Impact of Thrombus Burden on Outcomes After StandardVersus Mesh-Covered Stents in Acute Myocardial Infarction(from the MGuard for Acute ST Elevation Reperfusion Trial)

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.

MGuard Embolic Protection Stent - The Importance of Thrombus Management in ST-elevation Myocardial Infarction Primary Percutaneous Coronary Intervention: Proceedings of STEMI symposium at EuroPCR on 20-23rd May 2014 in Paris.

Distal embolisation of atherothrombotic material is a frequent consequence of percutaneous coronary intervention (PCI) in ST-elevation myocardial infarction (STEMI). This causes microvascular occlusions, leading to a further reduction in myocardial reperfusion. The MGuard™ embolic protection stent (EPS) features a unique polymer micronet mesh coating. When used in acute STEMI, the MGuard EPS shows significant improvement in myocardial flow and ST resolution, even in complicated clinical cases vs the standard approach with conventional bare metal or drug-eluting stents. Data from the andomised Safety and Efficacy Study of MGuard Stent After a Heart Attack (MASTER II) trial and from a real-life registry have shown the efficacy and safety of the MGuard in primary PCI. This report of the proceedings of a symposium at EuroPCR, 20-23 May 2014, Paris, France, discussed clinical trial data, as well as a number of clinical cases, illustrating the utility of the MGuard EPS in difficult situations.

Desfechos clínicos por região geográfica em pacientes com implante de stent eluidor de Zotarolimus / Clinical outcomes by geographic region for patients implanted with the zotarolimus-eluting stent / Desenlaces clínicos por región geográfica en pacientes con implante de Stent liberador de Zotarolimus

FUNDAMENTO: Diferenças entre regiões geográficas em relação à características de pacientes e desfechos, particularmente em síndromes coronarianas agudas, tem sido demonstradas em testes clínicos. Os desfechos clínicos após intervenções coronarianas percutâneas com o stent eluidor de Zotarolimus em uma população real foram analisados com o tempo. OBJETIVO: A influência da localização geográfica sobre os desfechos clínicos com o stent eluidor de Zotarolimus foi avaliada em três regiões: Pacífico Asiático, Europa e América Latina. MÉTODOS: Um total de 8.314 pacientes (6.572 da Europa, 1.522 do Pacífico Asiático e 220 da América Latina) foram acompanhados por 1 ano; 2.116 desses (1.613, 316, e 187, respectivamente) foram acompanhados por 2 anos. Características dos pacientes e lesões, terapia antiplaquetária dupla e desfechos clínicos foram comparados entre a América Latina e as outras duas regiões. RESULTADOS: Os pacientes da América Latina apresentavam a maior proporção de fatores de risco e infarto do miocárdio prévio. O uso da terapia antiplaquetária dupla declinou rapidamente na América Latina, de 44,9 por cento em 6 meses para 22,5 por cento em 1 ano e 7,8 por cento em 2 anos (Europa: 87,4 por cento, 61,5 por cento, 19,7 por cento; Pacífico Asiático: 82,4 por cento, 67,0 por cento, 45,7 por cento, respectivamente). Não houve diferenças significantes entre a América Latina e a Europa ou Pacífico Asiático para qualquer desfecho em qualquer ponto do tempo. A incidência de trombose de stent provável e definitiva pelo Academic Research Consortium foi baixa (<1,2 por cento) entre todos os pacientes em 1 ano e 2 anos. CONCLUSÃO: Os desfechos clínicos foram comparáveis entre os pacientes da América Latina e Europa, e América Latina e Pacífico Asiático, a despeito dos subgrupos clínicos menos favoráveis na América Latina, perfil de risco mais elevado e menor uso acentuado de terapia antiplaquetária dupla com o tempo.

BACKGROUND: Differences between geographic regions in patient characteristics and outcomes, particularly for acute coronary syndromes, have been demonstrated in clinical trials. Clinical outcomes after percutaneous coronary interventions with the Zotarolimus-eluting stent in a real-world population were assessed over time. OBJECTIVE: The influence of geographic location on clinical outcomes with the Zotarolimus-eluting stent was assessed in 3 regions: Asia Pacific, Europe, and Latin America. METHODS: A total of 8,314 patients (6,572 Europe, 1,522 Asia Pacific, and 220 Latin America) were followed for 1 year; 2,116 of these (1,613, 316, and 187, respectively) were followed for 2 years. Patient and lesion characteristics, dual antiplatelet therapy, and clinical outcomes were compared between Latin America and the other regions. RESULTS: Patients in Latin America had the highest proportions of risk factors and prior myocardial infarction. Dual antiplatelet therapy usage rapidly declined in Latin America, from 44.9 percent at 6 months to 22.5 percent at 1 year and 7.8 percent at 2 years (Europe: 87.4 percent, 61.5 percent, 19.7 percent; Asia Pacific: 82.4 percent, 67.0 percent, 45.7 percent). There were no significant differences between Latin America and Europe or Asia Pacific for any outcome at either time point. The incidence of Academic Research Consortium definite and probable stent thrombosis was low (<1.2 percent) among all patients at 1 year and 2 years. CONCLUSION: Clinical outcomes were comparable between patients in Latin America and Europe, and Latin America and Asia Pacific, despite less favorable clinical subsets in Latin America, a higher risk profile, and markedly lower use of dual antiplatelet therapy over time.

FUNDAMENTO: Las diferencias entre las regiones geográficas en relación con las características de pacientes y desenlaces, sobre todo en los síndromes coronarios agudos se ha demostrado en ensayos clínicos. Los desenlaces clínicos después de las intervenciones coronarias percutáneas con stent liberador de zotarolimus en una población real se analizaron a través del tiempo. Objetivos: La influencia de la ubicación geográfica sobre los desenlaces clínicos con el stent liberador de zotarolimus se evaluó en tres regiones: Pacífico Asiático, Europa y América Latina. MÉTODOS: A total of 8,314 patients (6.572 Europe, 1.522 Asia Pacific, and 220 Latin America) were followed for 1 year; 2.116 of these (1.613, 316, and 187, respectively) were followed for 2 years. Patient and lesion characteristics, dual antiplatelet therapy, and clinical outcomes were compared between Latin America and the other regions. RESULTADOS: Los pacientes en América Latina tuvieron la mayor proporción de factores de riesgo e infarto de miocardio previo. Hubo un rápido descenso en el uso de la terapia antiplaquetaria en América Latina, el 44,9 por ciento en 6 meses para 22,5 por ciento en 1 año y 7,8 por ciento en 2 años (Europa: un 87,4 por ciento, un 61,5 por ciento, un 19,7 por ciento; Pacífico Asiático: un 82,4 por ciento, un 67,0 por ciento, un 45,7 por ciento, respectivamente). No hubo diferencias significativas entre América Latina y Europa o Pacífico Asiático para cualquier desenlace en cualquier momento. La incidencia de trombosis de stent probable y definitiva por el Academic Research Consortium fue baja (< 1,2 por ciento) entre todos los pacientes en 1 año y 2 años. CONCLUSIONES: Los desenlaces clínicos fueron comparables entre los pacientes de América Latina y Europa, y América Latina y Pacífico Asiático, pese a los subgrupos clínicos menos favorables en América Latina, perfil de riesgo más elevado y menor uso acentuado de terapia antiplaquetaria doble con el ...

Clinical outcomes by geographic region for patients implanted with the zotarolimus-eluting stent.

BACKGROUND: Differences between geographic regions in patient characteristics and outcomes, particularly for acute coronary syndromes, have been demonstrated in clinical trials. Clinical outcomes after percutaneous coronary interventions with the Zotarolimus-eluting stent in a real-world population were assessed over time. OBJECTIVES: The influence of geographic location on clinical outcomes with the Zotarolimus-eluting stent was assessed in 3 regions: Asia Pacific, Europe, and Latin America. METHODS: A total of 8,314 patients (6,572 Europe, 1,522 Asia Pacific, and 220 Latin America) were followed for 1 year; 2,116 of these (1,613, 316, and 187, respectively) were followed for 2 years. Patient and lesion characteristics, dual antiplatelet therapy, and clinical outcomes were compared between Latin America and the other regions. RESULTS: Patients in Latin America had the highest proportions of risk factors and prior myocardial infarction. Dual antiplatelet therapy usage rapidly declined in Latin America, from 44.9% at 6 months to 22.5% at 1 year and 7.8% at 2 years (Europe: 87.4%, 61.5%, 19.7%; Asia Pacific: 82.4%, 67.0%, 45.7%). There were no significant differences between Latin America and Europe or Asia Pacific for any outcome at either time point. The incidence of Academic Research Consortium definite and probable stent thrombosis was low (<1.2%) among all patients at 1 year and 2 years. CONCLUSION: Clinical outcomes were comparable between patients in Latin America and Europe, and Latin America and Asia Pacific, despite less favorable clinical subsets in Latin America, a higher risk profile, and markedly lower use of dual antiplatelet therapy over time.

Safety and effectiveness of the Endeavor zotarolimus-eluting stent in real-world clinical practice: 12-month data from the E-Five registry.

OBJECTIVES: The E-Five registry was designed to evaluate the safety and effectiveness of the Endeavor zotarolimus-eluting stent (ZES) (Medtronic CardioVascular, Santa Rosa, California) for the treatment of coronary artery stenosis across a wide range of patients treated in real-world clinical practice settings. BACKGROUND: Early clinical trials with the Endeavor ZES have demonstrated low rates of target lesion revascularization with a favorable safety profile including low late stent thrombosis with up to 4 years of follow-up. A clinical registry was designed to complement controlled trial data by examining a large patient population, including high-risk patient subsets. METHODS: The E-Five registry is a prospective, nonrandomized, multicenter global registry conducted at 188 centers worldwide. Adult patients (n = 8,314) with coronary artery disease who underwent single-vessel or multivessel percutaneous coronary intervention were enrolled. The primary end point was the rate of major adverse cardiac events (MACE) at 12 months. A secondary analysis stratified patients by standard versus extended-use clinical and lesion characteristics. RESULTS: Overall 12-month outcome rates were MACE 7.5%; cardiac death 1.7%; myocardial infarction (all) 1.6%; target lesion revascularization 4.5%; and stent thrombosis (Academic Research Consortium definite and probable) 1.1%. The 12-month MACE rates were 4.3% and 8.6% for standard- and extended-use patients, respectively (p < 0.001). CONCLUSIONS: This large, international multicenter registry provides important information regarding the long-term safety and efficacy of the Endeavor ZES across standard and extended-use patients in the real-world setting. Rates of MACE and measures of safety including cardiac death, myocardial infarction, and stent thrombosis were low and consistent with pooled results of clinical trials. (E-Five Registry: A World-Wide Registry With The Endeavor Zotarolimus Eluting Coronary Stent [eFive Registry]; NCT00623441).

Safety of Coronary Sirolimus-Eluting Stents in Daily Clinical Practice

Background—The expanding indications for sirolimus-eluting stents (SES) include increasingly complex coronary lesions and populations with clinical profiles markedly different from those of early pivotal controlled studies. The e-Cypher registry monitored the safety and efficacy of SES currently implanted worldwide in daily practice. Methods and Results—Between April 2002 and September 2005, data were collected on 15 157 patients who underwent implantation of 1 SES at 279 medical centers from 41 countries. An independent endpoint review committee adjudicated all reported major adverse cardiovascular events, stent thromboses, and target-vessel revascularizations. Data were managed and analyzed by independent organizations. Predictors of adverse clinical events were identified by regression analysis. The mean age of the sample was 61.7 11.4 years; 77.7% were men, and 28.6% were diabetics. A total of 18 295 lesions were treated (20 503 SES) during the index procedure. The cumulative rates of major adverse cardiovascular events were 1.36% at 30 days, 3.38% at 6 months, and 5.80% at 1 year. The rates of acute, subacute, and late stent thrombosis were 0.13%, 0.56%, and 0.19% of patients, respectively, representing a 12-month actuarial incidence of 0.87%. Insulin-dependent diabetes, acute coronary syndrome at presentation, and advanced age were clinical predictors, whereas TIMI flow grade 3 after the index procedure, treatment of multiple lesions, a prominently calcified or totally occluded target lesion, and multivessel disease were the angiographic or procedural predictors of stent thrombosis at 12 months. Conclusions—This analysis of 1-year data collected by the e-Cypher registry suggests a high degree of safety of SES, with a rate of stent thrombosis similar to that observed in randomized trials.

Safety of coronary sirolimus-eluting stents in daily clinical practice one-year follow-up of the e-cypher registry

Background—The expanding indications for sirolimus-eluting stents (SES) include increasingly complex coronary lesions and populations with clinical profiles markedly different from those of early pivotal controlled studies. The e-Cypher registry monitored the safety and efficacy of SES currently implanted worldwide in daily practice. Methods and Results—Between April 2002 and September 2005, data were collected on 15 157 patients who underwent implantation of 1 SES at 279 medical centers from 41 countries. An independent endpoint review committee adjudicated all reported major adverse cardiovascular events, stent thromboses, and target-vessel revascularizations. Data were managed and analyzed by independent organizations. Predictors of adverse clinical events were identified by regression analysis. The mean age of the sample was 61.7 11.4 years; 77.7% were men, and 28.6% were diabetics. A total of 18 295 lesions were treated (20 503 SES) during the index procedure. The cumulative rates of major adverse cardiovascular events were 1.36% at 30 days, 3.38% at 6 months, and 5.80% at 1 year. The rates of acute, subacute, and late stent thrombosis were 0.13%, 0.56%, and 0.19% of patients, respectively, representing a 12-month actuarial incidence of 0.87%. Insulin-dependent diabetes, acute coronary syndrome at presentation, and advanced age were clinical predictors, whereas TIMI flow grade 3 after the index procedure, treatment of multiple lesions, a prominently calcified or totally occluded target lesion, and multivessel disease were the angiographic or procedural predictors of stent thrombosis at 12 months. Conclusions—This analysis of 1-year data collected by the e-Cypher registry suggests a high degree of safety of SES, with a rate of stent thrombosis similar to that observed in randomized trials