Department of Cardiology, Deutsches Herzzentrum, Technische Universität, Munich, Germany.
Catheter Cardiovasc Interv. 2011 Aug 1;78(2):161-6. doi: 10.1002/ccd.22823. Epub 2011 Mar 11.
In the Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents (ISAR-TEST-4) trial, we demonstrated the noninferiority of biodegradable polymer (BP) sirolimus-eluting stent to permanent polymer (PP) sirolimus/everolimus-eluting stent (Cypher/Xience-V) on the basis of clinical outcomes. In this study, we compare the antirestenotic efficacy of these stents in ISAR-TEST-4 patients with paired angiographic studies.
Patients with de novo coronary lesions in native vessels (excluding left main lesions) were randomly assigned to receive a BP stent or a PP stent. Endpoints of interest of this study were in-stent late lumen loss, in-segment binary restenosis, and restenosis morphology at 6-8-month follow-up angiogram.
Of the 2,603 patients (3,372 lesions) enrolled in ISAR TEST-4 trial, 2,016 patients (2,637 lesions) underwent repeat angiographic examination 6-8 months after randomization: 1,006 patients (1,323 lesions) treated with BP stents and 1,010 patients (1,314 lesions) treated with PP stents. No difference was observed between BP and PP stents in in-stent late lumen loss (0.24 ± 0.6 vs. 0.26 ± 0.5 mm, respectively, P = 0.49) or in in-segment binary restenosis (11.6% [153 lesions] vs. 11.8% [155 lesions], P = 0.85). Focal pattern of restenosis was observed in the majority of patients receiving either BP or PP stents. The diffuse pattern of restenosis was observed in 26.8% of patients treated with BP stent and 26.5% of patients treated with PP stent (P = 0.79).
Angiographic characteristics of restenosis after BP-based limus-eluting stents are similar to those of PP-based limus-eluting stents.
在冠状动脉支架置入和血管造影结果：3 种雷帕霉素洗脱支架的疗效测试（ISAR-TEST-4）试验中，我们基于临床结果证明了生物可降解聚合物（BP）西罗莫司洗脱支架与永久性聚合物（PP）西罗莫司/依维莫司洗脱支架（Cypher/Xience-V）的非劣效性。在这项研究中，我们比较了这两种支架在 ISAR-TEST-4 患者中配对血管造影研究中的抗再狭窄效果。
在这项研究中，将患有原发性血管（不包括左主干病变）新发病变的患者随机分配接受 BP 支架或 PP 支架治疗。本研究的主要终点是支架内晚期管腔丢失、节段内二元再狭窄和 6-8 个月随访血管造影时的再狭窄形态。
在 ISAR TEST-4 试验中，共纳入 2603 例患者（3372 处病变），其中 2016 例患者（2637 处病变）在随机分组后 6-8 个月接受了重复血管造影检查：1006 例患者（1323 处病变）接受 BP 支架治疗，1010 例患者（1314 处病变）接受 PP 支架治疗。BP 支架和 PP 支架在支架内晚期管腔丢失（分别为 0.24±0.6mm 和 0.26±0.5mm，P=0.49）或节段内二元再狭窄（分别为 11.6%[153 处]和 11.8%[155 处]，P=0.85）方面无差异。接受 BP 或 PP 支架治疗的患者中，多数患者表现为局灶性再狭窄模式。弥漫性再狭窄模式分别见于 26.8%接受 BP 支架治疗的患者和 26.5%接受 PP 支架治疗的患者（P=0.79）。
BP 支架置入后再狭窄的血管造影特征与 PP 支架置入后再狭窄的特征相似。
