One year results of a new in situ length-adjustable stent platform with a biodegradable biolimus A9 eluting polymer: results of the CUSTOM-II trial.
One year results of a new in situ length-adjustable stent platform with a biodegradable biolimus A9 eluting polymer: results of the CUSTOM-II trial.
复制标题
采用可生物降解的 Biolimus A9 洗脱聚合物的新型原位长度可调支架平台的一年结果：CUSTOM-II 试验的结果。
DOI：
10.4244/eijv4i2a37
复制
发表时间：
2008
期刊：
影响因子：
--
通讯作者：
E. Grube
中科院分区：
文献类型：
--
作者：
P. Stella;R. Mueller;G. Pavlakis;B. de Bruyne;K. Hauptmann;M. Morice;B. Chevalier;J. Fajadet;H. Sievert;E. Grube
旨在
评估XTENT可定制药物洗脱支架系统治疗转诊接受PCI的单处长或多处冠状动脉病变患者的安全性和有效性。
方法和结果
CUSTOM-II试验入组了100例自体冠状动脉原发病变患者，表现为长度≥ 20 mm的单处长病变（n=69）或最多2处病变，支架的总累积预期支架长度为60 mm（n=31）。在6个月时对患者进行血管造影评估，并在1年时进行临床评估。在入组的100例患者中，9例患者发生了MACE，包括5例在首次住院期间发生MACE的患者（2例非Q-MI、2例Q-MI和1例可能的支架血栓形成相关死亡），以及4例6个月时的靶病变血运重建（TLR）。6 - 12个月随访期间未报告MACE或支架内血栓形成。6个月时节段内晚期丢失为0.22 ± 0.28 mm，支架内晚期丢失范围为0.31 ± 0.31 mm。
结论
根据12个月随访期间的血管造影和临床变量判断，XTENT可定制支架在临床上安全有效。其临床定位需要进一步的随访和更大规模的随机比较研究。
AIMS
To assess the safety and efficacy of the XTENT customisable drug-eluting stent system in the treatment of patients with single long or multiple coronary lesions referred for PCI.
METHODS AND RESULTS
The CUSTOM-II trial enrolled 100 patients with de novo lesions in native coronary arteries presenting with either single long lesions (n=69) of > or =20 mm length or up to two lesions with a total cumulative anticipated stent length of 60 mm of stent (n=31). Patients were assessed angiographically at six months, and clinically at one year. Of the 100 patients enrolled, nine patients experienced a MACE, including five patients whose MACE occurred during index hospitalisation (two non-Q-MI, two Q-MI and one probable stent thrombosis-related death), and four target lesion revascularisations (TLR) at six months. No MACE or stent thrombosis was reported between six and 12 months follow-up. In-segment late loss at 6-months was 0.22 +/- 0.28 mm, and in-stent late loss had a range of 0.31 +/- 0.31 mm.
CONCLUSIONS
The XTENT customisable stent is clinically safe and efficacious as judged by angiographic and clinical variables through 12 months follow-up. Further follow-up and larger randomised comparative studies are needed for its clinical positioning.