RESUMO

OBJECTIVES: To evaluate the long-term safety and efficacy of the novel combined sirolimus-eluting endothelial progenitor cell capture Combo stent (OrbusNeich, Fort Lauderdale, FL) at 5 years in the REMEDEE (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coated bio-Engineered stEnt) trial. BACKGROUND: Drug-eluting stents have limited restenosis and reintervention but are complicated by late and very late thrombosis and accelerated neoatherosclerosis. Alternative or adjunctive technologies are needed to address these limitations. METHODS: A total of 183 patients with de novo lesions in native coronary arteries were randomized 2:1 to Combo (n = 124) or Taxus Liberté (n = 59). Primary endpoint was 9 month angiographic in-stent late lumen loss and the secondary endpoint was the occurrence of major adverse events (MACE) through 5-year follow-up. RESULTS: Compared with Taxus, after 5 years the Combo stent was associated with similar rates of MACE (18.3% vs. 16.9%, p = .89), cardiac death (0.8% vs. 5.1%, p = .07), myocardial infarction (4.1% vs. 3.4%, p = .81), target lesion (9.4% vs. 10.2%, p = .78), and target vessel revascularization (14.4% vs. 11.9%, p = .73). No cases of definite stent thrombosis were reported in the Combo group. The follow-up rate at 5 years was 97.7%. CONCLUSION: At 5-year follow-up, the Combo stent remained clinically safe and effective with an overall low rate of MACE comparable to Taxus.

Assuntos

Stents Farmacológicos , Intervenção Coronária Percutânea , Sirolimo , Células Progenitoras Endoteliais

RESUMO

OBJECTIVES: The authors evaluated the 5-year cumulative incidence of cardiovascular events following Resolute zotarolimus-eluting stent (R-ZES) implantation. BACKGROUND: Individual trials are often underpowered to show differences for low-frequency adverse events. The R-ZES was studied in 10 prospective clinical trials, designed with identical adverse event definitions, ascertainment, and adjudication. METHODS: The RESOLUTE Global Clinical Trial Program includes 7,618 patients treated with R-ZES: RESOLUTE first-in-human study (N = 139), RESOLUTE All Comers (N = 1,140), RESOLUTE International (N = 2,349), RESOLUTE US (N = 1,402), RESOLUTE US 38 mm (N = 114), RESOLUTE Japan (N = 100), RESOLUTE Japan Small Vessel Study (N = 65), RESOLUTE Asia (N = 311), RESOLUTE China Randomized Controlled Trial (N = 198), and RESOLUTE China Registry (N = 1,800). The 5-year cumulative incidence of events was calculated. RESULTS: The 5-year cumulative incidence of cardiac events was 13.4% for target lesion failure and included 5.0% cardiac death, 4.4% target vessel myocardial infarction, and 6.3% clinically driven target lesion revascularization. Dual-antiplatelet therapy at 1, 3, and 5 years was 91%, 37%, and 32%, respectively. The 5-year cumulative incidence of definite or probable stent thrombosis was 1.2%, which comprised 0.7% at 1 year and an annualized rate of 0.1% thereafter. Five-year use of dual-antiplatelet therapy varied geographically from 63% in Japan to 11% in Europe. CONCLUSIONS: In the largest group of R-ZES patients examined to date, the majority of stent-related events, including target vessel myocardial infarction and stent thrombosis, occurred within the first year of implantation with much lower risks of these events out to 5 years.

Assuntos

Fármacos Cardiovasculares/administração & dosagem , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Intervenção Coronária Percutânea/instrumentação , Sirolimo/análogos & derivados , Idoso , Ásia/epidemiologia , Austrália , Fármacos Cardiovasculares/efeitos adversos , Ensaios Clínicos como Assunto , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/mortalidade , Trombose Coronária/epidemiologia , Quimioterapia Combinada , Europa (Continente)/epidemiologia , Medicina Baseada em Evidências , Feminino , Humanos , Incidência , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , América do Norte/epidemiologia , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Inibidores da Agregação Plaquetária/administração & dosagem , Desenho de Prótese , Fatores de Risco , Sirolimo/administração & dosagem , Sirolimo/efeitos adversos , América do Sul/epidemiologia , Fatores de Tempo , Resultado do Tratamento

RESUMO

AIMS: To evaluate the rate of clinical events and bleeding risk according to age in patients undergoing percutaneous coronary intervention (PCI) with a new-generation drug-eluting stent (DES) enrolled in the RESOLUTE Global Clinical Program. METHODS: This study represents a pooled analysis of five trials included in the RESOLUTE program including 5,130 patients, of whom 1,675 (32.6%) were ≥70 years old (elderly patients). RESULTS: After adjusting for confounders, age ≥70 years was a significant predictor of high mortality at 30 days (0.6 vs. 0.1%, P = 0.017) and 2 years (7.2 vs. 2%, P < 0.001). No differences were seen with respect to acute myocardial infarction (MI) or target lesion and vessel revascularization rates between young and elderly patients. Bleeding rates were higher in the elderly throughout follow-up. In the elderly, 7 of the 27 (26%) patients with bleeding episodes died, with a median time between bleeding episode to death of 21 days. In the younger population, 1 patient of 17 with a bleeding episode died (400 days later). CONCLUSIONS: Elderly patients undergoing PCI with a new-generation DES have increased mortality and bleeding risk, with similar rates of acute MI and repeat revascularization. Bleeding risk was higher in the elderly and strongly related to death. Target lesion failure rates were not significantly different between the two age groups, suggesting that the Resolute zotarolimus-eluting stent (R-ZES) is effective for patients younger and older than 70 years of age. R-ZES may be recommended for elderly patients when PCI with a DES is identified as a suitable option.

Assuntos

Fármacos Cardiovasculares/administração & dosagem , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Intervenção Coronária Percutânea/instrumentação , Sirolimo/análogos & derivados , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/mortalidade , Feminino , Hemorragia/etiologia , Humanos , Estimativa de Kaplan-Meier , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Infarto do Miocárdio/etiologia , Estudos Observacionais como Assunto , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Desenho de Prótese , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Risco , Sirolimo/administração & dosagem , Fatores de Tempo , Resultado do Tratamento

RESUMO

Large thrombus burden negatively affects the results of percutaneous coronary intervention(PCI) for acute ST-segment elevation myocardial infarction (STEMI). We investigated theimpact of thrombus burden in patients with STEMI undergoing primary PCI with the meshcoveredMGuard stent (InspireMD Ltd., Tel Aviv, Israel) versus a control bare-metal or drugelutingstent. In 433 patients with STEMI randomized to the MGuard stent versus a controlstent, angiographically visible thrombus was identified in 383 patients (88.5%), with medianthrombus area 30.15 mm2 (22.70, 41.93). Lesions with large thrombus (area > median) weretreated with more frequent use of manual aspiration (80.8% vs 65.8%, p[0.0009) and longer(22.1 – 5.9 vs 19.4 – 5.4 mm, p <0.0001) and larger (3.46 – 0.40 vs 3.29 – 0.36 mm, p <0.0001)stents. PCI of lesions with large thrombus burden had more thrombotic complications (30.6%vs 15.9%, p [ 0.0007) and reduced angiographic success (80.3% vs 91.1%, p [ 0.003). Inlarge thrombus lesions, the MGuard stent was more effective than control stents in achievingThrombolysis In Myocardial Infarction-3 flow (87.9% vs 74.5%, p [ 0.02) and tended toresult in less slow flow or no reflow (8.8% vs 17.6%, p [ 0.07). ST-segment resolution wasimproved with the MGuard, and clinical outcomes were favorable in both stent groups,regardless of thrombus burden. In conclusion, reperfusion success is reduced after primaryPCI in lesions with large thrombus burden, an outcome that may be modified by the MGuardstent.

Assuntos

Infarto do Miocárdio , Intervenção Coronária Percutânea , Stents

RESUMO

Primary percutaneous coronary intervention (PCI) is therecommended method of reperfusion in patients withST-segment elevation myocardial infarction (STEMI).1However, extended delay from symptom onset to mechanicalreperfusion has a negative impact on clinical outcomes.This may be explained by larger infarct size with morefrequent transmural infarction, larger areas of microvasculardysfunction and myocardial edema, and lower proceduralsuccess.2e5 The longer time to reperfusion may promotelarger and more organized thrombus formation and renderboth pharmacologic and mechanical (aspiration thrombectomy)strategies less effective. It is unknown if this limitationmay be overcome with a novel embolic protection stentdesign geared to reduce distal embolization. The purpose ofthis analysis from the MGuard for Acute ST ElevationReperfusion (MASTER) trial was to evaluate the impact ofdelay to reperfusion on outcomes in patients with STEMIundergoing primary PCI according to the type of stent placed.

Assuntos

Infarto do Miocárdio , Reperfusão , Stents

RESUMO

OBJECTIVES: This study sought to compare the efficacy and safety results after coronary implantation of a combined sirolimus-eluting CD34 antibody coated Combo stent (OrbusNeich Medical, Ft. Lauderdale, Florida) with the paclitaxel-eluting Taxus Liberté stent (PES) (Boston Scientific, Natick, Massachusetts). This report summarizes the first-in-man randomized, controlled multicenter REMEDEE trial (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coatED bio-Engineered StEnt) angiographic, intravascular ultrasound, and clinical results up to 12 months. BACKGROUND: Drug-eluting stents have limited restenosis and reintervention but are complicated by especially late and very late stent thrombosis and accelerated neoatherosclerosis. Alternative or adjunct technologies should address these limitations. METHODS: One hundred eighty-three patients with de novo native coronary artery stenoses were randomized 2:1 to Combo stent or PES implantation. The primary endpoint is the angiographic in-stent late lumen loss at 9 months, which was tested for noninferiority between the 2 stent groups. Secondary endpoints include the occurrence of major adverse cardiac events. RESULTS: The Combo stent was found to be noninferior to the PES in 9-month angiographic in-stent late lumen loss with 0.39 ± 0.45 mm versus 0.44 ± 0.56 mm (pnoninferiority = 0.0012). At 12 months, the occurrence of major adverse cardiac events was 8.9% in the Combo group and 10.2% in the PES group (p = 0.80) with no difference in mortality, occurrence of myocardial infarction, or target lesion revascularization. No stent thrombosis was reported in either group. CONCLUSIONS: In the REMEDEE trial the Combo stent has shown to be effective by meeting the primary noninferiority angiographic endpoint and safe, with an overall low rate of clinical events in both stent groups, including no stent thrombosis up to 12 months.

Assuntos

Anticorpos/administração & dosagem , Fármacos Cardiovasculares/administração & dosagem , Materiais Revestidos Biocompatíveis , Estenose Coronária/terapia , Stents Farmacológicos , Células Endoteliais/patologia , Paclitaxel/administração & dosagem , Intervenção Coronária Percutânea/instrumentação , Sirolimo/administração & dosagem , Células-Tronco/patologia , Idoso , Antígenos CD34/imunologia , Ásia , Austrália , Brasil , Angiografia Coronária , Reestenose Coronária/etiologia , Estenose Coronária/imunologia , Estenose Coronária/mortalidade , Estenose Coronária/patologia , Trombose Coronária/etiologia , Células Endoteliais/imunologia , Europa (Continente) , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Desenho de Prótese , Fatores de Risco , Células-Tronco/imunologia , Fatores de Tempo , Resultado do Tratamento , Ultrassonografia de Intervenção

RESUMO

BACKGROUND: Primary percutaneous coronary intervention (PCI) improves survival compared with thrombolytic therapy in ST-segment elevation myocardial infarction (STEMI), with much of the benefit attributable to greater rates of normal epicardial and myocardial perfusion resulting in enhanced myocardial salvage. However, reduced tissue reperfusion after primary PCI may occur from distal thromboemboli with capillary plugging. The MGuard stent consists of a balloon-expandable metallic scaffold with mesh sleeve fibers of polyethylene terephthalate attached to its outer surface to trap friable debris/thrombi and reduce distal embolization. The MGuard for Acute ST Elevation Reperfusion (MASTER) trial has been designed to evaluate the MGuard stent in patients with STEMI. STUDY DESIGN: The MASTER trial is a prospective, multicenter, randomized study designed to compare the incidence of complete (=70%) ST-segment resolution with PCI using bare metal or drug-eluting stents (the control arm) versus PCI with the MGuard stent, measured 60 to 90 min after the last angiogram (primary endpoint). Secondary endpoints include the rates of TIMI flow and myocardial blush, and clinical outcomes through 1-year follow-up. The study has enrolled 432 patients with STEMI undergoing primary or rescue angioplasty within 12 hr of symptom onset and includes substudies with cardiac magnetic resonance imaging and quantitative coronary angiography to evaluate infarct size, microvascular obstruction, and angiographic restenosis. CONCLUSIONS: Distal embolization is common during primary PCI and results in reduced myocardial perfusion and lack of reduction of infarct size. The MASTER trial is a prospective, randomized trial designed to assess the potential of the novel MGuard stent with protective mesh net to reduce embolization and enhance myocardial reperfusion compared with routine PCI in the setting of STEMI.

Assuntos

Dispositivos de Proteção Embólica , Infarto do Miocárdio/terapia , Intervenção Coronária Percutânea/instrumentação , Desenho de Prótese , Stents , Brasil , Protocolos Clínicos , Angiografia Coronária , Reestenose Coronária/etiologia , Reestenose Coronária/prevenção & controle , Stents Farmacológicos , Europa (Continente) , Humanos , Imageamento por Ressonância Magnética , Metais , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/mortalidade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Estudos Prospectivos , Projetos de Pesquisa , Tromboembolia/etiologia , Tromboembolia/prevenção & controle , Fatores de Tempo , Resultado do Tratamento , Estados Unidos

RESUMO

Background: Primary percutaneous coronary intervention (PCI) improves survival comparedwith thrombolytic therapy in ST-segment elevation myocardial infarction (STEMI),with much of the benefit attributable to greater rates of normal epicardial and myocardialperfusion resulting in enhanced myocardial salvage. However, reduced tissue reperfusionafter primary PCI may occur from distal thromboemboli with capillary plugging.The MGuard stent consists of a balloon-expandable metallic scaffold with mesh sleevefibers of polyethylene terephthalate attached to its outer surface to trap friable debris/thrombi and reduce distal embolization. The MGuard for Acute ST Elevation Reperfusion(MASTER) trial has been designed to evaluate the MGuard stent in patients with STEMI.Study Design: The MASTER trial is a prospective, multicenter, randomized studydesigned to compare the incidence of complete (=70%) ST-segment resolution withPCI using bare metal or drug-eluting stents (the control arm) versus PCI with theMGuard stent, measured 60 to 90 min after the last angiogram (primary endpoint). Secondaryendpoints include the rates of TIMI flow and myocardial blush, and clinical outcomesthrough 1-year follow-up. The study has enrolled 432 patients with STEMIundergoing primary or rescue angioplasty within 12 hr of symptom onset and includessubstudies with cardiac magnetic resonance imaging and quantitative coronary angiographyto evaluate infarct size, microvascular obstruction, and angiographic restenosis.Conclusions: Distal embolization is common during primary PCI and results inreduced myocardial perfusion and lack of reduction of infarct size. The MASTER trial isa prospective, randomized trial designed to assess the potential of the novel MGuardstent with protective mesh net to reduce embolization and enhance myocardial reperfusioncompared with routine PCI in the setting of STEMI. VC 2013 Wiley Periodicals, Inc.

Assuntos

Reperfusão , Reperfusão Miocárdica , Stents

RESUMO

Background: Measuring circulating cardiac troponin using novel sensitive assays has revealed that even minute elevations are associated with increased mortality in patients with coronary artery disease or even in the general population. Less well defined, however, is the incremental value of measuring circulating cardiac troponin I (cTnI) by a sensitive assay for risk assessment in primary prevention. Methods: We measured circulating concentrations of cTnI, N-terminal pro-B-type natriuretic peptide (NT-proBNP), and high-sensitivity C-reactive protein (hsCRP) in 5388 individuals free of known cardiovascular disease recruited into the DETECT study, a prospective longitudinal population-based cohort study. We determined the prognostic implications for incident major adverse cardio­vascular events (MACE) during 5 years of follow-up. Results: Circulating cTnI was detectable in 19% of the subjects. Increased cTnI concentrations were associated with established risk factors for atherosclerosis and demonstrated a graded relationship with all-cause mortality and incident MACE during 5-year follow-up. A single measurement of cTnI significantly improved risk prediction over established risk factors, and also added prognostic information, when adjusted for serum concentrations of NT-proBNP and hsCRP. Conclusions: Minute increases in cTnI are associated with increased mortality and incident MACE in a large primary prevention cohort and, thus, identify contributors to cardiovascular risk not fully captured by traditional risk factor assessment.

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Antecedentes: La medición de troponina cardíaca en circulación mediante nuevos ensayos sensibles ha revelado que incluso mínimas elevaciones se asocian con mayor mortalidad en pacientes con enfermedad arterial coronaria, o incluso en la población general. Sin embargo, menos conocido es el valor incremental o agregado de la medición de la troponina I cardiaca (cTnI) circulante mediante un ensayo sensible para la evaluación del riesgo en prevención primaria. Métodos: Se midieron las concentraciones circulantes de cTnI, de pro- péptido natriurético tipo B N-terminal (NT-proBNP), y de proteína C reactiva de alta sensibilidad (PCRus), en 5388 personas sin enfermedad cardiovascular conocida reclutadas en el estudio DETECT, un estudio prospectivo longitudinal de cohorte de base poblacional. Se determinaron las implicancias pronósticas en la incidencia de eventos adversos cardiovasculares mayores (MACE) durante 5 años de seguimiento. Resultados: La cTnI se detectó en el 19% de los sujetos. El aumento de las concentraciones de cTnI se asoció con factores de riesgo establecidos para la aterosclerosis y demostró una relación gradual con la mortalidad por todas las causas y la incidencia de MACE durante los 5 años de seguimiento. Una sola medición de cTnI mejoró significativamente la predicción del riesgo por encima de los factores de riesgo establecidos, y también agregó información pronóstica cuando se ajustó por la concentración sérica de NT-proBNP y PCRus. Conclusiones: Mínimos incrementos de cTnI se asociaron con mayor mortalidad e incidencia de MACE en una gran cohorte de prevención primaria y, por tanto, la identificación de sujetos con riesgo cardiovascular no siempre son detectados completamente por la evaluación de factores de riesgo tradicionales.

Assuntos

Humanos , Doenças Cardiovasculares/prevenção & controle , Troponina I/sangue , Biomarcadores , Doenças Cardiovasculares/diagnóstico , Prevenção Primária , Fatores de Risco

RESUMO

Background: Measuring circulating cardiac troponin using novel sensitive assays has revealed that even minute elevations are associated with increased mortality in patients with coronary artery disease or even in the general population. Less well defined, however, is the incremental value of measuring circulating cardiac troponin I (cTnI) by a sensitive assay for risk assessment in primary prevention. Methods: We measured circulating concentrations of cTnI, N-terminal pro-B-type natriuretic peptide (NT-proBNP), and high-sensitivity C-reactive protein (hsCRP) in 5388 individuals free of known cardiovascular disease recruited into the DETECT study, a prospective longitudinal population-based cohort study. We determined the prognostic implications for incident major adverse cardio¡vascular events (MACE) during 5 years of follow-up. Results: Circulating cTnI was detectable in 19% of the subjects. Increased cTnI concentrations were associated with established risk factors for atherosclerosis and demonstrated a graded relationship with all-cause mortality and incident MACE during 5-year follow-up. A single measurement of cTnI significantly improved risk prediction over established risk factors, and also added prognostic information, when adjusted for serum concentrations of NT-proBNP and hsCRP. Conclusions: Minute increases in cTnI are associated with increased mortality and incident MACE in a large primary prevention cohort and, thus, identify contributors to cardiovascular risk not fully captured by traditional risk factor assessment.(AU)

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Antecedentes: La medición de troponina cardíaca en circulación mediante nuevos ensayos sensibles ha revelado que incluso mínimas elevaciones se asocian con mayor mortalidad en pacientes con enfermedad arterial coronaria, o incluso en la población general. Sin embargo, menos conocido es el valor incremental o agregado de la medición de la troponina I cardiaca (cTnI) circulante mediante un ensayo sensible para la evaluación del riesgo en prevención primaria. Métodos: Se midieron las concentraciones circulantes de cTnI, de pro- péptido natriurético tipo B N-terminal (NT-proBNP), y de proteína C reactiva de alta sensibilidad (PCRus), en 5388 personas sin enfermedad cardiovascular conocida reclutadas en el estudio DETECT, un estudio prospectivo longitudinal de cohorte de base poblacional. Se determinaron las implicancias pronósticas en la incidencia de eventos adversos cardiovasculares mayores (MACE) durante 5 años de seguimiento. Resultados: La cTnI se detectó en el 19% de los sujetos. El aumento de las concentraciones de cTnI se asoció con factores de riesgo establecidos para la aterosclerosis y demostró una relación gradual con la mortalidad por todas las causas y la incidencia de MACE durante los 5 años de seguimiento. Una sola medición de cTnI mejoró significativamente la predicción del riesgo por encima de los factores de riesgo establecidos, y también agregó información pronóstica cuando se ajustó por la concentración sérica de NT-proBNP y PCRus. Conclusiones: Mínimos incrementos de cTnI se asociaron con mayor mortalidad e incidencia de MACE en una gran cohorte de prevención primaria y, por tanto, la identificación de sujetos con riesgo cardiovascular no siempre son detectados completamente por la evaluación de factores de riesgo tradicionales.(AU)