网状覆盖式栓塞保护支架植入术治疗ST段抬高型心肌梗死：MGUARD急性ST段抬高再灌注试验的1年临床及血管造影最终结果
Mesh-covered embolic protection stent implantation in ST-segment-elevation myocardial infarction: final 1-year clinical and angiographic results from the MGUARD for acute ST elevation reperfusion trial.
作者信息
Dudek Dariusz, Dziewierz Artur, Brener Sorin J, Abizaid Alexandre, Merkely Béla, Costa Ricardo A, Bar Eli, Rakowski Tomasz, Kornowski Ran, Dressler Ovidiu, Abizaid Andrea, Silber Sigmund, Stone Gregg W
机构信息
From the Department of Interventional Cardiology, Jagiellonian University Medical College, Krakow, Poland (D.D., A.D., T.R.); Cardiovascular Research Foundation, New York, NY (S.J.B., O.D., G.W.S.); Department of Cardiology, New York Methodist Hospital, Brooklyn (S.J.B.); Department of Cardiology, Institute Dante Pazzanese of Cardiology, Sao Paulo, Brazil (Alexandre Abizaid, R.A.C., Andrea Abizaid); Department of Cardiology, Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Cardiovascular Research Center, São Paolo, Brazil (R.A.C.); InspireMD, Tel Aviv, Israel (E.B.); Department of Cardiology, Rabin Medical Center, Petach Tiqva, Israel (R.K.); Department of Cardiology, Heart Center at the Isar, Munich, Germany (S.S.); and Department of Cardiology, Columbia University Medical Center, New York Presbyterian Hospital (G.W.S.).
出版信息
Circ Cardiovasc Interv. 2015 Feb;8(2):e001484. doi: 10.1161/CIRCINTERVENTIONS.114.001484.
BACKGROUND
The MGuard, a bare metal stent covered with a polymer mesh, was designed to reduce distal embolization during percutaneous coronary intervention in ST-segment-elevation myocardial infarction. In the MGUARD for Acute ST Elevation Reperfusion trial, the primary end point of complete ST-segment resolution was significantly improved with the MGuard compared with control. We evaluated 1-year clinical and angiographic results.
METHODS AND RESULTS
Patients with ST-segment-elevation myocardial infarction ≤12 hours undergoing primary percutaneous coronary intervention of a single de novo native lesion were randomized to the MGuard versus any commercially available metallic stent (39.8% drug-eluting). Clinical follow-up was performed through 1 year, and angiography at 13 months was planned in 50 MGuard patients. There was no difference in major adverse cardiac events (1.8% versus 2.3%; P=0.75) at 30 days between the groups. Major adverse cardiac events at 1 year were higher with the MGuard, driven by greater ischemia-driven target lesion revascularization (8.6% versus 0.9%; P=0.0003). Conversely, mortality tended to be lower with the MGuard at 30 days (0% versus 1.9%; P=0.04) and at 1 year (1.0% versus 3.3%; P=0.09). Late lumen loss at 13 months in the MGuard was 0.99±0.80 mm, and binary restenosis was 31.6%.
CONCLUSIONS
In patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention, a trend toward reduced 1-year mortality was present in patients treated with the MGuard stent. Target lesion revascularization and major adverse cardiac events rates during follow-up were higher in the MGuard group than in the control stent group, and angiographic late loss of the MGuard was consistent with that expected from bare metal stents.
CLINICAL TRIAL REGISTRATION URL
http://www.clinicaltrials.gov. Unique identifier: NCT01368471.
背景
MGuard是一种覆盖有聚合物网的裸金属支架，旨在减少ST段抬高型心肌梗死患者经皮冠状动脉介入治疗期间的远端栓塞。在MGUARD急性ST段抬高再灌注试验中，与对照组相比，MGuard显著改善了完全ST段回落的主要终点。我们评估了1年的临床和血管造影结果。
方法与结果
对发病≤12小时、接受单处初发原位病变直接经皮冠状动脉介入治疗的ST段抬高型心肌梗死患者，随机分为MGuard组和任何市售金属支架组（39.8%为药物洗脱支架）。进行为期1年的临床随访，并计划对50例MGuard组患者在13个月时进行血管造影。两组在30天时的主要不良心脏事件发生率无差异（1.8%对2.3%；P = 0.75）。MGuard组1年时的主要不良心脏事件发生率较高，主要是由于缺血驱动的靶病变血运重建率更高（8.6%对0.9%；P = 0.0003）。相反，MGuard组在30天时的死亡率趋于较低（0%对1.9%；P = 0.04），在1年时也是如此（1.0%对3.3%；P = 0.09）。MGuard组在13个月时的晚期管腔丢失为0.99±0.80 mm，支架内再狭窄率为31.6%。
结论
在接受直接经皮冠状动脉介入治疗的ST段抬高型心肌梗死患者中，使用MGuard支架治疗的患者1年死亡率有降低趋势。随访期间，MGuard组的靶病变血运重建率和主要不良心脏事件发生率高于对照支架组，且MGuard的血管造影晚期管腔丢失与裸金属支架预期相符。
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