Background: Magnesium Reabsorbable Scaffold (MRS), is the newest reabsorbable technology with low thrombogenicity, short scaffolding time and almost complete resorption at 12-months (95%). Preliminary 12 -months data in selected patients has shown that safety and efficacy are comparable with second generation Drug Eluting Stent (DES). Magmaris Multicenter registry showed 1-and 2-years clinical outcome on the first pa-tients suitable for MRS enrolled in 4 Italian centers.Methods: We evaluated 12-and 24-months clinical results in "real world" experience with Magnesium Reabosrbable Scaffold in terms of Target Lesion Failure (TLF) and scaffold thrombosis (ST). TLF is the primary endpoint and was defined as composite of cardiac mortality, target vessel myocardial infarction (MI), and ischemia-driven target lesion revascularization (ID-TLR). 4P's strategy (Patient/lesion selection, Pre-dilatation, Proper scaffold sizing and Post-dilatation) was strongly recommended. Dual Antiplatelet Therapy (DAPT) has been recommended for 12 months.Results: Data from 207 patients, including initial experience, have been collected. Patients were 83% male, 20% di-abetic and Acute Coronary Syndrome (ACS) in 23%. Lesion type were A-B1 in 54% and B2\\C in 46%. 4P's strategy was respected in 94%. Procedural success was 98% (2% peri-procedural MI). Compliance at 12-months follow up was 97.6%, TLF rate was 5.4% (including 1 case of myocardial infarction with late scaffold thrombosis (ST), all pa-tients were successfully treated with in-scaffold segment DES implantation). At 24-months compliance was 92.8% (192 patients) and TLF was 7.4%. In the period between 13 and 24 months only 4 patients had TLF (includ-ing 1 case of myocardial infarction, all patients were successfully treated with in-scaffold segment DES implanta-tion). None of the patients died for a cardiac reason.Conclusion: Our 2-years results confirm safety and efficacy showed at 12-months, reinforcing long-term perfor-mance with only 2% rate of TLF increase and no ST after 1 year.(c) 2022 Published by Elsevier Inc.
Sustained Safety and Efficacy of Magnesium Reabsorbable Scaffold: 2-Year Follow-Up Analysis From First Magmaris Multicenter Italian Registry / S. Galli, S. Troiano, A. Palloshi, C. Rapetto, F. Pisano, G. Aprigliano, M. Leoncini, P. Ravagnani, M. Del Maestro, P. Montorsi. - In: CARDIOVASCULAR REVASCULARIZATION MEDICINE. - ISSN 1553-8389. - 41:(2022 Aug 25), pp. 69-75. [10.1016/j.carrev.2022.01.020]
Sustained Safety and Efficacy of Magnesium Reabsorbable Scaffold: 2-Year Follow-Up Analysis From First Magmaris Multicenter Italian Registry
S. Troiano;P. Montorsi
2022
Abstract
Background: Magnesium Reabsorbable Scaffold (MRS), is the newest reabsorbable technology with low thrombogenicity, short scaffolding time and almost complete resorption at 12-months (95%). Preliminary 12 -months data in selected patients has shown that safety and efficacy are comparable with second generation Drug Eluting Stent (DES). Magmaris Multicenter registry showed 1-and 2-years clinical outcome on the first pa-tients suitable for MRS enrolled in 4 Italian centers.Methods: We evaluated 12-and 24-months clinical results in "real world" experience with Magnesium Reabosrbable Scaffold in terms of Target Lesion Failure (TLF) and scaffold thrombosis (ST). TLF is the primary endpoint and was defined as composite of cardiac mortality, target vessel myocardial infarction (MI), and ischemia-driven target lesion revascularization (ID-TLR). 4P's strategy (Patient/lesion selection, Pre-dilatation, Proper scaffold sizing and Post-dilatation) was strongly recommended. Dual Antiplatelet Therapy (DAPT) has been recommended for 12 months.Results: Data from 207 patients, including initial experience, have been collected. Patients were 83% male, 20% di-abetic and Acute Coronary Syndrome (ACS) in 23%. Lesion type were A-B1 in 54% and B2\\C in 46%. 4P's strategy was respected in 94%. Procedural success was 98% (2% peri-procedural MI). Compliance at 12-months follow up was 97.6%, TLF rate was 5.4% (including 1 case of myocardial infarction with late scaffold thrombosis (ST), all pa-tients were successfully treated with in-scaffold segment DES implantation). At 24-months compliance was 92.8% (192 patients) and TLF was 7.4%. In the period between 13 and 24 months only 4 patients had TLF (includ-ing 1 case of myocardial infarction, all patients were successfully treated with in-scaffold segment DES implanta-tion). None of the patients died for a cardiac reason.Conclusion: Our 2-years results confirm safety and efficacy showed at 12-months, reinforcing long-term perfor-mance with only 2% rate of TLF increase and no ST after 1 year.(c) 2022 Published by Elsevier Inc.File | Dimensione | Formato | |
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