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1.
Panminerva Med ; 65(3): 327-334, 2023 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34761888

RESUMO

BACKGROUND: Few studies compared paclitaxel-coated balloon (PCB) versus sirolimus-coated balloon (SCB) in the treatment of drug-eluting stent (DES) instent restenosis (ISR). METHODS: Between November 5, 2009, and October 14, 2020, in our center 212 patients with first DES-ISR were treated with PCB (Restore®; Cardionovum GmbH, Bonn, Germany), whereas 230 patients were treated with SCB (Devoir®; MINVASYS SAS, Gennevilliers, France). Following a propensity matching, 186 patients were included into PCB group (PCB group), and in the SCB group (SCB group). The primary purpose of the study was the 1-year target lesion failure (TLF) rate, including cardiac death, target vessel-related myocardial infarction, and repeated target lesion or target vessel revascularization. RESULTS: Procedural success occurred in all cases. Fully optimal predilation (that is, balloon-to-stent ratio >0.91, time of DCB inflation >60 sec, and residual percent diameter stenosis after lesion preparation <20%) was observed more often in the SCB group (126 [68%] patients versus 106 [57%] patients; P=0.042). One-year TLF occurred in 29 (15.5%) patients in the SCB group and in 32 (17%) patients in the PCB group (OR=1.12 [0.65-1.95]; P=0.78). By logistic Cox regression analysis fully optimal predilation (OR=0.06; 95% CI: 0.01-0.21; P<0.001) but not DCB type (OR=0.74; 95% CI: 0.41-1.31; P=0.29) was independent predictor of 1-year TLF. CONCLUSIONS: The current study suggests that 1-year TLF is not statistically and clinically different in patients with DES ISR treated with a PCB and a SCB.


Assuntos
Angioplastia Coronária com Balão , Reestenose Coronária , Stents Farmacológicos , Intervenção Coronária Percutânea , Humanos , Angioplastia Coronária com Balão/efeitos adversos , Sirolimo/uso terapêutico , Intervenção Coronária Percutânea/efeitos adversos , Resultado do Tratamento , Fatores de Tempo , Reestenose Coronária/terapia , Reestenose Coronária/induzido quimicamente , Paclitaxel/uso terapêutico , Angiografia Coronária , Materiais Revestidos Biocompatíveis
2.
JACC Cardiovasc Interv ; 13(17): 2065-2074, 2020 09 14.
Artigo em Inglês | MEDLINE | ID: mdl-32912462

RESUMO

OBJECTIVES: This study compared left ventricular end-diastolic pressure (LVEDP)-guided and urine flow rate (UFR)-guided hydration. BACKGROUND: Tailored hydration regimens improve the prevention of contrast-associated acute kidney injury (CA-AKI). METHODS: Between July 15, 2015, and June 6, 2019, patients at high risk for CA-AKI scheduled for coronary and peripheral procedures were randomized to 2 groups: 1) normal saline infusion rate adjusted according to the LVEDP (LVEDP-guided group); and 2) hydration controlled by the RenalGuard System in order to reach UFR ≥300 ml/h (UFR-guided group). The primary endpoint was the composite of CA-AKI (i.e., serum creatinine increase ≥25% or ≥0.5 mg/dl at 48 h) and acute pulmonary edema (PE). Major adverse events (all-cause death, renal failure requiring dialysis, PE, and sustained kidney injury) at 1 month were assessed. RESULTS: The primary endpoint occurred in 20 of 351 (5.7%) patients in the UFR-guided group and in 36 of 351 (10.3%) patients in the LVEDP-guided group (relative risk [RR]: 0.560; 95% confidence interval [CI]: 0.390 to 0.790; p = 0.036). CA-AKI and PE rates in the UFR-guided group and LVEDP-guided group were 5.7% and 10.0% (RR: 0.570; 95% CI: 0.300 to 0.960; p = 0.048), and, respectively, 0.3% and 2.0% (RR: 0.070; 95% CI: 0.020 to 1.160; p = 0.069). Three patients in the UFR-guided group experienced complications related to the Foley catheter. Hypokalemia rate was 6.2% in the UFR-guided group and 2.3% in the LVEDP-guided group (p = 0.013). The 1-month major adverse events rate was 7.1% in the UFR-guided group and 12.0% in the LVEDP-guided group (p = 0.030). CONCLUSIONS: The study demonstrates that UFR-guided hydration is superior to LVEDP-guided hydration to prevent the composite of CA-AKI and PE.


Assuntos
Injúria Renal Aguda/prevenção & controle , Meios de Contraste/efeitos adversos , Hidratação , Edema Pulmonar/prevenção & controle , Urodinâmica , Função Ventricular Esquerda , Pressão Ventricular , Injúria Renal Aguda/diagnóstico , Injúria Renal Aguda/etiologia , Injúria Renal Aguda/mortalidade , Idoso , Idoso de 80 Anos ou mais , Angiografia/efeitos adversos , Angioplastia/efeitos adversos , Feminino , Hidratação/efeitos adversos , Hidratação/mortalidade , Humanos , Itália , Masculino , Edema Pulmonar/diagnóstico , Edema Pulmonar/etiologia , Edema Pulmonar/mortalidade , Radiografia Intervencionista/efeitos adversos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
3.
Catheter Cardiovasc Interv ; 94(3): 323-331, 2019 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-30773807

RESUMO

BACKGROUND: Proximal optimization technique (POT) has been proposed to adapt the conventional drug-eluting stent (DES) with the fractal anatomy of the bifurcation. However, only few DES are labeled for post-expansion beyond 5.0 mm. Furthermore, recrossing in the side branch (SB) through the main vessel (MV) stent cells may be challenging. OBJECTIVES: To compare the sirolimus-eluting, balloon-expandable dedicated bifurcation stent BiOSS LIM DES versus the second generation DES in the treatment of distal unprotected left main coronary arteries (ULMCAs) lesions. METHODS: Forty-two consecutive patients with distal ULMCA lesions were treated with the BiOSS LIM (BiOSS LIM group) in our center. A matched-group of patients treated with second-generation DES was selected from our database (Control group). The primary endpoint was the procedural complication rate, including (a) SB occlusion, defined as intraprocedural TIMI flow grade <3 immediately after MV stenting; and/or (b) trouble in SB access, defined as the need of ≥2 guidewires or a failure to recross in the SB trough the MV stent cells. The need of POT in the two groups was also analyzed. RESULTS: The primary endpoint occurred in four (9.5%) patients in the BiOSS LIM group and in 13 (31%) in the Control group (p = 0.028; OR = 4.25; 95% confidence interval: 1.25-14.43). POT was performed more often in the Control group (71% vs. 35%; p = 0.004). CONCLUSIONS: Compared to conventional DES, the BiOSS LIM stent (1) facilitates SB recrossing and (2) fits well with the fractal anatomy of the left main bifurcation.


Assuntos
Angioplastia Coronária com Balão/instrumentação , Fármacos Cardiovasculares/administração & dosagem , Estenose Coronária/terapia , Stents Farmacológicos , Sirolimo/administração & dosagem , Idoso , Idoso de 80 Anos ou mais , Angioplastia Coronária com Balão/efeitos adversos , Fármacos Cardiovasculares/efeitos adversos , Estudos de Casos e Controles , Estenose Coronária/diagnóstico por imagem , Estenose Coronária/fisiopatologia , Bases de Dados Factuais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Desenho de Prótese , Sirolimo/efeitos adversos , Resultado do Tratamento
4.
Catheter Cardiovasc Interv ; 91(7): 1185-1191, 2018 06.
Artigo em Inglês | MEDLINE | ID: mdl-28799717

RESUMO

BACKGROUND: Contrast-induced acute kidney injury (CI-AKI) may led to both a transient and a persistent serum creatinine (sCr) increase. OBJECTIVES: To assess whether serum cystatin C (sCyC) and urine and serum neutrophil gelatinase-associated lipocalin (uNGAL, sNGAL) are useful in the early identification of persistent sCr increase following CI-AKI. METHODS: One hundred and eighteen patients who developed CI-AKI were included into the study. Persistent sCr elevation was defined as a persistent increase ≥0.3 mg dL-1 at 1 month after contrast media (CM) administration. RESULTS: sCr levels recovered in 87 patients (74%; Transient group), whereas a persistent elevation of sCr was observed in the remaining 31 patients (26%; Persistent group). By multivariable logistic regression analysis, independent predictors of persistent sCr increase were insulin therapy, uNGAL at 48 hr and absolute sCr difference between 48 and 72 hr. On the contrary, sCyC assessment did not help in the early identification of this subset of patients. By receiver operating curve analysis, the best cutoff values for predicting persistent sCr increase were uNGAL ≥0.50 ng dL-1 at 48 hr, and the absolute sCr increase ≥0.20 mg dL-1 between 48 and 72 hr. CONCLUSIONS: uNGAL ≥0.50 ng dL-1 at 48 hr and absolute sCr increase ≥0.20 mg dL-1 between 48 and 72 hr but not sCyC are useful in the early identification of patients developing persistent sCr increase after CM administration.


Assuntos
Injúria Renal Aguda/sangue , Meios de Contraste/efeitos adversos , Creatinina/sangue , Rim/efeitos dos fármacos , Injúria Renal Aguda/induzido quimicamente , Injúria Renal Aguda/diagnóstico , Injúria Renal Aguda/urina , Idoso , Idoso de 80 Anos ou mais , Biomarcadores/sangue , Meios de Contraste/administração & dosagem , Diagnóstico Precoce , Feminino , Taxa de Filtração Glomerular/efeitos dos fármacos , Humanos , Rim/fisiopatologia , Lipocalina-2/sangue , Lipocalina-2/urina , Masculino , Valor Preditivo dos Testes , Recuperação de Função Fisiológica , Insuficiência Renal Crônica/complicações , Insuficiência Renal Crônica/fisiopatologia , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Regulação para Cima
5.
Int J Cardiol ; 244: 112-118, 2017 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-28668399

RESUMO

BACKGROUND: A low number (that is, ≤0.0038 per 100 peripheral mononuclear cells) of circulating endothelial progenitor cells (EPC) is common in diabetic patients. Statins increase EPC levels. It is unclear whether intensity of statin therapy has a different impact on EPC levels. METHODS: Diabetic patients undergoing drug-eluting stent (DES) implantation were randomized to 1) High intensity statin therapy (atorvastatin 80mg/day; n=66) or 2) Moderate intensity statin therapy (atorvastatin 20mg/day; n=64). EPC levels were assessed at baseline, 24h and 3months. Endpoints assessed at 3months were 1) changes in the proportion of patients with low EPC levels, and 2) uncovered struts rate and neointima growth evaluated by optical coherence tomography. RESULTS: Low EPC levels rate significantly decreased in the High intensity statin therapy group (from 31.7% to 12.7%; p=0.017) but not in the Moderate intensity statin therapy group (from 25.5% to 21.8%; p=0.81). Uncovered struts rate was similar in the 2 groups (2.4±2.6% vs 2.3±2.2%; p=0.82), whereas mean neointima area and volume were lower in the High intensity statin therapy group (0.68±0.69 vs 1.22±1.29mm2; p=0.001; and, respectively, 13.10±5.77 vs 20.19±24.08mm3; p=0.042). CONCLUSIONS: In diabetic patients, a high intensity statin therapy 1) significantly increases EPC levels and decreases in-stent neointima area and volume, and 2) does not have an impact on the degree of stent re-endothelialization at 3months after DES implantation.


Assuntos
Diabetes Mellitus/sangue , Stents Farmacológicos/tendências , Células Progenitoras Endoteliais/efeitos dos fármacos , Células Progenitoras Endoteliais/metabolismo , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Intervenção Coronária Percutânea/tendências , Idoso , Diabetes Mellitus/diagnóstico , Diabetes Mellitus/terapia , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade
6.
Catheter Cardiovasc Interv ; 89(4): E112-E123, 2017 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-27469063

RESUMO

OBJECTIVES: To compare the safety and efficacy of the Axxess™ biolimus-eluting stent with the second-generation drug-eluting stent (DES) in the treatment of bifurcation lesions. BACKGROUND: The Axxess™ is a dedicated bifurcation stent, designed to cover the lesion at the carina level. METHODS: Between April 2012 and August 2014, 165 patients with de novo bifurcation lesions were treated with the Axxess™ stent (Axxess group). A propensity-score matched group of 165 patients treated with DES in the same period was selected (Control group). The primary objectives were (1) the procedural complication rate, including side branch (SB) occlusion and trouble in SB access after main vessel stenting; and (2) the device, the angiographic, and the procedural success rate. RESULTS: Procedural complications occurred in 1 patient (0.6%) in the Axxess group and in 20 patients (12%) in the Control group (OR = 0.03; 95% confidence interval 0.005-0.27; P < 0.001). Device success was obtained in 164 (99.5%) patients in the Axxess group and in all in the Control group (P = 1.00). Angiographic success was obtained in all patients. Inaccurate Axxess™ stent position occurred in 21 (13%) patients, and was more often associated with moderate-to-severe calcifications and distal lesion site. Procedural success was obtained in 91.5% patients in the Axxess group and in 90% patients in the Control group (P = 0.72). CONCLUSIONS: The present registry suggests that the Axxess™ stent (1) may represent a valid alternative approach for the treatment of bifurcation lesions and (2) should be avoided in moderate-to-severe calcifications and/or in distal lesions. © 2016 Wiley Periodicals, Inc.


Assuntos
Estenose Coronária/cirurgia , Vasos Coronários/cirurgia , Stents Farmacológicos , Intervenção Coronária Percutânea/métodos , Sistema de Registros , Sirolimo/análogos & derivados , Idoso , Angiografia Coronária , Estenose Coronária/diagnóstico , Vasos Coronários/diagnóstico por imagem , Feminino , Seguimentos , Humanos , Imunossupressores/farmacologia , Masculino , Pontuação de Propensão , Estudos Prospectivos , Desenho de Prótese , Sirolimo/farmacologia , Ultrassonografia de Intervenção
7.
J Interv Cardiol ; 29(6): 559-568, 2016 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-27625144

RESUMO

INTRODUCTION: Stent delivery failure may occur especially when treating complex coronary artery stenosis. XLIMUS (CARDIONOVUM GmbH, Bonn, Germany) is a new sirolimus-eluting stent (SES) with the following features: 1) cobalt chromium stent platform, with low (73 µm) strut thickness, (2) biodegradable polymer, and 3) potent antiproliferative drug (Sirolimus). Preliminary data suggest that XLIMUS SES may be ideal for the treatment of complex lesions. METHODS: In this registry, we assessed the deliverability, safety, and efficacy of percutaneous coronary interventions (PCI) using the XLIMUS SES in patients undergoing elective PCI in native coronary vessels for complex de novo lesions, including severe calcification, severe tortuosity, and chronic total occlusion. The primary objective of the study is the delivery success of the XLIMUS SES. The secondary objective is the 1-year rate of major adverse cardiac events (MACE; including all-cause death, nonfatal myocardial infarction, and repeat revascularization). RESULTS: A total of 200 consecutive patients with 255 lesions were included. Delivery success was obtained in 196 (98%) patients and in 251 (98.4%) lesions. The XLIMUS SES was successfully implanted on the first attempt with a single guidewire in 176 (88%) patients and in 208 (81.6%) lesions. Additional techniques to facilitate stent delivery (i.e., buddy wire, anchoring-balloon, or GuideLiner catheter) were necessary in 47 (18.4%) lesions. Failure in XLIMUS SES implantation occurred in 4 (1.6%) lesions. MACE rate at 1 year was 9%. CONCLUSIONS: This registry supports the positive performance of the XLIMUS SES in the treatment of complex coronary artery lesions.


Assuntos
Stents Farmacológicos/efeitos adversos , Intervenção Coronária Percutânea , Sirolimo/uso terapêutico , Idoso , Angiografia Coronária/métodos , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/mortalidade , Doença da Artéria Coronariana/cirurgia , Doença da Artéria Coronariana/terapia , Reestenose Coronária/diagnóstico , Reestenose Coronária/etiologia , Feminino , Humanos , Itália/epidemiologia , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Intervenção Coronária Percutânea/métodos , Estudos Prospectivos , Sistema de Registros , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do Tratamento
8.
EuroIntervention ; 11(14): e1658-61, 2016 Apr 08.
Artigo em Inglês | MEDLINE | ID: mdl-27056126

RESUMO

AIMS: We aimed to assess whether the RenalGuard™ System is effective in preventing acute kidney injury (AKI) following transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: Forty-eight consecutive patients with chronic kidney disease (CKD) scheduled for TAVI were assigned to: 1) hydration with sodium bicarbonate solution (Control group), or 2) hydration with RenalGuard Therapy (RenalGuard group). Hypotension was defined as periprocedural mean blood pressure <55 mmHg. The primary endpoint was the occurrence of AKI (i.e., an increase of ≥0.3 mg/dL in the serum creatinine concentration at seven days). AKI occurred in 10/26 (38.5%) patients in the Control group and in 1/22 (4.5%) patients in the RenalGuard group (p=0.005, odds ratio [OR] 0.076, 95% confidence interval [CI]: 0.009-0.66). RenalGuard Therapy protected against AKI (OR 0.71, 95% CI: 0.07-0.775, p=0.026), whereas post-procedural hypotension (OR 3.88, 95% CI: 1.06-14.24, p=0.040), and contrast media volume (OR 3.65, 95% CI: 1.15-5.75, p=0.043) increased the risk of AKI. CONCLUSIONS: This non-randomised pilot study suggests that RenalGuard Therapy may be effective in preventing AKI in CKD patients undergoing TAVI.


Assuntos
Injúria Renal Aguda/prevenção & controle , Injúria Renal Aguda/cirurgia , Estenose da Valva Aórtica/terapia , Implante de Prótese de Valva Cardíaca , Substituição da Valva Aórtica Transcateter , Injúria Renal Aguda/fisiopatologia , Cateterismo Cardíaco/métodos , Creatinina/sangue , Feminino , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/métodos , Humanos , Masculino , Fatores de Risco , Substituição da Valva Aórtica Transcateter/métodos , Resultado do Tratamento
9.
Am Heart J ; 173: 67-76, 2016 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-26920598

RESUMO

BACKGROUND: High urine flow rate (UFR) has been suggested as a target for effective prevention of contrast-induced acute kidney injury (CI-AKI). The RenalGuard therapy (saline infusion plus furosemide controlled by the RenalGuard system) facilitates the achievement of this target. METHODS: Four hundred consecutive patients with an estimated glomerular filtration rate ≤30 mL/min per 1.73 m(2) and/or a high predicted risk (according to the Mehran score ≥11 and/or the Gurm score >7%) treated by the RenalGuard therapy were analyzed. The primary end points were (1) the relationship between CI-AKI and UFR during preprocedural, intraprocedural, and postprocedural phases of the RenalGuard therapy and (2) the rate of acute pulmonary edema and impairment in electrolytes balance. RESULTS: Urine flow rate was significantly lower in the patients with CI-AKI in the preprocedural phase (208 ± 117 vs 283 ± 160 mL/h, P < .001) and in the intraprocedural phase (389 ± 198 vs 483 ± 225 mL/h, P = .009). The best threshold for CI-AKI prevention was a mean intraprocedural phase UFR ≥450 mL/h (area under curve 0.62, P = .009, sensitivity 80%, specificity 46%). Performance of percutaneous coronary intervention (hazard ratio [HR] 4.13, 95% CI 1.81-9.10, P < .001), the intraprocedural phase UFR <450 mL/h (HR 2.27, 95% CI 1.05-2.01, P = .012), and total furosemide dose >0.32 mg/kg (HR 5.03, 95% CI 2.33-10.87, P < .001) were independent predictors of CI-AKI. Pulmonary edema occurred in 4 patients (1%). Potassium replacement was required in 16 patients (4%). No patients developed severe hypomagnesemia, hyponatremia, or hypernatremia. CONCLUSIONS: RenalGuard therapy is safe and effective in reaching high UFR. Mean intraprocedural UFR ≥450 mL/h should be the target for optimal CI-AKI prevention.


Assuntos
Injúria Renal Aguda/prevenção & controle , Angiografia/efeitos adversos , Meios de Contraste/efeitos adversos , Sistemas de Liberação de Medicamentos/instrumentação , Furosemida/administração & dosagem , Cloreto de Sódio/administração & dosagem , Injúria Renal Aguda/induzido quimicamente , Injúria Renal Aguda/diagnóstico , Idoso , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Creatinina/sangue , Diuréticos/administração & dosagem , Combinação de Medicamentos , Desenho de Equipamento , Feminino , Seguimentos , Taxa de Filtração Glomerular/fisiologia , Humanos , Soluções Isotônicas , Masculino , Estudos Prospectivos , Fatores de Risco , Urodinâmica
10.
Circ Cardiovasc Interv ; 8(9): e002673, 2015 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-26333343

RESUMO

BACKGROUND: Neutrophil gelatinase-associated lipocalin (NGAL) is an early marker of acute kidney injury (AKI). METHODS AND RESULTS: Urine NGAL and serum NGAL (sNGAL) were assessed at 2, 6, 24, and 48 hours after contrast media (CM) exposure in 458 high-risk patients (development set). Optimal thresholds in predicting contrast-induced AKI (serum creatinine [sCr] increase ≥0.3 mg/dL at 48 hours after CM administration) were identified. Major adverse events (MAE; death, dialysis, nonfatal myocardial infarction, sustained kidney injury, and myocardial revascularization) at 1 year were assessed. In the development set, optimal thresholds for contrast-induced AKI occurred at 6 hours for both urine NGAL (≥20 ng/mL; 97% negative predictive value and 27% positive predictive value) and sNGAL (≥179 ng/mL; 93% negative predictive value and 20% positive predictive value). Furthermore, sNGAL ≥179 ng/mL at 6 hours was an independent predictor of 1-year MAE. 1-year MAE occurred in 27/198 patients (13.5%) with sNGAL <179 ng/mL and sCr <0.3 mg/dL, in 57/193 (29.5%) patients with only sNGAL ≥179 ng/mL, and in 37/67 (55%) patients with sCr ≥0.3 mg/dL. In additional 253 patients (validation set), no patient with urine NGAL <20 ng/mL or sNGAL <179 ng/mL at 6 hours developed contrast-induced AKI. Furthermore, 6/68 (9%) patients with sNGAL <179 ng/mL and sCr increase <0.3 mg/dL had 1-year MAE versus 17/57 (30%) patients with sNGAL ≥179 ng/mL and sCr increase <0.3 mg/dL and 8/16 (50%) patients with sCr increase ≥0.3 mg/dL. CONCLUSIONS: Urine NGAL <20 ng/mL and sNGAL <179 ng/mL at 6 hours are reliable markers for ruling out contrast-induced AKI. sNGAL ≥179 ng/mL at 6 hours predicts 1-year MAE. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01098032.


Assuntos
Injúria Renal Aguda/diagnóstico , Meios de Contraste/efeitos adversos , Lipocalinas/sangue , Proteínas Proto-Oncogênicas/sangue , Insuficiência Renal Crônica/complicações , Ácidos Tri-Iodobenzoicos/efeitos adversos , Injúria Renal Aguda/induzido quimicamente , Injúria Renal Aguda/metabolismo , Proteínas de Fase Aguda/urina , Idoso , Idoso de 80 Anos ou mais , Angiografia , Angioplastia , Biomarcadores/sangue , Biomarcadores/urina , Creatinina/sangue , Feminino , Humanos , Lipocalina-2 , Lipocalinas/urina , Masculino , Proteínas Proto-Oncogênicas/urina
11.
JACC Cardiovasc Interv ; 8(11): 1506-1514, 2015 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-26298226

RESUMO

OBJECTIVES: This study sought to investigate acute kidney injury (AKI) following carotid artery stenting (CAS). BACKGROUND: Few data exist on AKI following CAS. METHODS: This study evaluated 126 chronic kidney disease (CKD) patients who underwent CAS. The risk for contrast-induced AKI was defined by the Mehran score. Hemodynamic depression (i.e., periprocedural systolic blood pressure <90 mm Hg or heart rate <60 beats/min), AKI (i.e., an increase of ≥0.3 mg/dl in the serum creatinine concentration at 48 h), and 30-day major adverse events (including death, stroke, and acute myocardial infarction) were assessed. RESULTS: AKI occurred in 26 patients (21%). Although baseline kidney function and contrast volume were similar in the AKI group and the non-AKI group, the risk score was higher (10 ± 3 vs. 8 ± 3; p = 0.032), and hemodynamic depression (mostly due to hypotension) (65.5% vs. 35%; p = 0.005) was more common in the AKI group. The threshold of hemodynamic depression duration for AKI development was 2.5 min (sensitivity 54%, specificity 82%). Independent predictors of AKI were hemodynamic depression (odds ratio [OR]: 4.01; 95% confidence interval [CI]: 1.07 to 15.03; p = 0.009), risk score (OR: 1.29; 95% CI: 1.03 to 1.60; p = 0.024), and male sex (OR: 6.07; 95% CI: 1.18 to 31.08; p = 0.021). Independent predictors of 30-day major adverse events that occurred more often in the AKI group (19.5% vs. 7%; p = 0.058) were AKI (HR: 4.83; 95% CI: 1.10 to 21.24; p = 0.037) and hemodynamic depression (HR: 5.58; 95% CI: 1.10 to 28.31; p = 0.038). CONCLUSIONS: AKI in CKD patients undergoing CAS is mostly due to hemodynamic depression and is associated with a higher 30-day major adverse events rate.


Assuntos
Injúria Renal Aguda/induzido quimicamente , Angioplastia com Balão/efeitos adversos , Angioplastia com Balão/instrumentação , Doenças das Artérias Carótidas/terapia , Meios de Contraste/efeitos adversos , Hemodinâmica , Insuficiência Renal Crônica/complicações , Stents , Injúria Renal Aguda/diagnóstico , Injúria Renal Aguda/mortalidade , Injúria Renal Aguda/fisiopatologia , Idoso , Idoso de 80 Anos ou mais , Angioplastia com Balão/mortalidade , Biomarcadores/sangue , Doenças das Artérias Carótidas/complicações , Doenças das Artérias Carótidas/diagnóstico , Doenças das Artérias Carótidas/mortalidade , Distribuição de Qui-Quadrado , Creatinina/sangue , Feminino , Humanos , Itália , Estimativa de Kaplan-Meier , Modelos Lineares , Masculino , Razão de Chances , Modelos de Riscos Proporcionais , Insuficiência Renal Crônica/diagnóstico , Insuficiência Renal Crônica/mortalidade , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
12.
Catheter Cardiovasc Interv ; 86(3): E131-9, 2015 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-25639945

RESUMO

BACKGROUND: Vessel tapering represents an important limitation of the balloon-expandable drug-eluting stent (DES) in the treatment of distal unprotected left main coronary artery (ULMCA) lesions. In this study, we assessed the suitability of the STENTYS DES((P)) , a self-apposing nitinol paclitaxel-eluting stent, for use in the treatment of distal ULMCA lesions. METHODS AND RESULTS: From February 2012 to September 2013, 75 consecutive patients with tapered (that is a >1 mm difference in the diameter from the proximal to the distal main vessel) distal ULMCA lesions were treated with the STENTYS DES((P)) (STENTYS-DES group) at the Clinica Mediterranea (Naples, Italy). A matched-group of 75 patients treated with second-generation DES in the same period (Control group) was selected from the database of New Tokyo Hospital (Chiba, Japan). The result was assessed by both quantitative coronary angiography and intravascular ultrasound (IVUS). Although the final balloon diameter was larger in the Control group (4.51 ± 0.51 vs. 3.62 ± 0.49 mm; P < 0.001), the IVUS analysis showed a larger final minimal lumen area in the STENTYS-DES group than in the Control group (left main: 17.45 ± 3.45 vs. 14.84 ± 3.45 mm(2) ; P < 0.001; polygon of confluence: 15.74 ± 3.28 vs. 12.55 ± 5.45 mm(2) ; P < 0.002; ostial left anterior descending artery: 11.73 ± 1.97 vs. 8.56 ± 1.80 mm(2) ; P < 0.001). At 12 ± 5 months, major adverse cardiac events (including death, myocardial infarction, and repeat revascularization) occurred in seven patients in both groups. CONCLUSIONS: This pilot study suggests that the self-apposing properties of the STENTYS DES((P)) offer a valid alternative for the treatment of the distal ULMCA lesions.


Assuntos
Antineoplásicos Fitogênicos/administração & dosagem , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Paclitaxel/administração & dosagem , Idoso , Ligas , Angiografia Coronária , Feminino , Humanos , Itália , Japão , Masculino , Intervenção Coronária Percutânea , Projetos Piloto , Resultado do Tratamento
13.
JACC Cardiovasc Interv ; 8(3): 414-423, 2015 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-25703878

RESUMO

OBJECTIVES: This study sought to assess the safety and the efficacy of bivalirudin compared with unfractionated heparin (UFH) alone in the subset of patients at increased risk of bleeding undergoing transfemoral elective percutaneous coronary intervention (PCI). BACKGROUND: Bivalirudin, a synthetic direct thrombin inhibitor, determines a significant decrease of in-hospital bleeding following PCI. METHODS: This is a single-center, investigator-initiated, randomized, double-blind, controlled trial. Consecutive biomarker-negative patients at increased bleeding risk undergoing PCI through the femoral approach were randomized to UFH (UFH group; n = 419) or bivalirudin (bivalirudin group; n = 418). The primary endpoint was the rate of in-hospital major bleeding. RESULTS: The primary endpoint occurred in 11 patients (2.6%) in the UFH group versus 14 patients (3.3%) in the bivalirudin group (odds ratio: 0.78; 95% confidence interval: 0.35 to 1.72; p = 0.54). Distribution of access-site and non-access-site bleeding was 18% and 82% in the UFH group versus 50% and 50% in the bivalirudin group (p = 0.10). CONCLUSIONS: The results of this randomized study, carried out at a single institution, suggest that there is no difference in major bleeding rate between bivalirudin and UFH in increased-risk patients undergoing transfemoral PCI. (Novel Approaches in Preventing and Limiting Events III Trial: Bivalirudin in High-Risk Bleeding Patients [NAPLES III]; NCT01465503).


Assuntos
Doença da Artéria Coronariana/terapia , Artéria Femoral , Hemorragia/induzido quimicamente , Heparina/efeitos adversos , Hirudinas/efeitos adversos , Fragmentos de Peptídeos/efeitos adversos , Intervenção Coronária Percutânea/métodos , Idoso , Idoso de 80 Anos ou mais , Doença da Artéria Coronariana/diagnóstico , Método Duplo-Cego , Feminino , Humanos , Itália , Masculino , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Estudos Prospectivos , Punções , Proteínas Recombinantes/efeitos adversos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
15.
Catheter Cardiovasc Interv ; 85(3): 382-90, 2015 Feb 15.
Artigo em Inglês | MEDLINE | ID: mdl-24740711

RESUMO

Subintimal tracking and re-entry (STAR) technique has been described as a bailout strategy for coronary total occlusion (CTO) recanalization. However, the length of the dissected segment represents a major concern. The aim of this study is, to evaluate whether "deferred" stent implantation may limit the total stent length following STAR recanalization of CTO. All consecutive patients with CTO in a native coronary artery treated by successful STAR technique in our institution were included. In the first period (March 2004-December 2009) all procedures were completed with stent implantation (Elective Stent Group; n = 60). Thereafter (January 2010-June 2012) stent implantation was postponed until a scheduled (within 3 months) angiographic follow-up (Deferred Stent Group; n = 69). The dissection length was 75 ± 37 mm in the Elective Stent Group and 83 ± 31 mm in the Deferred Stent Group (P = 0.22). In the Deferred Stent Group, at the angiographic follow-up, the dissection length was significantly shorter than at the index procedure (40 ± 35 mm versus 83 ± 31 mm, P <0.001). The total stent length was significantly shorter in the Deferred Stent Group versus the Elective Stent Group (22 ± 33 mm versus 56 ± 28 mm; P < 0.001). At six-month follow-up, rate of cardiac death and myocardial infarction (6.7% vs 0; P = 0.049) and of stent thrombosis (5% vs 0%; P = 0.10) were higher in the Elective Stent Group. The present study suggests that deferring stenting implantation following STAR recanalization (1) limits the stent length and (2) is associated with a lower rate of objective endpoints.


Assuntos
Oclusão Coronária/terapia , Intervenção Coronária Percutânea/instrumentação , Stents , Idoso , Angiografia Coronária , Oclusão Coronária/diagnóstico , Oclusão Coronária/mortalidade , Trombose Coronária/etiologia , Feminino , Humanos , Itália , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Desenho de Prótese , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Ultrassonografia de Intervenção
16.
Cardiovasc Drugs Ther ; 28(3): 273-9, 2014 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-24781074

RESUMO

PURPOSE: Bivalirudin (Angiox, The Medicine's Company, Parsippany, NJ), a synthetic direct thrombin inhibitor, when compared with standard antithrombotic therapy (including unfractionated heparin [UFH] alone or plus a glycoprotein IIb/IIIa inhibitor) determines a significant decrease of major and minor bleeding and similar protection against ischemic events both in elective and in urgent percutaneous coronary intervention (PCI). There is a lack of prospective clinical trial assessing the safety and the efficacy of bivalirudin compared with UFH alone in the subset of biomarker negative patients at high risk of bleeding undergoing to elective PCI through the femoral approach. METHODS: This is a single-center, investigator-driven, randomized, double-blind, controlled trial ( www.clinicaltrial.gov registration: NCT01465503). Consecutive patients at high bleeding risk (score ≥10 according to Nikolsky et al.) undergoing elective PCI through the femoral approach will be screened for eligibility. Included patients will be randomized (ratio 1.1) to bivalirudin (Bivalirudin group) and UFH (UFH group). The primary endpoint will be the rate of major bleeding (REPLACE 2 criteria). We expect a major bleeding rate ≥5 % in the UFH group versus a ≤3 % event rate in the Bivalirudin group. Aiming for a 0.05 alpha and 0.80 power, a total of 662 patients will be needed. This number will be increased by about 25 % (leading to a total of ≈830 patients) because of uncertainty about expected endpoint rates. CONCLUSIONS: The present trial will give important information on what is the best anticoagulation regimen when performing PCI through the femoral approach in patients at high risk for bleeding.


Assuntos
Hemorragia/induzido quimicamente , Fragmentos de Peptídeos/uso terapêutico , Intervenção Coronária Percutânea/métodos , Stents , Anticoagulantes/uso terapêutico , Antitrombinas/uso terapêutico , Método Duplo-Cego , Procedimentos Cirúrgicos Eletivos/métodos , Heparina/efeitos adversos , Hirudinas/efeitos adversos , Humanos , Fragmentos de Peptídeos/efeitos adversos , Estudos Prospectivos , Proteínas Recombinantes/efeitos adversos , Proteínas Recombinantes/uso terapêutico , Projetos de Pesquisa
18.
Catheter Cardiovasc Interv ; 83(2): E155-8, 2014 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-21207421

RESUMO

Management of patient with concomitant severe coronary and carotid artery disease is challenging. The combined or staged surgical revascularization is burdened by a high risk of morbidity and mortality. Carotid artery stenting (CAS) has been recently introduced as an alternative revascularization approach. We describe a case of simultaneous hybrid revascularization by CAS followed by immediate coronary artery bypass graft in a patient with a severe coronary artery disease and bilateral carotid artery stenosis.


Assuntos
Angioplastia com Balão/instrumentação , Estenose das Carótidas/terapia , Ponte de Artéria Coronária , Doença da Artéria Coronariana/cirurgia , Stents , Estenose das Carótidas/complicações , Estenose das Carótidas/diagnóstico , Angiografia Coronária , Doença da Artéria Coronariana/complicações , Doença da Artéria Coronariana/diagnóstico , Feminino , Humanos , Pessoa de Meia-Idade , Índice de Gravidade de Doença , Resultado do Tratamento
19.
JACC Cardiovasc Interv ; 6(11): 1166-75, 2013 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-24262617

RESUMO

OBJECTIVES: This study sought to assess the usefulness of clopidogrel-pathway genotyping and on-treatment platelet reactivity (OTR) testing in predicting major adverse cardiac events (MACE) in stable coronary artery disease (CAD) patients receiving drug-eluting stents (DES) under dual antiplatelet (clopidogrel plus aspirin) therapy. BACKGROUND: The role of pharmacogenetics and OTR in predicting MACE-death, myocardial infarction, or stent thrombosis-in stable CAD patients scheduled for DES implantation is still debated. METHODS: Patients with stable CAD treated by DES implantation (n = 1,432) were genotyped with a TaqMan OpenArray (Applied Biosystems, Carlsbad, California) and assessed for OTR with the VerifyNow P2Y12 test (Accumetrics Inc., San Diego, California). Genes tested were ABCB1, CYP1A2, CYP2B6*9, CYP2C8*3, CYP2C9*2, CYP2C19, CYP3A4, CYP3A5*3, P2RY12, and PON1CYP2C19. High OTR was defined as P2Y12 reaction units ≥230. The endpoint at 12-month follow-up was MACE occurring during antiplatelet therapy. RESULTS: All groups that were stratified for loss-of-function variants of the cytochrome P450 gene CYP2C19 had significant hazard ratios (HR) for MACE (genotypic HR: 1.41, 95% confidence interval [CI]: 1.06 to 1.89, p = 0.01; allelic HR: 1.56, 95% CI: 2.26 to 1.2, p = 0.01). Variants of other clopidogrel-pathway genes were not significantly associated with MACE. When OTR was assessed, clinical significance was found only in high-risk diabetic (HR: 2.11, 95% CI: 1.29 to 3.45, p < 0.001) and chronic kidney disease (HR: 2.03, 95% CI: 1.03 to 4.02, p = 0.04) patients. CONCLUSIONS: CYP2C19 metabolizer status is an independent predictor of MACE after DES implantation and can be used for prognostication in all stable CAD patients. High OTR, as assessed by the VerifyNow P2Y12 test, is an independent predictor of MACE only for high-risk subsets, that is, patients with diabetes or chronic kidney disease.


Assuntos
Hidrocarboneto de Aril Hidroxilases/genética , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Intervenção Coronária Percutânea/instrumentação , Inibidores da Agregação Plaquetária/uso terapêutico , Agregação Plaquetária/efeitos dos fármacos , Polimorfismo Genético , Ticlopidina/análogos & derivados , Idoso , Hidrocarboneto de Aril Hidroxilases/metabolismo , Aspirina/uso terapêutico , Biotransformação/genética , Clopidogrel , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/mortalidade , Trombose Coronária/etiologia , Citocromo P-450 CYP2C19 , Técnicas de Apoio para a Decisão , Quimioterapia Combinada , Feminino , Genótipo , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Seleção de Pacientes , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Farmacogenética , Fenótipo , Inibidores da Agregação Plaquetária/efeitos adversos , Inibidores da Agregação Plaquetária/farmacocinética , Testes de Função Plaquetária , Valor Preditivo dos Testes , Modelos de Riscos Proporcionais , Medição de Risco , Fatores de Risco , Ticlopidina/efeitos adversos , Ticlopidina/farmacocinética , Ticlopidina/uso terapêutico , Fatores de Tempo , Resultado do Tratamento
20.
Int J Cardiol ; 168(4): 3208-11, 2013 Oct 09.
Artigo em Inglês | MEDLINE | ID: mdl-23611747

RESUMO

BACKGROUND: Final kissing balloon dilatation (FKBD) is a recommended final step in case of treatment of bifurcation lesions by two stents approaches. Furthermore, dilatation of the side branch (SB) may be necessary following main vessel (MV) stenting. Occasionally, recrossing the stent struts with a balloon is hampered because the tip hits a stent strut. METHODS: The Glider (TriReme Medical, Pleasanton, CA) is a dedicated balloon designed for crossing through struts of deployed stents toward a SB. From October 2010 to January 2012, FKBD was attempted in 236 consecutive bifurcation lesions treated in our Institution. FKBD was successfully performed by conventional balloon catheters in 221 (93.5%) lesions (Conventional group). In the remaining 15 (6.5%) lesions, where a conventional balloon failed to cross the stent strut, the Glider balloon was attempted (Glider group). RESULTS: The angle beta (between the axis of the MV after the branch point and the SB axis at the point of divergence) was wider in the Glider group (83±17° versus 65±27°; p=0.032). A trend toward an higher rate of the true bifurcation lesions was observed in the Glider group (93% versus 70.5%; p=0.07). The Glider balloon successfully crossed through MV stent struts toward a SB in 12 patients (80%), whereas failed in the remaining 3 patients. CONCLUSIONS: The Glider balloon represents an unique bail-out device which offers an effective rescue strategy for recrossing stent struts during complex bifurcation stenting.


Assuntos
Angioplastia Coronária com Balão/instrumentação , Angioplastia Coronária com Balão/métodos , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/terapia , Stents , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento
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