The Lancet：一种全新药物洗脱支架的临床数据发布
Abbott公司在3月13日的爱思唯尔期刊《柳叶刀》（The Lancet）上发布了世界上首例完全生物可吸收的药物洗脱支架（drug eluting stent）-ABSORB的临床测试数据，这种支架一般用于冠状动脉疾病的治疗。针对30位病人为期1年的测试结果显示，该支架不会引起支架血栓症以及临床靶血管重塑（target lesion revascularization），并且严重心脏不良事件（MACE）的发生率也很低，仅为3.3%。这些研究结果与2007年10月报导的为期6个月的系统测试结果相一致。Abboot关于ABSORB的临床测试是为了全面评估这种支架5年期的安全性能。
鹿特丹Erasmus大学医院介入心脏病学教授Patrick W. Serruys是项目参与者之一，他表示：“针对冠状动脉疾病患者的为期一年的测试表明，Abbott的生物可吸收药物洗脱支架有很好的临床安全性。这些结果为发展可吸收支架平台提供了强大基础，并可能用于消除金属支架带来的某些限制，例如对血管成像以及重塑的影响。”
在6个月时，测试中的MACE发生率为3.3%（1位病人，n=30），而血管内腔直径减少为0.44mm。一年时，MACE发生率与6个月时一致，为3.3%。MACE是一种综合的评估，同时ABSORB在测试中表现出100%的程序成功率以及94%的装置成功率。新西兰奥克兰的奥克兰城市医院心脏病学家John A. Ormiston说：“病人和医生都希望得到在完成作用后自然吸收的支架。Abbott的可吸收支架能使血管张开足够长时间，以完成愈合。”
Abbott是唯一一家完成完全生物可吸收药物洗脱支架的临床测试的公司。该支架用聚乳酸制成，这是一种生物相容材料，被广泛用于医疗设备中。Abbott的可吸收支架可用于恢复阻塞冠状动脉的血流，并且为血管提供支持直到其愈合。与金属支架不同的是，这种支架能最终被身体吸收。
Abbott医疗设备部门执行副总裁John M. Capek表示：“这是科学创新引领心脏病治疗重大突破的最好例子，它能提高病人的生活质量。接下来我们将继续评估生物可吸收支架平台的安全性和效果。”（科学网 何宏辉/编译）
生物谷推荐原始出处：
（The Lancet），doi:10.1016/S0140-6736(08)60415-8，John A Ormiston, Susan Veldhof
A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial
John A Ormiston MBa, Prof Patrick W Serruys MDb, 
, 
, Evelyn Regar MDb, Dariusz Dudek MDc, Leif Thuesen MDd, Mark WI Webster MBa, Yoshinobu Onuma MDb, Hector M Garcia-Garcia MDe, Robert McGreevy PhDf and Susan Veldhof RNg
bThoraxcenter, Erasmus Medical Center, Rotterdam, Netherlands
cJagiellonian University, Krakow, Poland
dSkejby Sygehus, Aarhus University Hospital, Skejby, Denmark
eCardialysis BV, Rotterdam, Netherlands
fAbbott Vascular, Santa Clara, CA, USA
gAbbott Vascular, Diegem, Belgium
Summary
Background
A fully bioabsorbable drug-eluting coronary stent that scaffolds the vessel wall when needed and then disappears once the acute recoil and constrictive remodelling processes have subsided has theoretical advantages. The bioasorbable everolimus-eluting stent (BVS) has a backbone of poly-L-lactic acid that provides the support and a coating of poly-D,L-lactic acid that contains and controls the release of the antiproliferative agent everolimus. We assessed the feasibility and safety of this BVS stent.
Methods
In this prospective, open-label study we enrolled 30 patients who had either stable, unstable, or silent ischaemia and a single de-novo lesion that was suitable for treatment with a single 3·0×12 mm or 3·0×18 mm stent. Patients were enrolled from four academic hospitals in Auckland, Rotterdam, Krakow, and Skejby. The composite endpoint was cardiac death, myocardial infarction, and ischaemia-driven target lesion revascularisation. Angiographic endpoints were available for 26 patients and intravascular-ultrasound endpoints for 24 patients. Clinical endpoints were assessed in all 30 patients at 6 and 12 months. In a subset of 13 patients, optical coherence tomography was undertaken at baseline and follow-up. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00300131.
Findings
Procedural success was 100% (30/30 patients), and device success 94% (29/31 attempts at implantation of the stent). At 1 year, the rate of major adverse cardiac events was 3·3%, with only one patient having a non-Q wave myocardial infarction and no target lesion revascularisations. No late stent thromboses were recorded. At 6-month follow-up, the angiographic in-stent late loss was 0·44 (0·35) mm and was mainly due to a mild reduction of the stent area (−11·8%) as measured by intravascular ultrasound. The neointimal area was small (0·30 [SD 0·44] mm2), with a minimal area obstruction of 5·5%.
Interpretation
This study shows the feasibility of implantation of the bioabsorbable everolimus-eluting stent, with an acceptable in-stent late loss, minimal intrastent neointimal hyperplasia, and a low stent area obstruction.
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