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BELOW

THE
KNEE

Absorbable
Metal Stents
An update on the clinical data resulting from study of this innovative technology.
BY MARC BOSIERS, MD; KOEN DELOOSE, MD; JÜRGEN VERBIST, MD; AND PATRICK PEETERS, MD

P
ercutaneous coronary and peripheral vascular sented with an ulcerated lesion, three patients present-
intervention procedures frequently include ed with associated thrombi, and 14 calcified stenoses
implantation of permanent metal stents to were diagnosed. Prior to the infrapopliteal procedure,
minimize the risk of vessel recoil after balloon all inflow-limiting lesions above the knee were treated.
dilatation. Despite the positive initial impact of stent All lesions were first dilated, and AMS implantation was
placement on the success rate of percutaneous inter- only performed in cases of suboptimal angiographic
ventions, permanent metallic implants pose the risk of result after PTA (>30% residual stenosis, flow-limiting
a continuous interaction between nonabsorbable stents dissection, or intimal flap). In two cases, postdilatation
and surrounding tissue, leading to physical irritation, was performed. Procedural success was achieved in all
long-term endothelial dysfunction, or chronic inflam- 20 patients. A total of 23 AMS stents were implanted; in
matory reactions.1 three patients, two stents were implanted for longer or
Absorbable stents are currently discussed as a means tandem lesions.
to combine a midterm mechanical vessel support with The follow-up included blood analysis, clinical exami-
the advantage of having no long-term presence of the nation, and duplex at discharge, 1, 3, 6, 12, and 24
implant,2-6 which removes a potential trigger for late months. Duplex and occasional MR angiography con-
restenosis (Figure 1).7 The chance of having a tool that trols were able to demonstrate the gradual absorption
supports the vessel wall after percutaneous interven- process. The 24-month follow-up (Kaplan-Meier calcu-
tion procedures, while retaining a quasi-native vessel in lation) showed a primary patency rate of 73.3% and a
the long-term perspective, seems to be attractive. With limb salvage rate of 94.7%. This experience showed that
respect to the possible necessity of a bypass graft in the in the first-in-man below-the-knee use AMS implanta-
following years, the discontinued use of implanted tion resulted in safe procedures, with a good 2-year
stents is advisable. patency and limb salvage rate. Moreover, the AMS pro-
vided sufficient support and was absorbed producing
CLINICAL EXPERIENCE almost no artifact on MR imaging.
The first clinical experience with the Absorbable
Metal Stent (AMS; Biotronik GmbH & Co., Berlin, AMS Insight Study
Germany) was performed in the treatment of below- The next step in the clinical evaluation of AMS in
the-knee lesions.8-12 Twenty patients (10 male, 10 below-the-knee indications is the prospective, random-
female; mean age, 76 years) with cronic limb ischemia ized, international, and multicenter AMS Insight I study,
(CLI) and short, localized infrapopliteal disease under- which is being conducted in Europe and is currently
went AMS placement between December 2003 and finalizing patient inclusion. In the AMS Insight I study,
January 2004. The mean lesion length was 11 mm the effect of AMS implantation is compared to PTA in
(range, 2 mm to 20 mm), and the mean vessel diameter the treatment of infrapopliteal lesions in CLI patients.
was 2.7 mm (range, 2.5 mm to 3 mm), with a mean One hundred seventeen patients (Rutherford class 4
stenosis of 84% (range, 75% to 95%). One patient pre- and 5) will be enrolled in 15 international centers. The

JULY 2006 I ENDOVASCULAR TODAY I 63


COVER STORY

study primary endpoints are


the safety (1-month MACE
rate) and efficacy (6-month
patency rate) of the AMS com-
pared to optimal PTA. The
study is currently ongoing.
Clinical and duplex follow-up
will be performed at 1 day, 1, 6,
and 12 months, with a control
angiography planned at 6
months. Based on the same A B C
protocol, the US counterpart
of this trial, AMS Insight II, will Figure 1. Stent application (A), stent dilatation (B), and absorbtion of the system (C). After
start enrolling patients in fall 3 months, the whole system is absorbed.
2007. In total, 200 patients will
be enrolled in 20 clinical centers. reached at + 32 5225 28 22; marc.bosiers@telenet.be.
Koen Deloose, MD, is from the Department of Vascular
Progress-AMS Surgery, AZ St-Blasius, Dendermonde, Belgium. He has dis-
In addition to the investigations performed in the closed that he holds no financial interest in any product or
peripheral indication, the AMS has also been evaluated manufacturer mentioned herein. Dr. Deloose may be
for the coronaries. Progress-AMS was a prospective, reached at +32 5225 25 17; koen.deloose@telenet.be.
multicenter, consecutive, nonrandomized first-in-man Jürgen Verbist, MD, is from the Department of
(coronary) study to evaluate the clinical feasibility of the Cardiovascular and Thoracic Surgery, Imelda Hospital,
AMS in the treatment of a single de novo lesion in a Bonheiden, Belgium. He has disclosed that he holds no
native coronary artery. The study included 63 patients at financial interest in any product or manufacturer mentioned
eight international clinical sites. The first-in-man coro- herein. Dr. Verbist may be reached at +32 1550 61 97;
nary study showed that the application of the stents is jurgen.verbist@imelda.be.
feasible (high technical and procedural success); we have Patrick Peeters, MD, is from the Department of
seen no death, no myocardial infarction, and no stent Cardiovascular and Thoracic Surgery, Imelda Hospital,
thrombosis in the 63 patients. The study met the pri- Bonheiden, Belgium. He has disclosed that he holds no
mary endpoint (MACE <30%). Further improvement in financial interest in any product or manufacturer men-
stent design, coating, and combination with drug are the tioned herein. Dr. Peeters may be reached at +32 1550 61
focus of the present research and development efforts to 97; patrick.peeters@imelda.be.
further improve efficacy for coronary use.
1. Migliavacca F, Petrini L, Massarotti P, et al. Stainless and shape memory alloy coronary
stents: a computational study on the interaction with the vascular wall. Biomech Model
CONCLUSION Mechanobiol. 2004;2:205-217.
2. Inoue K, Abe K, Ando K, et al. Pathological analyses of long-term intracoronary Palmaz-
The AMS technology platform is proven and MRI/CT Schatz stenting: Is its efficacy permanent? Cardiovasc Pathol. 2004;13:109-115.
compatible, with absorption confirmed by IVUS during 3. Peuster M, Wohlsein P, Brugmann M, et al. A novel approach to temporary stenting:
degradable cardiovascular stents produced from corrodible metal—results 6-18 months after
follow-up. Future AMS projects are the development of a implantation into New Zealand white rabbits. Heart. 2001;86:563-569.
large balloon-expandable AMS for the treatment of 4. Tamai H, Igaki K, Kyo E, et al. Initial and 6-month results of biodegradable poly-l-lactic
acid coronary stents in humans. Circulation. 2000;102:399-404.
peripheral stenosis in large vessels. Even more appealing is 5. Tsuji T, Tamai H, Igaki K, et al. Biodegradable stents as a platform to drug loading. Int J
Cardiovasc Intervent. 2003;5:13-16.
the perspective to combine the advantages of AMS with 6. Tsuji T, Tamai H, Igaki K, et al. Biodegradable polymeric stents. Curr Interv Cardiol Rep.
local drug-eluting technology: this double approach can 2001;3:10-17.
7. Heublein B, Rohde R, Kaese V, et al. Biocorrosion of magnesium alloys: a new principle in
better address the overall patient clinical outcome cardiovascular implant technology? Heart. 2003;89:651-656.
because local drug therapy may optimize the results 8. Griffiths H, Peeters P, Verbist J, et al. Future device: bioabsorbable stents. Br J Cardiol.
2004;11:80-84.
obtained with mechanical treatment (ie, minimizing 9. Peeters P, Bosiers M, Verbist J, et al. Preliminary results after application of absorbable
inflammation, reducing cells’ proliferation, etc.). ■ metal stents in patients with critical limb ischemia. J Endovasc Ther. 2005;12:1-5.
10. Peeters P, Verbist J, Bosiers M, et al. 12 month result of biodegradable stents. Technicas
Endovasculares. 2005;8:1347.
Marc Bosiers, MD, is from the Department of Vascular 11. Bosiers M, Deloose K, Verbist J, et al. First clinical application of absorbable metal
stents in the treatment of critical limb ischemia: 12-month results. Vasc Dis Manage.
Surgery, AZ St-Blasius, Dendermonde, Belgium. He has dis- 2005;2:86-91.
12. Bosiers M, Deloose K, Verbist J, et al. Update on advantages and limitations of
closed that he holds no financial interest in any product or biodegradable (Biotronik) metal stents: are they better than PTA alone? 12-month results.
manufacturer mentioned herein. Dr. Bosiers may be Vascular. 2005;13:S35.

64 I ENDOVASCULAR TODAY I JULY 2006