Author + information
- Received September 14, 2008
- Accepted September 29, 2008
- Published online April 1, 2009.
- Ron Waksman, MD⁎,⁎ (, )
- Raimund Erbel, MD†,
- Carlo Di Mario, MD‡,
- Jozef Bartunek, MD§,
- Bernard de Bruyne, MD§,
- Franz R. Eberli, MD∥,
- Paul Erne, MD¶,
- Michael Haude, MD, MS†,
- Mark Horrigan, MD⁎⁎,
- Charles Ilsley, MD‡,
- Dirk Böse, MD†,
- Hans Bonnier, MD#,
- Jacques Koolen, MD#,
- Thomas F. Lüscher, MD∥,
- Neil J. Weissman, MD⁎,
- PROGRESS-AMS (Clinical Performance Angiographic Results of Coronary Stenting with Absorbable Metal Stents) Investigators
- ↵⁎Reprint requests and correspondence:
Dr. Ron Waksman, Washington Hospital Center, 110 Irving Street, Northwest, Suite 4B-1, Washington, DC 20010
Objectives This study aimed to evaluate the degradation rate and long-term vascular responses to the absorbable metal stent (AMS).
Background The AMS demonstrated feasibility and safety at 4 months in human coronary arteries.
Methods 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.
Results 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 mm3, with an increase in the stent cross sectional area of 0.5 ± 1.0 mm2 (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.
Conclusions 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.
- Received September 14, 2008.
- Accepted September 29, 2008.
- American College of Cardiology Foundation