Effectiveness and Safety of Biolimus A9™-Eluting stEnt in Patients with AcUTe Coronary sYndrome; A Multicenter, Observational Study (BEAUTY Study)

PURPOSE: This study sought to determine the 1-year clinical effectiveness and safety of a biodegradable, polymer-containing Biolimus A9™-eluting stent (BES) in Korean patients with acute coronary syndrome (ACS). MATERIALS AND METHODS: A total of 1000 ACS patients with 1251 lesions who underwent implantation of BESs at 22 centers in Korea were enrolled between May 2011 and July 2013. We assessed major adverse cardiac events (MACE) defined as the composite of cardiac death, non-fatal myocardial infarction (MI), and clinical-driven target vessel revascularization at 12 months. RESULTS: Patient mean age was 62.6±11.4 years. 72.8% of the patients were male, 28.5% had diabetes, 32.8% had multi-vessel disease (MVD), and 47.9% presented with acute MI (AMI). The mean global registry of acute coronary events risk score of all patients was 103.0±27.6. The number of stents per patient was 1.3±0.6. The incidences of MACE and definite stent thrombosis at 12 months were 3.9% and 0.2%, respectively. On multivariate Cox-regression analysis, age ≥65 years was identified as an independent predictors of 1-year MACE (hazard ratio=2.474; 95% confidence interval=1.202−5.091). Subgroup analyses revealed no significant differences in the incidence of MACE between patients with and without diabetes (4.3% vs. 3.7%, p=0.667), between those who presented with and without AMI (4.4% vs. 3.4%, p=0.403), and between those with and without MVD (4.6% vs. 3.5%, p=0.387). CONCLUSION: Our study demonstrated excellent 1-year clinical outcomes of BES implantation in patients at low-risk for ACS.

Segurança e eficácia dos stents farmacológicos eluidores de biolimus com polímero biodegradável: análise do registro EINSTEIN (Evaluation of Next-generation drug-eluting STEnt IN patients with coronary artery disease) / Safety and efficacy of biolimus-eluting stent with biodegradable polymer: insights from EINSTEIN (Evaluation of Next-generation drug-eluting STEnt IN patients with coronary artery disease) Registry

OBJETIVO: Avaliar a incidência de eventos adversos cardíacos maiores (morte cardíaca, infarto agudo do miocárdio ou necessidade de nova revascularização do vaso-alvo) em 1 ano em pacientes do "mundo real". MÉTODOS: O registro EINSTEIN é um estudo observacional prospectivo, unicêntrico, que incluiu consecutivamente 103 pacientes (152 lesões) tratados com o stent BiomatrixTM, eluidor de biolimus A9 e polímero biodegradável. RESULTADOS: A média das idades foi de 65,0±12,4 anos; o gênero masculino representou 83,5% dos pacientes; e 37,9% deles eram diabéticos. Em 1 ano, eventos adversos cardíacos maiores ocorreram em 11,7% dos pacientes, incluindo 2,9% de morte cardíaca, 4,9% de infarto agudo do miocárdio sem supradesnivelamento do segmento ST e 3,9% de revascularização do vaso-alvo. Trombose de stent esteve presente em apenas 1% (1 paciente) após o seguimento clínico de 1 ano. CONCLUSÃO: O presente registro sugere que os novos stents farmacológicos eluidores de biolimus A9 com polímero biodegradável são seguros e eficazes em pacientes da prática clínica diária, com baixas taxas de eventos adversos cardíacos maiores no longo prazo.

OBJECTIVE: To evaluate the incidence of major adverse cardiac events (cardiac death, or acute myocardial infarct, or target vessel revascularization) at one year in "real world" patients. METHODS: The EINSTEIN registry is an observational, prospective, single center study that consecutively included 103 patients (152 lesions) treated with the BiomatrixTM stent, a biolimus A9-eluting stent with biodegradable polymer. RESULTS: The mean age was 65.0±12.4 years; male gender represented 83.5% of the patients; and 37.9% of them were diabetic. At one-year, major adverse cardiac events occurred in 11.7% of the patients, including 2.9% of cardiac death, 4.9% of with non ST- segment elevation acute myocardial infarction, and 3.9% of target vessel revascularization. Stent thrombosis occurred in only 1% (1 patient) at one-yearfollow-up. CONCLUSION: The present Registry suggests that new generation biolimus A9 drug-eluting stents are safe and effective in a "real world", all-comers patients, showing low rates of major cardiac adverse events on long-term follow-up.

New Horizons of Acute Myocardial Infarction: From the Korea Acute Myocardial Infarction Registry

As the first nationwide Korean prospective multicenter data collection registry, the Korea Acute Myocardial Infarction Registry (KAMIR) launched in November 2005. Through a number of innovative approaches, KAMIR suggested new horizons about acute myocardial infarction (AMI) which contains unique features of Asian patients from baseline characteristics to treatment strategy. Obesity paradox was existed in Korean AMI patients, whereas no gender differences among them. KAMIR score suggested new risk stratifying method with increased convenience and an enhanced accuracy for the prediction of adverse outcomes. Standard loading dose of clopidogrel was enough for Asian AMI patients. Triple antiplatelet therapy with aspirin, clopidogrel and cilostazol could improve clinical outcomes than dual antiplatelet therapy with aspirin and clopidogrel. Statin improved clinical outcomes even in AMI patients with very low LDL-C levels. The rate of percutaneous coronary intervention was higher and door-to-balloon time was shorter than the previous reports. Zotarolimus eluting stents as the 2nd generation drug-eluting stent (DES) was not superior to the 1st generation DES, in contrast to the western AMI studies. KAMIR made a cornerstone in the study of Korean AMI and expected to be new standards of care for AMI with the renewal of KAMIR design to overcome its pitfalls.

Comparison of sirolimus-, paclitaxel-, and everolimus-eluting stent in unprotected left main coronary artery percutaneous coronary intervention

This retrospective study evaluated the outcomes of patients who underwent unprotected left main coronary artery [ULMCA] percutaneous coronary intervention [PCI] with different types of drug-eluting stents [DES]. The standard of care for patients with ULMCA is coronary artery bypass surgery. However, current guidelines recommend PCI in clinical conditions where there is an increased risk of adverse surgical outcomes. Clinical outcomes of patients undergoing ULMCA PCI with different types of drug-eluting stents [DES] are unknown. Data from a multicenter international registry, which included 239 consecutive patients from four institutions who ULMCA PCI with DES, were collected. There were 42 patients receiving paclitaxel-eluting stent [PES], 158 patients receiving sirolimus-eluting stent [SES], and 39 patients receiving everolimus-eluting stent [EES]. There was no statistical difference in major adverse cardiovascular events, cardiac death, myocardial infarction, target lesion revascularization, and stent thrombosis among PES, SES, and EES at 30 days and 1 year. There are no differences in clinical events among patients receiving PES, SES, and EES for ULMCA disease

Acute and Long-Term Angiographic Outcomes of Side Branch Stenosis after Randomized Treatment of Zotarolimus-, Sirolimus-, and Paclitaxel-Eluting Stent for Coronary Artery Stenosis

This was designed to assess the outcomes of side branch (SB) stenosis after implantation of three drug-eluting stents (DES). From 2,645 patients in the ZEST (Comparison of the Efficacy and Safety of Zotarolimus-Eluting Stent with Sirolimus-Eluting and PacliTaxel-Eluting Stent for Coronary Lesions) Trial, 788 patients had 923 bifurcation lesions with SB > or = 1.5 mm were included. SB was treated in 150 lesions, including 35 (3.8%) receiving SB stenting. Of untreated SB with baseline stenosis < 50%, the incidences of periprocedural SB compromise was similar in the zotarolimus (15.8%), sirolimus (17.2%), and paclitaxel (16.6%) stent groups (P = 0.92). At follow-up angiography, delayed SB compromise occurred in 13.9%, 3.2%, and 9.4% (P = 0.010) of these groups. When classified into four groups (< 50%, 50%-70%, 70%-99%, and 100%), 9.0% of untreated SB were worsened, whereas improvement and stationary were observed in 9.6% and 81.4%. In a multivariable logistic regression model, main branch (MB) stenosis at follow-up (%) was the only independent predictor of SB stenosis worsening (odds ratio, 1.03; 95% confidence interval, 1.01-1.04; P < 0.001). After MB stenting in bifurcation lesions, a minority of SB appears to worsen. DES with strong anti-restenotic efficacy may help maintain SB patency.

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 ...

The Initial Extent of Malapposition in ST-Elevation Myocardial Infarction Treated with Drug-Eluting Stent: The Usefulness of Optical Coherence Tomography

PURPOSE: The aim of this study is to identify the extent of initial malapposition using optical coherence tomography (OCT) in ST-elevation myocardial infarctions (STEMI) treated with different types of drug-eluting stents (DES). MATERIALS AND METHODS: Twenty four STEMI patients that underwent primary percutaneous coronary intervention (PCI) were enrolled. The OCT and intravascular ultrasound (IVUS) were performed within 72 hours after the primary PCI. Distances between the endo-luminal surface of the strut reflection and the vessel wall and the extent of malapposition were measured and analyzed. RESULTS: Sirolimus-eluting stents (SES), paclitaxel-eluting stents (PES) and zotarolimus-eluting stents (ZES) were deployed in 7 patients (29%), 7 patients (29%) and 10 patients (42%). In total, 4951 struts in 620 mm single-stent segments were analyzed (1463 struts in SES, 1522 in PES, and 1966 in ZES). In strut analysis by OCT, the incidence of malapposition was 17 % (860/4951) and in stent analysis by IVUS, malapposition rate was 21% (5/24). The malapposition rate of strut level using OCT in 5 patients who had malapposition in IVUS was significantly higher than the 19 of those who had not (32 +/- 5% vs. 12 +/- 6%, p = 0.001). In addition, the frequency of malapposition was also significantly different (28% in SES, 11% in PES, 10% in ZES, p = 0.001). The use of SES was an independent predictor of malapposed struts. CONCLUSION: The incidence of malapposition using OCT was quite prevalent in STEMI after primary PCI with DES implantation and SES has especially higher rates of malapposition compared to other DESs.

Análise volumétrica tardia após implante de stents eluidores de sirolimus versus biolimus A9 / Late volumetric analysis after implantation of sirolimus versus biolimus A9-eluting stents

Os stents eluidores de sirolimus (SES) reduaem significativamente a incidência de reestenose e de eventos cardíacos maiores em comparação a stents convencionais. O sirolimus A9 (BA9), um análogo do sirolimus, demosntrou eficácia e segurança simulares no estudo randomizado e controlado STEALTH I. O objetivo deste estudo é comparar a eficácia do stent eluidor de BA9 com os SES, assim como seu desempenho em relação ao respectivos grupos controle, utilizando a análise volumétrica pelo ultra-som intracoronário (3D-USIC). Método: No total, 45 pacientes foram randomizados 2:1 para o grupo submetido a implante de stents eluidores de BA9(n igual 30) ou para o grupo conrole (n igual 15). Os resultados de angiografia coronária quantitativa e 3D-USIC foram comparados a uma série histórica de pacientes submetidos a implante de SES (n igual 30) ou controle (n igual 15). As características clínicas e angiográficas foram semelhantes entre os grupos , exceto pela maior quantidade de lesões tipo C e mulheres no grupo dos stents eluidores de BA9. Resultados: Aos seis meses de seguimento, a perda tardia intra-stent foi significativamente inferior...

Introduction: Sirolimus-eluting stents (SES) significantly reduce restenosis and major adverse cardiac events (MACE) compared to bare metal stents (BMS). The novel sirolimus analog, Biolimus A9T (BA9), presented similar safety and efficacy in the randomized, controlled STEALTH I trial. This study compared the efficacy of a BA9-eluting stent versus sirolimus-eluting and bare metal control stents. Methods: Forty-five patients with de novo coronary lesions were randomly assigned in a 2:1 basis to receive either BA9-eluting (n = 30) or bare metal (n=15) S-stents. Quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS), at 6 months, were then compared to a matched series of patients who received either sirolimus-eluting (n = 30) or bare metal (n = 15) Bx Velocity stents. Baseline clinical and angiographic characteristics were similar among all groups, except for a significantly higher percentage of females and Class C lesions in the BA9-eluting stent group. Results: At 6 month follow-up, there was no significant difference in clinical outcomes between any of the groups. QCA revealed significantly lower late loss in both drug-eluting stents (DES) groups compared to bare metal controls, but no significant difference between BA9 and SES groups was observed (0.24 ± 0.39mm vs. 0.15 ± 0.38mm, p = NS). Obstruction volume measured by 3D IVUS was significantly reduced in both DES groups compared to bare metal controls, but did not differ between the BA9 and SES groups (2.23% vs. 3.30%, BA9 vs. SES, p=NS). Conclusions: BA9-eluting stents reduce neointimal hyperplasia, safely and effectively, compared to BMS, and the magnitude of this inhibition is similar to that of SES.

Inibição da proliferação neointimal após o implante de stents eluidores de biolimus A9: Análise volumétrica tardia com ultra-som intracoronário / Supressiion of intimal proliferation after implantation of biolimus A9-eluting stents: 6-month single-center intravascular ultrasound follow-up

Introdução: O estudo STEALTH I demonstrou a eficácia e segurança dos stents eluidores de Biolimus A (BA9) em reduzir a perda-tardia angiográfica e apresentar uma baixa incidência de eventos cardíacos maiores, entretanto os achados de ultra-som intracoronário (USIC) ainda não foram descritos. O objetivo deste estudo é descrever os achados de análise volumétrica por USIC nos pacientes recrutados em nossa instituição. Métodos e Resultados: Quarenta e cinco pacientes apresentando lesão coronária de novo, única, foram randomizados 2:1 para receber stents eluidores de BA9 (n igual 30) ou stents controle (n igual 15). A média de idade foi de 58 anos, com 16 por cento diabéticos e 62 por cento do sexo masculino. As características clínicas e angiográficas foram similares entre os grupos. Aos 6 meses de seguimento não houve diferença significativa entre os grupos quanto a desfechos clínicos. O índice de hiperplasia intimal intra-stent foi inferior no grupo dos stents eluidores de BA9 em comparação ao grupo controle 0,19 mais/menos 0,08 vs. 2.71 mais/menos 0.50, ) menor 0.0001), assim como o percentual de obstrução...

Background: Biolimus A9 (BA9) is a novel sirolimus analog with similar antiproliferative properties. BA9-eluting stents reduce angiographic late-loss compared to bare metal stents (BMS), with a low incidence of major adverse cardiac events (MACE), as reported in the randomized, controlled STEALTH I trial. We describe the intravascular ultrasound (IVUS) volumetric findings of patients enrolled at our institution. Methods and Results: Forty-five patients presenting a single, de novo coronary lesion (2.5-4.0 mm vessels; lesion length <24 mm) were randomly assigned in a 2:1 basis to receive either BA9-eluting (n=30) or bare metal stents (n=15). Mean age was 58 years, with 16% diabetics and 62% men. Baseline clinical and angiographic characteristics were similar between groups. At 6 month follow-up, there was no statistical difference in clinical outcomes between groups. In-stent intimal hyperplasia index measured by IVUS was 0.19+/-0.08 mm3/ mm3 for the BA9 group vs. 2.71+/-0.50 mm3/mm3 for BMS controls. The percentage of stent obstruction was also significantly lower for the BA9 group when compared to BMS (2.2+/-0.80% vs. 19.9+/-4.67%, P<0.0001). No stent thrombosis, aneurysm formation or incomplete stent apposition was observed in any group. Conclusions: Using IVUS volumetric analysis, we showed that BA9-eluting stents have a potent inhibitory effect on neointimal proliferation when compared to BMS at 6-month follow-up.

Análise ultra-sonográfica da resposta vascular tardia das bordas de stents liberadores de drogas análogas ao sirolimus: comparação entre diabéticos e não-diabéticos / IVUS analysis of the late vascular response at the edges of sirolimus analogue-eluting stents: comparison among diabetic and non-diabetic patients

Introdução: A resposta vascular dos segmentos adjacentes aos stents liberadores de medicamentos continua sendo objeto de estudo, principalmente nos pacientes diabéticos (DM), nos quais a progressão da aterosclerose é mais freqüentemente observada. Recentemente, os fármacos Biolimus e Zotarolimus demonstraram eficácia semelhante ao Sirolimus na redução da hiperplasia intimal intra-stent. Objetivo: Comparar a resposta vascular tardia nas bordas proximais (BP) e distais (BD), entre DM e não-diabéticos (NDM) tratados com stents liberadores de sirolimus ou fármacos análogos (Biolimus e Zotarolimus), avaliada pelo ultra-som intracoronário (USIC). Método: Foram incluídos 153 pacientes (306 bordas) tratados com stents (53% Sirolimus, 26% Zotarolimus e 21% Biolimus) e divididos em dois grupos em relação à presença de diabetes: DM, 122 bordas e NDM, 166 bordas; 18 bordas foram excluídas. As análises pelo USIC foram realizadas nos 5 mm proximal e distal aos stents após o implante (basal) e no seguimento tardio (± 6 meses). Os volumes do vaso (VV), do lúmen (VL) e da placa (VP) foram calculados pela regra de Simpson. A porcentagem de obstrução (% Obs) e a variação dos volumes (Delta - Δ) entre seguimento e basal foram também calculados. Reestenose das bordas foi definida como uma obstrução >50% no seguimento. Resultados: A media para idade foi 58±9 anos, sendo 59% do sexo masculino. Não houve diferença nas características basais dos grupos...

Introduction: Late vascular response of the segments adjacent to proximal and distal edges of the drug-eluting stents is still not well established, particularly in diabetic patients who are prone to atherosclerosis plaque progression. Recently, new sirolimus-analogue eluting stents (Biolimus and Zotarolimus) have demonstrated potent antiproliferative effects. Objective: To compare the late vascular responses at proximal (PE) and distal (DE) edges of sirolimus analogue-eluting stents in patients with and without diabetes (DM or NDM) using intravascular ultrasound (IVUS). Method: 306 IVUS edge analyses were performed in 153 patients treated with drug-eluting stents(53% Sirolimus, 26% Zotarolimus, 21% Biolimus). Patients were divided in two groups: DM, 122 edges and NDM, 166 edges; 18 edges were excluded. IVUS analyses were performed post-intervention (PI) and after 6-month follow-up (FU) and included 5 mm distal and proximal to the stented segment. Vessel, lumen and plaque volumes were calculated by Simpon’s rule. Percentage of obstruction and volumes changes (FUminus PI values) were also calculated. Edge restenosis was defined as obstruction >50% at FU. Results: The mean age was 58±9 y, and 59% were male. The baseline characteristics were similar between groups. In both groups, the entire lesion length was totally covered (stent length / lesion length was 1.51 and 1.52). There were no significant differences in edge volumes between the two groups...