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1.
J Am Coll Cardiol ; 83(11): 1059-1069, 2024 Mar 19.
Artigo em Inglês | MEDLINE | ID: mdl-38479953

RESUMO

BACKGROUND: Acute kidney injury (AKI) is common in patients with acute coronary syndromes (ACS) treated by percutaneous coronary intervention. OBJECTIVES: Contrast media (CM) volume minimization has been advocated for prevention of AKI. The DyeVert CM diversion system (Osprey Medical, Inc) is designed to reduce CM volume during coronary procedures. METHODS: In this randomized, single-blind, investigator-driven clinical trial conducted in 4 Italian centers from February 4, 2020 to September 13, 2022, 550 participants with ACS were randomly assigned in a 1:1 ratio to the following: 1) the contrast volume reduction (CVR) group (n = 276), in which CM injection was handled by the CM diversion system; and 2) the control group (n = 274), in which a conventional manual or automatic injection syringe was used. The primary endpoint was the rate of AKI, defined as a serum creatinine (sCr) increase ≥0.3 mg/dL within 48 hours after CM exposure. RESULTS: There were 412 of 550 (74.5%) participants with ST-segment elevation myocardial infarction (211 of 276 [76.4%] in the CVR group and 201 of 274 [73.3%] in the control group). The CM volume was lower in the CVR group (95 ± 30 mL vs 160 ± 23 mL; P < 0.001). Seven participants (1 in the CVR group and 6 in the control group) did not have postprocedural sCr values. AKI occurred in 44 of 275 (16%) participants in the CVR group and in 65 of 268 (24.3%) participants in the control group (relative risk: 0.66; 95% CI: 0.47-0.93; P = 0.018). CONCLUSIONS: CM volume reduction obtained using the CM diversion system is effective for prevention of AKI in patients with ACS undergoing invasive procedures. (REnal Insufficiency Following Contrast MEDIA Administration TriaL IV [REMEDIALIV]: NCT04714736).


Assuntos
Síndrome Coronariana Aguda , Injúria Renal Aguda , Intervenção Coronária Percutânea , Humanos , Síndrome Coronariana Aguda/diagnóstico por imagem , Injúria Renal Aguda/induzido quimicamente , Injúria Renal Aguda/epidemiologia , Meios de Contraste/efeitos adversos , Creatinina , Rim , Intervenção Coronária Percutânea/efeitos adversos , Fatores de Risco , Método Simples-Cego
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 ; 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
4.
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
5.
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
6.
Circulation ; 126(25): 3008-16, 2012 Dec 18.
Artigo em Inglês | MEDLINE | ID: mdl-23147173

RESUMO

BACKGROUND: The role of statins in the prevention of contrast-induced acute kidney injury (CIAKI) is controversial. METHODS AND RESULTS: First, we investigated the in vivo effects of atorvastatin on CIAKI. Patients with chronic kidney disease enrolled in the Novel Approaches for Preventing or Limiting Events (NAPLES) II trial were randomly assigned to (1) the atorvastatin group (80 mg within 24 hours before contrast media [CM] exposure; n=202) or (2) the control group (n=208). All patients received a high dose of N-acetylcysteine and sodium bicarbonate solution. Second, we investigated the in vitro effects of atorvastatin pretreatment on CM-mediated modifications of intracellular pathways leading to apoptosis or survival in renal tubular cells. CIAKI (ie, an increase >10% of serum cystatin C concentration within 24 hours after CM exposure) occurred in 9 of 202 patients in the atorvastatin group (4.5%) and in 37 of 208 patients in the control group (17.8%) (P=0.005; odds ratio=0.22; 95% confidence interval, 0.07-0.69). CIAKI rate was lower in the atorvastatin group in both diabetics and nondiabetics and in patients with moderate chronic kidney disease (estimated glomerular filtration rate, 31-60 mL/min per 1.73 m(2)). In the in vitro model, pretreatment with atorvastatin (1) prevented CM-induced renal cell apoptosis by reducing stress kinases activation and (2) restored the survival signals (mediated by Akt and ERK pathways). CONCLUSIONS: A single high loading dose of atorvastatin administered within 24 hours before CM exposure is effective in reducing the rate of CIAKI. This beneficial effect is observed only in patients at low to medium risk.


Assuntos
Injúria Renal Aguda/prevenção & controle , Meios de Contraste/efeitos adversos , Ácidos Heptanoicos/farmacologia , Inibidores de Hidroximetilglutaril-CoA Redutases/farmacologia , Pirróis/farmacologia , Acetilcisteína/farmacologia , Injúria Renal Aguda/induzido quimicamente , Idoso , Animais , Atorvastatina , Células Cultivadas , Feminino , Humanos , Proteínas Quinases JNK Ativadas por Mitógeno/metabolismo , Masculino , Pessoa de Meia-Idade , Proteína Supressora de Tumor p53/metabolismo
7.
Thrombosis ; 2012: 372371, 2012.
Artigo em Inglês | MEDLINE | ID: mdl-22448320

RESUMO

Background. Treatment of patients who need coronary revascularization before undelayable non-cardiac surgery is challenging. Methods. We assessed the safety and efficacy of percutaneous coronary interventions (PCI) using the Avantgarde( TM) Carbostent (CID, Italy) in patients undergoing PCI before undelayable non-cardiac surgery. The Multiplate analyzer point-of-care was used to assess residual platelet reactivity. One major cardiac events (MACE, defined as death, myocardial infarction, and stent thrombosis and major bleeding) were assessed. Results. 42 consecutive patients were analyzed. Total stent length ≥25 mm was observed in 16 (37%) patients. Multivessel stenting was performed in 11 (31.5%) patients. Clopidogrel was interrupted 5 days before surgery in 35 patients, whereas it was stopped the day of the surgery in 7 patients. Surgery was performed after 27 ± 9 (7-42) days from PCI. MACE occurred in one patient (2.4%; 95% confidence interval: 0.01-13%), who had fatal acute myocardial infarction 3 days after abdominal aortic aneurysm surgery and 12 days after stent implantation. No case of major bleeding in the postoperative phase was observed. Conclusions. The present pilot study suggests that, although at least 10-14 days of dual antiplatelet therapy remain mandatory, the Avantgarde( TM) stent seems to have a role in patients requiring undelayable surgery.

8.
Circulation ; 124(11): 1260-9, 2011 Sep 13.
Artigo em Inglês | MEDLINE | ID: mdl-21844075

RESUMO

BACKGROUND: The RenalGuard System, which creates high urine output and fluid balancing, may be beneficial in preventing contrast-induced acute kidney injury. METHODS AND RESULTS: The Renal Insufficiency After Contrast Media Administration Trial II (REMEDIAL II) trial is a randomized, multicenter, investigator-driven trial addressing the prevention of contrast-induced acute kidney injury in high-risk patients. Patients with an estimated glomerular filtration rate ≤30 mL · min(-1) · 1.73 m(-2) and/or a risk score ≥11 were randomly assigned to sodium bicarbonate solution and N-acetylcysteine (control group) or hydration with saline and N-acetylcysteine controlled by the RenalGuard System and furosemide (RenalGuard group). The primary end point was an increase of ≥0.3 mg/dL in the serum creatinine concentration at 48 hours after the procedure. The secondary end points included serum cystatin C kinetics and rate of in-hospital dialysis. Contrast-induced acute kidney injury occurred in 16 of 146 patients in the RenalGuard group (11%) and in 30 of 146 patients in the control group (20.5%; odds ratio, 0.47; 95% confidence interval, 0.24 to 0.92). There were 142 patients (48.5%) with an estimated glomerular filtration rate ≤30 mL · min(-1) · 1.73 and 149 patients (51.5%) with only a risk score ≥11. Subgroup analysis according to inclusion criteria showed a similarly lower risk of adverse events (estimated glomerular filtration rate ≤30 mL · min(-1) · 1.73 m(-2): odds ratio, 0.44; risk score ≥11: odds ratio, 0.45; P for interaction=0.97). Changes in cystatin C at 24 hours (0.02±0.32 versus -0.08±0.26; P=0.002) and 48 hours (0.12±0.42 versus 0.03±0.31; P=0.001) and the rate of in-hospital dialysis (4.1% versus 0.7%; P=0.056) were higher in the control group. CONCLUSION: RenalGuard therapy is superior to sodium bicarbonate and N-acetylcysteine in preventing contrast-induced acute kidney injury in high-risk patients. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrial.gov. Unique identifier: NCT01098032.


Assuntos
Acetilcisteína/administração & dosagem , Injúria Renal Aguda/induzido quimicamente , Injúria Renal Aguda/prevenção & controle , Carbonatos/administração & dosagem , Meios de Contraste/efeitos adversos , Furosemida/administração & dosagem , Cloreto de Sódio/administração & dosagem , Idoso , Idoso de 80 Anos ou mais , Feminino , Hidratação/métodos , Humanos , Masculino , Insuficiência Renal/induzido quimicamente , Insuficiência Renal/prevenção & controle , Fatores de Risco
9.
Int J Cardiol ; 149(2): 199-204, 2011 Jun 02.
Artigo em Inglês | MEDLINE | ID: mdl-20138377

RESUMO

BACKGROUND: In an attempt to improve the stent's safety, development of bare metal stents (BMS) continues, with new materials and geometry. Chrono (CID, Italy) is a thin strut cobalt-chromium (Co-Cr) stent combining the clinical benefits of the bio- and haemo-compatible Carbofilm coating. METHODS: We assessed the safety and efficacy of percutaneous coronary interventions (PCI) using the new Co-Cr Chrono stent in patients undergoing elective PCI for de novo lesions in native coronary vessels. The patients were followed for 12 months for the occurrence of major cardiac events (MACE, defined as death, myocardial infarction, repeat PCI and bypass surgery). Patients with complex (B2/C) lesions were compared to those with non-complex lesions (A/B1). RESULTS: A total of 340 consecutive patients were analysed: 155 patients with complex lesions (Complex group) and 185 patients with non-complex lesions (Non-complex group). Dual antiplatelet therapy was maintained >1 month in 21% of patients in both Complex and Non-complex group. Stent length was longer in the Complex group (25 ± 10 mm versus 17 ± 6 mm; p<0.001). Stent diameter <3.0 mm was most frequent in the Complex group (35.5% versus 27.5%; p<0.05). During the 12-month follow-up period MACE occurred in 10.6% of the global population (12.3% in the Complex group and 9.2% in the Non-complex group; p=0.43). Repeat PCI was most frequent in the Complex group (9.7% versus 3.8%; p=0.044). The incidence of definite and probable stent thrombosis (ARC criteria) was 1.29% in the Complex group and 1.08% in the Non-complex group (p=1.0). CONCLUSIONS: Implantation of the Co-Cr Chrono stent results in a good safety and efficacy for both complex and non-complex de-novo coronary artery lesions.


Assuntos
Angioplastia Coronária com Balão/instrumentação , Ligas de Cromo , Cobalto , Stents , Idoso , Materiais Biocompatíveis/uso terapêutico , Doença da Artéria Coronariana/fisiopatologia , Doença da Artéria Coronariana/terapia , Reestenose Coronária/prevenção & controle , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Sistema de Registros
11.
Circulation ; 121(19): 2117-22, 2010 May 18.
Artigo em Inglês | MEDLINE | ID: mdl-20439784

RESUMO

BACKGROUND: Cystatin C (CyC) is more sensitive than serum creatinine (sCr) to rapidly detect acute changes in renal function. METHODS AND RESULTS: We measured CyC together with sCr in 410 consecutive patients with chronic kidney disease undergoing either coronary and/or peripheral angiography and/or angioplasty. sCr was assessed at baseline and 24 and 48 hours after contrast media exposure. CyC was assessed at baseline and at 24 hours. Major adverse events (including death of any cause and dialysis) at 12 months were assessed. At 48 hours after contrast media exposure, contrast-induced acute kidney injury (defined as a sCr increase > or =0.3 mg/dL) occurred in 34 patients (8.2%). A CyC increase concentration > or =10% at 24 hours after contrast media exposure was detected in 87 patients (21.2%). This was the best CyC cutoff for the early identification of patients at risk for contrast-induced acute kidney injury (negative predictive value=100%; positive predictive value=39.1%). According to the defined cutoffs (that is, increase in CyC > or =10% and sCr > or =0.3 mg/dL), major adverse events occurred in 16 of 297 patients (5.4%) without any cutoffs satisfied (group 1), in 9 of 49 patients (18.4%) with only a CyC increase > or =10% (group 2), and in 9 of 31 patients (29%) with both cutoffs satisfied (group 3). By logistic regression analysis, the independent predictors of major adverse events at 1 year were group 2 (odds ratio=2.52; 95% confidence interval, 1.17 to 5.41; P=0.02), group 3 (odds ratio=4.45; 95% confidence interval, 1.72 to 11.54; P=0.002), and baseline glomerular filtration rate (odds ratio=0.91; 95% confidence interval, 0.88 to 0.95; P<0.001). CONCLUSIONS: In patients with chronic kidney disease, CyC seems to be a reliable marker for the early diagnosis and prognosis of contrast-induced acute kidney injury.


Assuntos
Injúria Renal Aguda/sangue , Injúria Renal Aguda/induzido quimicamente , Biomarcadores/sangue , Meios de Contraste/efeitos adversos , Angiografia Coronária/efeitos adversos , Cistatina C/sangue , Injúria Renal Aguda/mortalidade , Adulto , Idoso , Idoso de 80 Anos ou mais , Creatinina/sangue , Feminino , Taxa de Filtração Glomerular , Cardiopatias/diagnóstico por imagem , Cardiopatias/mortalidade , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Prognóstico , Fatores de Risco , Sensibilidade e Especificidade
12.
Am J Cardiol ; 99(6): 779-84, 2007 Mar 15.
Artigo em Inglês | MEDLINE | ID: mdl-17350364

RESUMO

We compared 1-year outcome after drug-eluting stent (DES) implantation with off-pump bypass grafing (OPCABG) in patients with type 2 diabetes mellitus and multivessel coronary artery disease involving the proximal segment of the left anterior descending coronary artery. All consecutive diabetic patients treated by DES (DES group) or OPCABG (CABG group) in our institution from April 2002 to December 2004 because of de novo coronary lesions were included. Patients in the CABG group (n = 149) were older and had a higher rate of 3-vessel disease than those in the DES group (n = 69). At 12 months, major adverse cardiac and cerebrovascular events occurred in 29% of the DES group and 20.5% of the CABG group (unadjusted analysis, odds ratio 1.20, 95% confidence interval [CI] 0.93 to 1.54, p = 0.17). After propensity score analysis, adjusting for baseline differences between the 2 cohorts, DESs increased the risk of 12-month major adverse cardiac and cerebrovascular events (hazard ratio 1.88, 95% CI 1.09 to 3.02, p = 0.020). This was due to the higher rate for repeat revascularization in the DES group (19% vs 5%, odds ratio 2.05, 95% CI 1.12 to 3.75, p = 0.001). In contrast, there was no difference in the rate of the composite end points of death, myocardial infarction, and stroke (DES group 13%, CABG group 12%; adjusted analysis, hazard ratio 0.80, 95% CI 0.80 to 1.35, p = 0.40). In conclusion, at 1 year in diabetic patients with multivessel coronary artery disease involving the proximal left anterior descending coronary artery, the advantage of OPCABG over DES implantation seems to be limited at a lower rate of repeat revascularization. No difference seems to exist in the rate of death, stroke, and myocardial infarction.


Assuntos
Angioplastia Coronária com Balão , Ponte de Artéria Coronária , Doença da Artéria Coronariana/terapia , Reestenose Coronária/mortalidade , Diabetes Mellitus Tipo 2/complicações , Stents , Idoso , Angiografia Coronária , Doença da Artéria Coronariana/complicações , Doença da Artéria Coronariana/cirurgia , Reestenose Coronária/diagnóstico por imagem , Diabetes Mellitus Tipo 2/sangue , Retinopatia Diabética/patologia , Intervalo Livre de Doença , Sistemas de Liberação de Medicamentos , Feminino , Humanos , Itália/epidemiologia , Masculino , Pessoa de Meia-Idade , Análise de Sobrevida , Resultado do Tratamento
13.
Circulation ; 115(10): 1211-7, 2007 Mar 13.
Artigo em Inglês | MEDLINE | ID: mdl-17309916

RESUMO

BACKGROUND: Volume supplementation by saline infusion combined with N-acetylcysteine (NAC) represents an effective strategy to prevent contrast agent-induced nephrotoxicity (CIN). Preliminary data support the concept that sodium bicarbonate and ascorbic acid also may be effective in preventing CIN. METHODS AND RESULTS: Three hundred twenty-six consecutive patients with chronic kidney disease, referred to our institutions for coronary and/or peripheral procedures, were randomly assigned to prophylactic administration of 0.9% saline infusion plus NAC (n=111), sodium bicarbonate infusion plus NAC (n=108), and 0.9% saline plus ascorbic acid plus NAC (n=107). All enrolled patients had serum creatinine > or = 2.0 mg/dL and/or estimated glomerular filtration rate < 40 mL x min(-1) x 1.73 m(-2). Contrast nephropathy risk score was calculated in each patient. In all cases, iodixanol (an iso-osmolar, nonionic contrast agent) was administered. The primary end point was an increase of > or = 25% in the creatinine concentration 48 hours after the procedure (CIN). The amount of contrast media administered (179+/-102, 169+/-92, and 169+/-94 mL, respectively; P=0.69) and risk scores (9.1+/-3.4, 9.5+/-3.6, and 9.3+/-3.6; P=0.21) were similar in the 3 groups. CIN occurred in 11 of 111 patients (9.9%) in the saline plus NAC group, in 2 of 108 (1.9%) in the bicarbonate plus NAC group (P=0.019 by Fisher exact test versus saline plus NAC group), and in 11 of 107 (10.3%) in the saline plus ascorbic acid plus NAC group (P=1.00 versus saline plus NAC group). CONCLUSIONS: The strategy of volume supplementation by sodium bicarbonate plus NAC seems to be superior to the combination of normal saline with NAC alone or with the addition of ascorbic acid in preventing CIN in patients at medium to high risk.


Assuntos
Acetilcisteína/uso terapêutico , Meios de Contraste/efeitos adversos , Nefropatias/fisiopatologia , Insuficiência Renal/induzido quimicamente , Insuficiência Renal/prevenção & controle , Ácidos Tri-Iodobenzoicos/efeitos adversos , Administração Oral , Idoso , Ácido Ascórbico/administração & dosagem , Doenças Cardiovasculares/complicações , Doenças Cardiovasculares/diagnóstico , Meios de Contraste/administração & dosagem , Creatinina/sangue , Método Duplo-Cego , Quimioterapia Combinada , Feminino , Taxa de Filtração Glomerular/efeitos dos fármacos , Humanos , Infusões Intravenosas , Nefropatias/complicações , Masculino , Insuficiência Renal/sangue , Fatores de Risco , Bicarbonato de Sódio/administração & dosagem , Cloreto de Sódio/administração & dosagem , Resultado do Tratamento , Ácidos Tri-Iodobenzoicos/administração & dosagem
14.
Am Heart J ; 150(4): 807-13, 2005 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-16209986

RESUMO

BACKGROUND: Restenosis rate is lower after sirolimus-eluting stent (SES) implantation than after bare metal stent (BS) implantation. We evaluated the impact of SES implantation on immediate and 12-month outcome in diabetic patients with multivessel coronary artery disease (MVD). METHODS: From April 2002 to September 2003, 100 consecutive diabetic patients with MVD without previous myocardial revascularization underwent successful elective percutaneous coronary intervention (PCI) with SES on native coronary arteries at our institutions. A group (n = 122) of consecutive diabetic patients with MVD treated with BS implantation (BS group) for de novo lesions was selected from our database and matched with the SES group. Major adverse cardiac events (MACEs) during hospital stay and at follow-up included nonfatal myocardial infarction, death, bypass surgery, and re-PCI. RESULTS: At 12 +/- 4 months, MACEs occurred in 25% of patients in the SES group and in 44% of those in the BS group (P = .003, OR .72, 95% CI 0.57-0.91). Need for repeat intervention (re-PCI or bypass surgery) occurred in 17% of patients in the SES group and in 41% of those in the BS group (P < .001, OR .67, 95% CI 0.52-0.86). No significant difference in the rate of death and myocardial infarction was observed. In the SES group, the independent predictors of MACEs at follow-up were premature clopidogrel discontinuation (hazard ratio 20.62, 95% CI 1.60-264.97, P = .020) and chronic renal insufficiency (hazard ratio 4.73, 95% CI 1.99-11.25, P = .0004). CONCLUSIONS: As compared with BS implantation, SES implantation favorably influences outcome in diabetic patients with MVD, mainly by reducing the need for new revascularization.


Assuntos
Doença da Artéria Coronariana/terapia , Diabetes Mellitus Tipo 2/complicações , Angiopatias Diabéticas/terapia , Sirolimo/administração & dosagem , Stents , Doença da Artéria Coronariana/complicações , Doença da Artéria Coronariana/mortalidade , Angiopatias Diabéticas/complicações , Angiopatias Diabéticas/mortalidade , Portadores de Fármacos , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio/etiologia , Complicações Pós-Operatórias/epidemiologia , Fatores de Tempo
15.
Kidney Int ; 68(5): 2250-5, 2005 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-16221226

RESUMO

BACKGROUND: Recent data support that iodixanol, an iso-osmolality contrast agent, is less nephrotoxic than low-osmolality contrast agents when hydration is the only prophylactic strategy used. We evaluated the nephrotoxicity of iso- and low-osmolality contrast agents with prophylactic administration of N-acetylcysteine (NAC) along with hydration. METHODS: Two hundred and twenty-five patients with chronic renal insufficiency (serum creatinine >1.5 mg/dL or an estimated glomerular filtration rate <60 mL/min/1.73 m(2)), referred to our institution for coronary and/or peripheral procedures, were assigned to receive low-osmolality (iobitridol group; N = 115) or iso-osmolality (iodixanol group; N = 110) contrast dye. In all cases prophylactic administration of 0.45% saline intravenously and NAC (1200 mg orally twice daily) was used. RESULTS: Baseline creatinine levels were similar in the 2 groups [iobitridol group = 1.70 (IQR: 1.54-1.98) mg/dL; iodixanol group = 1.73 (IQR: 1.56-2.00) mg/dL, P = 0.33]. The risk score for contrast nephrotoxicity was 5.0 +/- 1.6 in the iobitridol group versus 5.0 +/- 1.8 in the iodixanol group (P = 0.44). Increase of at least 0.5 mg/dL of the creatinine concentration 48 hours after the procedure occurred in 4/115 patients (3.5%) in the iobitridol group and 3/110 patients (2.7%) in the iodixanol group (P = 1.00; OR 0.78; 95% CI 0.17-3.56). Amount of contrast media administration was similar in the 2 groups (iobitridol group = 167 +/- 90 mL; iodixanol group = 164 +/- 82 mL; P = 0.61). CONCLUSION: Nephrotoxicity of iso-osmolality and low-osmolality contrast agents was similar when a prophylactic strategy of hydration plus NAC was utilized.


Assuntos
Acetilcisteína/administração & dosagem , Injúria Renal Aguda/induzido quimicamente , Meios de Contraste/efeitos adversos , Iohexol/análogos & derivados , Insuficiência Renal Crônica/diagnóstico , Ácidos Tri-Iodobenzoicos/efeitos adversos , Injúria Renal Aguda/prevenção & controle , Idoso , Feminino , Hidratação , Humanos , Iohexol/efeitos adversos , Rim/efeitos dos fármacos , Masculino , Pessoa de Meia-Idade , Concentração Osmolar , Estudos Retrospectivos
16.
J Am Coll Cardiol ; 44(4): 762-5, 2004 Aug 18.
Artigo em Inglês | MEDLINE | ID: mdl-15312855

RESUMO

OBJECTIVES: We performed a study to assess the efficacy of fenoldopam mesylate (a specific agonist of the dopamine-1 receptor) as compared with N-acetylcysteine (NAC) in preventing contrast agent-associated nephrotoxicity (CAN). BACKGROUND: Prophylactic administration of NAC, along with hydration, prevents CAN in patients with chronic renal insufficiency who are undergoing contrast media administration. Preliminary data support the hypothesis that fenoldopam might be as effective as NAC. METHODS: One hundred ninety-two consecutive patients with chronic renal insufficiency, referred to our institution for coronary and/or peripheral procedures, were assigned randomly to receive 0.45% saline intravenously and NAC (1,200 mg orally twice daily; NAC group; n = 97) or fenoldopam (0.10 microg/kg/min; fenoldopam group; n = 95) before and after a nonionic, iso-osmolality contrast dye administration. RESULTS: Baseline creatinine levels were similar in the two groups: NAC group = 1.72 mg/dl (interquartile range, 1.55 to 1.90 mg/dl) and fenoldopam group = 1.75 mg/dl (interquartile range, 1.62 to 2.01 mg/dl) (p = 0.17). An increase of at least 0.5 mg/dl of the creatinine concentration 48 h after the procedure occurred in 4 of 97 patients (4.1%) in the NAC group and in 13 of 95 patients (13.7%) in the fenoldopam group (p = 0.019; odds ratio 0.27; 95% confidence interval 0.08 to 0.85). The amount of contrast media administration was similar in the two groups (NAC group = 160 +/- 82 ml; fenoldopam group = 168 +/- 104 ml; p = 0.54). CONCLUSIONS: N-acetylcysteine seems to be more effective than fenoldopam in preventing CAN.


Assuntos
Acetilcisteína/administração & dosagem , Meios de Contraste/efeitos adversos , Agonistas de Dopamina/administração & dosagem , Fenoldopam/administração & dosagem , Sequestradores de Radicais Livres/administração & dosagem , Nefropatias/prevenção & controle , Administração Oral , Idoso , Angiografia Coronária/efeitos adversos , Doença da Artéria Coronariana/diagnóstico por imagem , Creatinina/sangue , Esquema de Medicação , Feminino , Humanos , Infusões Intravenosas , Nefropatias/sangue , Nefropatias/induzido quimicamente , Masculino
17.
Eur Heart J ; 25(3): 206-11, 2004 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-14972420

RESUMO

AIMS: Prophylactic administration of N-acetylcysteine (NAC) (600mg orally twice daily), along with hydration, prevents contrast agent-associated nephrotoxicity (CAN) induced by a low dose of non-ionic, low-osmolality contrast dye. We tested whether a double dose of NAC is more effective to prevent CAN. METHODS AND RESULTS: Two-hundred-twenty-four consecutive patients with chronic renal insufficiency (creatinine level > or =1.5mg/dl and/or creatinine clearance <60ml/min), referred to our institution for coronary and/or peripheral procedures, were randomly assigned to receive 0.45% saline intravenously and NAC at the standard dose (600mg orally twice daily; SD Group; n=110) or at a double dose (1200mg orally twice daily; DD Group; n=114) before and after a non-ionic, low-osmolality contrast dye administration. Increase of at least 0.5mg/dl of the creatinine concentration 48h after the procedure occurred in 12/109 patients (11%) in the SD Group and 4/114 patients (3.5%) in the DD Group (P=0.038; OR=0.29; 95% CI=0.09-0.94). In the subgroup with low (<140ml, or contrast ratio <=1) contrast dose, no significant difference in renal function deterioration occurred between the 2 groups. In the subgroup with high (> or =140ml, or contrast ratio >1) contrast dose, the event was significantly more frequent in the SD Group. Conclusions Double dose of NAC seems to be more effective than the standard dose in preventing CAN, especially with high volumes of non-ionic, low-osmolality contrast agent.


Assuntos
Acetilcisteína/administração & dosagem , Meios de Contraste/efeitos adversos , Sequestradores de Radicais Livres/administração & dosagem , Iohexol/análogos & derivados , Iohexol/efeitos adversos , Nefropatias/induzido quimicamente , Idoso , Esquema de Medicação , Feminino , Humanos , Nefropatias/prevenção & controle , Masculino , Estudos Prospectivos
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