Cardiologia Invasiva 2, Centro Cardiologico Fondazione Monzino, IRCCS, Università di Milano, Italy.
Cardiologia Invasiva 2, Centro Cardiologico Fondazione Monzino, IRCCS, Università di Milano, Italy.
Cardiovasc Revasc Med. 2022 Aug;41:69-75. doi: 10.1016/j.carrev.2022.01.020. Epub 2022 Jan 25.
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 patients suitable for MRS enrolled in 4 Italian centers.
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.
Data from 207 patients, including initial experience, have been collected. Patients were 83% male, 20% diabetic and Acute Coronary Syndrome (ACS) in 23%. Lesion type were A-B1 in 54% and B2C 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 patients 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 (including 1 case of myocardial infarction, all patients were successfully treated with in-scaffold segment DES implantation). None of the patients died for a cardiac reason.
Our 2-years results confirm safety and efficacy showed at 12-months, reinforcing long-term performance with only 2% rate of TLF increase and no ST after 1 year.
可吸收镁支架（MRS）是最新的可吸收技术，具有低血栓形成性、短支架时间和在 12 个月时几乎完全吸收（95%）的特点。在选定的患者中，初步的 12 个月数据表明，安全性和疗效与第二代药物洗脱支架（DES）相当。Magmaris 多中心注册研究显示，在意大利 4 个中心纳入的首批适合 MRS 的患者中，1 年和 2 年的临床结果显示出良好的效果。
我们评估了在“真实世界”中使用可吸收镁支架的 12 个月和 24 个月的临床结果，以评估靶病变失败（TLF）和支架血栓形成（ST）。TLF 是主要终点，定义为心脏死亡率、靶血管心肌梗死（MI）和缺血驱动的靶病变血运重建（ID-TLR）的综合结果。强烈推荐 4P 策略（患者/病变选择、预扩张、适当的支架尺寸和后扩张）。建议进行 12 个月的双联抗血小板治疗（DAPT）。
共收集了 207 例患者的初始经验数据。患者中 83%为男性，20%为糖尿病患者，23%为急性冠脉综合征（ACS）。病变类型为 54%为 A-B1 型，46%为 B2C 型。94%的患者遵循了 4P 策略。手术成功率为 98%（2%围手术期 MI）。12 个月随访时的依从率为 97.6%，TLF 发生率为 5.4%（包括 1 例支架内晚期血栓形成的心肌梗死，所有患者均成功接受了支架内段 DES 植入治疗）。24 个月时的依从率为 92.8%（192 例），TLF 为 7.4%。在 13 至 24 个月期间，仅有 4 例发生 TLF（包括 1 例心肌梗死，所有患者均成功接受了支架内段 DES 植入治疗）。无患者因心脏原因死亡。
我们的 2 年结果证实了 12 个月时显示的安全性和疗效，仅增加了 2%的 TLF 发生率和 1 年后无 ST，这进一步证明了长期疗效。
