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BACKGROUND: The impact of rosuvastatin versus atorvastatin on new-onset diabetes mellitus (NODM) among patients treated with high-intensity statin therapy for coronary artery disease (CAD) remains to be clarified. This study aimed to evaluate the risk of NODM in patients with CAD treated with rosuvastatin compared to atorvastatin in the randomized LODESTAR trial. METHODS: In the LODESTAR trial, patients with CAD were randomly assigned to receive either rosuvastatin or atorvastatin using a 2-by-2 factorial randomization. In this post-hoc analysis, the 3-year incidence of NODM was compared between rosuvastatin and atorvastatin treatment in the as-treated population with high-intensity statin therapy as the principal population of interest. RESULTS: Among 2932 patients without diabetes mellitus at baseline, 2377 were included in the as-treated population analysis. In the as-treated population with high-intensity statin therapy, the incidence of NODM was not significantly different between the rosuvastatin and atorvastatin groups (11.4% [106/948] versus 8.8% [73/856], hazard ratio [HR] = 1.32, 95% confidence interval [CI] = 0.98 to 1.77, P = 0.071). When the risk of NODM with rosuvastatin versus atorvastatin was assessed according to the achieved low-density lipoprotein cholesterol (LDL-C) level, the risk of NODM began to increase at a LDL-C level below 70 mg/dL. The incidence of NODM was significantly greater in the rosuvastatin group than it was in the atorvastatin group when the achieved LDL-C level was < 70 mg/dL (13.9% versus 8.0%; HR = 1.79, 95% CI 1.18 to 2.73, P = 0.007). CONCLUSIONS: Among CAD patients receiving high-intensity statin therapy, the incidence of NODM was not significantly different between rosuvastatin and atorvastatin. However, a drug effect of the statin type on NODM was observed when the achieved LDL-C level was < 70 mg/dL. TRIAL REGISTRATION: ClinicalTrials.gov, Identifier: NCT02579499.
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Atorvastatina , Enfermedad de la Arteria Coronaria , Diabetes Mellitus , Inhibidores de Hidroximetilglutaril-CoA Reductasas , Rosuvastatina Cálcica , Humanos , Rosuvastatina Cálcica/efectos adversos , Rosuvastatina Cálcica/uso terapéutico , Atorvastatina/efectos adversos , Atorvastatina/uso terapéutico , Enfermedad de la Arteria Coronaria/epidemiología , Enfermedad de la Arteria Coronaria/sangre , Enfermedad de la Arteria Coronaria/diagnóstico , Enfermedad de la Arteria Coronaria/tratamiento farmacológico , Masculino , Inhibidores de Hidroximetilglutaril-CoA Reductasas/efectos adversos , Inhibidores de Hidroximetilglutaril-CoA Reductasas/uso terapéutico , Femenino , Persona de Mediana Edad , Anciano , Diabetes Mellitus/diagnóstico , Diabetes Mellitus/epidemiología , Diabetes Mellitus/sangre , Diabetes Mellitus/tratamiento farmacológico , Incidencia , Resultado del Tratamiento , Factores de Riesgo , Factores de Tiempo , Biomarcadores/sangre , Medición de RiesgoRESUMEN
BACKGROUND: The optimal statin treatment strategy that is balanced for both efficacy and safety has not been clearly determined in older adults with coronary artery disease (CAD). METHODS: In the post hoc analysis of the LODESTAR (low-density lipoprotein cholesterol-targeting statin therapy versus intensity-based statin therapy in patients with coronary artery disease) trial, the impact between a treat-to-target strategy versus a high-intensity statin therapy strategy was compared in older adults (aged 75 years or older). The goal of treat-to-target low-density lipoprotein cholesterol (LDL-C) level was 50-70 mg/dl. The primary endpoint comprised the three-year composite of all-cause death, myocardial infarction, stroke or coronary revascularisation. RESULTS: Among 4,400 patients with CAD enrolled in the LODESTAR trial, 822 (18.7%) were aged 75 years or older. Poor clinical outcomes and risk factors for atherosclerosis were more frequently observed in older adults than in younger population (<75 years old). Among these older adults with CAD, the prescription rate of high-intensity statin was significantly lower in the treat-to-target strategy group throughout the study period (P < 0.001). The mean LDL-C level for three years was 65 ± 16 mg/dl in the treat-to-target strategy group and 64 ± 18 mg/dl in the high-intensity statin group (P = 0.34). The incidence of primary endpoint occurrence was 10.9% in the treat-to-target strategy group and 12.0% in the high-intensity statin group (hazard ratio 0.92, 95% confidence interval 0.61-1.38, P = 0.69). CONCLUSIONS: High-intensity statin therapy is theoretically more necessary in older adults because of worse clinical outcomes and greater number of risk factors for atherosclerosis. However, the primary endpoint occurrence with a treat-to-target strategy with an LDL-C goal of 50-70 mg/dl was comparable to that of high-intensity statin therapy and reduced utilisation of a high-intensity statin. Taking efficacy as well as safety into account, adopting a tailored approach may be considered for this high-risk population. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02579499.
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LDL-Colesterol , Enfermedad de la Arteria Coronaria , Inhibidores de Hidroximetilglutaril-CoA Reductasas , Humanos , Anciano , Inhibidores de Hidroximetilglutaril-CoA Reductasas/uso terapéutico , Inhibidores de Hidroximetilglutaril-CoA Reductasas/efectos adversos , Enfermedad de la Arteria Coronaria/tratamiento farmacológico , Enfermedad de la Arteria Coronaria/sangre , Enfermedad de la Arteria Coronaria/mortalidad , Masculino , Femenino , LDL-Colesterol/sangre , Resultado del Tratamiento , Factores de Edad , Anciano de 80 o más Años , Factores de Riesgo , Biomarcadores/sangre , Persona de Mediana Edad , Factores de Tiempo , Infarto del Miocardio/epidemiología , Accidente Cerebrovascular/prevención & control , Accidente Cerebrovascular/epidemiologíaRESUMEN
Importance: In patients with coronary artery disease, some guidelines recommend initial statin treatment with high-intensity statins to achieve at least a 50% reduction in low-density lipoprotein cholesterol (LDL-C). An alternative approach is to begin with moderate-intensity statins and titrate to a specific LDL-C goal. These alternatives have not been compared head-to-head in a clinical trial involving patients with known coronary artery disease. Objective: To assess whether a treat-to-target strategy is noninferior to a strategy of high-intensity statins for long-term clinical outcomes in patients with coronary artery disease. Design, Setting, and Participants: A randomized, multicenter, noninferiority trial in patients with a coronary disease diagnosis treated at 12 centers in South Korea (enrollment: September 9, 2016, through November 27, 2019; final follow-up: October 26, 2022). Interventions: Patients were randomly assigned to receive either the LDL-C target strategy, with an LDL-C level between 50 and 70 mg/dL as the target, or high-intensity statin treatment, which consisted of rosuvastatin, 20 mg, or atorvastatin, 40 mg. Main Outcomes and Measures: Primary end point was a 3-year composite of death, myocardial infarction, stroke, or coronary revascularization with a noninferiority margin of 3.0 percentage points. Results: Among 4400 patients, 4341 patients (98.7%) completed the trial (mean [SD] age, 65.1 [9.9] years; 1228 females [27.9%]). In the treat-to-target group (n = 2200), which had 6449 person-years of follow-up, moderate-intensity and high-intensity dosing were used in 43% and 54%, respectively. The mean (SD) LDL-C level for 3 years was 69.1 (17.8) mg/dL in the treat-to-target group and 68.4 (20.1) mg/dL in the high-intensity statin group (n = 2200) (P = .21, compared with the treat-to-target group). The primary end point occurred in 177 patients (8.1%) in the treat-to-target group and 190 patients (8.7%) in the high-intensity statin group (absolute difference, -0.6 percentage points [upper boundary of the 1-sided 97.5% CI, 1.1 percentage points]; P < .001 for noninferiority). Conclusions and Relevance: Among patients with coronary artery disease, a treat-to-target LDL-C strategy of 50 to 70 mg/dL as the goal was noninferior to a high-intensity statin therapy for the 3-year composite of death, myocardial infarction, stroke, or coronary revascularization. These findings provide additional evidence supporting the suitability of a treat-to-target strategy that may allow a tailored approach with consideration for individual variability in drug response to statin therapy. Trial Registration: ClinicalTrials.gov Identifier: NCT02579499.
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Atorvastatina , LDL-Colesterol , Enfermedad de la Arteria Coronaria , Inhibidores de Hidroximetilglutaril-CoA Reductasas , Hiperlipoproteinemias , Rosuvastatina Cálcica , Anciano , Femenino , Humanos , LDL-Colesterol/sangre , Enfermedad de la Arteria Coronaria/sangre , Enfermedad de la Arteria Coronaria/complicaciones , Enfermedad de la Arteria Coronaria/tratamiento farmacológico , Inhibidores de Hidroximetilglutaril-CoA Reductasas/administración & dosificación , Inhibidores de Hidroximetilglutaril-CoA Reductasas/efectos adversos , Inhibidores de Hidroximetilglutaril-CoA Reductasas/uso terapéutico , Infarto del Miocardio/etiología , Accidente Cerebrovascular/etiología , Resultado del Tratamiento , Hiperlipoproteinemias/sangre , Hiperlipoproteinemias/complicaciones , Hiperlipoproteinemias/tratamiento farmacológico , Masculino , Persona de Mediana Edad , Rosuvastatina Cálcica/administración & dosificación , Rosuvastatina Cálcica/efectos adversos , Rosuvastatina Cálcica/uso terapéutico , Atorvastatina/administración & dosificación , Atorvastatina/efectos adversos , Atorvastatina/uso terapéuticoRESUMEN
BACKGROUND: Total bilirubin (TB) concentration is inversely associated with stable coronary artery disease, but there have been few studies on initial TB in patients with ST-segment elevation myocardial infarction (STEMI). METHODSâANDâRESULTS: A total of 1,111 consecutive patients with STEMI undergoing primary percutaneous coronary intervention (PCI) with drug-eluting stents (DES) were divided into a high TB group (n=295) and a low TB group (n=816) according to the optimal cut-off 0.79 mg/dl. The high TB group had a higher rate of in-hospital major adverse cardiac events (MACE), a composite of cardiac death, non-fatal MI, and definite/probable stent thrombosis (14.2% vs. 4.2%, P<0.001) and cardiac death (13.9% vs. 3.9%, P<0.001) compared with the low TB group. The 30-day MACE-free survival rate was also significantly different between the groups (P<0.001, log-rank test). On multivariate Cox regression, initial high TB was a significant predictor of in-hospital MACE (HR, 2.69; 95% CI: 1.67-4.34, P=0.010) and of cardiac death (HR 2.72, 95% CI: 1.67-4.44, P=0.012). Adding initial TB to TIMI risk score significantly improved prediction for in-hospital MACE according to net reclassification improvement (NRI=5.2%, P=0.040) and integrated discrimination improvement (IDI=0.027, P=0.006). CONCLUSIONS: Initial TB is a powerful prognostic marker, and inclusion of this can improve prediction of in-hospital MACE in patients with STEMI undergoing primary PCI with DES. (Circ J 2016; 80: 1437-1444).
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Bilirrubina/análisis , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea/métodos , Infarto del Miocardio con Elevación del ST/terapia , Anciano , Biomarcadores/análisis , Estudios de Cohortes , Supervivencia sin Enfermedad , Femenino , Mortalidad Hospitalaria , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio con Elevación del ST/mortalidad , Resultado del TratamientoRESUMEN
BACKGROUND: Although previous studies have suggested clinical benefits of complete revascularization in patients with multivessel coronary artery disease, it is still controversial whether preventive percutaneous coronary intervention (PCI) leads to better clinical outcomes in the clinical setting of ST-segment elevation myocardial infarction (STEMI). METHODS: Relevant studies through September 2014 were searched and identified in the electronic databases.Primary endpoint was all-cause mortality at the longest follow-up. Secondary endpoints included myocardial infarction (MI), repeat revascularization, and major adverse cardiac events (MACE). RESULTS: From 836 initial citations, 7 randomized trials, and 23 observational studies with 44,256 patients (8,087 preventive and 36,169 culprit-only) were included in this study. Preventive PCI was associated with a significant reduction in repeat revascularization (odds ratios [OR]: 0.71; 95% CI: 0.510.99) with no differences in all-cause mortality (OR: 0.99; 95% CI: 0.761.29) or MI (OR: 1.08; 95% CI: 0.621.87) as compared with culprit-only PCI.Comparison of preventive PCI to the culprit-only PCI group revealed OR for MACE of 0.80 (95% CI: 0.571.12).Stratified analysis according to revascularization strategy demonstrated a significant survival benefit of culprit-only PCI over multivessel PCI during the index procedure and a significantly lower incidence of all-cause mortality with staged PCI as compared with culprit-only or multivessel PCI during the index procedure. CONCLUSIONS: Preventive PCI strategy appears to be effective in reducing the risk of repeat revascularization without significant benefits for mortality or MI when compared with culprit-only revascularization in STEMI patients with multivessel disease.
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Enfermedad de la Arteria Coronaria/terapia , Estenosis Coronaria/terapia , Infarto del Miocardio/terapia , Intervención Coronaria Percutánea , Humanos , Infarto del Miocardio/mortalidad , Recurrencia , RetratamientoRESUMEN
BACKGROUND: Aortic root rupture is a major concern with balloon-expandable transcatheter aortic valve replacement (TAVR). We sought to identify predictors of aortic root rupture during balloon-expandable TAVR by using multidetector computed tomography. METHODS AND RESULTS: Thirty-one consecutive patients who experienced left ventricular outflow tract (LVOT)/annular/aortic contained/noncontained rupture during TAVR were collected from 16 centers. A caliper-matched sample of 31 consecutive patients without annular rupture, who underwent pre-TAVR multidetector computed tomography served as a control group. Multidetector computed tomography assessment included short- and long-axis diameters and cross-sectional area of the sinotubular junction, annulus, and LVOT, and the presence, location, and extent of calcification of the LVOT, as well. There were no significant differences between the 2 groups in any preoperative clinical and echocardiographic variables. Aortic root rupture was identified in 20 patients and periaortic hematoma in 11. Patients with root rupture had a higher degree of subannular/LVOT calcification quantified by the Agatston score (181.2±211.0 versus 22.5±37.6, P<0.001), and a higher frequency of ≥20% annular area oversizing (79.4% versus 29.0%, P<0.001) and balloon postdilatation (22.6% versus 0.0%, P=0.005). In conditional logistic regression analysis for the matched data, moderate/severe LVOT/subannular calcifications (odds ratio, 10.92; 95% confidence interval, 3.23-36.91; P<0.001) and prosthesis oversizing ≥20% (odds ratio, 8.38; 95% confidence interval, 2.67-26.33; P<0.001) were associated with aortic root contained/noncontained rupture. CONCLUSIONS: This study demonstrates that LVOT calcification and aggressive annular area oversizing are associated with an increased risk of aortic root rupture during TAVR with balloon-expandable prostheses. Larger studies are warranted to confirm these findings.
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Angioplastia de Balón/efectos adversos , Rotura de la Aorta/etiología , Estenosis de la Válvula Aórtica/terapia , Cateterismo Cardíaco , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Anciano , Anciano de 80 o más Años , Rotura de la Aorta/diagnóstico por imagen , Rotura de la Aorta/epidemiología , Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/epidemiología , Calcinosis/complicaciones , Calcinosis/diagnóstico por imagen , Calcinosis/epidemiología , Estudios de Cohortes , Femenino , Implantación de Prótesis de Válvulas Cardíacas/métodos , Humanos , Modelos Logísticos , Masculino , Valor Predictivo de las Pruebas , Factores de Riesgo , Tomografía Computarizada por Rayos XRESUMEN
OBJECTIVE: Fractional flow reserve (FFR) computed from standard coronary CT scans (FFRCT) is a novel noninvasive method for determining the functional significance of coronary artery lesions. Compared with CT alone, FFRCT significantly improves diagnostic accuracy and discrimination for patients with and without hemodynamically significant coronary artery stenoses. To date, the impact of CT image quality on diagnostic performance of FFRCT is unknown. We evaluated the impact of patient preparation, CT scan protocol, and factors related to image quality on the diagnostic accuracy of FFRCT. SUBJECTS AND METHODS: We studied stable patients with suspected coronary artery disease (CAD), enrolled from 17 centers, who underwent CT, invasive coronary angiography, FFR, and FFRCT. The accuracy of CT and FFRCT for diagnosis of ischemia was compared against an invasive FFR reference standard. Anatomically obstructive CAD was defined by a stenosis value of at least 50 by CT or invasive coronary angiography, whereas ischemia was defined by an FFR or FFRCT of up to 0.80. Ischemia was assessed at the per-patient and per-vessel levels. Diagnostic performance of FFRCT was then evaluated in relation to patient preparation, including administration before CT of a ß-blocker or nitroglycerin, as well as in relation to imaging characteristics, including misalignment, noise, motion, and coronary artery calcium. RESULTS: Among 252 study participants, 137 (54.0%) had an abnormal FFR. Administration of a ß-blocker increased FFRCT specificity (51.0% vs 66.0%; p = 0.03) with lower bias (-0.084 vs -0.048; p = 0.008), whereas nitroglycerin pretreatment within 30 minutes of CT was associated with improved specificity (54.0% vs 75.0%; p = 0.013). Misalignment artifacts resulted in impaired sensitivity (43.0% vs 86.0%; p = 0.001) with resultant reductions in overall accuracy (56.0% vs 71.0%; p = 0.03). No differences in diagnostic performance of FFRCT were noted in the presence of coronary motion or increasing coronary artery calcium score. CONCLUSION: Use of ß-blockade and nitroglycerin administration before CT improve diagnostic performance of FFRCT. Diagnostic accuracy of FFRCT is significantly reduced in the setting of misalignment artifacts.
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Angiografía Coronaria/métodos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/fisiopatología , Reserva del Flujo Fraccional Miocárdico , Tomografía Computarizada por Rayos X , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios ProspectivosRESUMEN
Cardiac myxomas are benign intracavitary neoplasms. Their incidence in cardiac surgery is approximately 0.3%. Symptoms of cardiac myxomas are typically variable, from obstruction of mitral valve to coronary embolism resulting in acute myocardial infarction. In this case, left atrial myxoma is presented as paroxysmal supraventricular tachycardia.
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Neoplasias Cardíacas/diagnóstico por imagen , Mixoma/diagnóstico por imagen , Taquicardia Supraventricular/diagnóstico por imagen , Adulto , Femenino , Neoplasias Cardíacas/cirugía , Humanos , Mixoma/cirugía , Radiografía , Taquicardia Supraventricular/cirugíaRESUMEN
Polymer electrolyte membrane fuel cells (PEMFCs) have reached the commercialization phase, representing a promising approach to curbing carbon emissions. However, greater durability of PEMFCs is of paramount importance to ensure their long-term viability and effectiveness, and catalyst development has become a focal point of research. Pt nanoparticles supported on carbon materials (Pt/C) are the primary catalysts used in PEMFCs. Accomplishing both a high dispersion of uniform metal particles on the carbon support and robust adhesion between the metal particles and the carbon support is imperative for superior stability, and will thereby, advance the practical applications of PEMFCs in sustainable energy solutions. Ultrasound-assisted polyol synthesis (UPS) has emerged as a suitable method for synthesizing catalysts with a well-defined metal-support structure, characterized by the high dispersion and uniformity of metal nanoparticles. In this study, we focused on the effect of ultrasound on the synthesis of Pt/C via UPS and the resulting enhanced stability of Pt/C catalysts. Therefore, we compared Pt/C synthesized using a conventional polyol synthesis (Pt/C_P) and Pt/C synthesized via UPS (Pt/C_U) under similar synthesis conditions. The two catalysts had a similar Pt content and the average particle size of the Pt nanoparticles was similar; however, the uniformity and dispersion of Pt nanoparticles in Pt/C_U were better than those of Pt/C_P. Moreover, ex/in-situ analyses performed in a high-temperature environment, in which nanoparticles tend to agglomerate, have revealed that Pt/C_U exhibited a notable improvement in the adhesion of Pt particles to the carbon support compared with that of Pt/C_P. The enhanced adhesion is crucial for maintaining the stability of the catalyst, ultimately contributing to a better durability in practical applications. Ultrasound was applied to the carbon support without the Pt precursor under the same UPS conditions used to synthesize Pt/C_U to identify the reason for the increased adhesion between the Pt particles and the carbon support in Pt/C_U, and we discovered that oxygen functional groups (C-O, C = O, and O-C = O) for anchoring site of Pt particles were generated in the carbon support. Pt/C_U displayed an increase in stability in an electrochemical accelerated stress test (AST) in an acidic electrolyte. The physical and chemical effects of ultrasound on the synthesis of Pt/C via UPS were identified, and we concluded that UPS is suitable for synthesizing carbon supported electrocatalysts with high stability.
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OBJECTIVES: To assess whether different degrees of creatine kinase-myocardial band isoenzyme (CK-MB) elevation after percutaneous coronary intervention (PCI) affect the subsequent risk of death. BACKGROUND: While there is consensus that extensive cardiac enzyme elevation increase mortality significantly, there is uncertainty about the exact clinical impact of smaller CK-MB elevations after PCI. METHODS: The published literature was scanned by formal searches of electronic databases such as PubMed and MEDLINE from January 1999 to October 2011. Risk ratio (RR) was used as summary estimate. RESULTS: Ten studies have been included totaling 48,022 patients who underwent PCI (12,246 patients with CK-MB elevation and 35,776 patients without CK-MB elevation). Mean followup duration for each study ranged from 6 to 48 months. CK-MB elevation >1× the upper limit of normal (ULN) conferred a significant increase in the risk of mortality with an overall RR of 1.74 (95% confidence interval [CI], 1.42 to 2.13, P < 0.001). Compared with patients without CK-MB elevation, there was a dose-response relationship with RR for death being 1.48 (95% CI, 1.25-1.77, P < 0.001) with CK-MB elevation 1 to <3× ULN, 1.71 (95% CI, 1.23-2.37, P = 0.001) with CK-MB elevation 3 to 5× ULN, and 2.83 (95% CI, 1.98-4.04, P < 0.001) with CK-MB elevation ≥ 5× ULN. CONCLUSIONS: Even a small increase in CK-MB levels after PCI is associated with significantly higher risk of late mortality. Monitoring cardiac enzymes after PCI may help predict the long term clinical outcome.
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Forma MB de la Creatina-Quinasa/sangre , Infarto del Miocardio/enzimología , Miocardio/enzimología , Intervención Coronaria Percutánea/efectos adversos , Anciano , Biomarcadores/sangre , Distribución de Chi-Cuadrado , Femenino , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/sangre , Infarto del Miocardio/etiología , Infarto del Miocardio/mortalidad , Infarto del Miocardio/patología , Miocardio/patología , Necrosis , Oportunidad Relativa , Intervención Coronaria Percutánea/mortalidad , Valor Predictivo de las Pruebas , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Regulación hacia ArribaRESUMEN
Background: The impact of titrated versus fixed intensity statin therapy in patients with coronary artery disease (CAD) and diabetes mellitus (DM) remains to be elucidated. Methods: This was a pre-specified analysis of patients with and without DM from the LODESTAR trial. Patients with CAD were randomly assigned to receive either a treat-to-target strategy with a target LDL-C level of 50-70 mg/dL or a high-intensity statin treatment. Primary outcome was the 3-year composite of all-cause death, myocardial infarction, stroke, or coronary revascularization. Secondary outcomes were safety endpoints. This trial is registered with ClinicalTrials.gov, NCT02579499. Findings: Between September 9, 2016 and November 27, 2019, 4400 patients with CAD were enrolled in the LODESTAR trial. The median age was 65 years (interquartile range, 59-73 years), 3172 (72%) were male, and 1468 (33%) had DM at baseline. There was no significant difference in the occurrence of the primary outcome between the treat-to-target group and high-intensity statin group among patients with DM (10.5% versus 11.1%, hazard ratio [HR] 0.94, 95% confidence interval [CI] 0.69-1.29, p = 0.70) and those without DM (6.9% versus 7.5%, HR 0.93, 95% CI 0.71-1.21, p = 0.58). Among patients without DM, there was a trend towards a lower risk of new-onset DM in the treat-to-target group (8.4% versus 10.4% in the high-intensity statin group, HR 0.79, 95% CI 0.62-1.01; p = 0.06). Interpretation: In patients with CAD, a treat-to-target LDL-C strategy of 50-70 mg/dL as the goal was comparable to high-intensity statin therapy in terms of 3-year clinical efficacy and safety outcomes regardless of the presence of DM. Funding: Sam Jin Pharmaceutical, Seoul, Korea and Chong Kun Dang Pharmaceutical, Seoul, Korea.
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PURPOSE: The incidence and prognostic implications of atrial fibrillation (AF) in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) are controversial, especially for Korean patients. Furthermore, the pattern of antithrombotic therapy for these patients is unknown. The present study sought to identify the impact of AF on Korean patients undergoing TAVI and demonstrate the status of antithrombotic therapy for these patients. MATERIALS AND METHODS: A total of 660 patients who underwent TAVI for severe AS were recruited from the nationwide K-TAVI registry in Korea. The enrolled patients were stratified into sinus rhythm (SR) and AF groups. The primary endpoint was all-cause death at 1-year. RESULTS: AF was recorded in 135 patients [pre-existing AF 108 (16.4%) and new-onset AF 27 (4.1%)]. The rate of all-cause death at 1 year was significantly higher in patients with AF than in those with SR [16.2% vs. 6.4%, adjusted hazard ratio (HR): 2.207, 95% confidence interval (CI): 1.182-4.120, p=0.013], regardless of the onset timing of AF. The rate of new pacemaker insertion at 1 year was also significantly higher in patients with AF than in those with SR (14.0% vs. 5.5%, adjusted HR: 3.137, 95%CI: 1.621-6.071, p=0.001). Among AF patients, substantial number of patients received the combination of multiple antithrombotic agents (77.8%), and the most common combination was that of aspirin and clopidogrel (38.1%). CONCLUSION: AF was an independent predictor of 1-year mortality and new pacemaker insertion in Korean patients undergoing TAVI.
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Estenosis de la Válvula Aórtica , Fibrilación Atrial , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Fibrilación Atrial/tratamiento farmacológico , Fibrilación Atrial/etiología , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Fibrinolíticos , Pronóstico , Sistema de Registros , Estenosis de la Válvula Aórtica/complicaciones , Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/cirugía , Resultado del Tratamiento , Factores de RiesgoRESUMEN
BACKGROUND: Drug-eluting stents significantly improved angiographic and clinical outcomes compared with bare metal stents in diabetic patients. However, a comparison of everolimus-eluting stents and sirolimus-eluting stents in diabetic patients has not been evaluated. Therefore we compared effectiveness of everolimus-eluting stents and sirolimus-eluting stents in patients with diabetes mellitus. METHODS AND RESULTS: This prospective, multicenter, randomized study compared everolimus-eluting stent (n=149) and sirolimus-eluting stent (n=151) implantation in diabetic patients. The primary end point was noninferiority of angiographic in-segment late loss at 8 months. Clinical events were also monitored for at least 12 months. Everolimus-eluting stents were noninferior to sirolimus-eluting stents for 8-month in-segment late loss (0.23 ± 0.27 versus 0.37 ± 0.52 mm; difference, -0.13 mm; 95% confidence interval, -0.25 to -0.02; upper 1-sided 95% confidence interval, -0.04; P<0.001 for noninferiority), with reductions in in-stent restenosis (0% versus 4.7%; P=0.029) and in-segment restenosis (0.9% versus 6.5%; P=0.035). However, in-stent late loss (0.11 ± 0.26 versus 0.20 ± 0.49 mm; P=0.114) was not statistically different between the 2 groups. At 12 months, ischemia-driven target lesion revascularization (0.7% versus 2.6%; P=0.317), death (1.3% versus 3.3%; P=0.448), and myocardial infarction (0% versus 1.3%; P=0.498) were not statistically different between the 2 groups. Major adverse cardiac events, including death, myocardial infarction, and ischemia-driven target lesion revascularization (2.0% versus 5.3%; P=0.218), were also not statistically different between the 2 groups. CONCLUSION: Everolimus-eluting stents were noninferior to sirolimus-eluting stents in reducing in-segment late loss and reduced angiographic restenosis at 8 months in patients with diabetes mellitus and coronary artery disease.
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Angioplastia Coronaria con Balón/métodos , Enfermedad de la Arteria Coronaria/terapia , Angiopatías Diabéticas/terapia , Stents Liberadores de Fármacos , Sirolimus/análogos & derivados , Sirolimus/uso terapéutico , Adolescente , Adulto , Anciano , Angioplastia Coronaria con Balón/efectos adversos , Reestenosis Coronaria/prevención & control , Everolimus , Femenino , Estudios de Seguimiento , Humanos , Inmunosupresores/uso terapéutico , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Resultado del Tratamiento , Adulto JovenRESUMEN
BACKGROUND: Sodium bicarbonate has been postulated to prevent contrast-induced acute kidney injury (CI-AKI) by various mechanisms, although the reports are conflicting. METHODS AND RESULTS: We searched MEDLINE, EMBASE, and the Cochrane databases for randomized controlled trials that compared a sodium chloride with a sodium bicarbonate hydration regimen with regard to CI-AKI. Data across 19 clinical trials consisting of 3,609 patients were combined. Preprocedural hydration with sodium bicarbonate was associated with a significant decrease in the rate of CI-AKI (odds ratio [OR] 0.56; 95% confidence interval [CI] 0.36-0.86; P=0.008). Stratified analyses by the type of contrast medium suggested lower odds of CI-AKI with sodium bicarbonate in studies using low-osmolar contrast media (OR 0.40; 95% CI 0.23-0.71, P=0.002) compared with those using the iso-osmolar agents (OR 0.76; 95% CI 0.41-1.43; P=0.40). No significant difference in the rates of postprocedural death (OR 0.49; 95% CI 0.23-1.04; P=0.06) and the requirement for renal replacement therapy (OR 0.94; 95% CI 0.46-1.91; P=0.86) was observed. However, we found significant changes in serum bicarbonate and potassium levels after sodium bicarbonate infusion. CONCLUSIONS: This updated meta-analysis demonstrates that sodium bicarbonate-based hydration is superior to sodium chloride in preventing CI-AKI of patients undergoing exposure to iodinated contrast media.
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Lesión Renal Aguda/inducido químicamente , Lesión Renal Aguda/prevención & control , Medios de Contraste/efectos adversos , Bicarbonato de Sodio/uso terapéutico , Medios de Contraste/administración & dosificación , Femenino , Humanos , MEDLINE , Masculino , Terapia de Reemplazo Renal , Cloruro de Sodio/uso terapéuticoRESUMEN
OBJECTIVES: To evaluate the impact of cilostazol on the angiographic and clinical outcomes in patients undergoing percutaneous coronary intervention (PCI) with stents and treated with aspirin and thienopyridine. METHODS: A total of 11 randomized controlled trials including 8,525 patients comparing triple antiplatelet therapy (aspirin, thienopyridine and cilostazol) with standard dual antiplatelet therapy were included in the analysis. The primary end points were in-segment late loss and angiographic restenosis at angiographic follow-up. Secondary end points included mortality, stent thrombosis, target lesion revascularization (TLR) and major adverse cardiac events (MACE). RESULTS: Triple antiplatelet therapy was associated with a significant reduction in late loss [weighted mean difference 0.14, 95% confidence interval (CI) 0.08-0.20; p < 0.001] and angiographic restenosis [odds ratio (OR) 0.58, 95% CI 0.48-0.71; p < 0.001]. Addition of cilostazol to dual antiplatelet therapy was associated with a significant reduction in TLR (OR 0.56, 95% CI 0.41-0.77; p < 0.001) and MACE (OR 0.72, 95% CI 0.60-0.86; p < 0.001) with no differences in mortality (p = 0.29), stent thrombosis (p = 0.60) or bleeding episodes (p = 0.77). CONCLUSIONS: Cilostazol in addition to dual antiplatelet therapy appears to be effective in reducing the risk of restenosis and repeat revascularization after PCI without any significant benefits for mortality or stent thrombosis.
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Reestenosis Coronaria/prevención & control , Intervención Coronaria Percutánea/métodos , Inhibidores de Agregación Plaquetaria/uso terapéutico , Stents , Tetrazoles/uso terapéutico , Aspirina/uso terapéutico , Prótesis Vascular , Implantación de Prótesis Vascular/métodos , Cilostazol , Clopidogrel , Terapia Combinada , Quimioterapia Combinada , Femenino , Oclusión de Injerto Vascular/prevención & control , Humanos , Masculino , Persona de Mediana Edad , Piridinas/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como Asunto , Ticlopidina/análogos & derivados , Ticlopidina/uso terapéutico , Resultado del TratamientoRESUMEN
Although vasodilators are widely used in patients with vasospastic angina (VA), few studies have compared the long-term prognostic effects of different types of vasodilators. We investigated the long-term effects of vasodilators on clinical outcomes in VA patients according to the type of vasodilator used. Study data were obtained from a prospective multicenter registry that included patients who had symptoms suggestive of VA. Patients were classified into two groups according to use of nitrates (n = 239) or other vasodilators (n = 809) at discharge. The composite clinical events rate, including acute coronary syndrome (ACS), cardiac death, new-onset arrhythmia (including ventricular tachycardia and ventricular fibrillation), and atrioventricular block, was significantly higher in the nitrates group (5.3% vs. 2.2%, p = 0.026) during one year of follow-up. Specifically, the prevalence of ACS was significantly more frequent in the nitrates group (4.3% vs. 1.5%, p = 0.024). After propensity score matching, the adverse effects of nitrates remained. In addition, the use of nitrates at discharge was independently associated with a 2.69-fold increased risk of ACS in VA patients. In conclusion, using nitrates as a vasodilator at discharge can increase the adverse clinical outcomes in VA patients at one year of follow-up. Clinicians need to be aware of the prognostic value and consider prescribing other vasodilators.
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BACKGROUND AND OBJECTIVES: The aim of this study was to demonstrate the efficacy and safety of treatment with drug-coated balloon (DCB) in a large real-world population. METHODS: Patients treated with DCBs were included in a multicenter observational registry that enrolled patients from 18 hospitals in Korea between January 2009 and December 2017. The primary outcome was target lesion failure (TLF) defined as a composite of cardiovascular death, target vessel myocardial infarction, and clinically indicated target lesion revascularization at 12 months. RESULTS: The study included 2,509 patients with 2,666 DCB-treated coronary artery lesions (1,688 [63.3%] with in-stent restenosis [ISR] lesions vs. 978 [36.7%] with de novo lesions). The mean age with standard deviation was 65.7±11.3 years; 65.7% of the patients were men. At 12 months, the primary outcome, TLF, occurred in 179 (6.7%), 151 (8.9%), 28 (2.9%) patients among the total, ISR, and de novo lesion populations, respectively. A history of hypertension, diabetes, acute coronary syndrome, previous coronary artery bypass graft, reduced left ventricular ejection fraction, B2C lesion and ISR lesion were independent predictors of 12 months TLF in the overall study population. CONCLUSIONS: This large multicenter DCB registry study revealed the favorable clinical outcome of DCB treatment in real-world practice in patient with ISR lesion as well as small de novo coronary lesion.
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Background Chronic vasodilator therapy with long-acting nitrate is frequently used to treat vasospastic angina. However, the clinical benefits of this approach are controversial. We investigated the prognostic impact of vasodilator therapy in patients with vasospastic angina from the multicenter, prospective VA-KOREA (Vasospastic Angina in KOREA) registry. Methods and Results We analyzed data from 1895 patients with positive intracoronary ergonovine provocation test results. The patients were divided into 4 groups: no vasodilator (n=359), nonnitrate vasodilator (n=1187), conventional nitrate (n=209), and a combination of conventional nitrate and other vasodilators (n=140). The primary end point was a composite of cardiac death, acute coronary syndrome, and new-onset arrhythmia at 2 years. Secondary end points were the individual components of the primary end point, all-cause death, and rehospitalization due to recurrent angina. The groups did not differ in terms of the risk of the primary end point. However, the acute coronary syndrome risk was significantly higher in the conventional nitrate (hazard ratio [HR], 2.49; 95% CI, 1.01-6.14; P=0.047) and combination groups (HR, 3.34; 95% CI, 1.15-9.75, P=0.027) compared with the no-vasodilator group, as assessed using the inverse probability of treatment weights. Subgroup analyses revealed prominent adverse effects of nitrate in patients with an intermediate positive ergonovine provocation test result and in those with low Japanese Coronary Spasm Association scores. Conclusions Long-acting nitrate-based chronic vasodilator therapy was associated with an increased 2-year risk of acute coronary syndrome in patients with vasospastic angina, especially in low-risk patients.
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Angina Pectoris Variable , Vasoespasmo Coronario , Angina Pectoris Variable/tratamiento farmacológico , Angiografía Coronaria/métodos , Vasoespasmo Coronario/complicaciones , Vasoespasmo Coronario/diagnóstico , Vasoespasmo Coronario/tratamiento farmacológico , Humanos , Pronóstico , Estudios Prospectivos , Vasodilatadores/efectos adversosRESUMEN
BACKGROUND: There is only limited data on coronary artery aneurysms (CAA) after drug-eluting stent (DES) implantation. METHODS AND RESULTS: Two hundred-fifty one patients who had 2 angiographic follow-ups at 8 months and 28-36 months, respectively, after the index procedure with DES from 2003 to 2007 were enrolled. A CAA was defined as a localized dilatation exceeding 1.5 times the diameter of the adjacent artery. The independent risk factors and major adverse cardiac events (MACE) were determined, including cardiac death, myocardial infarction (MI) and target-vessel revascularization (TVR), between the patients with CAA (n=35) and without them (n=216). On multivariate analysis, a lesion in an infarct-related artery (IRA) (odds ratio (OR): 6.1, P=0.001), a lesion in the left anterior descending artery (OR: 4.9, P=0.005), a lesion length >33 mm (OR: 3.9, P=0.022), and a lesion with chronic total occlusion (CTO) (OR: 3.4, P=0.044) were the independent risk factors for CAA. Follow-up duration was 1,046±516 days. Although most patients (71.4%) were asymptomatic, MACE was found in 10 patients (28.6%). No deaths occurred. MI with stent thrombosis occurred in 5 patients (14.3%) and TVR occurred in 10 patients (28.6%). CONCLUSIONS: The risk factors for the development of CAA after DES are a long lesion over 33 mm, a lesion in the left anterior descending artery, a lesion in an IRA, and CTO. Long-term follow-up and large clinical trials are warranted for patients with CAA.
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Aneurisma Coronario/etiología , Aneurisma Coronario/patología , Stents Liberadores de Fármacos/efectos adversos , Anciano , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Factores de RiesgoRESUMEN
Limited data are available on the long-term clinical efficacy of drug-eluting stent (DES) in diffuse long lesions. From May 2006 to May 2007, a total of 335 consecutive patients (374 lesions) were underwent percutaneous coronary intervention with implantation of long DES (≥ 30 mm) in real world practice. Eight-month angiographic outcomes and 2-yr clinical outcomes were compared between SES (n = 218) and PES (n = 117). Study endpoints were major adverse cardiac events including cardiac death, myocardial infarction, target-lesion revascularization, target-vessel revascularization and stent thrombosis. Baseline characteristics were similar in the two groups as were mean stent length (44.9 ± 15.2 mm in SES and 47.4 ± 15.9 in PES, P = 0.121). Late loss at 8 months follow-up was significantly lower in SES than in PES group (0.4 ± 0.6 mm in SES vs 0.7 ± 0.8 mm in PES, P = 0.007). Mean follow-up duration was 849 ± 256 days, and 2-yr cumulative major adverse cardiac events were significantly lower in the SES than in the PES group (5.5% in SES vs 15.4% in PES, P = 0.003). In conclusion, long-term DES use in diffuse long coronary lesions is associated with favorable results, with SES being more effective and safer than PES in this real-world clinical experience.