Hemoglobin Level as a Predictor of Major Adverse Cardiovascular Events and Short-term Outcomes in Stemi Patient Treated with Pharmacoinvasive Strategy versus Primary PCI

Background: Anaemia is prevalent among cases with acute coronary syndrome (ACS) and has been linked to poor clinical prognosis. Guidelines for cases with ST-segment elevation myocardial infarction (STEMI) recommend timely primary percutaneous coronary intervention (pPCI) as the preferred reperfusion strategy. If timely pPCI cannot be performed, a pharmacoinvasive strategy (PI) is recommended within 12 hours of symptom onset. The aim of this work was to study and assess the impact of hemoglobin level as a predictor of MACE and short-term outcomes in cases treated with Primary PCI vs pharmacoinvasive strategy. Methods: This prospective case-control observational study was conducted on 100 cases that were divided into 2 groups. Group I consisted of 50 anaemic cases & group II consisted of 50 cases that were not anaemic. Both groups were subdivided into A subgroups that underwent revascularization by pPCI and B subgroups that underwent revascularization by pharmacoinvasive strategy. Results: There was no significant difference in LVEF, infarct site and final TIMI flow, the anaemic groups showed statistically significant more total MACE than non-anaemic groups whether revascularized by pPCI or pharmacoinvasive strategy. As expected, anaemic cases tended to have higher bleeding complications especially those undergoing pharmacoinvasive strategy. The anaemic cases also were less likely to be discharged on RAAS and beta blockers. Conclusions: Anaemic cases whether revascularized with pPCI or pharmacoinvasive strategy tend to have higher incidence of MACE and major bleeding with no significant difference in mortality. There was no significant difference between LVEF between the study groups.

Evaluation of pharmacoinvasive strategy versus percutaneous coronary intervention in patients with acute myocardial infarction with ST-segment elevation at the National Institute of Cardiology (PHASE-MX) / Evaluación de la estrategia farmacoinvasiva versus angioplastia coronaria transluminal percutánea primaria en pacientes con infarto agudo de miocardio con elevación del segmento ST en el Instituto Nacional de Cardiología (PHASE-MX)

Abstract Objective: The objective of PHASE-MX registry is to validate the efficacy and safety of the pharmacoinvasive strategy in comparison with percutaneous coronary intervention (PCI) in patients with acute myocardial infarction with ST segment elevation (STEMI) in a metropolitan region of Mexico. The primary outcome will consist of the composite of cardiovascular death, re-infarction, stroke and cardiogenic shock. Methods: The PHASE-MX registry will include a prospective cohort of patients with STEMI who received reperfusion treatment (mechanical of pharmacological) in the first 12 h after the onset of symptoms. The registry is designed to compare the efficacy and safety of primary PCI and pharmacoinvasive strategy. The simple size was calculated in 344 patients divided into two groups, with an estimated loss rate of 10%. Patients included in the PHASE-MX cohort will be followed for up to one year. Conclusion: In Mexico, only 5 out of 10 patients with STEMI have access to reperfusion therapy. Pharmacoinvasive strategy is takes advantage of the accessibility of fibrinolysis and the effectiveness of PCI. The present research protocol aims to provide information that serves as a link between information derived from controlled clinical trials and records derived from real world experience.

Resumen Objetivo: El objetivo del registro PHASE-MX es validar la eficacia y seguridad de la estrategia farmacoinvasiva en comparación con la angioplastia coronaria transluminal percutánea primaria (ACTPp) en pacientes con infarto agudo de miocardio con elevación del segmento ST (IAMCEST) en una región metropolitana de México. El desenlace primario es el compuesto de muerte cardiovascular, reinfarto, accidente vascular cerebral y choque cardiogénico. Métodos: El registro PHASE-MX es una cohorte prospectiva de pacientes con IAMCEST que recibieron tratamiento de reperfusión (mecánico o farmacológico) en las primeras 12 horas desde el inicio de los síntomas, atendidos en el Instituto Nacional de Cardiología Ignacio Chávez. El análisis estadístico se basa en la no inferioridad de la estrategia farmacoinvasiva en comparación con la ACTPp. Se calcula un tamaño de muestra de 344 pacientes divididos en dos grupos (angioplastia primaria y estrategia farmacoinvasiva), considerada una tasa de pérdidas de 10%. Los pacientes incluidos en la cohorte PHASE-MX se seguirán durante un año. Discusión: En México, sólo 5 de cada 10 pacientes con IAMCEST tienen acceso al tratamiento de reperfusión. La estrategia farmacoinvasiva aprovecha la accesibilidad de la fibrinólisis y la efectividad de la ACTPp, por lo que podría resultar el método de elección en el tratamiento del IAMCEST en la mayoría de los casos. El presente protocolo de investigación pretende aportar información que sirva como enlace entre la información derivada de los estudios clínicos controlados y los registros derivados de la experiencia del mundo real.

Pharmacoinvasive strategy versus primary angioplasty in patients with acute ST-segment elevation myocardial infarction / Estrategia farmacoinvasiva versus angioplastia primaria en pacientes con infarto agudo al miocardio con elevación del segmento ST

Abstract: Background: Primary percutaneous coronary intervention (PPCI) is the treatment of choice for acute ST-elevation myocardial infarction (STEMI). The delays associated with PPCI reduce the benefits of this therapy. To minimize these delays, the pharmacoinvasive strategy (PS) was developed, consisting of applying thrombolytic therapy followed by coronary angioplasty 2 to 24 hours after. Objective: To compare the safety and efficiency of PPCI vs PS in STEMI. Methods: We included patients with STEMI who had emergency PCI. The primary endpoint was combined major adverse cardiac events (MACE), death, reinfarction, stroke, target vessel revascularization (TVR) during hospitalization. The secondary endpoints were the individual components of MACE, and major bleeding (Bleeding Academic Research Consortium: BARC ≥ 3). Results: A total of 400 patients, 263 (65.8%) for PPCI group, 114 (28.5%) for PS group and 23 (5.75%) for diagnostic group. The PS group, 79 (69.3%) were then categorized as systematic angioplasty having had a successful thrombolysis, and 35 (30.7%) were rescue angioplasty because they had a failed thrombolysis. There were no differences in MACE: 13 (9.5%) patients in PS and 27 (10.3%) patients in the PPCI (p = 0.806), there were no differences in the individual components of MACE. The rate of major bleeding was the same, 5 (3.6%) and 4 (1.5%) respectively (p = 0.173). The multivariate analysis did not show a relationship between MACE and the reperfusion strategy. Conclusions: The pharmacoinvasive strategy when compared to PPCI has a similar rate of primary and secondary endpoints. There is no increase in major bleeding therefore, it is an important strategy that offers a reperfusion therapy for patients with STEMI in a non-PCI capable hospital.(AU)

Resumen: Antecedentes: La intervención coronaria percutánea primaria (ICPP) es el tratamiento de elección en infarto agudo al miocardio con elevación del ST (IAMCEST). El retraso relacionado con ICPP disminuye el beneficio. Buscando una reperfusión oportuna se implementa la estrategia farmacoinvasiva (EFI), que consiste en realizar trombólisis seguido de ICP entre 2 a 24 horas después. Objetivo: Comparar la seguridad y eficacia en pacientes sometidos a ICPP contra EFI en IAMCEST. Métodos: Se incluyeron pacientes con IAMCEST sometidos a ICP emergente. El punto final primario son eventos cardiacos adversos mayores (ECAM), muerte, reinfarto, evento vascular cerebral y revascularización del vaso tratado, durante la hospitalización. Los puntos finales secundarios son la presencia de los componentes individuales del ECAM, y el sangrado mayor (BARC ≥ 3). Resultados: Se estudiaron 400 pacientes, 263 (65.8%) de ICPP, 114 (28.5%) a EFI y 23 (5.75%) angiografía diagnóstica. Del grupo EFI, 79 (69.3%) fueron angioplastia sistemática por trombólisis exitosa y 35 (30.7%) por angioplastia de rescate por trombólisis fallida. No se observó diferencia en la frecuencia de ECAM: EFI 13 (9.5%) contra ICPP 27 (10.3%) respectivamente (p = 0.806), tampoco hubo diferencia en los componentes individuales. No se observó diferencia en sangrado mayor, 5 (3.6%) vs 4 (1.5%), (p = 0.173). El análisis multivariado no relacionó la estrategia de reperfusión con los ECAM. Conclusiones: La EFI comparada con ICPP demuestra una tasa similar de ECAM, así como de sus componentes individuales. No se asocia con aumento de hemorragia mayor, concluyendo que ofrece el beneficio de una reperfusión oportuna sin aumento del riesgo en los hospitales que no tienen la capacidad para realizar ICPP.(AU)

Reperfusion therapy of myocardial infarction in Mexico: A challenge for modern cardiology / La reperfusión en el infarto del miocardio en México: un reto para la cardiología moderna

Abstract: Mexico has been positioned as the country with the highest mortality attributed to myocardial infarction among the members of the Organization for Economic Cooperation and Development. This rate responds to multiple factors, including a low rate of reperfusion therapy and the absence of a coordinated system of care. Primary angioplasty is the reperfusion method recommended by the guidelines, but requires multiple conditions that are not reached at all times. Early pharmacological reperfusion of the culprit coronary artery and early coronary angiography (pharmacoinvasive strategy) can be the solution to the logistical problem that primary angioplasty rises. Several studies have demonstrated pharmacoinvasive strategy as effective and safe as primary angioplasty ST-elevation myocardial infarction, which is postulated as the choice to follow in communities where access to PPCI is limited. The Mexico City Government together with the National Institute of Cardiology have developed a pharmaco-invasive reperfusion treatment program to ensure effective and timely reperfusion in STEMI. The model comprises a network of care at all three levels of health, including a system for early pharmacological reperfusion in primary care centers, a digital telemedicine system, an inter-hospital transport network to ensure primary angioplasty or early percutaneous coronary intervention after fibrinolysis and a training program with certification of the health care personal. This program intends to reduce morbidity and mortality associated with myocardial infarction.

Resumen: México se ha posicionado como el país con mayor mortalidad atribuible al infarto del miocardio entre los países de la Organización de Cooperación y Desarrollo Económico. Esta tasa responde a múltiples factores, incluyendo una baja tasa de reperfusión y la ausencia de un sistema único y coordinado para la atención del infarto. Aun cuando la angioplastia es el método de reperfusión recomendado, requiere un sistema coordinado con personal entrenado y recursos materiales, condiciones que no siempre pueden ser alcanzadas. La reperfusión farmacológica temprana, seguida de angiografía coronaria temprana (estrategia farmacoinvasiva) es la solución al problema logístico que representa la angioplastia primaria. Múltiples estudios han demostrado que la estrategia farmacoinvasiva es tan segura y efectiva como la angioplastia primaria en el infarto agudo del miocardio con elevación del segmento ST, y se plantea como la estrategia de elección en comunidades donde el acceso a angioplastia está limitado por factores económicos, geográficos o socioculturales. El gobierno de la Ciudad de México en conjunto con el Instituto Nacional de Cardiología ha desarrollado un programa de estrategia farmacoinvasiva para asegurar la reperfusión temprana en el infarto del miocardio. El modelo comprende una red de atención en los 3 niveles, incluyendo un sistema de reperfusión farmacológica en centros de primer contacto, transferencia de electrocardiogramas mediante telemedicina entre el primer nivel y el Instituto Nacional de Cardiología, una red de transporte interhospitalario y un programa de entrenamiento y educación continua. El objetivo de este programa es reducir la morbilidad y la mortalidad asociadas al infarto del miocardio.

Trombólisis prehospitalaria: en perspectiva nacional. Estrategia farmacoinvasiva para la reperfusión temprana del IAMCEST en México / Prehospital thrombolysis: A national perspective. Pharmaco-invasive strategy for early reperfusion of STEMI in Mexico

Resumen: Objetivo: Revisar la evidencia existente sobre el papel de la trombólisis prehospitalaria en los pacientes con infarto agudo de miocardio con elevación del segmento ST (IAMCEST) como parte de una estrategia de vanguardia para reducir el tiempo de reperfusión miocárdica y, con ello, mejorar la supervivencia y la función. Métodos: Se utilizó la técnica de exploración-reducción-evaluación-análisis y síntesis de estudios relacionados, con una visión general de las recomendaciones actuales, de los datos de ensayos clínicos controlados y de los registros nacionales e internacionales sobre las diferentes estrategias de reperfusión para el IAMCEST. En total, se examinaron 186 referencias sobre trombólisis prehospitalaria, 130 referencias en tiempos puerta-tratamiento, 139 referencias en la gestión de IAMCEST y los registros nacionales e internacionales, así como 135 referencias en intervención coronaria percutánea primaria y de rescate en IAMCEST. Finalmente se retuvieron las 48 referencias que se consideraron más relevantes e informativas. Conclusión: El factor "tiempo" es esencial en el éxito de la reperfusión temprana en el IAMCEST sobre todo si se toma en cuenta la trombólisis prehospitalaria. La intervención coronaria percutánea primaria está sujeta a su factibilidad antes de 120 min del inicio de los síntomas. En nuestro medio, al igual que en el ámbito internacional, la trombólisis continúa siendo una estrategia con gran alcance en las expectativas de vida y función de los pacientes. Los sistemas de telecomunicación deben incorporarse en tiempo real a las necesidades prioritarias de enfermedades catastróficas como el IAMCEST, donde la vida es dependiente del tiempo.

Abstract: Objective: To review the existing evidence on the role of prehospital thrombolysis in patients with ST-segment elevation acute myocardial infarction (STEMI) as part of a strategy of cutting edge to reduce the time of coronary reperfusion and as a consequence improves both the survival and function. Methods: We used the technique of exploration-reduction-evaluation-analysis and synthesis of related studies, with an overview of current recommendations, data from controlled clinical trials and from the national and international registries about the different strategies for STEMI reperfusion. In total, we examined 186 references on prehospital thrombolysis, 130 references in times door-treatment, 139 references in STEMI management and national and international registries as well as 135 references on rescue and primary percutaneous coronary intervention for STEMI. Finally the 48 references that were more relevant and informative were retained. Conclusion: The "time" factor is crucial in the success of early reperfusion in STEMI especially if thrombolysis is applied correctly during the prehospital time. The primary percutaneous coronary intervention is contingent upon its feasibility before 120 min from the onset of symptoms. In our midst to internationally, thrombolysis continues to be a strategy with great impact on their expectations of life and function of patients. Telecommunication systems should be incorporate in real time to the priority needs of catastrophic diseases such as STEMI where life is depending on time.

Predictors of in-hospital mortality in patients with ST-segment elevation myocardial infarction undergoing pharmacoinvasive treatment

OBJECTIVES: To identify predictors of in-hospital mortality in patients with acute myocardial infarction undergoing pharmacoinvasive treatment. METHODS: This was an observational, prospective study that included 398 patients admitted to a tertiary center for percutaneous coronary intervention within 3 to 24 hours after thrombolysis with tenecteplase. ClinicalTrials.gov: NCT01791764 RESULTS: The overall in-hospital mortality rate was 5.8%. Compared with patients who survived, patients who died were more likely to be older, have higher rates of diabetes and chronic renal failure, have a lower left ventricular ejection fraction, and demonstrate more evidence of heart failure (Killip class III or IV). Patients who died had significantly lower rates of successful thrombolysis (39% vs. 68%; p = 0.005) and final myocardial blush grade 3 (13.0% vs. 61.9%; p<0.0001). Based on the multivariate analysis, the Global Registry of Acute Coronary Events score (odds ratio 1.05, 95% confidence interval (CI) 1.02-1.09; p = 0.001), left ventricular ejection fraction (odds ratio 0.9, 95% CI 0.89-0.97; p = 0.001), and final myocardial blush grade of 0-2 (odds ratio 8.85, 95% CI 1.34-58.57; p = 0.02) were independent predictors of mortality. CONCLUSIONS: In this prospective study that evaluated patients with ST-segment elevation myocardial infarction treated by a pharmacoinvasive strategy, the in-hospital mortality rate was 5.8%. The Global Registry of Acute Coronary Events score, left ventricular ejection fraction, and myocardial blush were independent predictors of mortality in this high-risk group of acute coronary syndrome patients. .