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Early- and Long-Term Intravascular Ultrasound and Angiographic Findings After Bioabsorbable Magnesium Stent Implantation in Human Coronary Arteries

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^_* on behalf of the PROGRESS-AMS (Clinical Performance Angiographic Results of Coronary Stenting with Absorbable Metal Stents) Investigators

^_* Division of Cardiology, Washington Hospital Center, Washington, DC
West-German Heart Center Essen, Department of Cardiology, Essen, Germany
Royal Brompton & Harefield NHS Trust, London, United Kingdom
Department of Cardiology, Cardiovascular Centre, Aalst, Belgium
^|| Division of Cardiology, University Hospital, Zurich, Switzerland
^¶ Cardiology Department, Kantonal Hospital, Lucerne, Switzerland
^# Department of Cardiology, Catharina Hospital, Eindhoven, Netherlands
^_** Cardiology Department, Austin and Repatriation Medical Centre, Victoria, Melbourne, Australia

^_* Reprint requests and correspondence: Dr. Ron Waksman, Washington Hospital Center, 110 Irving Street, Northwest, Suite 4B-1, Washington, DC 20010 (Email: ron.waksman{at}medstar.net).

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.

Key Words: bioabsorbable magnesium stent • intravascular ultrasound • neointima • recoil

Abbreviations and Acronyms   AMS = absorbable metal stent(s)   BMS = bare-metal stent(s)   CSA = cross sectional area   DES = drug-eluting stent(s)   DS = diameter stenosis   EEM = external elastic membrane   IVUS = intravascular ultrasound   LLL = late lumen loss   MLD = minimum lumen diameter