Registro unicéntrico a largo plazo (>12 meses) del implante de Magmaris en el síndrome coronario agudo
- Jeremías Bayón 1
- Verónica Gordo 1
- Melisa Santás 1
- Rosa Alba Abellás Sequeiros 1
- Raymundo Ocaranza 1
- Carlos González Juanatey 1
- 1 Servicio de Cardiología, Hospital Universitario Lucus Augusti, Lugo, España
ISSN: 2604-7276, 2604-7306
Año de publicación: 2021
Volumen: 3
Número: 4
Páginas: 274-277
Tipo: Artículo
Otras publicaciones en: REC: Interventional Cardiology
Resumen
Introduction and objectives: The results of Magmaris implantation in the acute coronary syndrome setting is uncertain and more studies will be needed to assess the long-term safety profile of these devices. The objective of this work was to conduct an observational study to analyze the clinical safety profile of Magmaris implanted in a single hospital center in the acute coronary syndrome setting beyond 12 months. Methods: Registry of 36 patients with Magmaris devices implanted between November 2016 through November 2018 with a diagnosis of acute coronary syndrome included consecutively. The primary endpoint was considered the device-oriented composite endpoint of target vessel myocardial infarction, target lesion failure, and cardiac death. Secondary endpoints included Magmaris related thrombosis. Results: Regarding the device-oriented combination, no target vessel myocardial infarction was observed, 0 cases (0%), while target lesion failure was seen in 2 cases (5.6%). There were no cases of Magmaris thrombosis at the follow-up and only 1 case of cardiac death (2.8%) was found 36 months after Magmaris implantation. The cause of death could not be determined since no autopsy was performed. Conclusions: Our results with long-term follow-up confirm that Magmaris has a favorable clinical profile in the acute coronary syndrome complex setting.
Referencias bibliográficas
- 1. Haude M, Ince H, Abizaid A, et al. Safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de-novo coronary artery lesions (BIOSOLVE-II):6 month results of a prospective, multicentre, non-randomised, first-in-man trial. Lancet. 2016;387:31-39.
- 2. Haude M, Ince H, Kische S, et al. Sustained safety and clinical performance of a drug-eluting absorbable metal scaffold up to 24 months:pooled outcomes of BIOSOLVE-II and BIOSOLVE-III. EuroIntervention. 2017;13:432-439.
- 3. Datos de la Sección de Hemodinámica 2019. Disponible en:https://www.hemodinamica.com/wp-content/uploads/2020/12/Presentacion-Registro.pdf. Consultado 15 Mar 2021.
- 4. Sotomi Y, Onuma Y, Collet C, et al. Bioresorbable scaffold:the emerging reality and future directions. Circ Res. 201;120:1341-1352.
- 5. Ortega-Paz L, Capodanno D, Gori T, et al. Predilation, sizing, and post-dilation scoring in patients undergoing everolimus-eluting bioresorbable scaffold implantation for prediction of cardiac adverse events:development and internal validation of the PSP score. EuroIntervention. 2017;12:2110-2117.
- 6. Fajadet J, Haude M, Joner M, et al. Magmaris preliminary recommendation upon commercial launch:a consensus from the expert panel on 14 April 2016. Eurointervention. 2016;18:828-833.
- 7. Ortega-Paz L, Bruggaleta S, Capodanno D, et al. Efecto de la te-cnica de implantacio-n en los resultados en pacientes tratados con armazo-n bioabsorbible en diferentes escenarios cli-nicos. REC Interv Cardiol. 2019;1:83-91.
- 8. Abellas-Sequeiros RA, Ocaranza-Sánchez R, Bayon-Lorenzo J, et al. 12-month clinical outcomes after Magmaris percutaneous coronary intervention in a real-world cohort of patients:Results from CardioHULA registry. Rev Port Cardiol. 2020;39:421-425.
- 9. Wlodarczak A, Lanocha M, Jastrzebski A, et al. Early outcome of magnesium bioresorbable scaffold implantation in acute coronary syndrome-the initial report from the Magmaris-ACS registry. Catheter Cardiovasc Interv. 2019;93:E287-E292.
- 10. SabatéM, Alfonso F, Cequier A, et al. Magnesium-Based Resorbable Scaffold Versus Permanent Metallic Sirolimus-Eluting Stent in Patients With ST-Segment Elevation Myocardial Infarction:The MAGSTEMI Randomized Clinical Trial. Circulation. 2019;140:1904-1916.
- 11. Verheye S, Wlodarczak A, Montorsi P, et al. Safety and performance of a reservable magnesium scaffold under real-world conditions:12 month outcomes of the first 400 patients enrolled in the BIOSOLVE- IV registry. Eurointervention. 2020;15:e1383-e1386.