Impact of endothelial shear stress on absorption process of resorbable magnesium scaffold: A BIOSOLVE-II substudy

BACKGROUND/PURPOSE: Local hemodynamic forces such as endothelial shear stress (ESS) may have an influence on appropriate neointimal healing, vessel remodeling, and struts absorption process following second-generation drug-eluting resorbable magnesium scaffold (RMS, Magmaris, Biotronik AG, Buelach, Switzerland) placement. The aim of this study was to investigate the impact of ESS assessed by optical coherence tomography (OCT)- based computational fluid dynamic (CFD) simulations on absorption process and coronary lumen dimension after Magmaris implantation. METHODS AND RESULTS: A total of 22 patients who were enrolled in the BIOSOLVE-II trial and underwent serial OCT assessment immediately after Magmaris implantation and at 6- and 12-month follow-up were included. We evaluated qualitative OCT findings frame by frame, and CFD simulations were performed to calculate the ESS at 3-dimensional (3D) reconstructed arteries. For quantitative calculation, the average ESS within each 1-mm section was classified into three groups: low (2.5 Pa). A significant difference of percentage remnants of scaffold was observed among the 3 groups at 12-month follow-up (P = 0.001) but not at 6-month follow-up. Low-ESS segment at baseline resulted in a greater lumen change of −1.857 ± 1.902 mm2 at 1 year compared to −1.277 ± 1.562 mm2 in the intermediate-ESS segment (P = 0.017) and − 0.709 ± 1.213 mm2 in the high-ESS segment (P = 0.001). CONCLUSION: After Magmaris implantation, the presence of higher ESS might be associated with slower strut absorption process but less luminal loss. SUMMARY FOR TABLE OF CONTENTS: The authors analyzed 22 patients from the BIOSOLVE-II trial who underwent optical coherence tomography assessment immediately after receiving a Magmaris second-generation drug-eluting resorbable magnesium scaffold. The analysis found that after Magmaris implantation, the presence of higher endothelial shear stress (ESS) might be associated with slower strut absorption process but less luminal loss. This study is the first demonstrating the impact of ESS assessed by OCT on absorption process and coronary lumen dimension after Magmaris implantation.

Comparison of clinical outcomes between Magmaris and Orsiro drug eluting stent at 12 months: Pooled patient level analysis from BIOSOLVE II-III and BIOFLOW II trials

Background The aim of this study was to compare the 12-month clinical outcomes of patients treated with Magmaris or Orsiro. Second generation drug-eluting absorbable metal scaffold Magmaris (Dreams 2G) has proved to be safe and effective in the BIOSOLVE-II study. Similarly, biodegradable polymer sirolimus-eluting stent, Orsiro has shown notable clinical results even in all-comer populations. Methods Magmaris group patients were taken from the BIOSOLVE-II and BIOSOLVE-III trials, while the patients from Orsiro group were enrolled in BIOFLOW-II trial. The primary outcome was explored using a time-to-event assessment of the unadjusted clinical outcomes for target lesion failure (TLF) at 12 months, followed by a multivariate analysis adjusting for all the significantly different covariates between the groups. Results The study population consisted of 482 patients (521 lesions), 184 patients (189 lesions) in Magmaris group and 298 patients (332 lesions) in Orsiro group. The mean age was 65.5 ±â€¯10.8 and 62.7 ±â€¯10.4 years in Magmaris and Orsiro groups, respectively ( p = 0.005). Magmaris and Orsiro unadjusted TLF rates were 6.0 and 6.4% with no significant difference between the groups ( p = 0.869). In the multivariate analysis, there were no meaningful differences between Magmaris and Orsiro groups. Finally, none of the groups presented device thrombosis cases at 12 months. Conclusion At 12 months there were no significant differences between Magmaris and Orsiro groups neither in the unadjusted assessment nor in the multivariate analysis for target lesion failure. These results should be taken as hypothesis generating and may warrant a head to head comparison on a randomized fashion.

Resultados de los stents Resolute Integrity y Promus Element en el infarto de miocardio: análisis del ensayo aleatorizado DUTCH PEERS (TWENTE II ) / Outcome after myocardial infarction treated with Resolute Integrity and Promus Element stents: insights from the DUTCH PEERS (TWENTE II) randomized trial

Introducción y objetivos: En el infarto agudo de miocardio (IAM), los nuevos stents farmacoactivos (SFA) de alta liberación de fármacos pueden ser de especial utilidad, ya que su diseño flexible podría reducir los traumatismos inducidos por el dispositivo en la lesión culpable. El objetivo del estudio es evaluar la seguridad y la eficacia de las intervenciones coronarias percutáneas con 2 nuevos SFA con recubrimiento de polímero duradero en pacientes con IAM. Métodos: El ensayo multicéntrico prospectivo y aleatorizado DUTCH PEERS (TWENTE II) compara los stents Resolute Integrity y Promus Element en 1.811 pacientes consecutivos no seleccionados (all-comers); a 817 (45,1%) de ellos se los trató por un IAM con o sin elevación del segmento ST y se dispuso de un seguimiento de 2 años del 99,9% de los casos. El objetivo clínico principal es el fallo del vaso diana (FVD), que consiste en la combinación de muerte cardiaca, infarto de miocardio relacionado con el vaso diana y revascularización del vaso diana. Resultados: De los 817 pacientes tratados por un IAM, 421 (51,5%) recibieron un stent Resolute Integrity y 396 (48,5%), un Promus Element. A los 2 años de seguimiento, las tasas de FVD (el 7,4 frente al 6,1%; p = 0,45), revascularización de la lesión diana (el 3,1 frente al 2,8%; p = 0,79) y trombosis del stent definitiva (el 1,0 frente al 0,5%; p = 0,69) fueron bajas en los 2 grupos de stents. En consonancia con estos resultados obtenidos en el conjunto de los pacientes con IAM, los resultados observados con los 2 SFA fueron favorables y similares con ambos dispositivos en 370 pacientes con IAM con elevación del segmento ST (FVD, el 5,1 frente al 4,9%; p = 0,81) y 447 pacientes con IAM sin elevación del segmento ST (FVD, el 9,0 frente al 7,5%; p = 0,56). Conclusiones: Los stents Resolute Integrity y Promus Element fueron seguros y eficaces en el tratamiento de pacientes con IAM. Los datos de seguimiento a 2 años subrayan la seguridad de emplear estos dispositivos en este contexto clínico específico (AU)

Introduction and objectives: In acute myocardial infarction (MI), novel highly deliverable drug-eluting stents (DES) may be particularly valuable as their flexible stent designs might reduce device-induced traumas to culprit lesions. The aim of the study was to assess the safety and efficacy of percutaneous coronary interventions with 2 novel durable polymer-coated DES in patients with acute MI. Methods: The prospective, randomized DUTCH PEERS (TWENTE II) multicenter trial compares Resolute Integrity and Promus Element stents in 1811 all-comer patients, of whom 817 (45.1%) were treated for ST-segment elevation MI or non—ST-segment elevation MI and the 2-year outcome is available in 99.9%. The primary clinical endpoint is target vessel failure (TVF), a composite of cardiac death, target vessel related MI, or target vessel revascularization. Results: Of all 817 patients treated for acute MI, 421 (51.5%) were treated with Resolute Integrity and 396 (48.5%) with Promus Element stents. At the 2-year follow-up, the rates of TVF (7.4% vs 6.1%; P = .45), target lesion revascularization (3.1% vs 2.8%; P = .79), and definite stent thrombosis (1.0% vs 0.5%; P = .69) were low for both stent groups. Consistent with these findings in all patients with acute MI, outcomes for the 2 DES were favorable and similar in both, with 370 patients with ST-segment elevation MI (TVF, 5.1% vs 4.9%; P = .81) and 447 patients with non—ST-segment elevation MI (TVF, 9.0% vs 7.5%; P = .56). Conclusions: Resolute Integrity and Promus Element stents were both safe and efficacious in treating patients with acute MI. The present 2-year follow-up data underline the safety of using these devices in this particular clinical setting (AU)

Disfunción endotelial tras infarto de miocardio con elevación del segmento ST y evolución a largo plazo: un estudio con tonometría arterial periférica e hiperemia reactiva / Endothelial dysfunction after ST-segment elevation myocardial infarction and long-term outcome: a study with reactive hyperemia peripheral artery tonometry

Introducción y objetivos: Escasean datos a largo plazo sobre la relación entre disfunción endotelial tras infarto agudo de miocardio con elevación del segmento ST y futuros eventos clínicos adversos. El objetivo de este estudio es evaluar de manera no invasiva si la disfunción endotelial 4-6 semanas tras una intervención coronaria percutánea primaria por infarto agudo de miocardio con elevación del segmento ST predice la aparición futura de eventos clínicos. Métodos: Este estudio prospectivo de cohortes se llevó a cabo en 70 pacientes del ensayo aleatorizado RESPONSE, a los que se evaluó de manera no invasiva la función endotelial 4–6 semanas después de la intervención coronaria percutánea primaria. Se determinó la función endotelial por el método de tonometría arterial periférica con hiperemia reactiva; la disfunción endotelial se identificó por un índice < 1,67. Resultados: El índice de tonometría arterial periférica con hiperemia reactiva fue en promedio 1,90 ± 0,58. Un total de 35 (50%) pacientes presentaban disfunción endotelial y 35 (50%) tenían función endotelial normal. Las «complicaciones» periintervención (como shock cardiogénico o bloqueo auriculoventricular completo) fueron más frecuentes entre los pacientes con disfunción endotelial que entre quienes no la presentaban (el 25,7 frente al 2,9%; p < 0,01). Durante un seguimiento medio de 4,0 ± 1,7 años, 20 pacientes (28,6%) presentaron eventos adversos cardiovasculares mayores: se produjeron eventos de este tipo en 9 pacientes (25,7%) con disfunción endotelial y 11 (31,5%) con función endotelial normal (p = 0,52). Se observó asociación entre la prevalencia basal de diabetes mellitus y la aparición de eventos adversos cardiovasculares mayores durante el seguimiento (análisis univariable, hazard ratio = 2,8; intervalo de confianza del 95%, 1,0-7,8; p < 0,05) e incluso en los análisis multivariable el riesgo parecía aumentar, aunque sin alcanzar significación estadística (análisis multivariable, hazard ratio = 2,5; intervalo de confianza del 95%, 0,8-7,5). Conclusiones: En esta serie de pacientes que habían sobrevivido a un infarto agudo de miocardio con elevación del segmento ST, la disfunción endotelial evaluada mediante tonometría arterial periférica con hiperemia reactiva 4-6 semanas tras el infarto de miocardio, no predijo los eventos clínicos futuros en una media de seguimiento de 4 años (AU)

Introduction and objectives: Long-term data on the relationship between endothelial dysfunction after ST-segment elevation myocardial infarction and future adverse clinical events are scarce. The aim of this study was to noninvasively assess whether endothelial dysfunction 4 weeks to 6 weeks after primary percutaneous coronary intervention for acute ST-segment elevation myocardial infarction predicts future clinical events. Methods: This prospective cohort study was performed in 70 patients of the RESPONSE randomized trial, who underwent noninvasive assessment of endothelial function 4 weeks to 6 weeks after primary percutaneous coronary intervention. Endothelial function was measured by the reactive hyperemia peripheral artery tonometry method; an index < 1.67 identified endothelial dysfunction. Results: The reactive hyperemia peripheral artery tonometry index measured on average 1.90 ± 0.58. A total of 35 (50%) patients had endothelial dysfunction and 35 (50%) patients had normal endothelial function. Periprocedural «complications» (eg, cardiogenic shock, total atrioventricular block) were more common in patients with endothelial dysfunction than in those without (25.7% vs 2.9%; P < .01). During 4.0 ± 1.7 years of follow-up, 20 (28.6%) patients had major adverse cardiovascular events: events occurred in 9 (25.7%) patients with endothelial dysfunction and in 11 (31.5%) patients with normal endothelial function (P = .52). There was an association between the prevalence of diabetes mellitus at baseline and the occurrence of major adverse cardiovascular events during follow-up (univariate analysis: hazard ratio = 2.8; 95% confidence interval, 1.0-7.8; P < .05), and even in multivariate analyses the risk appeared to be increased, although not significantly (multivariate analysis: hazard ratio = 2.5; 95% confidence interval, 0.8-7.5). Conclusions: In this series of patients who survived an ST-segment elevation myocardial infarction, endothelial dysfunction, as assessed by reactive hyperemia peripheral artery tonometry 4 weeks to 6 weeks after myocardial infarction, did not predict future clinical events during a mean follow-up of 4 years (AU)

Bifurcaciones coronarias: ¿siguen siendo la piedra de toque para los stents liberadores de fármacos y los armazones vasculares bioabsorbibles? / Coronary Bifurcations: Still the Touchstone of Drug-eluting Stents and Bioresorbable Vascular Scaffolds?

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