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Acta Metall Sin  2017, Vol. 53 Issue (10): 1215-1226    DOI: 10.11900/0412.1961.2017.00258
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Advances in Clinical Research of Biodegradable Stents
Xiaonong ZHANG1(), Minchao ZUO1, Shaoxiang ZHANG2, Hongliu WU1, Wenhui WANG1, Wenzhi CHEN1, Jiahua NI1
1 School of Materials Science and Engineering, Shanghai Jiao Tong University, Shanghai 200240, China
2 Suzhou Origin Medical Technology Co. Ltd., Suzhou 215513, China
Cite this article: 

Xiaonong ZHANG, Minchao ZUO, Shaoxiang ZHANG, Hongliu WU, Wenhui WANG, Wenzhi CHEN, Jiahua NI. Advances in Clinical Research of Biodegradable Stents. Acta Metall Sin, 2017, 53(10): 1215-1226.

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Abstract  

Cardiovascular disease has become the first major disease that is harmful to people's health, vascular stents and other percutaneous coronary interventions are considered the most important and effective treatment technology of cardiovascular disease. In this review, the development about percutaneous coronary interventions was simply introduced, through comparing a series of randomized clinical trial data of bioabsorbable vascular stents developed by Abbott of the United States and absorbable magnesium stents developed by Biotronik of Germany, summarizing the shortcomings and analyzing trend in the future of absorbable stents.
Key words:  percutaneous coronary intervention      bioabsorbable vascular stent      absorbable magnesium stent      thrombosis      lumen loss     
Received:  30 June 2017     
ZTFLH:  TB31  
Fund: Supported by National Natural Science Foundation of China (No.51571142), National Key Research and Development Program of China (No.2016YFC1102403) and Shanghai Committee of Science and Technology, China (No.14441901801)
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Xiaonong ZHANG
Minchao ZUO
Shaoxiang ZHANG
Hongliu WU
Wenhui WANG
Wenzhi CHEN
Jiahua NI

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https://www.ams.org.cn/EN/10.11900/0412.1961.2017.00258     OR     https://www.ams.org.cn/EN/Y2017/V53/I10/1215

Fig.1  Development of percutaneous coronary intervention[3]
Fig.2  Structure comparison between Absorb BVS revision 1.0 and revision 1.1[29]
Device thrombosis 30 d 1 a
BVS 2.1% 2.4%
EES 0.3% 1.4%
BMS 1.0% 1.7%
Table 1  Comparison of device thrombosis among BVS/EES/BMS (n=290)[33]
Absorb AIDA BVS Co-Cr EES p
(n=924) (n=921)
TVF 11.7% 10.7% 0.43
Target-vessel MI 5.5% 3.2% 0.04
Cardiac death 2.0% 2.7% 0.43
TVR 8.7% 7.5% 0.37
Definite or probable 3.5% 0.9% <0.001
device thrombosis
Table 2  Clinical outcomes after 2 a follow-up of Absorb AIDA trial[34]
Absorb III Absorb Xience p
(n=1322) (n=686)
TLF 7.8% 6.1% pNI=0.007
Rate of cardiac death 0.6% 0.1% 0.29
Target vessel MI 6.0% 4.6% 0.18
ID-TLR 3.0% 2.5% 0.50
Stent thrombosis 1.5% 0.7% 0.13
Table 3  Clinical outcomes after 1 a follow-up of Absorb III trial[36]
Fig.3  Timing of Absorb bioabsorbable vascular stent reabsorption by OCT[3]
Fig.4  Absorbable magnesium stent before (a) and after (b) expansion[50]
Fig.5  Angiographic results of proximal right coronary artery before (a) and after (b) implantation of AMS[49]
Scaffold Strut material Coating Eluted drug Strut thickness Radio-opacity Radial support Resorption
material μm month month
AMS Mg alloy None None 165 None 2 <4
DREAMS-1G Mg alloy with PLGA Paclitaxel 125 None 3~6 9
rare metal
DREAMS-2G Mg alloy with PLLA Sirolimus 150 Tantalum 3~6 9
rare metal marker
Table 4  Parameters of absorbable magnesium scaffolds[3,49-51]
Fig.6  Angiography and intravascular ultrasound of proximal right coronary artery after post-procedure (a) and 4 months follow-up (b)[49]
Fig.7  Device functionality of drug-eluting absorbable magnesium scaffold over time[24]
Fig.8  Intracoronary ultrasonography findings after drug-eluting absorbable metal scaffold implantation and at 6 months and 12 months follow-up[50] (Δ means area change)
Trial Patient RVD / mm Length of lesion / mm Diameter stenosis
BIOSOLVE-I 46 3.0~3.5 <12 50%~99%
BIOSOLVE-II 123 2.2~3.7 <21 50%~99%
Table 5  Parameters of lesions in BIOSOLVE serial clinical trials[50,51]
Fig.9  Optical coherence tomographs of the second-generation drug-eluting absorbable metal scaffold after post-procedure (a) and 6 months (b)[51]
Fig.10  Comparisons of cumulative frequency curves for late lumen loss among absorbable magnesium scaffolds[51](a) in-segment late lumen loss(b) in-scaffold late lumen loss(c) in segment late lumen loss by comparison among 3 absorbable magnesium scaffolds(d) in scaffold late lumen loss by comparison among 3 absorbable magnesium scaffolds
Parameter AMS DREAMS-1G DREAMS-2G
Patient 63 46 123
Follow-up 4 months (n=63) 6 months (n=36) 12 months (n=34) 6 months (n=112)
In segment LLL / mm 0.83±0.51 0.52±0.48 0.39±0.33 0.27±0.37
In scaffold LLL / mm 1.08±0.49 0.65±0.50 0.52±0.39 0.44±0.36
In segment DS 49.66%±16.25% 29.02%±18.99% 25.31%±12.01% 25.9%±12.3%
In scaffold DS 48.37%±17.00% 25.01%±21.07% 20.92%±16.70% 22.6%±12.9%
In segment MLD / mm 1.34±0.49 1.84±0.52 1.96±0.43 2.55±0.41
In scaffold MLD / mm 1.38±0.51 1.95±0.59 2.06±0.47 2.59±0.40
TLF NA NA 7% 3%
Target vessel MI 0 NA 3% <1%
Clinically driven TLR 23.8% NA 4.3% 1.7%
Scaffold thrombosis 0 0 0 0
Table 6  Comparisons of clinical outcomes among absorbable magnesium scaffolds[49-51]
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