Waksman Ron, Erbel Raimund, Di Mario Carlo, Bartunek Jozef, de Bruyne Bernard, Eberli Franz R, Erne Paul, Haude Michael, Horrigan Mark, Ilsley Charles, Böse Dirk, Bonnier Hans, Koolen Jacques, Lüscher Thomas F, Weissman Neil J
Division of Cardiology, Washington Hospital Center, Washington, DC 20010, USA.
JACC Cardiovasc Interv. 2009 Apr;2(4):312-20. doi: 10.1016/j.jcin.2008.09.015.
This study aimed to evaluate the degradation rate and long-term vascular responses to the absorbable metal stent (AMS).
The AMS demonstrated feasibility and safety at 4 months in human coronary arteries.
The PROGRESS-AMS (Clinical Performance and Angiographic Results of Coronary Stenting) was a prospective, multicenter clinical trial of 63 patients with coronary artery disease who underwent AMS implantation. Angiography and intravascular ultrasound (IVUS) were conducted immediately after AMS deployment and at 4 months. Eight patients who did not require repeat revascularization at 4 months underwent late angiographic and IVUS follow-up from 12 to 28 months.
The AMS was well-expanded upon deployment without immediate recoil. The major contributors for restenosis as detected by IVUS at 4 months were: decrease of external elastic membrane volume (42%), extra-stent neointima (13%), and intra-stent neointima (45%). From 4 months to late follow-up, paired IVUS analysis demonstrated complete stent degradation with durability of the 4-month IVUS indexes. The neointima was reduced by 3.6 +/- 5.2 mm(3), with an increase in the stent cross sectional area of 0.5 +/- 1.0 mm(2) (p = NS). The median in-stent minimal lumen diameter was increased from 1.87 to 2.17 mm at long-term follow-up. The median angiographic late loss was reduced from 0.62 to 0.40 mm by quantitative coronary angiography from 4 months to late follow-up.
Intravascular ultrasound imaging supports the safety profile of AMS with degradation at 4 months and maintains durability of the results without any early or late adverse findings. Slower degradation is warranted to provide sufficient radial force to improve long-term patency rates of the AMS.
本研究旨在评估可吸收金属支架（AMS）的降解速率及长期血管反应。
AMS在人体冠状动脉中4个月时显示出可行性和安全性。
PROGRESS-AMS（冠状动脉支架置入的临床性能和血管造影结果）是一项前瞻性、多中心临床试验，纳入63例接受AMS植入的冠心病患者。在AMS植入后即刻及4个月时进行血管造影和血管内超声（IVUS）检查。8例在4个月时无需再次血运重建的患者在12至28个月时接受了晚期血管造影和IVUS随访。
AMS植入后扩张良好，无即刻回缩。IVUS在4个月时检测到的再狭窄主要促成因素为：外弹力膜容积减少（42%）、支架外新生内膜（13%）和支架内新生内膜（45%）。从4个月至晚期随访，配对IVUS分析显示支架完全降解，4个月时IVUS指标具有耐久性。新生内膜减少3.6±5.2 mm³，支架横截面积增加0.5±1.0 mm²（p=无显著性差异）。长期随访时，支架内最小管腔直径中位数从1.87 mm增加至2.17 mm。通过定量冠状动脉造影，从4个月至晚期随访，血管造影晚期管腔丢失中位数从0.62 mm降至0.40 mm。
血管内超声成像支持AMS在4个月时降解的安全性，且结果具有耐久性，无任何早期或晚期不良发现。有必要减缓降解速度以提供足够的径向力，从而提高AMS的长期通畅率。
