Kahlert Philipp, Hildebrandt Heike Annelie, Patsalis Polykarpos Christos, Al-Rashid Fadi, Jánosi Rolf Alexander, Nensa Felix, Schlosser Thomas Wilfried, Schlamann Marc, Wendt Daniel, Thielmann Matthias, Kottenberg Eva, Frey Ulrich, Neuhäuser Markus, Forsting Michael, Jakob Heinz Günther, Rassaf Tienush, Peters Jürgen, Heusch Gerd, Kleinbongard Petra
Department of Cardiology and Vascular Medicine, West-German Heart and Vascular Center Essen, Universitätsklinikum Essen, Universität Duisburg-Essen, Germany.
Institute for Diagnostic and Interventional Radiology and Neuroradiology, Universitätsklinikum Essen, Universität Duisburg-Essen, Germany.
Int J Cardiol. 2017 Mar 15;231:248-254. doi: 10.1016/j.ijcard.2016.12.005. Epub 2016 Dec 6.
Remote ischemic preconditioning (RIPC) reduces myocardial injury and improves clinical outcome in patients undergoing coronary revascularization, but only in the absence of propofol-anesthesia. We investigated whether RIPC provides protection of heart, kidneys and brain and improves outcome in patients undergoing transfemoral transcatheter aortic valve implantation (TF-TAVI).
Patients undergoing TF-TAVI were randomized to receive RIPC (3cycles of 5min left upper arm ischemia and 5min reperfusion) or placebo. The primary endpoint was myocardial injury, reflected by the area under the curve for serum troponin I concentrations (AUC-TnI) over the first 72h. Secondary endpoints included the incidences of periprocedural myocardial infarction, delayed gadolinium enhancement on postprocedural cardiac MRI, acute kidney injury, periprocedural stroke, and the incidence and volume of new lesions on postprocedural cerebral MRI. All-cause and cardiovascular mortality and major adverse cardiac and cerebrovascular events (MACCE) were assessed over 1-year follow-up. A prespecified interim-analysis was performed after the last patient had completed 1-year follow-up (NCT02080299).
100 consecutive patients were enrolled between September 2013 and June 2015. There were no significant between-group differences in the primary endpoint of peri-interventional myocardial injury (ratio RIPC/placebo AUC-TnI: 0.87, 95% CI: 0.57-1.34, p=0.53) or the secondary endpoints of cardiac, renal and cerebral impairment. There was no significant treatment effect in subgroup-analyses of patients undergoing cardiac or cerebral MRI. Mortality and MACCE did not differ. No RIPC-related adverse events were observed.
RIPC did neither protect heart, kidneys and brain nor improve clinical outcome in patients undergoing TF-TAVI.
远程缺血预处理（RIPC）可减轻接受冠状动脉血运重建患者的心肌损伤并改善临床结局，但仅在无丙泊酚麻醉的情况下有效。我们研究了RIPC是否能为接受经股动脉导管主动脉瓣植入术（TF-TAVI）的患者提供心脏、肾脏和大脑保护并改善结局。
接受TF-TAVI的患者被随机分为接受RIPC组（左上臂缺血5分钟和再灌注5分钟，共3个周期）或安慰剂组。主要终点是心肌损伤，通过血清肌钙蛋白I浓度曲线下面积（AUC-TnI）在最初72小时内反映。次要终点包括围手术期心肌梗死的发生率、术后心脏磁共振成像延迟钆增强、急性肾损伤、围手术期卒中以及术后脑磁共振成像上新病变的发生率和体积。在1年随访期间评估全因死亡率和心血管死亡率以及主要不良心脏和脑血管事件（MACCE）。在最后一名患者完成1年随访后进行了预先指定的中期分析（NCT02080299）。
2013年9月至2015年6月连续纳入100例患者。在介入期心肌损伤的主要终点（RIPC/安慰剂AUC-TnI比值：0.87，95%CI：0.57-1.34，p=0.53）或心脏、肾脏和大脑损伤的次要终点方面，两组间无显著差异。在接受心脏或脑磁共振成像的患者亚组分析中没有显著的治疗效果。死亡率和MACCE无差异。未观察到与RIPC相关的不良事件。
RIPC既不能保护接受TF-TAVI患者的心脏、肾脏和大脑，也不能改善临床结局。
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