Randomized Evaluation of Two Drug-Eluting Stents With Identical Metallic Platform and Biodegradable Polymer But Different Agents (Paclitaxel or Sirolimus) Compared Against Bare Stents: 1-Year Results of the PAINT Trial
Randomized Evaluation of Two Drug-Eluting Stents With Identical Metallic Platform and Biodegradable Polymer But Different Agents (Paclitaxel or Sirolimus) Compared Against Bare Stents: 1-Year Results of the PAINT Trial
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DOI：
10.1002/ccd.22166
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发表时间：
2009-11-01
影响因子：
2.3
通讯作者：
Martinez, Eulogio E.
中科院分区：
文献类型：
--
作者：
Lemos, Pedro A.;Moulin, Bruno;Martinez, Eulogio E.
目的：我们测试了两种新型药物洗脱支架（DES），覆盖有生物可降解聚合物载体并释放紫杉醇或西罗莫司，并与裸金属支架进行比较（主要目的）。DES因药物不同而不同，但在其他方面相同，允许比较西罗莫司与紫杉醇的抗再狭窄作用（次要目的）。背景资料：新型DES与生物可降解聚合物的疗效应在随机试验的背景下进行测试，即使使用已知有效的药物，如西罗莫司和紫杉醇。研究方法：总体而言，274例计划植入支架的自体血管原发冠状动脉病变患者被随机分配（2：21比例）至紫杉醇（n = 111）、西罗莫司（n = 106）或裸金属支架（n = 57）组。在9个月时进行血管造影随访，并对长达12个月的主要心脏不良事件进行随访。结果如下：与对照组相比，紫杉醇和西罗莫司支架均降低了9个月支架内晚期丢失（分别为0.54-0.44 mm，0.32-0.43 mm，vs. 0.90-0.45 mm）和1年靶血管血运重建和合并主要不良心脏事件的风险（所有比较中，两者均P < 0.05）。西罗莫司支架的晚期丢失率低于紫杉醇支架（P < 0.01），但1年临床结局相似。研究组之间的死亡、梗死或支架内血栓形成风险无差异。结论：与裸金属支架相比，两种新型DES均可有效减少新生内膜增生和1年再介入。我们的研究结果还表明，西罗莫司在减少血管造影新生内膜方面比紫杉醇更有效，尽管这种作用与更好的临床结局无关。(C)2009 Wiley-Liss，Inc.
Objectives: We tested two novel drug-eluting stents (DES), covered with a biodegradable-polymer carrier and releasing paclitaxel or sirolimus, which were compared against a bare metal stent (primary objective). The DES differed by the drug, but were identical otherwise, allowing to compare the anti-restenosis effects of sirolimus versus paclitaxel (secondary objective). Background: The efficacy of novel DES with biodegradable polymers should be tested in the context of randomized trials, even when using drugs known to be effective, such as sirolimus and paclitaxel. Methods: Overall, 274 patients with de novo coronary lesions in native vessels scheduled for stent implantation were randomly assigned (2:21 ratio) for the paclitaxel (n = 111), sirolimus (n = 106), or bare metal stent (n = 57) groups. Angiographic follow-up was obtained at 9 months and major cardiac adverse events up to 12 months. Results: Both paclitaxel and sirolimus stents reduced the 9-month in-stent late loss (0.54-0.44 mm, 0.32-0.43 mm, vs. 0.90-0.45 mm respectively), and 1-year risk of target vessel revascularization and combined major adverse cardiac events (P < 0.05 for both, in all comparisons), compared with controls. Sirolimus stents had lower late loss than paclitaxel stents (P < 0.01), but similar 1-year clinical outcomes. There were no differences in the risk of death, infarction, or stent thrombosis among the study groups. Conclusion: Both novel DES were effective in reducing neointimal hyperplasia and 1-year re-intervention, compared to bare metal stents. Our findings also suggest that sirolimus is more effective than paclitaxel in reducing angiographic neointima, although this effect was not associated with better clinical outcomes. (C) 2009 Wiley-Liss, Inc.