.01) and implanted stents of side branch (1.8%(10/560) vs. 7.8% (45/576), P<0.01) were significantly lower in the ATP group than those in the PS group. During the one year follow up, the rate of target lesion revascularization was similar between ATP group and PS group (4.6%(26/560) vs. 4.0%(23/576), P=0.66). Conclusions: The effectiveness and safetyof ATP techniquein the patients with coronary bifurcation lesions is comparable to the PS technique. However, ATP technique is superior to PS technique on effectively reducing the incidence of implanted stents in the side branch.


Assuntos
Angioplastia Coronária com Balão , Doença da Artéria Coronariana , Stents Farmacológicos , Angiografia Coronária , Humanos , Estudos Prospectivos , Stents , Fatores de Tempo , Resultado do Tratamento
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