Intraindividual Comparison of Everolimus-Eluting Bioresorbable Vascular Scaffolds Versus Drug-Eluting Metallic Stents

Intraindividual Comparison of Everolimus-Eluting Bioresorbable Vascular Scaffolds Versus Drug-Eluting Metallic Stents
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DOI:
10.1161/circinterventions.116.003698
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发表时间:
2016-08-01
影响因子:
5.6
通讯作者:
Kastrati, Adnan
Kastrati, Adnan
中科院分区:
医学1区
文献类型:
--
作者:
Cassese, Salvatore;Hoppmann, Petra;Kastrati, Adnan

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背景-在接受多病变经皮冠状动脉介入治疗(PCI)的同一个体中,依维莫司洗脱生物可吸收血管支架(BVS)与药物洗脱金属支架(DES)的性能研究仍然很少。本报告研究了BVS和DES在接受多病变PCI和随访血管造影术的患者中的个体内性能。方法和结果-前瞻性收集了2012年至2014年在德国慕尼黑的2家中心接受BVS植入治疗原发病变的患者的数据。研究了接受BVS和DES多病变PCI和6 - 8个月随访血管造影的个体。主要终点为器械内晚期管腔丢失。次要终点为二元再狭窄、靶病变血运重建和明确的支架/支架血栓形成。共有90例PCI患者(239处病变)接受了BVS(n=112)和DES(n=127)。中位6.6个月(5.8-7.1)后的随访血管造影显示,使用BVS治疗的病变的晚期管腔丢失程度高于DES(0.30 +/- 0.59 vs 0.22 +/- 0.48 mm; P=0.035)。然而,基线血管造影不平衡的调整排除了支架类型对晚期管腔丢失的影响(P=0.82)。在同一时间点,BVS和DES的二元再狭窄率相当(7.8% vs 8.9%; P=0.90)。在中位数为13.2个月(9.2-17.6)后,靶病变血运重建(9.8%对10.2%; P=0.97)和明确的支架/支架血栓形成(2.7%对1.6%; P=0.48)在BVS和DES之间没有差异。更大规模的试验、延长的随访和持续的设备迭代对于改进BVS技术仍然至关重要。
Background-The performance of everolimus-eluting bioresorbable vascular scaffold (BVS) versus drug-eluting metallic stent (DES) in the same individual receiving multilesion percutaneous coronary intervention (PCI) remains poorly studied. This report investigates the intraindividual performance of BVS and DES in patients receiving multilesion PCI and follow-up angiography.Methods and Results-Data of patients undergoing BVS implantation for de novo lesions from 2012 to 2014 at 2 centers in Munich, Germany, were prospectively collected. Individuals receiving multilesion PCI with BVS and DES and follow-up angiography at 6 to 8 months were studied. Primary end point was in-device late lumen loss. Secondary end points were binary restenosis, target lesion revascularization, and definite stent/scaffold thrombosis. A total of 90 PCI patients with 239 lesions received BVS (n=112) and DES (n=127). Follow-up angiography after a median of 6.6 months (5.8-7.1) showed a higher degree of late lumen loss in lesions treated with BVS versus DES (0.30 +/- 0.59 versus 0.22 +/- 0.48 mm; P=0.035). However, the adjustment for baseline angiographic imbalances discarded an influence of stent type on late lumen loss (P=0.82). At the same time point, binary restenosis was comparable between BVS and DES (7.8% versus 8.9%; P=0.90). After a median of 13.2 months (9.2-17.6), target lesion revascularization (9.8% versus 10.2%; P=0.97) and definite stent/scaffold thrombosis (2.7% versus 1.6%; P=0.48) did not differ between BVS and DES.Conclusions-In patients receiving multilesion PCI, BVS displays acceptable intraindividual performance compared with DES. Larger trials, extended follow-up, and continuous device iteration remain essential to improve BVS technology.