Abstract：
Use of a Bioresorbable Scaffolds (BRS) either in clinical practice or in the setting of an acute myocardial infarction (MI) is controversial. Despite an overall high rate of thrombosis, vascular healing response following BRS implantation tend to superiority as compared to metallic drug-eluting stent in ST-segment elevation myocardial infarction (STEMI) patients. We sought to compare the in-stent/scaffold vasomotion between metallic BRS and sirolimus eluting stent (SES) at 12-month angiographic follow-up in the setting of patients with STEMI treated by primary PCI.
This is an investigator-driven, prospective, multicenter, randomized, single blind, two-arm, controlled trial (ClinicalTrials.gov number: NCT03234348). This trial will randomize ~148 patients 1:1 to SES or BRS. Primary end-point is the in-stent/scaffold change in mean lumen diameter after nitroglycerin administration at 12-month angiographic follow-up. Besides, patient-oriented combined endpoint of all-cause death, any MI, and any revascularization, together with scaffold/stent thrombosis rate and device-oriented endpoint of cardiac death, target vessel (TV)-MI and TVR at 1 year will be also evaluated. Clinical follow-up will be scheduled yearly up to 5 years.
This trial will shed light on the vascular vasomotion following BRS implantation in the complex scenario of STEMI.
This is an investigator-driven, prospective, multicenter, randomized, single blind, two-arm, controlled trial (ClinicalTrials.gov number: NCT03234348). This trial will randomize ~148 patients 1:1 to SES or BRS. Primary end-point is the in-stent/scaffold change in mean lumen diameter after nitroglycerin administration at 12-month angiographic follow-up. Besides, patient-oriented combined endpoint of all-cause death, any MI, and any revascularization, together with scaffold/stent thrombosis rate and device-oriented endpoint of cardiac death, target vessel (TV)-MI and TVR at 1 year will be also evaluated. Clinical follow-up will be scheduled yearly up to 5 years.
This trial will shed light on the vascular vasomotion following BRS implantation in the complex scenario of STEMI.
摘要：
在临床实践中或在急性心肌梗塞（MI）的情况下使用生物可吸收支架（BRS）是有争议的。尽管总体上血栓形成率很高，在ST段抬高型心肌梗死(STEMI)患者中,与金属药物洗脱支架相比,BRS植入后的血管愈合反应倾向于优势.在接受原发性PCI治疗的STEMI患者的情况下，我们试图在12个月的血管造影随访中比较金属BRS和西罗莫司洗脱支架（SES）之间的支架内/支架内血管运动。
这是一个调查员驱动的,prospective,多中心，随机化，单盲,双臂，对照试验（ClinicalTrials.gov编号：NCT03234348）。该试验将以1：1的比例将148名患者随机分配给SES或BRS。主要终点是在12个月血管造影随访时给予硝酸甘油后支架内/支架内平均管腔直径的变化。此外,以患者为导向的全因死亡综合终点，任何MI,和任何血运重建，连同支架/支架血栓形成率和以装置为导向的心源性死亡终点，还将评估1年时的目标血管（TV）-MI和TVR。临床随访将安排每年长达5年。
本试验将阐明在STEMI的复杂情况下BRS植入后的血管血管舒缩。
这是一个调查员驱动的,prospective,多中心，随机化，单盲,双臂，对照试验（ClinicalTrials.gov编号：NCT03234348）。该试验将以1：1的比例将148名患者随机分配给SES或BRS。主要终点是在12个月血管造影随访时给予硝酸甘油后支架内/支架内平均管腔直径的变化。此外,以患者为导向的全因死亡综合终点，任何MI,和任何血运重建，连同支架/支架血栓形成率和以装置为导向的心源性死亡终点，还将评估1年时的目标血管（TV）-MI和TVR。临床随访将安排每年长达5年。
本试验将阐明在STEMI的复杂情况下BRS植入后的血管血管舒缩。
